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23.1.2013 Official
Journal
of
the
European
Union L
20/33
COMMISSION REGULATION (EU) No 51/2013
of 16 January 2013
amending Regulation (EC) No 152/2009 as regards the methods of analysis for the determination of
constituents of animal origin for the official control of feed
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
the methods of analysis for the determination of consti
tuents of animal origin for the official control of feed.
The microscopic method, which is currently the only
method validated to detect the presence of animal
Having regard to the Treaty on the Functioning of the European
proteins in feed, is able to distinguish the presence of
Union,
constituents derived from terrestrial animals from the
presence of constituents derived from fish, but unable
to quantify with a sufficient level of accuracy the
amount of animal constituents present in feed, and
Having regard to Regulation (EC) No 882/2004 of the European
therefore should not be used for this purpose.
Parliament and of the Council of 29 April 2004 on official
controls performed to ensure the verification of compliance
with feed and food law, animal health and animal welfare
rules ( 1 ), and in particular Article 11(4) thereof,
(4) A
new
method
of
detection
of
animal
constituents
based
on polymerase chain reaction (PCR) was validated by the
EU reference laboratory for animal proteins in feeding
Whereas:
stuffs. An implementation study, organised with the
national reference laboratories of the Member States,
proved that the new method is sufficiently robust to be
used as an official control method in the Union. This
new method is able to detect the presence of animal
(1)
Article 7(1) of Regulation (EC) No 999/2001 of the
European Parliament and of the Council of 22 May
constituents in feed, and also able to identify the
2001 laying down rules for the prevention, control and
species origin of these constituents. The use of this
eradication of certain transmissible spongiform encepha
new method in combination with or in replacement of,
lopathies (
as appropriate, the microscopic method would be very

2 ) provides that the feeding to ruminants of
protein derived from animals is prohibited. That
valuable for the control of the correct implementation of
prohibition is extended to animals other than
the feeding prohibitions laid down in Regulations (EC)
ruminants and restricted, as regards the feeding of
No 999/2001 and (EC) No 1069/2009.
those animals with products of animal origin, in
accordance with Annex IV to that Regulation.
(5) Annex
VI
to
Regulation
(EC)
No
152/2009
should
therefore be replaced accordingly.
(2)
Article 11(1) of Regulation (EC) No 1069/2009 of the

European Parliament and of the Council of 21 October
2009 laying down health rules as regards animal by-
products and derived products not intended for human
consumption and repealing Regulation (EC) No
1774/2002 ( 3 ) prohibits the feeding of terrestrial
(6) The
measures
provided
for
in
this
Regulation
are
in
animals of a given species other than fur animals with
accordance with the opinion of the Standing
processed animal protein derived from the bodies or
Committee on the Food Chain and Animal Health and
parts of bodies of animals of the same species, as well
neither the European Parliament nor the Council have
as the feeding of farmed fish with processed animal
opposed them,
protein derived from the bodies or parts of bodies of
farmed fish of the same species.
HAS ADOPTED THIS REGULATION:
(3) Commission
Regulation
(EC)
No
152/2009
of
27
January
2009 laying down the methods of sampling and analysis
for the official control of feed ( 4 ) sets out in its Annex VI
( 1 ) OJ L 165, 30.4.2004, p. 1.
Article 1
( 2 ) OJ L 147, 31.5.2001, p. 1.
( 3 ) OJ L 300, 14.11.2009, p. 1.
Annex VI to Regulation (EC) No 152/2009 is replaced by the
( 4 ) OJ L 54, 26.2.2009, p. 1.
text set out in the Annex to this Regulation.

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L 20/34
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Official Journal of the European Union
23.1.2013
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
This Regulation is binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 January 2013.
For the Commission
The President
José Manuel BARROSO

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EN
23.1.2013 Official
Journal
of
the
European
Union L
20/35
ANNEX
‘ANNEX VI
METHODS OF ANALYSIS FOR THE DETERMINATION OF CONSTITUENTS OF ANIMAL ORIGIN FOR THE
OFFICIAL CONTROL OF FEED
1. PURPOSE
AND
SCOPE
The determination of constituents of animal origin in feed shall be performed by light microscopy or
polymerase chain reaction (PCR) in accordance with the provisions laid down in this Annex.
These two methods make it possible to detect the presence of constituents of animal origin in feed
materials and compound feed. However, they do not make it possible to calculate the amount of such
constituents in feed materials and compound feed. Both methods have a limit of detection below
0,1 % (w/w).
The PCR method makes it possible to identify the taxonomic group of constituents of animal origin
present in feed materials and compound feed.
These methods shall apply for the control of the application of the prohibitions laid down in Article 7(1)
and Annex IV to Regulation (EC) No 999/2001 and in Article 11(1) of Regulation (EC) No 1069/2009.
Depending on the type of feed being tested, these methods may be used, within one single operational
protocol, either on their own or combined together in accordance with the standard operating procedures
(SOP) established by the EU reference laboratory for animal proteins in feedingstuffs (EURL-AP) and
published on its website ( 1 ).
2. METHODS
2.1. Light
microscopy
2.1.1. Principle
The constituents of animal origin which may be present in feed materials and compound feed sent for
analysis are identified on the basis of typical and microscopically identifiable characteristics like muscle
fibres and other meat particles, cartilage, bones, horn, hair, bristles, blood, feathers, egg shells, fish bones
and scales.
2.1.2. Reagents
and
equipment
2.1.2.1. Reagents
2.1.2.1.1. Concentrating
agent
2.1.2.1.1.1. Tetrachloroethylene
(specific
gravity
1,62)
2.1.2.1.2. Staining
reagent
2.1.2.1.2.1. Alizarin Red solution (dilute 2,5 ml 1M hydrochloric acid in 100 ml water and add 200 mg Alizarin Red to
this solution)
2.1.2.1.3. Mounting
media
2.1.2.1.3.1. Lye (NaOH 2,5 % w/v or KOH 2,5 % w/v)
2.1.2.1.3.2. Glycerol
(undiluted,
viscosity:
1
490
cP)
2.1.2.1.3.3. Norland

Optical
Adhesive
65
(viscosity:
1
200
cP)
or
a
resin
with
equivalent
properties
for
permanent
slide preparation
2.1.2.1.4. Mounting
media
with
staining
properties
2.1.2.1.4.1. Lugol
solution
(dissolve
2
g
potassium
iodide
in
100
ml
water
and
add
1
g
iodine
while
frequently
shaking)
( 1 ) http://eurl.craw.eu/

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L 20/36
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Official Journal of the European Union
23.1.2013
2.1.2.1.4.2. Cystine reagent (2 g lead acetate, 10 g NaOH/100 ml water)
2.1.2.1.4.3. Fehling’s reagent (prepared before use from equals parts (1/1) of two stock solutions A and B. Solution A:
dissolve 6,9 g copper (II) sulphate pentahydrate in 100 ml water. Solution B: dissolve 34,6 g potassium
sodium tartrate tetrahydrate and 12 g NaOH in 100 ml water)
2.1.2.1.4.4. Tetramethylbenzidine/Hydrogen peroxide. (dissolve 1 g 3,3’,5,5’ tetramethylbenzidine (TMB) in 100 ml
glacial acetic acid and 150 ml water. Before use, mix 4 parts of this TMB solution with 1 part 3 %
hydrogen peroxide)
2.1.2.1.5. Rinsing
agents
2.1.2.1.5.1. Ethanol
≥ 96 % (technical grade)
2.1.2.1.5.2. Acetone
(technical
grade)
2.1.2.1.6. Bleaching
reagent
2.1.2.1.6.1. Commercial
sodium
hypochlorite
solution
(9
-
14
%
active
chlorine)
2.1.2.2. Equipment
2.1.2.2.1. Analytical
balance
with
an
accuracy
of
0,001
g
2.1.2.2.2. Grinding
equipment:
mill
-
or
mortar
2.1.2.2.3. Sieves
with
square
meshes
of
0,25
mm
and
1
mm
width
2.1.2.2.4.
Conical glass separation funnel with a content of 250 ml with Teflon or ground glass stopcock at the base
of the cone. Stopcock opening diameter shall be ≥ 4mm. Alternatively, a conical bottomed settling beaker
may be used provided the laboratory has demonstrated that detection levels are equivalent to that obtained
using the conical glass separation funnel.
Separation funnel
2.1.2.2.5. Stereomicroscope
covering
at
least
a
6,5×
to
40×
final
magnification
range
2.1.2.2.6.
Compound microscope covering at least a 100× to 400× final magnification range with transmitted light
bright field. Polarised light and differential interferential contrast can additionally be used
2.1.2.2.7. Standard
laboratory
glassware
2.1.2.2.8. Equipment
for
slide
preparation:
classical
microscope
slides,
hollow
slides,
coverslips
(20
×
20
mm),
tweezers, fine spatula
2.1.3. Sampling
and
sample
preparation
2.1.3.1. Sampling
A representative sample, taken in accordance with the provisions laid down in Annex I shall be used.

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EN
23.1.2013 Official
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European
Union L
20/37
2.1.3.2. Precautions
to
be
taken
In order to avoid laboratory cross-contamination, all reusable equipment shall be carefully cleaned before
use. Separation funnel pieces shall be disassembled before cleaning. Separation funnel pieces and glassware
shall be pre-washed manually and then washed in a washing machine. Sieves shall be cleaned by using a
brush with stiff synthetic hairs. A final cleaning of sieves with acetone and compressed air is recommended
after sieving of fatty material like fishmeal.
2.1.3.3. Preparation
of
samples
other
than
fat
or
oil
2.1.3.3.1. Sample
drying:
samples
with
a
moisture
content
>
14
%
shall
be
dried
prior
to
handling.
2.1.3.3.2.
Sample pre-sieving: it is recommended to pre-sieve at 1 mm pelleted feeds and kernels and to subsequently
prepare and analyse the two resulting fractions as distinct samples.
2.1.3.3.3.
Sub-sampling and grinding: at least 50 g of the sample shall be sub-sampled for analysis and subsequently
ground.
2.1.3.3.4.
Extraction and preparation of the sediment: a portion of 10 g (accurate to 0,01 g) of the ground sub-
sample shall be transferred into the separation funnel or conical bottomed settling beaker and 50 ml of
tetrachloroethylene shall be added. The portion transferred into the funnel shall be limited to 3 g in case of
fishmeal or other pure animal products, mineral ingredients or premixes which generate more than 10 % of
sediment. The mixture shall be vigorously shaken for at least 30 s and at least 50 ml more of tetrach
loroethylene shall be added cautiously while washing down the inside surface of the funnel to remove any
adhering particles. The resulting mixture shall be left to stand for at least 5 minutes before the sediment is
separated off by opening the stopcock.
If a conical bottomed settling beaker is used then the mixture shall be vigorously stirred for at least 15 s
and any particles adhering to the side of the beaker shall be carefully washed down the inside surface with
at least 10 ml of clean tetrachloroethylene. The mixture shall be left to stand for 3 minutes and then stirred
again for 15 seconds and any particles adhering to the side of the beaker shall be carefully washed down
the inside surface with at least 10 ml of clean tetrachloroethylene. The resulting mixture shall be left to
stand for at least 5 minutes and then the liquid fraction is removed and discarded by careful decanting,
taking care not to lose any of the sediment.
The sediment shall be dried and subsequently weighed (accurate to 0,001 g). If more than 5 % of the
sediment consists of particles > 0,50 mm, it shall be sieved at 0,25 mm and the two resulting fractions
shall be examined.
2.1.3.3.5.
Extraction and preparation of the flotate: after recovery of the sediment with the method described above,
two phases should remain in the separation funnel: a liquid one consisting of tetrachloroethylene and a
solid one made of floating material. This solid phase is the flotate and shall be recovered by pouring off
completely tetrachloroethylene from the funnel by opening the stopcock. By inverting the separation
funnel, the flotate shall be transferred into a large Petri dish and air dried in a fumehood. If more than
5 % of the flotate consists of particles > 0,50 mm, it shall be sieved at 0,25 mm and the two resulting
fractions shall be examined.
2.1.3.3.6.
Preparation of raw material: a portion of at least 5 g of the ground sub-sample shall be prepared. If more
than 5 % of the material consists of particles > 0,50 mm, it shall be sieved at 0,25 mm and the two
resulting fractions shall be examined.
2.1.3.4.
Preparation of samples consisting of fat or oil
The following protocol shall be followed for the preparation of samples consisting of fat or oil:
— if the fat is solid, it shall be warmed in a oven until it is liquid.
— by using a pipette, 40 ml of fat or oil shall be transferred from the bottom of the sample to a
centrifugation tube.
— centrifuge during 10 minutes at 4 000 r.p.m.
— if the fat is solid after centrifugation, it shall be warmed in an oven until it is liquid.
— repeat the centrifugation during 5 minutes at 4 000 r.p.m.

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L 20/38
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Official Journal of the European Union
23.1.2013
— by using a small spoon or a spatula, one half of the decanted impurities shall be transferred to
microscopic slides for examination, Glycerol is recommended as mounting medium.
— the remaining impurities shall be used for preparing the sediment as described in point 2.1.3.3.
2.1.3.5. Use
of
staining
reagents
In order to facilitate the correct identification of the constituents of animal origin, the operator may use
staining reagents during the sample preparation in accordance with guidelines issued by the EURL-AP and
published on its website.
In case Alizarin Red solution is used to colour the sediment, the following protocol shall apply:
— the dried sediment shall be transferred into a glass test tube and rinsed twice with approximately 5 ml
of ethanol (each time a vortex of 30 s shall be used, the solvent shall be let settle about 1 min 30 s and
poured off).
— the sediment shall be bleached by adding at least 1 ml sodium hypochlorite solution. The reaction shall
be allowed to continue for 10 min. The tube shall be filled with water, the sediment shall be let settle
2-3 min, and the water and the suspended particles shall be poured off gently.
— the sediment shall be rinsed twice more with about 10 ml of water (a vortex shall be used for 30 s, let
settle, and pour off the water each time).
— 2 to 10 drops of the Alizarin Red solution shall be added and the mixture shall be vortexed. The
reaction shall be let occur for 30 s and the coloured sediment shall be rinsed twice with approximately
5 ml ethanol followed by one rinse with acetone (each time a vortex of 30 s shall be used, the solvent
shall be let settle about 1 min and poured off).
— the coloured sediment shall be dried.
2.1.4. Microscopic
examination
2.1.4.1. Slide
preparation
Microscopic slides shall be prepared from the sediment and, depending of operator’s choice, from either the
flotate or the raw material. In case sieving has been used during the sample preparation, the two resulting
fractions (the fine and the coarse one) shall be prepared. Test portions of fractions spread on slides shall be
representative of the whole fraction.
A sufficient number of slides shall be prepared in order to ensure that a complete examination protocol as
laid down in point 2.1.4.2 can be carried-out.
Microscopic slides shall be mounted with the adequate mounting medium in accordance with the SOP
established by the EURL-AP and published on its website. The slides shall be covered with coverslips.
2.1.4.2.
Observation protocols for the detection of animal particles in compound feed and feed material
The prepared microscopic slides shall be observed in accordance with the observation protocols laid down
in diagram 1 for compound feed and feed materials other than pure fishmeal, or in diagram 2 for pure
fishmeal.
The microscopic observations shall be conducted using the compound microscope on the sediment and,
depending of the operator’s choice, either on the flotate or on the raw material. The stereomicroscope may
be used in addition to the compound microscope for the coarse fractions. Each slide shall be screened
entirely at various magnifications.
The minimum numbers of slides to be observed at each step of the observation protocol shall be strictly
respected unless the entire fraction material does not permit to reach the stipulated slide number. No more
than 6 slides per determination shall be observed.
In order to facilitate the identification of the particles’ nature and origin, the operator may use support
tools like decision support systems, image libraries and reference samples.

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EN
23.1.2013 Official
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of
the
European
Union L
20/39
Diagram 1
Observation protocol for the detection of animal particles in compound feed and feed material other than
fishmeal

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L 20/40
EN
Official Journal of the European Union
23.1.2013
Diagram 2
Observation protocol for the detection of animal particles in fishmeal

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EN
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European
Union L
20/41
2.1.4.3. Number
of
determinations
If following a first determination carried out in accordance with the observation protocol laid down in
diagram 1 or diagram 2 as relevant, no animal particle of a given nature (i.e. terrestrial animal or fish) is
detected, no additional determination is necessary and the result of the analysis shall be reported using the
terminology laid down in point 2.1.5.1.
If, following a first determination carried out in accordance with the observation protocols laid down in
diagram 1 or in diagram 2 as relevant, the total number of animal particles of a given nature (i.e. terrestrial
animal or fish) detected ranges from 1 to 5, a second determination shall be performed from a new 50 g
sub-sample. If, following this second determination, the number of animal particles of this given nature
detected ranges from 0 to 5, the result of the analysis shall be reported using the terminology laid down in
point 2.1.5.2., else a third determination shall be carried out from a new 50 g sub-sample. Nevertheless, if
following the first and the second determination, the sum of the particles of a given nature detected over
the two determinations is higher than 15, no additional determination is necessary and the result of the
analysis shall be directly reported using the terminology laid down in point 2.1.5.3. If, following the third
determination, the sum of the animal particles of a given nature detected over the three determinations is
higher than 15, the result of the analysis shall be reported using the terminology laid down in point
2.1.5.3. Otherwise, the result of the analysis shall be reported using the terminology laid down in point
2.1.5.2.
If following a first determination carried out in accordance with the observation protocols laid down in
diagram 1 or in diagram 2 as relevant, more than 5 animal particles of a given nature (i.e. terrestrial animal
or fish) are detected, the result of the analysis shall be reported using the terminology laid down in point
2.1.5.3.
2.1.5. Expression
of
the
results
When reporting the results, the laboratory shall indicate on which type of material the analysis has been
carried-out (sediment, flotate or raw material) and how many determinations have been carried-out.
The laboratory report shall at least contain information on the presence of constituents derived from
terrestrial animals and from fish.
The different situations shall be reported in the following ways.
2.1.5.1. No
animal
particle
of
a
given
nature
detected:
— as far as was discernible using a light microscope, no particle derived from terrestrial animals was
detected in the submitted sample,
— as far as was discernible using a light microscope, no particle derived from fish was detected in the
submitted sample.
2.1.5.2. Between
1
and
5
animal
particles
of
a
given
nature
detected
on
average:
— as far as was discernible using a light microscope, no more than 5 particles derived from terrestrial
animals were detected on average per determination in the submitted sample. The particles were
identified as … [bone, cartilage, muscle, hair, horn…]. This low level presence, being below the
limit of detection of the microscopic method, means that a risk of false positive result cannot be
excluded.
Or, as relevant,
— as far as was discernible using a light microscope, no more than 5 particles derived from fish were
detected on average per determination in the submitted sample. The particles were identified as …
[fishbone, fish scale, cartilage, muscle, otolith, gill…]. This low level presence, being below the limit of
detection of the microscopic method, means that a risk of false positive result cannot be excluded.
In case of sample pre-sieving, the laboratory report shall mention in which fraction (sieved fraction, pelleted
fraction or kernels) the animal particles have been detected insofar as the detection of animal particles only
in the sieved fraction may be the sign of an environmental contamination.
2.1.5.3. More
than
5
animal
particles
of
a
given
nature
detected
on
average
— as far as was discernible using a light microscope, more than 5 particles derived from terrestrial animals
were detected on average per determination in the submitted sample. The particles were identified as …
[bone, cartilage, muscle, hair, horn…].

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L 20/42
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Official Journal of the European Union
23.1.2013
Or, as relevant,
— as far as was discernible using a light microscope, more than 5 particles derived from fish were detected
on average per determination in the submitted sample. The particles were identified as … [fishbone, fish
scale, cartilage, muscle, otolith, gill…].
In case of sample pre-sieving, the laboratory report shall mention in which fraction (sieved fraction, pelleted
fraction or kernels) the animal particles have been detected insofar as the detection of animal particles only
in the sieved fraction may be the sign of an environmental contamination.
2.2. PCR
2.2.1. Principle
Deoxyribonucleic acid (DNA) fragments of animal origin which may be present in feed materials and
compound feed are detected by a genetic amplification technique through PCR, targeting species-specific
DNA sequences.
The PCR method first requires a DNA extraction step. The amplification step shall be applied afterwards to
the so-obtained DNA extract, in order to detect the animal species targeted by the assay.
2.2.2. Reagents
and
equipment
2.2.2.1. Reagents
2.2.2.1.1. Reagents
for
DNA
extraction
step
Only reagents approved by the EURL-AP and published on its website shall be used.
2.2.2.1.2. Reagents
for
genetic
amplification
step
2.2.2.1.2.1. Primers
and
probes
Only primers and probes with sequences of oligonucleotides validated by the EURL-AP shall be used ( 1 ).
2.2.2.1.2.2. Master
Mix
Only Master Mix solutions which do not contain reagents susceptible to lead to false results due to
presence of animal DNA shall be used ( 2 ).
2.2.2.1.2.3. Decontamination
reagents
2.2.2.1.2.3.1. Hydrochloric acid solution (0,1 N)
2.2.2.1.2.3.2. Bleach (solution of sodium hypochlorite at 0,15 % of active chlorine)
2.2.2.1.2.3.3. Non-corrosive reagents for decontaminating costly devices like analytical balances (e.g. DNA Erase TM of MP
Biomedicals)
2.2.2.2. Equipment
2.2.2.2.1. Analytical
balance
with
an
accuracy
of
0,001
g
2.2.2.2.2. Grinding
equipment
2.2.2.2.3. Thermocycler
enabling
real-time
PCR
2.2.2.2.4. Microcentrifuge
for
microfuge
tubes
2.2.2.2.5. Set
of
micropipettes
allowing
to
pipet
from
1
μl up to 1 000 μl
2.2.2.2.6. Standard
molecular
biology
plastic-ware:
microfuge
tubes,
filtered
plastic
tips
for
micropipettes,
plates
suitable for the thermocycler.
2.2.2.2.7. Freezers
to
store
samples
and
reagents
( 1 ) The list of these primers and probes for each animal species targeted by the assay is available on the EURL-AP website.
( 2 ) Examples of Master Mixes that are functional are available on the EURL-AP website.

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Union L
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2.2.3. Sampling
and
sample
preparation
2.2.3.1. Sampling
A representative sample, taken in accordance with the provisions laid down in Annex I, shall be used.
2.2.3.2. Sample
preparation
The preparation of laboratory samples up to DNA extraction shall comply with the requirements set out in
Annex II. At least 50 g of the sample shall be sub-sampled for analysis and subsequently ground.
The sample preparation shall be performed in a room different from the ones dedicated to DNA extraction
and to genetic amplification reactions as described by ISO 24276.
Two test portions of at least 100 mg each shall be prepared.
2.2.4. DNA
extraction
The DNA extraction shall be performed on each test portion prepared using the SOP established by the
EURL-AP and published on its website.
Two extraction controls shall be prepared for each extraction series as described by ISO 24276.
— an extraction blank control,
— a positive DNA extraction control.
2.2.5. Genetic
amplification
The genetic amplification shall be performed using the methods validated for each species requiring
identification. These methods are laid down in the SOP established by the EURL-AP and published on
its website. Each DNA extract shall be analysed at least at two different dilutions in order to evaluate
inhibition.
Two amplification controls shall be prepared per species target as described by ISO 24276.
— a positive DNA target control shall be used for each plate or series of PCR assays,
— an amplification reagent control (also called no template control) shall be used for each plate or series
of PCR assays.
2.2.6. Interpretation
and
expression
of
results
When reporting the results, the laboratory shall indicate at least the weight of the test portions used, the
extraction technique used, the number of determinations carried-out and the limit of detection of the
method.
Results shall not be interpreted and reported if the positive DNA extraction control and the positive DNA
target controls do not provide positive results for the target under assay while the amplification reagent
control is negative.
In case results from the two test portions are not consistent, at least the genetic amplification step shall be
repeated. If the laboratory suspects that the DNA extracts can be the cause of the inconsistency, a new
DNA extraction and a subsequent genetic amplification shall be performed before interpreting the results.
The final expression of the results shall be based on the integration and the interpretation of the results of
the two test portions in accordance with the SOP established by the EURL-AP and published on its website.
2.2.6.1. Negative
result
A negative result shall be reported as follows:
No DNA from X was detected in the submitted sample (with X being the animal species or group of
animal species that is targeted by the assay).
2.2.6.2. Positive
result
A positive result shall be reported as follows:
DNA from X was detected in the submitted sample (with X being the animal species or group of animal
species that is targeted by the assay).’

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