2. Public consultation report on the Draft Guidance on stunning studies assessment criteria
EFSA supporting publication 2013:EN-530
TABLE OF CONTENTS
Abstract .................................................................................................................................................... 1
Table of contents ...................................................................................................................................... 2
Background as provided by EFSA ........................................................................................................... 3
Terms of reference as provided by EFSA ................................................................................................ 3
Consideration ........................................................................................................................................... 4
1. Public consultation .......................................................................................................................... 4
1.1. Comments received................................................................................................................. 4
1.2. Assessment of comments........................................................................................................ 4
Appendices............................................................................................................................................... 5
Appendix A. Explanatory text for the public consultation on the draft guidance on the assessment
criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at
the time of killing ..................................................................................................................................... 5
Appendix B. Full list of comments received on the draft guidance on the assessment criteria for
studies evaluating the effectiveness of stunning interventions regarding animal protection at the time
of killing……….. ..................................................................................................................................... 6
3. Public consultation report on the Draft Guidance on stunning studies assessment criteria
EFSA supporting publication 2013:EN-530
BACKGROUND AS PROVIDED BY EFSA
Council Regulation (EC) No 1099/2009 on the protection of animals at the time of killing defines
“stunning” in Article 2 (f) as “any intentionally induced process which causes loss of consciousness
and sensibility without pain including any process resulting in instantaneous death”. Annex I of the
Regulation lists the stunning interventions and related specifications. Article 4 on stunning
interventions regulates that “animals shall only be killed after stunning in accordance with the methods
and specific requirements related to the application of those methods set out in Annex I of the
Regulation” and “that the loss of consciousness and sensibility shall be maintained until the death of
the animal”. Furthermore, the methods referred to in Annex I which do not result in instantaneous
death shall be followed as quickly as possible by a procedure ensuring death such as bleeding, pithing,
electrocution or prolonged exposure to anoxia. Article 4 (2) of the Regulation allows the Commission
to amend Annex I to this Regulation as to take account of scientific and technical progress on the basis
of an opinion of the EFSA. Any such amendments shall ensure a level of animal welfare at least
equivalent to that ensured by the existing methods.
Several studies assessing the efficacy of modified protocols of stunning interventions listed in Annex I
or new stunning interventions have been submitted to the Commission who has requested EFSA's
view on the studies, and it is likely that more studies of stunning intervention efficacy will be carried
out and submitted to EFSA for assessment. Inconsistencies with reporting of intervention studies in
the animal health area have been documented in the past and the lack of harmonization of designing
and reporting intervention studies investigating stunning interventions’ efficacy has been specifically
identified as a drawback to assessing the proposed stunning interventions in previous EFSA opinions4
.
Therefore it is important to provide clear guidance to researchers on how these studies will be assessed
by EFSA, i.e. what minimum eligibility criteria, reporting quality criteria and further study quality
criteria need to be fulfilled for a given study so that it can be considered for assessment as a potential
alternative to the stunning methods and related specifications listed in Council Regulation (EC) No
1099/2009.
TERMS OF REFERENCE AS PROVIDED BY EFSA
The European Food Safety Authority requests the Animal Health and Welfare Panel to develop a
guidance document which defines the criteria against which studies evaluating the efficacy of
stunning interventions regarding animal protection during stunning will be assessed.
The guidance should comprise a checklist of reporting quality criteria, eligibility criteria and
further study quality criteria, accompanied with the scientific reasoning for each checklist item. It
should also provide a description of the guidance development process and explain how studies
will be evaluated. The guidance should cover mechanical, electrical and gas methods for the main
livestock species (bovines, sheep, goats, pigs, poultry, and rabbits).
Work done on the critical appraisal of scientific studies by the Scientific Assessment Support Unit
of EFSA should be considered during the preparation of the guidance document. A public
consultation of the guidance document will also be made before adoption of the guidance in
November 2013.
4
Scientific Opinion on the electrical requirements for waterbath stunning equipment applicable for poultry.
EFSA Journal 2012;10(6):2757 [80 pp.]. doi:10.2903/j.efsa.2012.2757
4. Public consultation report on the Draft Guidance on stunning studies assessment criteria
EFSA supporting publication 2013:EN-530
CONSIDERATION
1. Public consultation
In line with EFSA’s policy on openness and transparency, a web-consultation on the draft scientific
output was carried out from 15 July 2013 to 18 September 2013 in order to receive comments from the
scientific community, stakeholders and all interested parties. The public consultation was published
on-line with an invitation for submission of written comments by 18th September 2013. The
comments had to be sent exclusively by means of on-line submission form. Interested parties were
invited to submit comments and to refer to the line and page numbers. Technical criteria for not
considering the comments were also presented (Appendix A).
EFSA received comments from six interested parties. The comments were submitted by two private
institutes, a public institution, one national authority of an EU Member State, one regional authority of
an EU Member State and industry. A seventh comment was not eligible.
All eligible comments were recorded and assessed by the ad hoc Working Group of the AHAW Panel
on the guidance on the assessment criteria for studies evaluating the effectiveness of stunning
interventions regarding animal protection at the time of killing with the support of hearing experts at a
physical meeting. The working group members agreed on the changes to the guidance document
(Appendix B).
1.1. Comments received
The majority of the comments received concerned the eligibility criteria for the different intervention
methods. Several parties suggested additional specifications of parameters to be included with view to
properly characterising the stunning intervention. Some suggestions focussed on improving the clarity
of the guidance document.
1.2. Assessment of comments
The AHAW Panel considered all relevant comments in finalising the guidance document. Details of
the assessment and consequent changes made in finalising the guidance document can be found in
Appendix B.
5. Public consultation report on the Draft Guidance on stunning studies assessment criteria
EFSA supporting publication 2013:EN-530
APPENDICES
Appendix A. Explanatory text for the public consultation on the draft guidance on the
assessment criteria for studies evaluating the effectiveness of stunning interventions
regarding animal protection at the time of killing
In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments
from the scientific community and stakeholders, EFSA’s Panel on Animal Health and Welfare
(AHAW) has launched an open consultation on the draft Guidance on the assessment criteria for
studies evaluating the effectiveness of stunning interventions regarding animal protection at the time
of killing. This document defines the assessment process and the criteria that will be applied to studies
on alternative stunning methods to determine their eligibility for further assessment.
Interested parties are invited to submit written comments by 08 September 2013.
Comments regarding the clarity, comprehensiveness, relevance and practicality of the assessment
process and the evaluation criteria presented in the guidance are welcome.
Please use exclusively the electronic template provided with the documents to submit comments and
refer to the line and page numbers. Please note that comments submitted by e-mail or by post cannot
be taken into account and that a submission will not be considered if it is:
• submitted after the deadline set out in the call
• presented in any form other than what is provided for in the instructions and template
• not related to the contents of the document
• contains complaints against institutions, personal accusations, irrelevant or offensive
statements or material
• is related to policy or risk management aspects, which is out of the scope of EFSA's activity.
EFSA will assess all comments from interested parties which are submitted in line with the criteria
above. The comments will be further considered by the relevant EFSA Panel and taken into
consideration if found to be relevant.
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Appendix B. Full list of comments received on the draft guidance on the assessment criteria for studies evaluating the effectiveness of stunning
interventions regarding animal protection at the time of killing
Contributor Section Comment received EFSA comment
EU Member
State
national
authority 1
General
comments
1. Where a 1099/2009 method complies however a new
process is developed (i.e. captive bolt stunning on a
different position to that generally done for a given
species) are researchers expected to follow this
protocol?
2. There are several references across the document to
monitoring indicators – it would be helpful that this are
consistent with the monitoring indicators paper
currently on draft given that both documents are been
prepared under the umbrella of 1099/2009.
3. It would be helpful to have a statement to flag up that
all research studies need to conform with experimental
animal legislation and be carried out under license
issued by the authorities of the relevant country in
which the research takes place.
4. In some industries there are internationally agreed
procedures for testing under ISO (nanotechnology is
one example). I wonder if there is scope for exploring
agreed testing ISO standards for some of the stunning
processes to ensure consistency amongst specific parts
of research studies and ensure they are comparable (i.e.
EEG or ECoG). I did enquire within the British
Standards Institute and it would be possible to do
(though would take some time to get it agreed) however
I have not been able to take forward or explore further
yet.
5. We have funded a research project looking at stunning
piglets and goat kids by concussion as this is not
currently permitted by 1099/2009, however has been
common practice within industry on farm in the past –
given that this opinion considers LAPS, should it also
include concussion by a blow to the head ? We are not
aware of results at this stage, therefore I cannot
1. The AHAW Panel will follow the guidance in assessing
any new stunning method, be it a stunning procedure
included in the Regulation with changed parameters or a
completely new stunning procedure.
2. The indicators mentioned in the guidance are consistent
with those listed in the EFSA scientific opinions on
monitoring procedures at slaughterhouses.
3. A statement on the need for humane endpoints in
research and ethical approval of research has been added
to the document.
4. Applying internationally agreed upon procedures for
testing under ISO standards, while commendable, is
beyond the scope of the mandate.
5. The criteria and rules defined in this document apply also
to back-up stunning methods used in slaughterhouses.
While no detailed eligibility criteria for interventions
other than those already defined in the Regulation can be
provided in this document, the intervention has to be
reported in sufficient detail and the outcome eligibility
criteria must be fulfilled.
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comment on whether we will request in the future
EFSA to review this method for inclusion.
Public
institution
Assessment 1. This comment is a general one about the methodology
proposed. Overall, this guidance document provides
valuable information about the different aspects that
should be considered when assessing new stunning
method and may be considered as a good basis for the
development of such studies. However, it seems that
the proposed methodology intends to apply to
completely new stunning method. As an example, it is
written that “Indicators for recognising a successful stun
should be applied in slaughterhouse settings, after
their correlation with EEGs has been demonstrated
in controlled environment studies” but, on an other side,
EFSA will produce an opinion on “Monitoring
procedure at slaughterhouse” that includes a list of
indicators for assessing stunning efficiency. Therefore
we can suppose that this list may be used to assess signs
of uncounsciousness/consciousness without the need of
revalidation, in particular when assessing new variant of
well known method (eg captive bolt for bovine).
2. Furthermore, Regulation (EC) N° 1099/2009 allows the
Commission to amend Annex I on the basis of new
scientific evidence and that “Any such amendments
shall ensure a level of animal welfare at least
equivalent to that ensured by the existing methods”.
But, in the guidance document, there is no reference to
the comparison to existing methods. In my opinion, the
possibility to assess a new stunning method in
comparison to existing methods especially when based
on the same general principle may be an alternative to
laboratory studies.
3. Field study is of particular importance to assess the
variability of the results obtained with a stunning
method. Key parameters are relevant parameters but
details provide in tables seems sometimes difficult to
measure in practice and not very useful. On the
contrary, it seems to me that there is no information on
1. The indicators mentioned in this document to assess
unconsciousness and absence of pain, distress and
suffering are in agreement with the EFSA opinions on
monitoring procedures at slaughterhouse.
2. Any new stunning method, be it a stunning procedure
included in the Regulation with changed parameters or a
completely new stunning procedure, needs to be assessed
both in laboratory and under slaughterhouse conditions as
described in the guidance.
3. The guidance specifies that for each stunning intervention
description, the target parameters and their variances
need to be reported.
4. The scope of this document is limited to scientific
evidence for welfare at stunning.
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the definition of the objective. For example, when
assessing a new stunning, we will analyse average and
variability compared to expected values. Guidance to
choose expected values may be more relevant than
some requirements on detailed parameter. In
conclusion, I think that comparison to existing method
and analyse of the variability in slaughterhouse should
be an alternative to lab/field study in particular when
assessing new method based on the same general
principle of existing method. This option should be
evaluated by expert panel.
4. My last comment is a more practical one. The
methodology proposed is a very detailed one. But there
is a risk that it may be applicable in a very limited
number of situation because we can suppose that a very
few manufacturers will be able to carry out the whole
process due to resources needed and limited market.
EU Member
State
national
authority 1
1. Introduction 1. It would be helpful to know why stunning methods used
outside slaughterhouses are outside the scope of this
guidance? Annex 1 includes both stunning methods
type and there is no reason why the laboratory
assessment scrutiny process cannot be the same.
2. General aspects applicable to stunning methods– it
would be helpful to review the structure of this section
as it could be made more clear: Page 6 - Figure 2 – part
1 column 3 – suggest that bullets are numbered and
correlated with the relevant explanatory paragraphs
through this section (1-5); bullet 1 – suggest to add “and
key parameters” at the end;; page 6 - Paragraph 3 – this
correlates with bullet 5 from figure 2, part I column 3 if
a number correlation is included; Page 6 - Paragraph 4 –
this correlates with bullet 2; Page 7 – paragraph 4 –this
correlates with bullet 2 ; Page 7 – paragraph 5 – this
correlates with bullet 3 ; Page 7 – paragraph 6 – this
correlates with bullet 4
3. There is a requirement to re-stun and sacrifice animals
as they regain consciousness – it may be important to
flag up that this should be done in accordance with
1. A clarification was added that the scope of this document
is limited to stunning methods used at slaughter and does
not include depopulation nor on-farm killing.
2. The editorial comments have been addressed in the
document.
3. A comment on humane endpoints in research and the
need for ethical approval of research has been added to
the document.
4. While it is certainly important to study a relevant number
of animals, the required minimum number is a study-
specific decision.
5. This editorial comment has been addressed in the
document.
6. The suggestion to add “In addition animal welfare
indicators should be recorded until the time to loss of
consciousness” was accepted.
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relevant legislation under the Animal Scientific
Procedures – for some methods, such as high
concentration CO2 exposure there may need to be a
requirement to use a different stunning method for re-
stunning – again it may be helpful to flag this up.
4. Page 7 – paragraph 2 – does the guidance intend to
specify how many animals EFSA expects data from?
5. Page 7 – paragraph 3 – second line replace “been” for
“are”
6. I suggest to add “In addition AW indicators should be
recorded until the time to loss of consciousness” as per
B in section 2.1
EU Member
State
national
authority 1
2. Approach Page 8 - paragraph 4 (for the outcome) – it would be helpful
to clarify the two possible combinations = [A+C] or [B+C]
to avoid confusion between the insertion of OR / AND as
some may read this as A or [B+C]
The suggestions to change the formatting were followed in
the document.
EU Member
State
national
authority 1
2.3.
Methodological
quality criteria
Page 9 – paragraph 2 – line 2 “compared against those of
related studies”. This may not always be possible as a
current problem is that many studies are not comparable in
the inmediate future (i.e. water bath electrical stunning
papers). Suggest adding “where possible”.
The sentence was modified to “Appraisal of a study’s external
validity (i.e. its generalizability outside the study population)
requires that its results be assessed in the context of related
studies.” to account for this comment.
EU Member
State
regional
authority 1
2.1. Eligibility
criteria
Se puede deducir que el objetivo fundamental de todo el
documento es el control de un correcto aturdimiento ya que
se basa en que “ la pérdida de la conciencia deberia
mantenerse hasta la muerte del animal“ tal como se indica
en las líneas 2 y 3 de la pàgina 8.
Esto no siempre es así por los motivos siguientes :
1.- “ Hay métodos de aturdimiento donde los animales
pueden recuperar la consciencia durante los procedimientos
dolorosos subsiguientes ( pàgina 4, consideración 24 del
reglamento 1099/2009 sobre protección de los animales en
el sacrificio ) “.
2.- Un corte incorrecto/incompleto de los vasos sanguineos.
3.- En el caso del vacuno, la llegada importante de sangre al
cerebro a través de las arterias craneales.
Por todo ello, siempre hay que tener 2 tipos de
controles/indicadores en los mataderos :
This comment is not related to the scope of this guideline
document as it refers to monitoring procedures at
slaughterhouses.
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a) De un correcto aturdimiento.
b) De ausencia de vida antes del escaldado/faenado tal como
establece el Anexo III, punto 3.2 del Reglamento 1099/2009.
Y así hay que tenerlo presente en la elaboración de
guias/dictámenes.
EU Member
State
national
authority 1
3.1. Intervention 1. Page 9 – would the paper not need to demonstrate
compliance with relevant Article 3 requirements of
Regulation 1099 (i.e that it is humane) prior to
demonstrating whether it is simple stunning or not?
2. Page 9 – 3.1 – line 3 – Article 4.1 of Regulation 1099
defines simple stunning as those methods which do not
result in instantaneous death. This includes both
reversible and irreversible methods therefore the
guidance draft text needs amending to reflect this.
Suggest replacing “it needs to be demonstrated whether
the method is a simple stunning method or an
irreversible stunning method” by “it needs to be
demonstrated whether the [the method results in
instantaneous death (stunning) or not (simple stunning).
For simple stunning method it shall demonstrate
whether the stun is reversible or not] “
1. The need to demonstrate compliance with relevant
Article 3 requirements of Regulation 1099 (i.e that it is
humane) is covered in the introduction of the document.
2. This comment has been addressed by modifying the
phrase to “it needs to be demonstrated whether the
method results in immediate unconsciousness and
whether the stun is reversible or not”.
EU Member
State
national
authority 1
3.1.1.1.
Penetrative
captive bolt
1. Page 10 – Table 1 - bolt dimension/mass and velocity –
it may be helpful to consider the energy necessary to
stun an animal type as this will influence the parameters
covered here
2. Page 10 – Table 1 - type and size of animal – you may
wish to include “dimensions” as this are very relevant
of animal restraint purposes (i.e. will the head restraint
fit?, is the restraining box suitable? Is the distance
between the head of the animal and the slaughterman
suitable?)
3. Page 10 – Table 1 – equipment maintenance – it may be
helpful to include a reference to manufacturer
instructions here.
1. This can be derived from the mass and velocity which
need to be reported.
2. It is stated in the guidance document that authors are
expected to provide any information relevant to
describing the restraining system used. It is considered
that the detailed description of species and breed, age and
weight of the animals provides the information needed to
assess the study under scrutiny regarding this parameter.
3. The comment regarding equipment maintenance has been
addressed in the document by adding “Where
manufacturer maintenance instructions are available,
provide the details and how they were implemented.”
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EU Member
State
national
authority 1
3.1.1.2. Non-
penetrative
captive bolt
1. Page 10 -3.1.1.2 – line 2 – need to include poultry
alongside rabbits and hares.
2. Page 11 – Table 2 – comments on energy / animal
dimensions / reference to manufacturer instructions as
per Table 1 above.
1. The species was added to the text.
2. The suggested changes were made in the document.
Private
institute 1
3.1.2. Electrical
stunning methods
1. Page 12 Table 3 Description line 2: wrong spelling
“report the mark:space ratio” (not marks-spaced ratio)
Page 12 Table 3
2. Maximum stun-to-stick / kill interval: Describe also the
method of sticking (which blood vessels have been cut
(neck- or chest-cut) and how).
3. Maximum frequency /Lapse of frequency: Describe if
the frequency in each cycle stays on one level or if and
how it changes (many manufacturers use changing
frequencies, sometimes we do not know what effect this
has).
4. Description line 11: Provide information on the method
used for and the time intervals between consecutive
calibrations of the equipment (including transformer
and electrodes). This is of importance because the
cables and electrodes are often the reason for increasing
electrical resistance leading to different current
application.
5. Table 4 page 16 description line 17: spelling: shackling
(l is missing)
1. The spelling error was corrected.
2. The comment was addressed by requesting a description
of the exsanguination method applied in the study.
3. A respective specification was added to the waveform
section of the table.
4. The term “equipment” includes all components of the
stunning equipment used. Therefore, no change to the
text was considered necessary.
5. The spelling error has been corrected.
EU Member
State
national
authority 1
3.1.2.1. Head-
only and head-to-
body stunning
1. Page 12- 3.1.2.1 – line 1 “at the moment” – this implies
this particular method may be subject to change –
suggest consider a different wording to avoid confusion
2. Page 12 – Table 3 - minimum current level – there is 3
cycle equipment used in cattle – this should be included
alongside assurances that the 2nd and 3rd cycles will
not operate unless the first one is effective.
3. Page 13 – Table 3 – delivered minimum voltage –
should research papers describe somewhere the
mechanism by which the equipment works out the
resistance to adjust minimum current as/if necessary?
4. Page 13 – Table 3 Max. Stun-stick time – final 2 lines.
Why is the recommendation to only report the last
1. This point was changed accordingly in the guidance
document.
2. This comment was addressed by using the term “multiple
cycle system”.
3. The comment was addressed by adding the requirement
to describe how the preset constant current was applied.
4. The recommendation has been deleted from the table.
5. While the pressure applied and the contact achieved are
relevant points, it is not possible to measure/report them
in an objective way. Optimisation of the current flow
could be ascertained from the current profile, which is an
outcome.
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animal that did not recover consciousness rather than all
sampled animals?
5. Page 13 – Table 3 – electrode characteristics – suggest
this refers only to “electrode” and not to “stunning
tongs” as these fit later on within the type of electrode
row. Pressure required for good contact should be part
of the electrode characteristics to consider.
EU Member
State
national
authority 1
3.1.2.2. Electrical
waterbath
stunning
1. Page 14 – line 2-3: what if the study tries to validate
different currents to those in 1099?
2. Page 14 – line 8 – you could add the legal requirements
that the electrode should cover the full length of the
bath and that there should be breast support as per
Annex II 5.7 and 5.8.
3. Page 15 – prevention of electrical shocks – there is a
reference to other measures – note a breast comforter is
a legal requirement (Annex II 5.8)
4. Page 16 – Table 4 – electrical resistance/impedance –
leg keratinisation is considered – cleanliness and
wet/dry state are also factors which could impact
resistance and should be accounted for.
5. Page 16 – Table 4 – max. Shackle duration – this is now
a legal requirement and should be stated so – Annex II
5.2
1. The sentence “ The stunning intervention should be
carried out in accordance with the minimum currents laid
down in Table 2 of Annex I of Council Regulation (EC)
No 1099/2009 and exposure to the currents shall be for a
minimum duration of at least 4 seconds” was deleted.
2. The sentence “In addition, the legislation requires that the
shackles shall be wetted before live birds are shackled
and the birds should be hung by both legs. An alternative
method of slaughter should be used if birds are too small
for the waterbath stunner or if shackling is likely to
induce or increase pain (e.g. in visibly injured animal)”
was deleted.
3. The reference to breast comforters was considered not to
be relevant for this section.
4. The requirement was modified to “Provide details on the
species, breed, age, sex and weight of the birds and on
the cleanliness of the birds.”
5. The maximum duration permitted by law is stated in the
text and it has been specified in the table that it is the
legal limit.
EU Member
State
national
authority 1
3.1.3. Modified
atmosphere
stunning methods
1. Page 16 – 1st paragraph line4 – “this method is only
allowed for pigs {FOR SLAUGHTER} – check
consistency with 1099 Annex I
2. Page 17 – Animal stocking density – this should also
report the animal species/type (i.e. hens / chickens /
turkeys); Page 19 - Animal stocking density – this
should also report the animal species/type
1. The statement was removed as it was misleading.
2. It was specified that, in addition to animal density, which
should be expressed as number and kg per m , the
species, breed and age of animals need to be described.
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Private
institute 1
3.1.3. Modified
atmosphere
stunning methods
1. Table 5 page 17, Description 1st line: Specify the initial
CO2-concentration … and how long they are exposed
within; Table 5 page 17, description line 7: also the time
within lowest CO2 concentration is of importance and
also the time in the highest CO2 concentration
2. Description to quality of the gas description line 13:
besides humidity also the temperature within the
stunning equipment can have an impact, chicken can
bring a lot of temperature within stunning systems
3. Table 7 Description 3rd line: Specify the initial … and
how long they are exposed within.
4. Additional parameters in tables 5, 6 and 7 could be:
Light inside the stunning system and visibility (is it
possible to see the animals during the lapse through the
system?) and vibration.
1. The terms “lowest” and “highest” were changed to
“initial” and to “final” in the component field to reflect
the text in the description field of the table.
2. It was specified that it needs to be reported how and
when humidity of the gas and temperature inside the
chamber were monitored, and, if needed, adjusted.
3. The terms “lowest” and “highest” were changed to
“initial” and to “final” in the component field to reflect
the text in the description field of the table.
4. The working group considers that these issues are taken
care of in the outcome assessment section where it is
required that animals should be assessed for the absence
of pain, distress and suffering before the loss of
consciousness, which necessitates that animals can be
observed during this period.
Private
institute 1
3.1.3.4. Low
atmosphere
pressure
Table 8: Under the Parameter “Final pressure” also the
concentration of O2 is of importance
This sentence has been aligned with the respective
specification from the EFSA Scientific Opinion on Low
Atmosphere Pressure Systems for stunning.
EU Member
State
national
authority 1
3.1.3.4. Low
atmosphere
pressure
1. Page 21 – We have funded a research project looking at
stunning piglets and goat kids by concussion as this is
not currently permitted by 1099/2009 however it has
been common practice within industry on farm in the
past – given that this opinion considers LAPS should it
also include concussion by a blow to the head ? We are
not aware of results at this stage therefore I cannot
comment on whether we will request in the future
EFSA to review this method for inclusion.
2. Page 22 - Animal stocking density – this should also
report the animal species/type
1. The guidance considers all new or modified legal
stunning interventions and back-up stunning
interventions used at slaughter known to the AHAW
Panel at the initiation of the mandate.
2. It was specified that, in addition to animal density, which
should be expressed as number and kg per m , the
species, breed and age of animals need to be described.
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EU Member
State
regional
authority 1
3.2.1. Onset of
unconsciousness
and insensibility
En la pàgina 22, punto 3.2.1 sobre el inicio de la
inconciencia, dice que “ los métodos de aturdimiento
deberian inducir la pérdida de la inconciencia de manera
inmediata ( por ejemplo en menos de 1 segundo ) “, EFSA
2004.
Es por ello que en la elaboración de guias y dictámenes
habria que recomendar de cara al futuro la sustitución
progresiva del aturdimiento por CO2 en cerdos ( la
inconciencia llega en 15-20 segundos ) .
En la pàgina 2 del Reglamento CE 1099/2009 sobre
protección de los animales en el sacrificio dice que
actualmente por el tema económico no se recomienda la
eliminación pero reconoce que es un debate a seguir en el
futuro.
Hay que recordar que hasta el año 2012 se utilizaba el CO2
en aturdimiento de conejos y que actualmente no está
autorizado en esta especie por el citado Reglamento.
This comment is not related to the content of the guidance
document.
EU Member
State
national
authority 1
3.2.1. Onset of
unconsciousness
and insensibility
1. Page 22 – 3.2.1 line 3 (e.g. in less than one second) – I
am concerned about this example – electrical stunning
and captive bolt methods have to be immediate,
however the time delay of 1 second is in my view
unacceptable – at the moment delays to reach
unconsciousness when applying electrodes should be
within milliseconds figures – if, for example, an
electrical stunning method takes on average 1 second to
produce unconsciousness it should not be added to
1099.
2. Page 23 – final 2 paragraphs – Page 24 – final
paragraph line 2-3 – there is a recommendation for
collapse as indicator – check consistency for electrical
stunning indicators in the scientific monitoring opinion
to avoid confusion
3. Page 24 – bullet points – suggest to name A,B, C or
include numbers as preferred and clarify if it should be
A+B OR A+C // A+B OR C
4. Page 24 – final line – reference to electro
immobilisation – it would be helpful to consider
systems with 3 cycles (i.e. Jarvis box) as this would also
1. The example was removed from the document.
2. It has been assured that all references to the use of animal
based measures for welfare made in the guidance
document are consistent with the EFSA opinions on
monitoring procedures at slaughterhouses.
3. The text has been changed to “Therefore, in laboratory
condition studies, unconsciousness and insensibility can
be ascertained by the following EEG patterns:
• induction of a generalised epileptiform activity in the
brain, which can be recognised from the predominance of
8–13 Hz high-amplitude EEG activity, followed by a
quiescent EEG
OR
• an immediate onset of a quiescent EEG
OR
• no somatosensory, visual or auditory evoked responses
or potentials in the brain immediately after the stunning”
4. The document has been modified to consider also
multiple cycle systems.
5. The typing error has been corrected.
15. Public consultation report on the Draft Guidance on stunning studies assessment criteria
EFSA supporting publication 2013:EN-530 15
cause immobilisation. I am also aware that there is an
electrified landing platform for captive bolt stunned
cattle used in some countries (not permitted in UK as
we consider this does not allow recognition of effective
stunning) - this may need to be addressed here or in the
monitoring indicators scientific opinion.
5. Page 25 – line 8 from the bottom – there is a typo –
remove “to” between “Poultry” and “seems”
Private
institute 1
3.2.1.2. Electrical
stunning
1. Electrical stunning : The list of EEG patterns
ascertaining unconsciousness should be completed with
the duration during which these symptoms occur (see
Schütt-Abraham et al. 1983 cited in EFSA report on
stunning and killing 2004, page 128)
2. Page 25: first paragraph last sentence: lack of response
to painful stimuli this is not reasonable because external
stimuli can lead to reflexes which must not necessarily
mean, that the animal is suffering from it, I would
suggest to wait and see what happens during the
epileptic activity (tonic, tonic-clonic phase): Do
symptoms occur, which are incompatible with a full
epileptic fit?
3. Page 25 paragraph 7 last third: , hypercapnic hypoxia in
poultry to seems to result … (to must be erased)
1. The text has been changed to “Therefore, in laboratory
condition studies, unconsciousness and insensibility can
be ascertained by the following EEG patterns:
• induction of a generalised epileptiform activity in the
brain, which can be recognised from the predominance of
8–13 Hz high-amplitude EEG activity, followed by a
quiescent EEG
OR
• an immediate onset of a quiescent EEG
OR
• no somatosensory, visual or auditory evoked responses
or potentials in the brain immediately after the stunning”
2. It has been specified in the document that the sequence of
presence of tonic seizures after removal of the current
and apnoea during tonic seizures and lack of response to
painful stimuli needs to be applied to ascertain the
effectiveness of the stun.
3. The typing error has been corrected.
16. Public consultation report on the Draft Guidance on stunning studies assessment criteria
EFSA supporting publication 2013:EN-530 16
Industry 3.2.1.2. Electrical
stunning
1. Eligibility criteria to be complied with by stunning
procedures determine that the procedure (to be proposed
as an alternative) should be based on science and
legislation, and its outcome should give rise to:
immediate loss of consciousness and sensitivity OR
absence of pain, suffering and distress until loss of
consciousness and sensitivity AND duration of
unconsciousness and insensitivity (until death) as
follows on item “2.1 Eligibility criteria”. Regarding
criteria for the interventions’ outcome: In addition to the
animal welfare requisites defined in items A or B + C, it
is suggested that product quality criteria should be
included. Therefore, although the procedure is intended
to protect animal welfare at the moment of slaughtering,
meat quality criteria should be considered. By ensuring
this requisite, ethical principles that pervade discussions
on animal welfare, such as non-wasting of food and
sustainability of production, will be respected.
2. Regarding criteria for loss of sensitivity and
consciousness: The use of epilepsy as a reference for
detecting a state of unconsciousness and insensitivity is
controversial in literature, despite being well accepted.
A number of authors noted that as opposed to mammals,
birds not always demonstrate epilepsy following
electrical stunning: "Chickens, unlike red meat species,
do not show grand mal epilepsy in the brain following
electrical stunning.” (RAJ, 2003). “Poultry do not
usually produce the same type of epilepsy as the
redmeat species when they are electrically stunned. So,
for bird species the recommended minimum currents
have been based on other criteria.” (GREGORY, 1992,
and GREGORY, 1998). In Brazil, laboratory studies
(data not published yet) confirmed such findings by
demonstrating that the onset of epilepsy varies
considerably from one individual to another and is not
always evidenced, even in birds that are visibly stunned
and unconscious. This fact has been certified by means
of clinical signal analyses (abolition of somatosensory
1. Meat quality is outside the remit of this document. It has
to be acknowledged that for certain stunning methods,
e.g. multiple bird waterbath stunning, meat quality and
welfare targets are not reconcilable.
2. The interpretation of the referenced publications has
changed in the light of recent scientific understanding of
electrical waterbath stunning of poultry. In addition,
significant technological developments in the digital
recording and analysis of the EEG data also contributed
to a better understanding of the neurophysiological basis
of electrical stunning in poultry. Effective electrical
stunning of poultry produces epileptiform activity in the
brain (see references below) and therefore, the
requirements in this guidance are scientifically valid.
1) Raj, A.B.M. and O’Callaghan, M. 2004. Effect of
amount and frequency of head-only stunning currents on
the electroencephalograms and somatosensory evoked
potentials in broilers. Animal Welfare, 13: 159-170.
2) Raj, A.B.M. and O’Callaghan, M. 2004. Effects of
electrical water bath stunning current frequencies on the
spontaneous electroencephalograms and somatosensory
evoked potentials in hens. British Poultry Science, 45:
230-236.
3) Jackson, G. Raj, A.B.M., Lalies, M.D.M. and Hudson,
A.L. 2004. Identification of 5-HT1B autoreceptors in
hyperstriatal neurones of broiler chickens. British Journal
of Pharmacology, 138: Proceedings supplement 175P.
4) Raj, A.B.M., O’Callaghan, M. and Knowles, T. G.
2006. The effect of amount and frequency of alternating
current used in water bath stunning and neck cutting
methods on spontaneous electroencephalograms in
broilers. Animal Welfare, 15: 7-18.
5) Raj, A.B.M., O’Callaghan, M. and Hughes, S. I. 2006.
The effect of amount and frequency of pulsed direct
current used in water bath stunning and neck cutting
methods on spontaneous electroencephalograms in
broilers. Animal Welfare, 15: 19-24.
6) Raj, A.B.M., O’Callaghan, M. and Hughes, S. I. 2006.
17. Public consultation report on the Draft Guidance on stunning studies assessment criteria
EFSA supporting publication 2013:EN-530 17
evoked potentials (SEPs), induction of seizure and loss
of muscle tone or physical reflexes following electrical
stunning).
In addition, cerebral impedance tests have shown that
the estimated current and tension measured in birds’
brains is not significantly affected by the use of 200 Hz
frequency with a tension of 100 V and a current of 100
mA when compared to the electrical parameters
recommended by the Regulation (EC) 1099/2009.
Moreover, electrical parameters of the same magnitude
acting on the brains of birds were unable to produce the
same epilepsy effect in different individuals, although
all birds have shown the absence of induced
somatosensory, visual or aural signals.
Therefore, the adoption of epilepsy as the only criteria
for analyses of the stunning efficacy has important
technical limitations. The suggestion is for
consideration of the amount of electrical current that
reaches birds' brain and its relation with clinical signals
in birds (i.e. confirmation of an absence of induced
somatosensory, visual or aural signals) to be considered
as an additional criteria. Such methodological increment
would consider a likely variation among individuals and
the likelihood of the absence of epilepsy, thus avoiding
the setbacks found in scientific literature and preserving
the broadly accepted criteria of analyses based on the
animal response.
References:
Gregory, N.G. 1998. Animal welfare and meat science.
CABI Publishing, Wallingford,UK.
Raj, A. B. M. (2003): A critical appraisal of electrical
stunning in chickens.World`s Poultry Science Journal
59, 89-98
The effects of pulse width of a pulsed direct current used
in water bath stunning and neck cutting methods on
spontaneous electroencephalograms in broilers. Animal
Welfare, 15: 25-30.
Private
institute 1
3.2.2. Absence of
pain, distress and
suffering until the
loss of
unconsciousness
Page 29 second paragraph first sentence: at least one of the
two additional … (of is missing)
The typing error has been corrected.
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EFSA supporting publication 2013:EN-530 18
and sensibility
EU Member
State
national
authority 1
3.2.2.
Absence of pain,
distress and
suffering until the
loss of
unconsciousness
and sensibility
1. Page 26 – 3.2.2 – line 1-2 this is very important and
relates to my comment under 3.1 on humanness been a
prerequisite before a stun method is taken further into
research to look at simple stun etc.
2. Page 26 – line 3 – “mechanical and electrical stunning
induce immediate unconsciousness” – this should be
considered carefully – this is the outcome, however
whilst a new method is researched this needs to be
demonstrated. Further it is important to ensure lack of
pain, distress and suffering during the application of the
stun method (i.e. a captive bolt that needs to rest in the
animals head before shooting to achieve
unconsciousness resulting in pain caused at the time of
pressing the trigger)
1. This issue is taken into consideration in the section on
general aspects of stunning research.
2. The sentence has been removed from the document.
EU Member
State
national
authority 1
3.2.3. Duration of
unconsciousness
and insensibility
1. Page 29 – 3.2.3 paragraph 1 line7 – researchers
presenting new stun methods for 1099 should use
indicators consistent with the monitoring indicators
scientific opinion, unless new indicators are described
for a given method, in which case they will have to be
validated.
2. Page 29 – 3.2.3 paragraph 3 – reference to EFSA 2004
opinion on indicators –this should refer to the 1099
monitoring indicators opinion where possible.
1. Consistency with the EFSA scientific opinions on
monitoring procedures at slaughterhouses has been
assured in this document.
2. A reference to the EFSA scientific opinions on
monitoring procedures at slaughterhouses has been added
to the document.
19. Public consultation report on the Draft Guidance on stunning studies assessment criteria
EFSA supporting publication 2013:EN-530 19
Private
institute 2
3.2.3. Duration of
unconsciousness
and insensibility
Duration of Unconsciousness and Insensibility During the
Slaughter of Sheep Stunned Using Electronarcosis.
My clinical records show there is a risk of sensibility where
sheep are stunned by electronarcosis prior to slaughter.
Particularly where sheep are hoisted after shackling and the
completion of the incision of the carotids takes over 20
seconds from the stun. The tonic phase turns into the clonic
phase, while the carotid incision initiates a fresh Grand Mal
,probably due to to a fresh Glutamate and Aspartate surge.
These sheep show a 15 second traverse by the third eyelid of
the eyeball during this surge. During this phase the corneal,
palpebral and pupillary reflexes cannot be elicited. After this
15 seconds the corneal,palpebral and pupillary reflexes
return until 40 seconds plus in lambs and 60 seconds plus in
older sheep, timed from the incision of the carotids.
Whereas un-hoisted lambs presented to the stunner in a vee
restrainer have their carotids severed within 6 seconds of the
completion of the electric stun. These lambs are within the
tonic phase of the first Grand Mal, the incision of the
carotids initiates an additional Grand Mal type seizure,
which takes a further 15 seconds for the third eyelid to
traverse the eyeball, after which no corneal or other reflex
were found.
Whereas one found that lambs which have undergone non-
stunned slaughter remain on a cradle for 20 seconds or until
unconsciousness prevails, when hoisted swinging in an
inverted position, they can show corneal reflexes for over 60
seconds. Some of these lambs show in the first 15 seconds a
partial or complete traverse of the third eyelid across the
eyeball. These non-stunned hoisted lambs take longer to die
than the electrically stunned hoisted lambs, with the non-
hoisted lambs stunned and incised within 6 seconds taking
least time to die.
Hoisting and swinging of inverted sheep may distribute
fresh blood to the Circle of Willis by increased gravitational
force. This may be similar to the resuscitation of new born
lambs by swinging them and increasing gravitational force
within the lamb's circulation bathing its brain. The increase
The points raised in relation to the prolonged stun to stick
intervals are covered in the intervention eligibility criteria in
the parameter on maximum stun to stick intervals.
20. Public consultation report on the Draft Guidance on stunning studies assessment criteria
EFSA supporting publication 2013:EN-530 20
in blood supply to the Circle of Willis may lead to the
increased risk of resurgence of sensibility which may occur
as a single episode or a drifting in and out of consciousness.
The use of non-lethal electronarcosis has been accepted by
many Religious Authorities, as a reversible method of
stunning sheep during slaughter to produce religiously
approved sheep meat. This method is a commonly used also
to stun sheep during slaughter for the secular market
throughout the EU.
The requirement to have animals continually unconscious
between stunning and death set down in EC Regulation
1099/2009 is in doubt in the systems, where electronarcosis
has been used for stunning prior to slaughter but has waned
after hoisting or prolonged stun to stick intervals or both.
All new systems proposed should be viewed against the
effects of hoisting of long stun to stick intervals intrinsic to
their operation in a slaughterhouse context.
EU Member
State
national
authority 1
5. Methodological
quality
Page 31 – 5 - paragraph 1 point 3 – “allow broad
applicability of the results to populations [insert: AND
EQUIPMENT] beyond those studied [insert: WHERE
POSSIBLE]. For any stunning method, the more parameters
that can be given to help validating different equipment
which stuns following that method (i.e. energy delivered)
the better. In relation to different populations this should
only be done where possible (i.e. gas mixtures in broilers
versus waterfowl]
The sentence has been changed to “….3. allow broad
applicability of the results beyond any single study (= external
validity) “. The other points raised in the comment refer to
intervention eligibility criteria and are taken care of in that
section.
