Registration or Approval of Facilities to Export Animal By-Products Not Intended for Human Consumption to the European Union (EU)

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TAHD-DSAT-2009-8-2
May 10, 2012

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

I. Purpose

The purpose of this document is:

  • to explain the European Union's (EU) import requirements for animal products and by-products destined for animal consumption or to be used outside the feed chain; and
  • to standardize Canadian Food Inspection Agency (CFIA) inspections of facilities in which these products are collected, processed, and stored.

This document does not cover:

  • facilities approved by Veterinary Biologics;
  • facilities approved by the Pet Food Program; and
  • finished products exported in final package form and ready for distribution to the end user that are exempt from Regulation (EC) No. 1069/2009.

II. Background

Regulation (EC) No. 1069/2009 - PDF (1,527 kb) of the European Parliament and of the Council lays down health rules as regards animal by-products and derived products not intended for human consumption and repeals Regulation (EC) No. 1774/2002 (Animal By-Products Regulation).

Regulation (EU) No. 142/2011 - PDF (7,933 kb) implements Regulation (EC) No. 1069/2009 of the European Parliament and of the Council lays down health rules as regards animal by-products and derived products not intended for human consumption and implements Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that directive.

The Regulations require that the CFIA register (Article 23 of Regulation [EC] No. 1069/2009) or approve (Article 24 of Regulation [EC] No. 1069/2009) facilities exporting animal by-products not intended for human consumption. To grant this registration or approval, the CFIA must consider various factors, such as the nature and origin of the raw materials, processing methods, the existence of own check programs, the nature of the processed materials, hygiene conditions, and product storage.

These animal by-products may only be imported into the EU from an eligible country and from a facility approved for export to the EU.

Prior to the CFIA's inspection of facilities, owners are required to submit to the CFIA, for examination, specific forms attesting that the facility meets the minimum requirements. The district office will conduct an inspection of the facilities after examining these forms.

Regulation (EC) No. 853/2004 - PDF (461 kb) of the European Parliament and of the Council of 29 April 2004 lays down specific hygiene rules for food of animal origin.

III. Definitions

The EU Regulation (EC) No. 1069/2009 classifies animal by-products into three categories, 1, 2, and 3, based on the risk that they pose to animal health. Apart from a few exceptions (which will be covered in specific directives), in general, only Category 3 animal by-products are eligible for export; however for some uses outside the feed chain, the EU accepts derived products from Category 1 or 2 material (e.g. rendered fats for biodiesel). Generally, products classified as Category 3 must meet a minimum criterion; that is, they must come from animals that were not condemned during ante-mortem inspection. To prevent the cross-contamination between by-products of different categories, this categorization extends to the facilities that collect, process, or store animal by-products, as well as to the means of transport and the personnel handling these products.

1. European definition of Categories 1, 2, and 3 animal by-products: See the directive, Definition of Categories 1, 2, and 3 Animal Products and By-Products According to the European Legislation (EC) No. 1069/2009.

2. Approved facility: In this document, this term applies to facilities that have received authorization from the CFIA to collect and/or process and/or store one or more animal by-products destined for export to the EU (e.g. hides and skins, blood, dairy products).

3. Intermediate plant: According to Article 19(b) of Regulation (EU) No. 142/2011, this terms applies to a plant in which intermediate operations (which generally do not change the health status of the material) are carried out on animal by-products after their collection, such as the following:

  1. sorting, cutting, chilling, freezing, sieving, salting or other preservative processes;
  2. removal of hides and skins or specified risk material; and
  3. operations involving the handling of animal by-products which are carried out in compliance with obligations under Union veterinary legislation.

4. Processing plant: This term applies to a plant in which raw material of animal origin is processed. In general, the health status of the material is changed after the processing (e.g. plant processing animal proteins, rendered fats, hides salted in brine solution, treated blood).

5. Storage plant: This term applies to a plant (other than an intermediary) in which raw material or processed products are temporarily stored before their processing, final use or disposal.

Note: A single facility may include an intermediate section, a processing section, as well as a storage section. In this case, the entire facility or only part of the facility may be approved (as an intermediate or processing or storage plant).

6. Nature of operations to be registered or approved: According to Article 24 of Regulation (EC) No. 1069/2009, operators shall ensure that establishments or plants under their control are approved by the competent authority, where such establishments or plants carry out one or more of the following activities (see paragraph 6.1); otherwise, registration as per paragraph 6.2 is required.

6.1 Approval:

  1. processing of animal by-products by pressure sterilisation, by processing methods (2 to 6) approved by the EU or by alternative methods authorised by the EU;
  2. use of animal by-products and derived products as fuel for combustion;
  3. manufacturing of pet food;
  4. manufacturing of organic fertilisers and soil improvers;
  5. transformation of animal by-products and/or derived products into biogas or compost;
  6. handling of animal by-products after their collection, by way of operations such as sorting, cutting, chilling, freezing, salting, removal of hides and skins or of specified risk material;
  7. storage of animal by-products; and
  8. storage of derived products intended to be used:
    1. as fuel for combustion,
    2. as feed, excluding establishments or plants approved or registered in accordance with Regulation (EC) No. 183/2005, or
    3. as organic fertilisers and soil improvers.

6.2 Registration:

  1. According to Article 23 of Regulation (EC) No. 1069/2009, operators shall act as follows:
    1. before commencing operations, notify the competent authority of any establishments or plants under their control which are active at any stage of the generation, transport, handling, processing, storage, placing on the market, distribution, use or disposal of animal by-products and derived products; and
    2. provide the competent authority with information on:
      1. the category of animal by-products or derived products under their control,
      2. the nature of the operations performed using animal by-products or derived products as starting material.
  2. Operators shall provide the competent authority with up-to-date information on any establishments or plants under their control as referred to in point (a) of paragraph 1, including any significant change in activities such as any closure of an existing establishment or plant.
  3. By way of derogation from paragraph 1, no notification with a view to registration shall be required for activities with respect to which establishments generating animal by-products have already been approved for the same commodity or registered in accordance with Regulation (EC) No. 852/2004 or Regulation (EC) No. 853/2004; and for activities with respect to which establishments or plants have already been approved in accordance with point 6.1 of this directive (e.g. taxidermists, establishment exporting pig bristles, treated feathers, or honey).

IV. Approval of Facilities to Export to the European Union

The general hygiene requirements (Article 25 of Regulation [EC] No. 1069/2009) are as follows:

1. Operators shall ensure that establishments or plants under their control carrying out the activities referred to in paragraph III 6.1 of this document:

  1. are constructed in a way that permits their effective cleaning and disinfection and where appropriate the construction of floors facilitates the draining of liquids;
  2. have access to adequate facilities for personal hygiene such as lavatories, changing rooms and washbasins for staff;
  3. have appropriate arrangements for protection against pests, such as insects, rodents and birds;
  4. keep installations and equipment in good condition and ensuring that measuring equipment is calibrated regularly; and
  5. have appropriate arrangements for the cleaning and the disinfection of containers and vehicles in place to avoid risks of contamination.

2. Any person working in the establishment or plant referred to in paragraph 1 shall wear suitable, clean and, where necessary, protective clothing.

Where appropriate in a particular establishment or plant:

  1. persons working in the unclean sector shall not enter the clean sector without first changing their work clothes and shoes or without having disinfected them;
  2. equipment and machinery shall not be moved from the unclean to the clean sector without first being cleaned and disinfected; and
  3. the operator shall establish a procedure relating to the movements of persons in order to monitor their movements and describe the correct use of footbaths and wheel baths.

3. In establishments or plants carrying out the activities referred to in paragraph III 6.1(a) of this document:

  1. animal by-products shall be handled in such a way as to avoid risks of contamination;
  2. animal by-products shall be processed as soon as possible. After processing, derived products shall be handled and stored in such a way as to avoid risks of contamination;
  3. where appropriate, during any processing applied to animal by-products and derived products every part of the animal by-product and derived products shall be treated to a given temperature for a given period of time and risks of re-contamination shall be prevented;
  4. the operators shall check regularly the applicable parameters, particularly temperature, pressure, time, size of particles, where appropriate by automatic devices; and
  5. cleaning procedures shall be established and documented for all parts of the establishments or plants.

IV.a Requirements for Intermediate Plants

(Annex IX, Chapter II, Sections 1, 2 of Regulation [EU] No. 142/2011)

General Requirements

1. Premises and facilities where intermediate operations are carried out shall meet at least the following requirements:

  1. They must be adequately separated from thoroughfares through which contamination may be spread and from other premises such as slaughterhouses. The layout of plants shall ensure the total separation of Category 1 and Category 2 material from Category 3 material respectively, from reception until dispatch, unless in a completely separate building.
  2. The plant must have a covered space to receive and dispatch animal by-products, unless the animal by-products are being discharged through installations which prevent the spreading of risks to public and animal health, such as through closed tubes for liquid animal by-products.
  3. The plant must be constructed in such a way that it is easy to clean and disinfect. Floors must be laid down in such a way as to facilitate the draining of liquids.
  4. The plant must have adequate facilities including lavatories, changing rooms, washbasins for staff and, if appropriate, office space which can be made available to the staff performing official controls.
  5. The plant must have appropriate arrangements for protection against pests, such as insects, rodents and birds.
  6. Where it is necessary for the purpose of achieving the objectives of this Regulation, plants must have suitable temperature-controlled storage facilities of sufficient capacity for maintaining animal by-products at appropriate temperatures and designed to allow the monitoring and recording of those temperatures.

2. The plant shall be equipped with adequate facilities for cleaning and disinfecting the containers or receptacles in which animal by-products are received and for the vehicles, other than ships, in which they are transported. Adequate facilities shall be available for the disinfecting of vehicle wheels.

Hygiene Requirements

1. The sorting of animal by-products shall be carried out in such a way as to avoid any risk of the propagation of animal diseases.

2. At all times during storage, animal by-products shall be handled and stored separately from other goods and in such a way as to prevent any propagation of pathogens.

3. Animal by-products shall be stored properly, including under appropriate temperature conditions, until re-dispatched.

IV.b Requirements for Storage Plants

(Annex IX, Chapter III, Sections 1, 2 of Regulation [EU] No. 142/2011)

General Requirements

1. Premises and facilities storing derived products from Category 3 material must not be at the same site as premises storing derived products from Category 1 or Category 2 material, unless cross-contamination is prevented due to the layout and management of the premises, such as by means of storage in completely separate buildings.

2. The plant must:

  1. have a covered space to receive and dispatch the derived products, unless the derived products are:
    1. being discharged through installations which prevent the spreading of risks to public and animal health, such as through closed tubes for liquid products, or
    2. received in packaging, such as in big bags, or in covered leak-proof containers or means of transport;
  2. be constructed in such a way that it is easy to clean and disinfect, with floors laid down in such a way as to facilitate the draining of liquids;
  3. have adequate facilities including lavatories, changing rooms and washbasins for staff; and
  4. have appropriate arrangements for protection against pests, such as insects, rodents and birds.

3. The plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which the derived products are received and the vehicles, other than ships, in which they are transported.

4. Derived products must be stored properly until redispatched.

Specific Requirements for Storage of Certain Milk, Milk-Based Products and Milk-Derived Products

1. The storage of the products referred to in Part II of Section 4 of Chapter II of Annex X shall take place at an appropriate temperature to avoid any risk to public or animal health in a dedicated approved or registered storage establishment or plant or in a dedicated, separate storage area within an approved or registered storage establishment or plant.

2. Samples of the final products taken during storage or at the time of withdrawal from storage, shall at least comply with the microbiological standards set out in Chapter I of Annex X.

IV.c Requirements for Processing Plants

(Annex IV, Chapter I, Sections 1, 3 and 4 of Regulation [EU] No. 142/2011)

General Conditions

1. Processing plants shall meet the following requirements, for processing by pressure sterilisation or in accordance with the processing methods referred to in Article 15(1)(b) of Regulation (EC) No. 1069/2009:

  1. Processing plants must not be situated on the same site as slaughterhouses or other establishments which have been approved or registered in accordance with Regulation (EC) No. 852/2004 or Regulation (EC) No. 853/2004, unless the risks to public and animal health resulting from the processing of animal by-products, which originate from such slaughterhouses or other establishments, are mitigated by compliance with at least the following conditions:

    1. The processing plant must be physically separated from the slaughterhouse or other establishment, where appropriate by locating the processing plant in a building that is completely separated from the slaughterhouse or other establishment.
    2. The following must be installed and operated in the processing plant:
      • a conveyer system which links the processing plant to the slaughterhouse or other establishment and which may not be by-passed; and
      • separate entrances, reception bays, equipment and exits for both the processing plant and the slaughterhouse or establishment.
    3. Measures must be taken to prevent the spreading of risks through the operation of personnel which is employed in the processing plant and in the slaughterhouse or other establishment.
    4. Unauthorised persons and animals must not have access to the processing plant.

    By way of derogation from points (i) to (iv), in the case of processing plants processing Category 3 material, the competent authority may authorise other conditions instead of those set out in those points, aimed at mitigating the risks to public and animal health, including the risks arising from the processing of Category 3 material, which originates from off-site establishments approved or registered in accordance with Regulation (EC) No. 852/2004 or Regulation (EC) No. 853/2004.

  2. The processing plant must have a clean and unclean sector, adequately separated. The unclean sector must have a covered place to receive animal by-products and must be constructed in such a way that it is easy to clean and disinfect. Floors must be laid in such a way as to facilitate the draining of liquids.
  3. The processing plant must have adequate facilities including lavatories, changing rooms and washbasins for staff.
  4. The processing plant must have sufficient production capacity for hot water and steam for the processing of animal by-products (e.g. Processed animal proteins and rendered fats, hides in brine solution).
  5. The unclean sector must, if appropriate, contain equipment to reduce the size of animal by-products and equipment for loading the crushed animal by-products into the processing unit (e.g. Processed animal proteins and rendered fats).
  6. Where heat treatment is required, all installations must be equipped with:
    1. measuring equipment to monitor temperature against time and, if applicable for the processing method used, pressure at critical points;
    2. recording devices to record continuously the results of these measurements in a way so that they remain accessible for the purpose of checks and official controls; and
    3. an adequate safety system to prevent insufficient heating.
  7. To prevent recontamination of the derived product by the introduction of animal by-products, there must be a clear separation between the area of the plant where incoming material for processing is unloaded and the areas set aside for the processing of that product and the storage of the derived product.

2. The processing plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which animal by-products are received and the means of transport, other than ships, in which they are transported.

3. Adequate facilities must be provided for the disinfecting of vehicle wheels and the other parts of the vehicle, as appropriate, on leaving the unclean sector of the processing plant.

4. All processing plants must have a waste-water disposal system meeting the requirements set out by the competent authority in accordance with Union legislation.

5. The processing plant must have its own laboratory or make use of the services of an external laboratory for the routine exams.

6. If on the basis of a risk assessment, the volume of products treated requires the regular or permanent presence of the competent authority, the processing plants must have an adequately equipped lockable room for the exclusive use of the inspection service.

Specific Requirements for the Processing of Category 1 and Category 2 Materials

The layout of processing plants processing Category 1 and Category 2 materials must ensure the total separation of Category 1 material from Category 2 material from reception of the raw material until dispatch of the resulting derived product, unless a mixture of Category 1 material and Category 2 material is processed as Category 1 material.

Specific Requirements for the Processing of Category 3 Materials

The following requirements shall apply in addition to the general conditions set out above:

1. Processing plants processing Category 3 materials shall not be located at the same site as processing plants processing Category 1 or Category 2 materials, unless located in a completely separate building.

2. However, the competent authority may authorise the processing of Category 3 material on a site where handling or processing of Category 1 or Category 2 material takes place, if cross-contamination is prevented due to:

  1. the layout of the premises, in particular the arrangements for the reception, and by way of the further handling of raw materials;
  2. the layout and the management of the equipment used for processing, including the layout and the management of separate processing lines or of cleaning procedures which are excluding the propagation of any possible risks to public and animal health; and
  3. the layout and the management of the areas for the temporary storage of the end products.

3. Processing plants processing Category 3 material shall have in place an installation to check the presence of foreign bodies, such as packaging material or metallic pieces, in the animal by-products or derived products, if they are processing materials which are destined for feeding. Such foreign bodies shall be removed before or during processing.

IV.d Hygiene and Processing Requirements

(Annex IV, Chapter II, Sections 1, 2, 3 and 4 of Regulation (EU) No. 142/2011)

(e.g. Processed animal proteins and rendered fats)

General Hygiene Requirements

In addition to the general hygiene requirements provided for in Article 25 of Regulation (EC) No. 1069/2009, processing plants shall have a documented pest control programme in place for the implementation of the arrangements for protection against pests, such as insects, rodents and birds, referred to in Article 25(1)(c) of that Regulation.

General Processing Requirements

1. Accurately calibrated gauges/recorders must be used to monitor continuously the processing conditions. Records must be kept to show the date of calibration of gauges/recorders.

2. Material that may not have received the specified heat treatment, such as material discharged at start up or leakage from cookers, must be recirculated through the heat treatment or collected and reprocessed or disposed of in accordance with Regulation (EC) No. 1069/2009.

Processing Methods for Category 1 and Category 2 Material

Unless the competent authority requires the application of pressure sterilisation (method 1), Category 1 and Category 2 material shall be processed in accordance with processing methods 2, 3, 4 or 5 as referred to in Chapter III of Annex IV of Regulation (EC) No. 142/2011.

Processing of Category 3 Material

1. The critical control points that determine the extent of the heat treatments applied in processing shall include for each processing method as specified in Chapter III of Annex IV of Regulation (EU) No. 142/2011, the following:

  1. raw material particle size;
  2. temperature achieved in the heat treatment process;
  3. pressure, if applied to the raw material; and
  4. duration of the heat treatment process or feed rate to a continuous system. Minimum processing standards must be specified for each applicable critical control point.

2. In the case of chemical treatments which have been authorised by the competent authority as processing method 7 in accordance with point G of Chapter III of Annex IV of Regulation (EU) No. 142/2011, the critical control points that determine the extent of the chemical treatments applied shall include the pH adjustment achieved.

3. Records shall be maintained for at least two years to show that the minimum process values for each critical control point are applied.

4. Category 3 material shall be processed in accordance with any of the processing methods 1 to 5 or processing method 7, or, in the case of material originating from aquatic animals, with any of the processing methods 1 to 7, as referred to in Chapter III of Annex IV of Regulation (EU) No. 142/2011.

IV.e Supervision of Production

(Annex XVI, Chapter I, Section 1 of Regulation [EU] No. 142/2011)

(e.g. Processed animal proteins and rendered fats, salted hides and treated blood)

1.The competent authority shall supervise processing plants to ensure compliance with the requirements of Regulation (EC) No. 1069/2009 and with Regulation (EC) No. 142/2011. It shall, in particular:

  1. check:
    1. the general conditions of hygiene of the premises, equipment and staff,
    2. the efficacy of the own checks carried out by the operator of the processing plant, in accordance with Article 28 of Regulation (EC) No. 1069/2009; such checks must include an examination of the results of those checks and if necessary, the taking of samples,
    3. the effective implementation of the permanent written procedure based on the HACCP principles in accordance with Article 29(1) of Regulation (EC) No. 1069/2009; such checks must include an examination of the results of this implementation and if necessary, the taking of samples,
    4. the standards of the products after processing; the analyses and tests must be carried out in accordance with scientifically recognised methods, in particular, those laid down in Union legislation or, where no such methods are laid down in Union legislation, in accordance with recognised international standards or, in their absence, national standards, and
    5. the storage conditions;
  2. take any samples required for laboratory tests; and
  3. make any other checks it considers necessary to ensure compliance with Regulation (EC) No. 1069/2009 and with Regulation (EU) No. 142/2011.

2. To allow it to carry out its responsibilities under point 1, the competent authority must have free access at all times to all parts of the processing plant and to records, commercial documents and health certificates.

IV.f Validation Procedures

(Annex XVI, Chapter I, Section 2 of Regulation [EU] No. 142/2011)

(e.g. Processed animal protein and rendered fats)

1. Prior to issuing an approval for a processing plant, the competent authority must check that a validation of the processing plant has been carried out by the operator in accordance with the following procedures and indicators:

  1. a description of the process by a process flow diagram;
  2. an identification of critical control points (CCPs) including the material process rate for continuous systems;
  3. the compliance with the specific process requirements laid down by this Regulation; and
  4. the achievement of the following requirements:
    1. particle size for batch-pressure and continuous processes, defined by the mincer hole or the anvil gap size, and
    2. temperature, pressure, processing time and, in the case of continuous processing systems, the material processing rate, as specified in points 2 and 3.

2. In the case of a batch pressure system:

  1. the temperature must be monitored with a permanent thermocouple and it must be plotted against real time;
  2. the pressure stage must be monitored with a permanent pressure gauge; pressure must be plotted against real time; and
  3. the processing time must be shown by time/temperature and time/pressure diagrams.

At least once a year the thermocouple and the pressure gauge must be calibrated.

3. In the case of a continuous pressure system:

  1. the temperature and the pressure must be monitored with thermocouples, or an infrared temperature gun, and pressure gauges must be used at defined positions throughout the process system in such a way that temperature and pressure comply with the required conditions inside the whole continuous system or in a section of it; the temperature and pressure must be plotted against real time; and
  2. measurement of the minimum transit time inside the whole relevant part of the continuous system where the temperature and pressure comply with the required conditions, must be provided to the competent authorities, using insoluble markers, such as manganese dioxide, or a method which offers equivalent guarantees.

    Accurate measurement and control of the material process rate is essential and must be measured during the validation test in relation to a CCP that can be continuously monitored such as:

    1. feed screw revolutions per minute (rev./min.);
    2. the electric power (amps at given voltage);
    3. the evaporation/condensation rate; or
    4. the number of pump strokes per unit time.

    All measuring and monitoring equipment must be calibrated at least once a year.

4. The competent authority must repeat the checks on the validation procedures when it considers it necessary, and in any case each time any significant alterations are made to the process, such as modifications of the machinery or changes of raw materials.

IV.g Own Checks and Hazard Analysis and Critical Control Points

(Articles 28 and 29 of Regulation [EC] No. 1069/2009)

Plant's Own Check

Operators shall put in place, implement and maintain own checks in their establishments or plants in order to monitor compliance with this Regulation. They shall ensure that no animal by-products or derived products suspected or discovered not to comply with this Regulation are exported to the EU.

Hazard Analysis and Critical Control Points (HACCP)

1. Operators carrying out one of the following activities shall put in place, implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (HACCP) principles for the:

  1. processing of animal by-products;
  2. transformation of animal by-products into biogas and compost;
  3. handling and storage of more than one category of animal by-products or derived products in the same establishment or plant; and
  4. manufacturing of pet food.

2. Operators as specified in paragraph 1 shall in particular:

  1. identify any hazards that must be prevented, eliminated or reduced to acceptable levels;
  2. identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels;
  3. establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards;
  4. establish and implement effective monitoring procedures at critical control points;
  5. establish corrective action when monitoring indicates that a critical control point is not under control;
  6. establish procedures to verify that the measures outlined in points (a) to (e) are complete and working effectively. Verification procedures shall be carried out regularly; and
  7. establish documents and records commensurate with the nature and size of the businesses to demonstrate the effective application of the measures set out in points (a) to (f).

3. When any modification is made to a product, process or any stage of production, processing, storage or distribution, operators shall review their procedures and make the necessary changes.

V. Hygiene Requirements for the Collection and Transport of Animal By-Products and Derived Products

Article 21 of Regulation (EC) No. 1069/2009 stipulates the following:

  1. Operators shall collect, identify and transport animal by-products without undue delay under conditions which prevent risks arising to public and animal health.
  2. Operators shall ensure that animal by-products and derived products are accompanied during transport by a commercial document, a traceability certificate or, when required, by a sanitary certificate.
  3. Commercial documents and sanitary certificates accompanying animal by-products or derived products during transport shall at least include information on the origin, the destination and the quantity of such products, and a description of the animal by-products or derived products and their marking, when such marking is required.

    However, for animal by-products and derived products transported within the territory of a third country, the competent authority of this country may authorise transmission of the information referred to in the first subparagraph by way of an alternative system.

Annex VIII of Regulation (EU) No. 142/2011 provides the requirements for the collection and transport of animal by-products and derived products.

V.a Vehicles and Containers

1. Animal by-products and derived products must be collected and transported in sealed new packaging, or covered leak-proof containers or vehicles.

2. Vehicles and reusable containers, and all reusable items of equipment or appliances that come into contact with animal by-products or derived products, must be maintained in a clean condition.

In particular, unless they are dedicated to the carriage of particular animal by-products or derived products in a way which avoids cross-contamination, they must be:

  1. clean and dry before use; and
  2. cleaned, washed, and/or disinfected after each use to the extent necessary to avoid cross-contamination.

3. Reusable containers must be dedicated to the transport of a particular animal by-product or derived product to the extent necessary to avoid cross-contamination.

However, reusable containers may be used, provided the competent authority has authorised such use:

  1. for the carriage of different animal by-products or derived products provided that they are cleaned and disinfected between the different uses in a manner which prevents cross-contamination; and
  2. for the carriage of products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise, following their use for the carriage of products intended for human consumption, under conditions which prevent cross-contamination.

V.b Temperature Conditions

1. The transport of animal by-products destined for the production of feed material or raw pet food must take place at an appropriate temperature, in the case of animal by-products from meat and meat products which have been destined for purposes other than human consumption, at a maximum of 7°C.

2. Unprocessed Category 3 material destined for the production of feed material or pet food must be stored and transported chilled, frozen or ensiled, unless:

  1. it is processed within 24 hours after collection or after the end of storage in chilled or frozen form, if the subsequent transport takes place in means of transport in which the storage temperature is maintained; and
  2. in the case of milk, milk-based products or milk-derived products which have not been subject to any of the treatments (pasteurization, sterilization, Ultra High Temperature treatment [UHT], High Temperature Short Time pasteurisation [HTST]) referred to in Part I of Section 4 of Chapter II of Annex X, it is transported chilled and in insulated containers, unless risks can be mitigated by other measures, due to the characteristics of the material.

3. The design of vehicles used for refrigerated transport must ensure the maintenance of an appropriate temperature throughout transport, and allow that temperature to be monitored.

V.c Identification

1. All necessary measures must be taken to ensure that:

  1. consignments of animal by-products and derived products are identifiable and kept separate and identifiable during collection where the animal by-products originate and during transportation.

V.d Traceability and Records

Article 22 of Regulation (EC) No. 1069/2009 and Chapter IV of Annex VIII of Regulation (EU) No. 142/2011 state as follows:

  1. Operators consigning, transporting or receiving animal by-products or derived products shall keep a record of consignments and related commercial documents or sanitary certificates.
  2. The operators referred to in paragraph 1 shall have in place systems and procedures to identify:
    1. the other operators to which their animal by-products or derived products have been supplied; and
    2. the operators from whom they have been supplied.

This information shall be made available to the competent authorities on request.

Chapter III of Annex VIII of Regulation (EU) No. 142/2011 provides the following requirements:

  1. During transportation, a commercial document, or a traceability or sanitary certificate, must accompany animal by-products and derived products.
  2. The commercial document (issued by the operator), the traceability or sanitary certificate (issued by the CFIA) must be produced at least in triplicate (one original and two copies). The original must accompany the consignment to its final destination. The receiver must retain it. The producer must retain one of the copies and the carrier the other. However the CFIA may authorize that animal by-products and derived products which are transported on its territory are accompanied by the following:
    1. a different commercial document, in paper or in electronic form, provided that such commercial document contains the information referred to in point 4 below; and
    2. a commercial document in which the quantity of the material is expressed in weight or volume of the material or in the number of packages.
  3. Records and related commercial documents, or the traceability or sanitary certificate, shall be kept for a period of at least two years for presentation to the competent authority.
  4. Commercial document, traceability or sanitary certificate contents:
    1. The commercial document, traceability or sanitary certificate must specify:
      1. the date on which the material was taken from the premises;
      2. the description of the material, including the following:
        • the identification of the material according to one of the three categories,
        • the animal species and the nature of the material; and
      3. the quantity of the material, in volume, weight or number of packages;
      4. the place of origin of the material, from where the material is dispatched;
      5. the name and the address of the carrier of the material;
      6. the name and the address of the receiver and, if applicable, its approval or registration number; and
      7. if appropriate, the approval or registration number of the establishment or plant of origin, and the nature and the methods of the treatment.
    2. The original of the accompanying document must be completed and signed by the responsible person (operator for the commercial document or the veterinarian for the traceability or sanitary certificate).
    3. The colour of the signature of the responsible person shall be different to that of the printing.
    4. The document reference number shall only be issued once for the same consignment.

VI. Registration of Facilities to Export to the European Union

Annex IX, Chapter IV of Regulation (EU) No. 142/2011 stipulates the following:

  1. Operators of registered plants or establishments or other registered operators shall handle animal by-products and derived products under the following conditions:
    1. premises must be constructed in a way permitting their effective cleaning and disinfection, where appropriate;
    2. premises must have appropriate arrangements for protection against pests, such as insects, rodents and birds;
    3. installations and equipment must be kept in hygienic condition, where necessary; and
    4. animal by-products and derived products must be stored under conditions preventing contamination.
  2. Operators shall keep records in a form which is accessible to the competent authority.
  3. Registered operators transporting animal by-products or derived products other than between premises of the same operator shall, in particular:
    1. have information at their disposal with regard to the identification of their vehicles, which allows the verification of the use of the vehicles for the transport of animal by-products or derived products;
    2. clean and disinfect their vehicles, as appropriate; and
    3. take all other necessary measures to prevent contamination and the spreading of diseases communicable to humans or animals.

VII. Official Control and Final Provisions

VII.a Procedure for Approval

Article 44 of Regulation (EC) No. 1069/2009 states as follows:

  1. The competent authority shall approve establishments or plants only where an on-site visit, prior to start-up of any activity, has demonstrated that they meet the relevant requirements laid down in this Regulation.
  2. The competent authority may grant conditional approval if it appears, from the on-site visit, that the establishment or plant meets all the infrastructure and equipment requirements with a view to ensuring the application of the operational procedures in compliance this Regulation. It shall grant full approval only if it appears, from another on-site visit carried out within three months of granting conditional approval, that the establishment or plant meets the other requirements referred to in paragraph 1. If clear progress has been made, but the establishment or plant still does not meet all of these requirements, the competent authority may extend conditional approval. However, conditional approval shall not exceed a total of six months.
  3. Operators shall ensure that an establishment or plant ceases to operate if the competent authority withdraws its approval or in the case of conditional approval fails to extend it or to grant full approval.

VII.b Official Control

Article 45 of Regulation (EC) No. 1069/2009 and Article 32 of Regulation (EU) No. 142/2011 state as follows:

  1. The competent authority shall take the necessary measures to control the entire chain of collection, transport, use and disposal of animal by-products and derived products.
  2. The competent authority shall at regular intervals carry out official controls and supervision of the handling of animal by-products and derived products falling within the scope of Regulation (EC) No. 1069/2009.
  3. The official controls shall include checks on the keeping of records and other documents required by the rules laid down in Regulation (EU) No. 142/2011.
  4. The competent authority shall carry out the following official controls:
    1. official controls in processing plants; and
    2. official controls of other activities which involve the handling of animal by-products, and derived products.
  5. The competent authority shall carry out checks on seals which are applied to consignments of animal by-products or derived products.

    When the competent authority applies a seal to such consignment which is transported to a place of destination, it must inform the competent authority of the place of destination.

VII.c Suspensions, Withdrawals and Prohibitions on Operations

Article 46 of Regulation (EC) No. 1069/2009 states as follows:

  1. If the official controls and supervision carried out by the competent authority reveal that one or more of the requirements of this Regulation are not met, it shall take appropriate action.

    The competent authority shall in particular, as appropriate to the nature and to the gravity of the deficiencies and to the potential risks for public and animal health:

    1. suspend approvals of establishments or plants approved pursuant to this Regulation, if:
      1. the conditions for approving or operating the establishment or plant are no longer fulfilled;
      2. the operator can be expected to remedy the deficiencies within a reasonable period of time; and
      3. the potential risks to public and animal health do not require action in accordance with point (b);
    2. withdraw approvals of establishments or plants approved pursuant to this Regulation, if:
      1. the conditions for approving or operating the establishment or plant are no longer fulfilled; and
      2. the operator cannot be expected to remedy the deficiencies within a reasonable period of time:
        • for reasons relating to the infrastructure of the establishment or plant,
        • for reasons relating to the personal capacity of the operator or the staff under his supervision, or
        • because of serious risks to public and animal health requiring major adjustments to the operation of the establishment or plant before the operator may apply for re-approval; and
    3. impose specific conditions on establishments or plants in order to rectify existing deficiencies.
  2. The competent authority shall, as appropriate to the nature and to the gravity of the deficiencies and to the potential risks for public and animal health, temporarily or permanently prohibit operators referred to in paragraph III 6 of this directive from carrying out operations under Regulation (EC) No. 1069/2009, as appropriate, following receipt of information indicating:
    1. that the requirements of the EU are not met; and
    2. potential risks to public or animal health arising from such operations.

VIII. Pre-Inspection Procedures

Before scheduling the inspection, the district office must send all the necessary documents to the facility's management, including the following:

  1. A form to be certified by a commissioner for oaths concerning the nature and origin of the processors' raw materials. In a few cases, a blanket statement regarding the source of raw materials can be included in the notarized processing method document (e.g. a taxidermist may state that raw materials are sourced from other approved plants, but that receiving records are maintained).
  2. A form to be certified by a commissioner for oaths regarding the processing method used. This form also requires that the facility attest to the application of an own check program, ensuring compliance with the required critical limits.

Prior to inspection by the CFIA, management of the facility must complete and submit the following documents to the district office.

Prior to inspection of the facility, the district office must confirm that the requisite forms have been submitted and that they meet all the requirements. All the forms must be certified by a commissioner for oaths. The certified forms must also indicate the signatory's position within the company, and said position should be such that the signatory may be expected to be aware of the information contained in the form certified by a commissioner for oaths. These documents must be updated (signed and submitted to the district office) annually.

IX. Inspection Procedures

Prior to arrival at the facility, the inspector must review the forms submitted to the district office, as well as the inspection checklist.

The inspection must begin in the facility management's office. The inspector must then review the requisite forms and the facility's own check program with management.

The inspector may then review, with the facility's guide, the appropriate checklist for each type of animal product or by-product, entitled Appendix C: CFIA Plant Inspection Checklist for Approval of Facilities to Export Animal By-Products to the European Union. This checklist provides the questions that require answering during the tour. The guide must then take the inspector on a tour of the facility, taking care to cover each point on the checklist. At the end of the tour, the inspector must ask the guide to return to any areas that require re-checking or that will provide supporting evidence for any unanswered questions.

During the inspection, the inspector must consider the information already reviewed in the forms provided, which are certified by a commissioner for oaths, as well as the own check plan, and be vigilant in identifying any inaccuracies.

X. Billing for Inspections

Facility approval inspections for export of animal by-products to the EU will be billed according to the CFIA Fees Notice, Part II, Item 27: $30 for each inspection (code 1483).

XI. Inspection Reports

A copy of the duly completed inspection form and all requisite forms, certified by a commissioner for oaths, must be sent to the CFIA Area network export specialist for approval.

Where an item of the Appendix C is not applicable, give all the explanations.

Where an Appendix C is not applicable (registration of taxidermists), a Form CFIA/ACIA 1520 – Report of Inspector should be completed, with a recommendation whether to approve the premises.

The documents for submission are indicated in the checklist. The form must be completed legibly. If notes taken during the inspection are illegible, the inspection form must be typed or completed again in legible block letters. A copy of the inspection documents must be kept at the district office.

The facility will not be approved to export to the EU until the Area network export specialist has reviewed the inspection results and provided approval. Once the approval is given, the eligibility of the production for export begins the date of recommendation for approval.

An export certificate must not be issues before the facility is registered in the TRAde Control and Expert System (TRACES).

XII. Approval Numbers

Facility approval numbers are issued by headquarters. The Area network export specialist will send the appropriate information (name, address of facility, and approval date) by email to Janet Goodall. A central list of approved facilities will be maintained and made available by headquarters.

The district office must not sign certificates for export to the EU unless the facility approval number is identical to the number on the list of approved facilities.

XIII. Facility Name or Address Changes

Facilities must notify the district office of changes to names or mailing addresses. This notification should be sent to the Area network export specialist, who will send the information by email to Janet Goodall for an amendment to the list. If a facility's physical address changes, the new facility will require an inspection.

Appendix A: Notarized Approved Supplier Form

To be used for product for which no directive has been written and which does not have a specific appendix

This serves to inform Canadian Food Inspection Agency (CFIA) officials that the establishment (name and full address)

space

space

only receives animal by-products:

checkbox of Category 1

checkbox of Category 2

checkbox of Category 3

not intended for human consumption according to the European Union legislation (EU) and from the following facilities:
Facility Name City (Country) CFIA Facility Approval Date

Origin of Category 3 Raw Animal By-Products: federally inspected abattoirs; provincially inspected abattoirs with a full-time veterinarian; or an EU-eligible plant from a third country.*

* The company provides certification from the competent authority of the third country, attesting to the category of the material.

I certify that I understand the European Union definition of "Category 1, 2, and 3 materials" as defined in Regulation (EC) No. 1069/2009, and that the statements above are true. I agree to inform the CFIA immediately if any changes are made to the above information.

Signed by: space

Position: space

Notary seal and Signature: space

Date: space

Appendix B: Notarized Processing Method Form for Animal By-Product Processing Facilities

To be used for product for which no directive has been written and which does not have a specific appendix

This serves to inform Canadian Food Inspection Agency (CFIA) officials that the establishment (name and full address)

space

space

processes the following animal by-products space

space

from the following species space

using the processing method noted below or attached, and has in place a self-inspection program with the critical limits referenced.

Comments: space

space

I certify that the statements above are true to the best of my knowledge and belief. I agree to notify the CFIA immediately if the above information changes or if the critical limits for processing material destined to the European Union (EU) are not met. I am aware that to maintain my EU approval status, I must be re-inspected at least once per year by the CFIA and that I am responsible for arranging this inspection prior to the expiration of my one-year validity period.

Signed by: space

Position: space

Notary seal and Signature: space

Date: space

Appendix C: CFIA Plant Inspection Checklist for Approval of Facilities to Export Animal By-Products to the European Union

To be used for product for which no directive has been written and which does not have a specific appendix

1. Canadian Food Inspection Agency (CFIA) Approval Number: space
(For newly inspected facilities, leave blank.)

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 name at plant: space

Telephone: space Facsimile: space

6. Please list animal by-products, species of origin produced at this plant for export to the EU, and their intended end use.
Animal By-Products Species of Origin Intended End Use

7. Comments: space

space

8. Recommendation for approval to export to the EU: checkbox Approve checkbox Disapprove

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Signature of Inspector

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Inspection date

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Name of Inspector (printed)

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Signature of Area network export specialist concurring with above recommendation for approval

space
Date

9. Approval valid until (date): space

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.

Preamble

1. checkbox Yes checkbox No

Has the plant provided you with a current Notarized 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 Notarized Processing Method Form? (Please attach to this checklist, and forward to area network export specialist.)

Checklist for Intermediate Plants

1. checkbox Yes checkbox No

The premises are adequately separated from other premises, such as slaughterhouses.

2. checkbox Yes checkbox No

The layout of plants ensures the total separation of Category 1 and 2 materials from Category 3 material, from reception until dispatch.

3. checkbox Yes checkbox No

The plant has a covered space to receive and dispatch animal by-products, unless the animal by-products are being discharged through installations which prevent the spreading of risks to public and animal health, such as through closed tubes for liquid animal by-products.

4. checkbox Yes checkbox No

The plant is constructed in a way that eases cleaning and disinfection. Floors are laid down in a way that facilitates the draining of liquids.

5. checkbox Yes checkbox No

The plant has adequate lavatories, change rooms, and wash basins for staff.

6. checkbox Yes checkbox No

The plant has appropriate arrangements for protection against pests, such as insects, rodents, and birds.

7. checkbox Yes checkbox No

Where it is necessary for the purpose of achieving the objectives of Regulation (EC) No. 142/2011, plants must have suitable temperature-controlled storage facilities of sufficient capacity for maintaining animal by-products at appropriate temperatures and designed to allow the monitoring and recording of those temperatures.

8. checkbox Yes checkbox No

The plant has adequate facilities for cleaning and disinfecting the containers or receptacles in which Category 3 material is received, as well as the vehicles in which they are transported. Adequate facilities must be provided for disinfecting vehicle wheels.

9. checkbox Yes checkbox No

The sorting of materials shall be carried out in such a way that avoids any risk of the propagation of animal diseases.

10. checkbox Yes checkbox No

At all times during sorting or storage, materials of different categories are handled and stored separately, and in a way that prevents any propagation of pathogens.

11. checkbox Yes checkbox No

Category 3 material is stored properly, including under appropriate temperature conditions, until re-dispatched.

Checklist for Storage Plants

1. checkbox Yes checkbox No

Premises and facilities storing derived products from Category 3 material must not be at the same site as premises storing derived products from Category 1 or Category 2 material, unless cross-contamination is prevented due to the layout and management of the premises, such as by means of storage in completely separate buildings.

2. checkbox Yes checkbox No

The plant must have a covered space to receive and dispatch the derived products, unless the derived products are:

  1. being discharged through installations which prevent the spreading of risks to public and animal health, such as through closed tubes for liquid products; or
  2. received in packaging, such as in tote bags, or in covered leak-proof containers or means of transport.

3. checkbox Yes checkbox No

The plant is constructed in a way that eases cleaning and disinfection. Floors are laid down in a way that facilitates the draining of liquids.

4. checkbox Yes checkbox No

The plant has adequate lavatories, change rooms, and wash basins for staff.

5. checkbox Yes checkbox No

The plant has appropriate arrangements for protection against pests such as insects, rodents, and birds.

6. 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.

7. checkbox Yes checkbox No

Derived products are stored properly until re-dispatched.

8. checkbox Yes checkbox No

Specific requirements for storage of certain milk, colostrum and derived products from milk and colostrum are met as follows:

  1. The storage shall take place at an appropriate temperature to avoid any risk to public or animal health in a dedicated approved or registered storage establishment or plant or in a dedicated, separate storage area within an approved or registered storage establishment or plant.
  2. Samples of the final products taken during storage or at the time of withdrawal from storage, shall at least comply with the microbiological standards set out in Chapter I of Annex X of Regulation (EC) No. 142/2011.

Checklist for Processing Plants

1. checkbox Yes checkbox No

The processing plant is not situated on the same site as slaughterhouses or other establishments which have been approved or registered in accordance with Regulation (EC) No. 852/2004 or Regulation (EC) No. 853/2004, unless the risks to public and animal health resulting from the processing of animal by-products, which originate from such slaughterhouses or other establishments, are mitigated by compliance with at least the following conditions:

  1. The processing plant is physically separated from the slaughterhouse or other establishment, where appropriate by locating the processing plant in a building that is completely separated from the slaughterhouse or other establishment.
  2. The following is installed and operated in the processing plant:

    checkbox a conveyer system which links the processing plant to the slaughterhouse or other establishment and which may not be by-passed; and

    checkbox separate entrances, reception bays, equipment and exits for both the processing plant and the slaughterhouse or establishment.

  3. Measures are taken to prevent the spreading of risks through the operation of personnel which is employed in the processing plant and in the slaughterhouse or other establishment.
  4. Unauthorised persons and animals do not have access to the processing plant.

By way of derogation from points (i) to (iv), in the case of processing plant processing Category 3 material, the competent authority may authorize other conditions instead of those set out in those points, aimed at mitigating the risks to public and animal health, including the risks arising from the processing of Category 3 material, which originates from off-site establishments approved or registered in accordance with Regulation (EC) No. 852/2004 or Regulation (EC) No. 853/2004.

2. 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 eases 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.

3. checkbox Yes checkbox No

The processing plant has adequate lavatories, change rooms, and wash basins for staff.

4. checkbox Yes checkbox No

The processing plant has sufficient production capacity for hot water and steam for the processing of animal by-products;

5. checkbox Yes checkbox No

If appropriate, the unclean sector contains equipment to reduce the size of animal by-products and equipment for loading the crushed animal by-products into the processing unit;

6. checkbox Yes checkbox No

Where heat treatment is required, all installations are equipped with:

  1. measuring equipment to monitor temperature against time and, if applicable for the processing method used, pressure at critical points;
  2. recording devices to record continuously the results of these measurements in a way so that they remain accessible for the purpose of checks and official controls;
  3. an adequate safety system to prevent insufficient heating;

7. checkbox Yes checkbox No

To prevent recontamination of the derived product by the introduction of animal by-products, a clear separation exists between the area of the plant where incoming material for processing is unloaded and the areas set aside for the processing of that product and the storage of the derived product.

8. 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.

9. checkbox Yes checkbox No

Adequate facilities are provided for disinfecting vehicle wheels, when departing the unclean sector of the processing plant.

10. checkbox Yes checkbox No

The processing plant has a waste water disposal system that meets the competent authority's requirements.

11. checkbox Yes checkbox No

Preventative measures against birds, rodents, insects, or other vermin are taken systematically. A documented pest control program is used for that purpose.

12. checkbox Yes checkbox No

Animal by-products are processed as soon as possible. After processing, derived products are handled and stored in such a way as to avoid risks of contamination.

13. checkbox Yes checkbox No

The processing plant has its own laboratory or makes use of the services of an external laboratory. The laboratory is equipped to carry out necessary analyses and is approved by the competent authority on the basis of an assessment of the capacity of the laboratory to carry out those analyses, is accredited according to internationally recognized standards or is subject to regular controls by the competent authority, to assess the capacity of the laboratory to carry out those analyses.

14. checkbox Yes checkbox No

Any person working in the establishment or plant referred to in this directive shall wear suitable, clean and, where necessary, protective clothing. Where appropriate in a particular establishment or plant:

  1. persons working in the unclean sector do not enter the clean sector without first changing their work clothes and shoes or without having disinfected them;
  2. equipment and machinery are not moved from the unclean to the clean sector without first being cleaned and disinfected; and
  3. the operator has established a procedure relating to the movements of persons in order to monitor their movements and describe the correct use of footbaths and wheel baths.

15. checkbox Yes checkbox No

Cleaning procedures are established and documented for all parts of the premises. Suitable equipment and cleaning agents are provided for cleaning.

16. checkbox Yes checkbox No

Processing plants processing Category 3 material have in place an installation to check the presence of foreign bodies, such as packaging material or metallic pieces, in the animal by-products or derived products, if they are processing materials which are destined for feeding. Such foreign bodies are removed before or during processing.

17. checkbox Yes checkbox No

Accurately calibrated gauges/recorders are used to monitor continuously the processing conditions. Records are kept to show the date of calibration of gauges/recorders.

18. checkbox Yes checkbox No

Material that has not received the specified heat treatment, such as material discharged at start up or leakage from cookers, is recirculated through the heat treatment or collected and reprocessed or disposed of.

19. checkbox Yes checkbox No

Category 1 and Category 2 materials are processed in accordance with processing methods 1, 2, 3, 4 or 5 as referred to in Chapter III of Annex IV of Regulation (EU) No. 142/2011.

20. checkbox Yes checkbox No

Category 3 material is processed in accordance with any of the processing methods 1 to 5 or processing method 7, or, in the case of material originating from aquatic animals, with any of the processing methods 1 to 7, as referred to in Chapter III of Annex IV of Regulation (EU) No. 142/2011.

21. checkbox Yes checkbox No

The critical control points that determine the extent of the heat treatments applied in processing include, for the processing method as specified in Chapter III of Annex IV of Regulation (EC) No. 142/2011, the following:

  1. raw material particle size;
  2. temperature achieved in the heat treatment process;
  3. pressure, if applied to the raw material; and
  4. duration of the heat treatment process or feed rate to a continuous system. Minimum processing standards are specified for each applicable critical control point.

22. checkbox Yes checkbox No

Records shall be maintained for at least two years to show that the minimum process values for each critical control point are applied.

Checklist for Collection and Transport

Identification

1. checkbox Yes checkbox No

All necessary measures are taken to ensure that consignments of animal by-products and derived products are identifiable and kept separate and identifiable during collection where the animal by-products originate and during transportation.

2. checkbox Yes checkbox No

During transport and storage, a label attached to the container or vehicle clearly indicates the category of the animal by-products or of the derived products.

Vehicles and Containers

1. checkbox Yes checkbox No

Animal by-products and processed products are collected and transported in sealed new packaging or covered leak-proof containers or vehicles.

2. 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:

  1. cleaned and dried before use; and
  2. cleaned, washed, and/or disinfected after each use to the extent necessary to avoid cross-contamination.

3. checkbox Yes checkbox No

Reusable containers must be dedicated to the carriage of Category 3 material or derived products to the extent necessary to avoid cross-contamination.

Temperature Conditions

1. checkbox Yes checkbox No

The transport of animal by-products destined for the production of feed material takes place at an appropriate temperature, in the case of animal by-products from meat and meat products which have been destined for purposes other than human consumption, at a maximum of 7°C, in order to avoid any risk to public or animal health.

2. checkbox Yes checkbox No

Unprocessed Category 3 material destined for the production of feed material or pet food are stored and transported chilled, frozen or ensiled, unless:

  1. it is processed within 24 hours after collection or after the end of storage in chilled or frozen form, if the subsequent transport takes place in means of transport in which the storage temperature is maintained; and
  2. in the case of milk, milk-based products or milk-derived products which have not been subject to any of the treatments (pasteurization, sterilization, UHT, HTST) referred to in Part I of Section 4 of Chapter II of Annex X of Regulation (EU) 142/2011, it is transported chilled and in insulated containers, unless risks can be mitigated by other measures, due to the characteristics of the material.

3. checkbox Yes checkbox No

The design of vehicles used for refrigerated transport ensures the maintenance of an appropriate temperature throughout transport, and allows that temperature to be monitored.

Traceability and Records

1. checkbox Yes checkbox No

Operators consigning, transporting or receiving animal by-products or derived products keep a record of consignments and related commercial documents or sanitary certificates.

2. checkbox Yes checkbox No

The operators referred to in point 1 have in place systems and procedures to identify:

  1. the other operators to which their animal by-products or derived products have been supplied; and
  2. the operators from whom they have been supplied.

This information is available to the competent authorities upon request.

Checklist for Self-Inspection Plan

1. checkbox Yes checkbox No

Did the plant show you a written "Self Inspection" program that meets the requirements outlined in section IV.g of this document (Appendix D)?

2. checkbox Yes checkbox No

Has the facility established Critical Control Points (CCPs) for each of the critical limits noted in section IV of this document (for the appropriate processing method)?

3. 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)?

4. checkbox Yes checkbox No

An effectiveness check is performed after the processing of the raw material.

5. 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, and does this plan specify that the CFIA will be contacted if the product is produced without meeting the critical limit?

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Signature of inspector

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Inspection date

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Name of inspector (printed)

Appendix D: Own Checks and Hazard Analysis and Critical Control Points

1. checkbox Yes checkbox No

Operators ensure that no animal by-products or derived products suspected or discovered not to comply with Regulation (EC) No. 1069/2009 are exported to the EU.

Hazard Analysis and Critical Control Points

1. checkbox Yes checkbox No

Operators carrying out one of the following activities put in place and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (HACCP) principles for the :

checkbox processing of animal by-products;

checkbox transformation of animal by-products into biogas and compost; and

checkbox handling and storage of more than one category of animal by-products or derived products in the same establishment or plant.

2. checkbox Yes checkbox No

Operators as specified in point 1 act as follows:

checkbox identify any hazards that must be prevented, eliminated or reduced to acceptable levels;

checkbox identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels;

checkbox establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards;

checkbox establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards;

checkbox establish corrective action when monitoring indicates that a critical control point is not under control;

checkbox establish procedures to verify that the measures outlined in the points above are complete and working effectively, and that these verification procedures are carried out regularly; and

checkbox establish documents and records commensurate with the nature and size of the business to demonstrate the effective application of the measures set out in the above-mentioned points.

3. checkbox Yes checkbox No

When any modification is made to a product, process or any stage of production, processing, storage or distribution, operators immediately notify the CFIA, review their procedures and make the necessary changes.

Comments:
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Date modified: