Registration or Approval of Facilities To Export Animal By-Products Not Intended For Human Consumption To The European Union (EU)

11/7/2020 Registration or Approval of Facilities to Export Animal By-Products Not Intended for Human Consumption to the European Union
on to the European Union (EU) - Canadian Food Inspection Agency
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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-2009-8-3
March 2018
Amendment: This directive was revised following the CFIA's decision to

mandate the approval of establishments for the export of animal by-
products not intended for human consumption to the EU, to veterinarians
who have compulsorily completed the course (I6T228 or I6D320):
Inspection and approval of animal by-products and pet food
establishments for export to the EU or the US.
I (1). Purpose
https://www.inspection.gc.ca/animal-health/terrestrial-animals/exports/export-policies/2009-8/eng/1321242008176/1321242106573 1/62
11/7/2020 Registration or Approval of Facilities to Export Animal By-Products Not Intended for Human Consumption to the European Union (EU) - Canadian Food Inspection Agency
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
(European community)) No. (number) 1069/2009.
II (1). Background
Regulation (EC (European community)) No. (number) 1069/2009 - PDF
(Portable Document Format) (1,527 kb (kilobytes)) 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 (European community)) No. (number) 1774/2002
(Animal By-Products Regulation).
Regulation (EU (European Union)) No. (number) 142/2011 - PDF (Portable

Document Format) (7,933 kb (kilobytes)) implements Regulation (EC
(European community)) No. (number) 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 (Canadian Food Inspection Agency)
register (Article 23 of Regulation [EC (European community)] No.
(number) 1069/2009) or approve (Article 24 of Regulation [EC (European
community)] No. (number) 1069/2009) facilities exporting animal by-
products not intended for human consumption. To grant this registration or
approval, the CFIA (Canadian Food Inspection Agency) 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 (European

Union) from an eligible country and from a facility approved for export to
the EU (European Union).
Prior to the CFIA (Canadian Egg Marketing Agency)'s inspection of facilities,

owners are required to submit to the CFIA (Canadian Food Inspection
Agency), 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 (European community)) No. (number) 853/2004 - PDF

(Portable Document Format) (461 kb (kilobytes)) of the European Parliament
and of the Council of 29 April 2004 lays down specific hygiene rules for food
of animal origin.
III (3). Definitions

The EU (European Union) Regulation (EC (European community)) No.
(number) 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 (European Union) accepts derived
products from Category 1 or 2 material (e.g. (for example) 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 (European community))
No. (number) 1069/2009.
2. Approved facility: In this document, this term applies to facilities that

have received authorization from the CFIA (Canadian Food Inspection
Agency) to collect and/or process and/or store one or more animal by-
products destined for export to the EU (European Union) (e.g. (for example)
hides and skins, blood, dairy products).
3. Intermediate plant: According to Article 19(b) of Regulation (EU

(European Union)) No. (number) 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:
a. sorting, cutting, chilling, freezing, sieving, salting or other preservative

processes;
b. removal of hides and skins or specified risk material; and
c. 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. (for example) 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 (European community)) No. (number) 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:
a. processing of animal by-products by pressure sterilisation, by

processing methods (2 to 6) approved by the EU (European Union) or by
alternative methods authorised by the EU (European Union);
b. use of animal by-products and derived products as fuel for combustion;
c. manufacturing of pet food;
d. manufacturing of organic fertilisers and soil improvers;
e. transformation of animal by-products and/or derived products into
biogas or compost;
f. 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;
g. storage of animal by-products; and
h. storage of derived products intended to be used:
i. as fuel for combustion,
ii. as feed, excluding establishments or plants approved or registered
in accordance with Regulation (EC (European community)) No.
(number) 183/2005, or
iii. as organic fertilisers and soil improvers.
6.2 Registration:
1. According to Article 23 of Regulation (EC (European community)) No.

(number) 1069/2009, operators shall act as follows:
a. 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
b. provide the competent authority with information on:
i. the category of animal by-products or derived products under
their control,
ii. 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 (European community)) No. (number) 852/2004 or
Regulation (EC (European community)) No. (number) 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. (for
example) taxidermists, establishment exporting pig bristles, treated
feathers, or honey).
IV (4). Approval of Facilities to Export to the

European Union
The general hygiene requirements (Article 25 of Regulation [EC (European
community)] No. (number) 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 (3) 6.1 of this
document:
a. are constructed in a way that permits their effective cleaning and

disinfection and where appropriate the construction of floors facilitates
the draining of liquids;
b. have access to adequate facilities for personal hygiene such as
lavatories, changing rooms and washbasins for staff;
c. have appropriate arrangements for protection against pests, such as
insects, rodents and birds;
d. keep installations and equipment in good condition and ensuring that
measuring equipment is calibrated regularly; and
e. 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:
a. 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;
b. equipment and machinery shall not be moved from the unclean to the
clean sector without first being cleaned and disinfected; and
c. 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 (3) 6.1(a) of this document:
a. animal by-products shall be handled in such a way as to avoid risks of

contamination;
b. 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;
c. 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;
d. the operators shall check regularly the applicable parameters,
particularly temperature, pressure, time, size of particles, where
appropriate by automatic devices; and
e. cleaning procedures shall be established and documented for all parts
of the establishments or plants.
IV (4).a Requirements for Intermediate Plants

(Annex IX (9), Chapter II (2), Sections 1, 2 of Regulation [EU (European
Union)] No. (number) 142/2011)
General Requirements
1. Premises and facilities where intermediate operations are carried out shall
meet at least the following requirements:
a. 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.
b. 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.
c. 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.
d. 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.
e. The plant must have appropriate arrangements for protection against
pests, such as insects, rodents and birds.
f. 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 (4).b Requirements for Storage Plants

(Annex IX (9), Chapter III (3), Sections 1, 2 of Regulation [EU (European
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:
a. have a covered space to receive and dispatch the derived products,

unless the derived products are:
i. being discharged through installations which prevent the spreading
of risks to public and animal health, such as through closed tubes
for liquid products, or
ii. received in packaging, such as in big bags, or in covered leak-proof
containers or means of transport;
b. 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;
c. have adequate facilities including lavatories, changing rooms and
washbasins for staff; and
d. 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 (2) of Section 4 of

Chapter II (2) of Annex X (10) 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 (1) of Annex X (10).
IV (4).c Requirements for Processing Plants

(Annex IV (4), Chapter I (1), Sections 1, 3 and 4 of Regulation [EU (European
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 (European community)) No.
(number) 1069/2009:
a. 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 (European community))
No. (number) 852/2004 or Regulation (EC (European community)) No.
(number) 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:
i. 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.
ii. 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.
iii. 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.
iv. Unauthorised persons and animals must not have access to the
processing plant.
By way of derogation from points (i (1)) to (iv (4)), 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 (European community)) No.
(number) 852/2004 or Regulation (EC (European community)) No.
(number) 853/2004.
b. 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.
c. The processing plant must have adequate facilities including lavatories,
changing rooms and washbasins for staff.
d. The processing plant must have sufficient production capacity for hot
water and steam for the processing of animal by-products (e.g. (for
example) Processed animal proteins and rendered fats, hides in brine
solution).
e. 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. (for example)
Processed animal proteins and rendered fats).
f. Where heat treatment is required, all installations must be equipped
with:
i. measuring equipment to monitor temperature against time and, if
applicable for the processing method used, pressure at critical
points;
ii. 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
iii. an adequate safety system to prevent insufficient heating.
g. 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:
a. the layout of the premises, in particular the arrangements for the

reception, and by way of the further handling of raw materials;
b. 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
c. 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 (4).d Hygiene and Processing Requirements

(Annex IV (4), Chapter II (2), Sections 1, 2, 3 and 4 of Regulation (EU
(European Union)) No. (number) 142/2011)
(e.g. (for example) Processed animal proteins and rendered fats)
General Hygiene Requirements
In addition to the general hygiene requirements provided for in Article 25 of

Regulation (EC (European community)) No. (number) 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 (European community)) No.
(number) 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 (3) of Annex IV (4) of Regulation (EC (European community))
No. (number) 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 (3) of Annex IV (4) of Regulation (EU (European
Union)) No. (number) 142/2011, the following:
a. raw material particle size;

b. temperature achieved in the heat treatment process;
c. pressure, if applied to the raw material; and
d. 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 (3) of Annex IV (4) of Regulation (EU (European Union)) No.
(number) 142/2011, the critical control points that determine the extent of
the chemical treatments applied shall include the pH (hydrogenion
concentration) 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 (3) of Annex IV (4) of Regulation
(EU (European Union)) No. (number) 142/2011.
IV (4).e Supervision of Production
(Annex XVI (16), Chapter I (1), Section 1 of Regulation [EU (European Union)]
No. (number) 142/2011)
(e.g. (for example) 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 (European community))
No. (number) 1069/2009 and with Regulation (EC (European community))
No. (number) 142/2011. It shall, in particular:
a. check:
i. the general conditions of hygiene of the premises, equipment and
staff,
ii. the efficacy of the own checks carried out by the operator of the
processing plant, in accordance with Article 28 of Regulation (EC
(European community)) No. (number) 1069/2009; such checks must
include an examination of the results of those checks and if
necessary, the taking of samples,
iii. the effective implementation of the permanent written procedure
based on the HACCP principles in accordance with Article 29(1) of
Regulation (EC (European community)) No. (number) 1069/2009;
such checks must include an examination of the results of this
implementation and if necessary, the taking of samples,
iv. 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
v. the storage conditions;
b. take any samples required for laboratory tests; and
c. make any other checks it considers necessary to ensure compliance with
Regulation (EC (European community)) No. (number) 1069/2009 and
with Regulation (EU (European Union)) No. (number) 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 (4).f Validation Procedures

(Annex XVI (16), Chapter I (1), Section 2 of Regulation [EU (European Union)]
No. (number) 142/2011)
(e.g. (for example) 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:
a. a description of the process by a process flow diagram;

b. an identification of critical control points (CCPs) including the material
process rate for continuous systems;
c. the compliance with the specific process requirements laid down by this
Regulation; and
d. the achievement of the following requirements:
i. particle size for batch-pressure and continuous processes, defined

by the mincer hole or the anvil gap size, and
ii. 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:
a. the temperature must be monitored with a permanent thermocouple

and it must be plotted against real time;
b. the pressure stage must be monitored with a permanent pressure
gauge; pressure must be plotted against real time; and
c. 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:
a. 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
b. 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 (critical control point) that can be continuously monitored such
as:
i. feed screw revolutions per minute (rev./min.);

ii. the electric power (amps at given voltage);
iii. the evaporation/condensation rate; or
iv. 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 (4).g Own Checks and Hazard Analysis and Critical Control

Points
(Articles 28 and 29 of Regulation [EC (European community)] No.
(number) 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 (European Union).
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:
a. processing of animal by-products;

b. transformation of animal by-products into biogas and compost;
c. handling and storage of more than one category of animal by-products
or derived products in the same establishment or plant; and
d. manufacturing of pet food.
2. Operators as specified in paragraph 1 shall in particular:
a. identify any hazards that must be prevented, eliminated or reduced to

acceptable levels;
b. 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;
c. establish critical limits at critical control points which separate
acceptability from unacceptability, for the prevention, elimination or
reduction of identified hazards;
d. establish and implement effective monitoring procedures at critical
control points;
e. establish corrective action when monitoring indicates that a critical
control point is not under control;
f. 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
g. 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 (5). Hygiene Requirements for the

Collection and Transport of Animal By-
Products and Derived Products
Article 21 of Regulation (EC (European community)) No. (number) 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 (8) of Regulation (EU (European Union)) No. (number) 142/2011
provides the requirements for the collection and transport of animal by-
products and derived products.
V (5).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:
a. clean and dry before use; and

b. 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:
a. 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
b. 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 (5).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 (celsius).
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:
a. 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
b. 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 (1)
of Section 4 of Chapter II (2) of Annex X (10), 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 (5).c Identification
1. All necessary measures must be taken to ensure that:
a. 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 (5).d Traceability and Records

and Chapter IV (4) of Annex VIII (8) of Regulation (EU (European Union)) No.
(number) 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:
a. the other operators to which their animal by-products or derived
products have been supplied; and
b. the operators from whom they have been supplied.
This information shall be made available to the competent authorities on

request.
Chapter III (3) of Annex VIII (8) of Regulation (EU (European Union)) No.
(number) 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 (Canadian Food Inspection
Agency)) 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 (Canadian Food
Inspection Agency) may authorize that animal by-products and derived
products which are transported on its territory are accompanied by the
following:
a. 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

b. 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:
a. The commercial document, traceability or sanitary certificate must
specify:
i. the date on which the material was taken from the premises;
ii. 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
iii. the quantity of the material, in volume, weight or number of
packages;
iv. the place of origin of the material, from where the material is
dispatched;
v. the name and the address of the carrier of the material;
vi. the name and the address of the receiver and, if applicable, its
approval or registration number; and
vii. if appropriate, the approval or registration number of the
establishment or plant of origin, and the nature and the
methods of the treatment.
b. 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).
c. The colour of the signature of the responsible person shall be
different to that of the printing.
d. The document reference number shall only be issued once for the
same consignment.
VI (6). Registration of Facilities to Export to

the European Union
Annex IX (9), Chapter IV (4) of Regulation (EU (European Union)) No.
(number) 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:
a. premises must be constructed in a way permitting their effective
cleaning and disinfection, where appropriate;
b. premises must have appropriate arrangements for protection
against pests, such as insects, rodents and birds;
c. installations and equipment must be kept in hygienic condition,
where necessary; and
d. 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:
a. 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;
b. clean and disinfect their vehicles, as appropriate; and
c. take all other necessary measures to prevent contamination and
the spreading of diseases communicable to humans or animals.
VII (7). Official Control and Final Provisions

VII (7).a Procedure for Approval
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 (7).b Official Control

and Article 32 of Regulation (EU (European Union)) No. (number) 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 (European
community)) No. (number) 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
(European Union)) No. (number) 142/2011.
4. The competent authority shall carry out the following official controls:
a. official controls in processing plants; and
b. 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 (7).c Suspensions, Withdrawals and Prohibitions on Operations

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:
a. suspend approvals of establishments or plants approved pursuant

to this Regulation, if:
i. the conditions for approving or operating the establishment or
plant are no longer fulfilled;
ii. the operator can be expected to remedy the deficiencies within
a reasonable period of time; and
iii. the potential risks to public and animal health do not require
action in accordance with point (b);
b. withdraw approvals of establishments or plants approved pursuant
to this Regulation, if:
i. the conditions for approving or operating the establishment or

plant are no longer fulfilled; and
ii. 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
c. 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 (3) 6 of this directive from carrying out operations
under Regulation (EC (European community)) No. (number) 1069/2009,
as appropriate, following receipt of information indicating:
a. that the requirements of the EU (European Union) are not met; and
b. potential risks to public or animal health arising from such
operations.
VIII (8). 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 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 processing method document (e.g.
(for example) a taxidermist may state that raw materials are sourced
from other approved plants, but that receiving records are maintained).
2. A form 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 (Canadian Food Inspection Agency),

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. The 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. These
documents must be updated (signed and submitted to the district office)
annually.
IX (9). 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 (Canadian Food Inspection Agency) 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, as well as the own check plan, and be
vigilant in identifying any inaccuracies.
X (10). Billing for Inspections

Facility approval inspections for export of animal by-products to the EU
(European Union) will be billed according to the CFIA (Canadian Food
Inspection Agency) Fees Notice, Part II (2), Item 27: $30 for each inspection
(code 1483).
XI (11). Inspection Reports
A copy of the duly completed inspection form and all requisite forms, must
be sent to the CFIA (Canadian Food Inspection Agency) Area Approving
Veterinarian 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 (European Union) until
the Area Approving Veterinarian 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 (12). Approval Numbers

Facility approval numbers are issued by headquarters. The Area Approving
Veterinarian 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 (European
Union) unless the facility approval number is identical to the number on the
list of approved facilities.
XIII (13). 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 Approving
Veterinarian, 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: 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)
only receives animal by-products: of Category 1
of Category 2
of Category 3
not intended for human consumption according to the European
Union legislation (EU) and from the following facilities:
Facility City CFIA (Canadian Food Inspection Agency)

Name (Country) 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 (European Union)-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 (European community)) No.
(number) 1069/2009, and that the statements above are true. I agree to
inform the CFIA (Canadian Food Inspection Agency) immediately if any
changes are made to the above information.
Signed by:
Position:
Date:
Appendix B: Processing Method Form for

Animal By-Product Processing Facilities
This serves to inform Canadian Food Inspection Agency (CFIA) officials that
the establishment (name and full address)
processes the following animal by-products
from the following species
using the processing method noted below or attached, and has in place a
self-inspection program with the critical limits referenced.
Comments:
I certify that the statements above are true to the best of my knowledge and
belief. I agree to notify the CFIA (Canadian Food Inspection Agency)
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 (European Union) approval status, I must be
re-inspected at least once per year by the CFIA (Canadian Food Inspection
Agency) and that I am responsible for arranging this inspection prior to the
expiration of my one-year validity period.
Signed by:
Position:
Date:
Appendix C: CFIA (Canadian Egg Marketing

Agency) Plant Inspection Checklist for
Approval of Facilities to Export Animal By-
Products to the European Union
1. Canadian Food Inspection Agency (CFIA) Approval Number:
(For newly inspected facilities, leave blank.)
2. Plant/Company name:
3. Address of location being inspected:
4. Address of headquarters, if different from above:
5. Contact name at plant:
Telephone: Facsimile:
6. Please list animal by-products, species of origin produced at

this plant for export to the EU (European Union), and their
intended end use.
Animal By-Products Species of Origin Intended End Use
7. Comments:
8. Recommendation for approval to export to the EU (European Union):

Approve Disapprove
Signature of Inspector
Inspection date
Name of Inspector (printed)
Signature of Area Approving Veterinarian
Date
9. Approval valid until (date):
Please forward a copy of the completed form and all required forms to
the Area Approving Veterinarian.
Note: To maintain approval, facilities must be inspected at least once

every 12 months.
Preamble
1. Yes No
Has the plant provided you with a current

Approval Supplier Form? (Please attach to this
checklist, and forward to Area Approving
Veterinarian.)
2. Yes No Has the plant provided you with a current

Processing Method Form for Animal By-
Products Processing Facilities? (Please attach to
this checklist, and forward to Area Approving
Veterinarian.)
Checklist for Intermediate Plants

1. Yes No The premises are adequately separated from
other premises, such as slaughterhouses.
2. Yes No The layout of plants ensures the total separation

of Category 1 and 2 materials from Category 3
material, from reception until dispatch.
3. Yes 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. Yes 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. Yes No The plant has adequate lavatories, change rooms,

and wash basins for staff.
6. Yes No The plant has appropriate arrangements for

protection against pests, such as insects, rodents,
and birds.
7. Yes No Where it is necessary for the purpose of achieving

the objectives of Regulation (EC (European
community)) No. (number) 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. Yes 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. Yes No The sorting of materials shall be carried out in

such a way that avoids any risk of the
propagation of animal diseases.
10. Yes 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. Yes No Category 3 material is stored properly, including

under appropriate temperature conditions, until
re-dispatched.
Checklist for Storage Plants

1. Yes 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. Yes No The plant must have a covered space to receive

and dispatch the derived products, unless the
derived products are:
i. being discharged through installations which

prevent the spreading of risks to public and
animal health, such as through closed tubes
for liquid products; or
ii. received in packaging, such as in tote bags,
or in covered leak-proof containers or means
of transport.
3. Yes 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. Yes No The plant has adequate lavatories, change rooms,

and wash basins for staff.
5. Yes No The plant has appropriate arrangements for

protection against pests such as insects, rodents,
and birds.
6. Yes 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. Yes No Derived products are stored properly until re-

dispatched.
8. Yes No Specific requirements for storage of certain milk,

colostrum and derived products from milk and
colostrum are met as follows:
i. 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.
ii. 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
(1) of Annex X (10) of Regulation (EC
(European community)) No.
(number) 142/2011.
Checklist for Processing Plants

1. Yes 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 (European
community)) No. (number) 852/2004 or
Regulation (EC (European community)) No.
(number) 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:
i. 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.
ii. The following is 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.
iii. 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.
iv. Unauthorised persons and animals do not
have access to the processing plant.
By way of derogation from points (i (1)) to (iv (4)),

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 (European
community)) No. (number) 852/2004 or
(number) 853/2004.
2. Yes 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. Yes No The processing plant has adequate lavatories,

change rooms, and wash basins for staff.
4. Yes No The processing plant has sufficient production

capacity for hot water and steam for the
processing of animal by-products;
5. Yes 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. Yes No Where heat treatment is required, all installations

are equipped with:
i. measuring equipment to monitor

temperature against time and, if applicable
for the processing method used, pressure at
critical points;
ii. 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;
iii. an adequate safety system to prevent
insufficient heating;
7. Yes 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. Yes 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. Yes No
Adequate facilities are provided for disinfecting

vehicle wheels, when departing the unclean
sector of the processing plant.
10. Yes No The processing plant has a waste water disposal

system that meets the competent authority's
requirements.
11. Yes No Preventative measures against birds, rodents,

insects, or other vermin are taken systematically.
A documented pest control program is used for
that purpose.
12. Yes 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. Yes 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. Yes 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:
i. 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;
ii. equipment and machinery are not moved
from the unclean to the clean sector without
first being cleaned and disinfected; and
iii. 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. Yes No Cleaning procedures are established and

documented for all parts of the premises.
Suitable equipment and cleaning agents are
provided for cleaning.
16. Yes 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. Yes 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. Yes 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. Yes 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
(3) of Annex IV (4) of Regulation (EU (European
Union)) No. (number) 142/2011.
20. Yes 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 (3) of Annex IV (4) of Regulation (EU
(European Union)) No. (number) 142/2011.
21. Yes 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 (3) of Annex IV (4) of
(number) 142/2011, the following:
i. raw material particle size;

ii. temperature achieved in the heat treatment
process;
iii. pressure, if applied to the raw material; and
iv. 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. Yes 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. Yes 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. Yes 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. Yes No Animal by-products and processed products are
collected and transported in sealed new
packaging or covered leak-proof containers or
vehicles.
2. Yes 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:
i. cleaned and dried before use; and

ii. cleaned, washed, and/or disinfected after
each use to the extent necessary to avoid
cross-contamination.
3. Yes 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. Yes 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
(celsius), in order to avoid any risk to public or
animal health.
2. Yes No Unprocessed Category 3 material destined for the

production of feed material or pet food are stored
and transported chilled, frozen or ensiled, unless:
i. 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
ii. 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 (Ultra High
Temperature), HTST (High Temperature Short
Time)) referred to in Part I (1) of Section 4 of
Chapter II (2) of Annex X (10) of Regulation
(EU (European Union)) 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. Yes 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. Yes 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. Yes No The operators referred to in point 1 have in place

systems and procedures to identify:
i. the other operators to which their animal by-

products or derived products have been
supplied; and
ii. the operators from whom they have been
supplied.
This information is available to the competent

authorities upon request.
Checklist for Self-Inspection Plan

1. Yes No
Did the plant show you a written "Self Inspection"

program that meets the requirements outlined in
section IV (4).g of this document (Appendix D)?
2. Yes No Has the facility established Critical Control Points

(CCPs) for each of the critical limits noted in
section IV (4) of this document (for the
appropriate processing method)?
3. Yes No Is the plant maintaining records for two years (or

since the beginning of the CCP (Critical Control
Points) implementation if less than two years)?
4. Yes No An effectiveness check is performed after the

processing of the raw material.
5. Yes 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
(Canadian Food Inspection Agency) will be
contacted if the product is produced without
meeting the critical limit?
Signature of inspector
Inspection date
Name of inspector (printed)
Appendix D: Own Checks and Hazard

Analysis and Critical Control Points
1. Yes No Operators ensure that no animal by-products or
derived products suspected or discovered not to
comply with Regulation (EC (European
community)) No. (number) 1069/2009 are
exported to the EU (European Union).
Hazard Analysis and Critical Control Points

1. Yes 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 :
processing of animal by-products;
transformation of animal by-products into

biogas and compost; and
handling and storage of more than one

category of animal by-products or derived
products in the same establishment or plant.
2. Yes No Operators as specified in point 1 act as follows:
identify any hazards that must be prevented,

eliminated or reduced to acceptable levels;
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;
establish critical limits at critical control points

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

which separate acceptability from unacceptability,
for the prevention, elimination or reduction of
identified hazards;
establish corrective action when monitoring

indicates that a critical control point is not under
control;
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
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. Yes No When any modification is made to a product,

process or any stage of production, processing,
storage or distribution, operators immediately
notify the CFIA (Canadian Food Inspection
Agency), review their procedures and make the
necessary changes.
Comments:
Date modified:
2018-08-02

Registration or Approval of Facilities To Export Animal By-Products Not Intended For Human Consumption To The European Union (EU)

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11/7/2020 Registration or Approval of Facilities to Export Animal By-Products Not Intended for Human Consumption to the European Union

on to the European Union (EU) - Canadian Food Inspection Agency

Canada.ca > Canadian Food Inspection Agency > Animal health

> Terrestrial animals > Exports > Export policies

Registration or Approval of Facilities to

Amendment: This directive was revised following the CFIA's decision to

The purpose of this document is:

to explain the European Union's (EU) import requirements for animal

This document does not cover:

facilities approved by Veterinary Biologics;

Regulation (EU (European Union)) No. (number) 142/2011 - PDF (Portable

These animal by-products may only be imported into the EU (European

Prior to the CFIA (Canadian Egg Marketing Agency)'s inspection of facilities,

Regulation (EC (European community)) No. (number) 853/2004 - PDF

III (3). Definitions

1. European definition of Categories 1, 2, and 3 animal by-products: See

2. Approved facility: In this document, this term applies to facilities that

3. Intermediate plant: According to Article 19(b) of Regulation (EU

a. sorting, cutting, chilling, freezing, sieving, salting or other preservative

4. Processing plant: This term applies to a plant in which raw material of

5. Storage plant: This term applies to a plant (other than an intermediary)

Note: A single facility may include an intermediate section, a processing

6. Nature of operations to be registered or approved: According to Article

approved by the competent authority, where such establishments or plants

a. processing of animal by-products by pressure sterilisation, by

1. According to Article 23 of Regulation (EC (European community)) No.

a. before commencing operations, notify the competent authority of

IV (4). Approval of Facilities to Export to the

1. Operators shall ensure that establishments or plants under their control

a. are constructed in a way that permits their effective cleaning and

2. Any person working in the establishment or plant referred to in

Where appropriate in a particular establishment or plant:

3. In establishments or plants carrying out the activities referred to in

a. animal by-products shall be handled in such a way as to avoid risks of

IV (4).a Requirements for Intermediate Plants

a. They must be adequately separated from thoroughfares through which

1. The sorting of animal by-products shall be carried out in such a way as to

2. At all times during storage, animal by-products shall be handled and

3. Animal by-products shall be stored properly, including under appropriate

IV (4).b Requirements for Storage Plants

1. Premises and facilities storing derived products from Category 3 material

2. The plant must:

a. have a covered space to receive and dispatch the derived products,

4. Derived products must be stored properly until redispatched.

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

1. The storage of the products referred to in Part II (2) of Section 4 of

2. Samples of the final products taken during storage or at the time of

IV (4).c Requirements for Processing Plants

1. Processing plants shall meet the following requirements, for processing

a. Processing plants must not be situated on the same site as

i. The processing plant must be physically separated from the

ii. The following must be installed and operated in the processing

easy to clean and disinfect. Floors must be laid in such a way as to

3. Adequate facilities must be provided for the disinfecting of vehicle wheels

4. All processing plants must have a waste-water disposal system meeting

6. If on the basis of a risk assessment, the volume of products treated

Specific Requirements for the Processing of Category 1 and Category 2

The layout of processing plants processing Category 1 and Category 2

Specific Requirements for the Processing of Category 3 Materials

The following requirements shall apply in addition to the general conditions

1. Processing plants processing Category 3 materials shall not be located at

2. However, the competent authority may authorise the processing of