Summary LAS – Rodents
Legisla(on
Exercise:
• Ta,ooing a number in a mouse’s ear for iden6fica6on purposes à this is not an animal
experiment, because marking an animal is not an animal experiment when it’s not invasive (so
it IS an animal experiment when it is invasive, and it exceeds the threshold)
• Anaesthe6ze a rat and carry out measurements on intes6nal func6on in intes6nal loops that
are clamped during the surgery (made ischemic). Kill the animal before it awakens with an
overdose of anesthe6cs à you perform a lot of experiments, while the animal is alive. So the
animal can experience pain, so it is an animal experiment.
• Humanely killing a chicken upon arrival to collect brain 6ssue à Not an animal experiment
• Sedate (via injec6on) a Bonobo and collect a blood sample to aid in the diagnosis of a possible
disease (it is feeling sick) and take some extra 100 ul for experimental purposes (gene analysis)
à you are using a bonobo, which is not allowed. So it is not an animal experiment
European level
• EU direc0ve 2010/63/EU
– The member states who signed and ra6fied the direc6ve must implement it into their
legisla6on.
– … EU direc6ve 1986/609/EEG
o was implemented in the law of 1986
o Led to a Royal Decree in 1993 (now replaced by RD 2013, which implemented
the changes because of 2010/63/EU)
• European; shared by many European countries
– Member states can ra6fy the direc6ve into na6onal legisla6on
– Implemented in the Belgian legisla6on in 1993
– Law was put in Royal Decree
EU direc6ve came up with a new direc6ve in 2010 which needs to be implemented in the law
Na0onal level (Belgium)
• Law animal welfare 1986
– More on the meta level: on every animal
• Royal Decree 30.11.01 Verbod op sommige dierproeven
• Royal Decree 29.05.13 Protec0on Laboratory animals incl annexes
• Decree 17.02.2017 Protec0on laboratory animals (changes)
• Decree 22.02.2017 Composi6on Vlaamse proefdierencommissie
• Vlaamse Codex Dierenwelzijn 2023
• Law
– Voted by parliament
– It takes a lot of 6me to change the law or to make up a new level
• Royal Decree
– Guideline on the law (but mandatory to follow)
– Decided via the federal parliament
– Decree = how the law should be put in prac6ce
• Decree = everything aaer 2013
– Guideline on the law (but mandatory to follow)
– Decided by the regional parliament
, • In 2014 animal welfare moved as a responsibility to the region level
– In 2014 responsibility for animal welfare was changed from federal level to the
different regions, therefore the royal was removed
o How the law of animal welfare is interpreted or put into prac6ce can be
differentent in flanders than in the french speaking part of Belgium
• We have an animal welfare law and how to interpret this law is decided by Flanders, Brussels
and the French speaking part of Belgium
• In 2024: Vlaamse Codes Dierenwelzijn
– Repeated what was men6oned in the previous decrees à will be implemented in
januari of 2025
In a nutshell: The protec6on of laboratory animals in Belgium/Flanders is basically ensured by the
Animal Welfare Law 1986 concerning the protec6on and welfare of animals and the Royal Decree of
1993 replaced by the Royal Decree of 2013 concerning the protec6on of laboratory animals.
à The legisla6on is the animal welfare law and everyhing is more detailed in the Decree
• Belgische grondwet / Consitu0on 2024
- Animals are sen6ent beings and their welfare should be protected.
- Note: all laws, decrees should comply with the cons6tu6on.
• The protec0on of laboratory animals in Belgium/Flanders is ensured by the Animal Welfare
Law 1986 concerning the protec0on and welfare of animals and the Royal Decree of 1993
replaced by the Royal Decree of 2013 concerning the protec0on of laboratory animals.
• Vlaamse Codex dierenwelzijn 2024 – starts 1/1/2025
- Sen6ence
- Vertebrates (unless specified)
Laboratory animal
Animal welfare law 1986
Art 3 - 15. Laboratory animal:
1. The living cephalopods used or intended for use in animal experiments, or which are
specifically kept so that their organs or 6ssues can be used for scien6fic purposes;
2. The living non-human vertebrates used or intended for use in animal experiments, or which
are kept specifically so that their organs or 6ssues may be used for scien6fic purposes,
including their self-feeding larval forms, as well as fetal forms of mammals from entry of the
last third of their normal development;
3. This defini6on also applies to animals used in animal experiments that are at an earlier stage
of development than the one in sec6on 15.2. if these animals are required to survive beyond
that stage of development and are in danger of suffering pain, suffering, distress or las0ng
harm aaer reaching that stage as a result of the animal experiments performed;
• What do we consider a laboratory animal?
– Cephalopods and non-human vertebrates à when these animals or their organs or
6ssues are used for experimental studies
o Drosophila is not a vertebrate = not a laboratory animal à you don’t need to
report that
– Dog as pet: animal welfare legisla6on but it is not a laboratory animal so certain
decrees you do not to take in considera6on
– self-feeding larval forms, as well as fetal forms of mammals from entry of the last third
of their normal development.
o Prior to the cell feeding phase: not a laboratory animal
– If you use a fetus, that is before the 3rd semester, but the animal survives beyond this
boarder (animal is for example born) à it is considered as a laboratory animal
,Art. 23. § 1. The Flemish Government can lay down rules regarding the origin of the experimental
animals and determine special condi6ons with regard to keeping laboratory animals of different
categories. The Flemish Government can also prescribe rules to determine and monitor the origin of
the animals. However, dogs and cats must be registered with an indica6on of their origin.
• In this animal welfare law, the local government can give more specifica6ons
– Flemish government: Demand that certain animal species very frequently used in
experiments should be purposed bred
o The animals should be purpose-bred by a breeder that has a license!
RD2013 annex 1
• All species that are listed here (slide 6) you should buy them by a licensed breeder, and they
should be breed to be used in an experiment
• These breeders should be licensed
– Standardized circumstances, some6mes training of animals à increase quality of
animals
• Use of monkeys is approved but they cannot be caught from the wild
– They should be of the F2 genera6on
o But grandparents can come from the wild
RD2013 Purpose bred
There is a need for certain species of vertebrate animals used in procedures to be bred specifically for
that purpose so that their gene6c, biological, and behavioral background is well-known to persons
undertaking the procedures. Such knowledge increases the scien0fic quality and reliability of the
results and decreases the variability, resul0ng in fewer procedures and reduced animal use.
• You wll have more standardiza6on
• Historical data
• Less variability à you will need to use less animals
• Increase the robustness of the study
• Exemp6on in case animals in annex 1 are not available in sufficient numbers
– but necessary to prove this and
– guarantee that animals were bred in good circumstances and
– guarantee that with these animals, the scien6fic goals can be met, and with the same
numbers of animals
– approval from the government necessary
• For every rule there must be an exemp6on
– In case that are not available in sufficient numbers
o First you need to find prove that you don’t have enough numbers and
contacted enough breeder
o Approval of governments
o Show where you are going to buy the animals à you need to show that the
companies treat the animals good, how they were breed…
o You need to show that you get equivalent results
o The companies also need to ask approval to the government
à you prove to the government why you need these animals, and that they are bred in good
circumstances
RD2013 - What about animals not listed in the annex?
• must not be purpose-bred, but bred by a licensed breeder, supplier
– This assures some kind of quality and reduces variability.
– except farm animals (no license necessary) (not purpose-bred, no licensed breeder)
, • (Art 5) Can endangered species be used? No
– Exemp6on possible
o Proof that no other animal (or alterna6ve method) can be used
o Only for purposes
§ Basic research
§ Applied research
§ Development of drugs
§ Preserva6on of species
• (Art 7) can animals be ‘caught’ in the wild? Yes but
– License should be requested and approved by the government and
o ‘proof’ that no other animals (or alterna6ve methods) can be used
o Caught by a competent person
• (Art 8) Can stray or ferral animals be used ? No
– Exemp6on possible
o Proof that the stray, ferral animal is the subject of the scien6fic ques6on
o And that no other animals (or alterna6ve methods) can be used
Animals taken from the wild
= a previously free-living animal that has been captured or otherwise brought under the control of man
• Catching, handling, restraining or transpor0ng animals should not be considered an animal
experiment (even if it exceeds the threshold, e.g. when the animals have to be sedated to do
so), unless the scien6fic procedures are aimed (at least in part) at inves6ga6ng the catching,
handling, restraining or transpor6ng of animals. Nevertheless, even when this does not
cons6tute an animal experiment, it may involve laboratory animals for which the most refined
methods must always be used to ensure the animals' welfare.
• Many iden0fica0on methods cause pain, but this is not a regulated procedure.
• Equipping the animals with a tracking device
– Using a non-invasive method (e.g. , backpack with GPS transmi,er a,ached, collar with
a transmi,er, leg ring with integrated transponder, etc.) is not an animal experiment,
except when the threshold is expected to be exceeded.
– Equipping the animals with a tracking device by an invasive method (e.g. , transmi,er
implanta6on, etc.) is considered an animal experiment if the threshold is exceeded
(which will usually be the case given the invasive nature of the method).
• Buy from breeder à bring to lab à experiments starts when you give injec6on
• If we are catching animals in the wild because it is important for the scien6fic ques6on when
does the experiment start?
– The catching, handling and the transport is not part of animal experiment
– The experiment starts when you do scien6fic experiment
• To tag an animal is not animal experiment
• Tracking
– Non-invasive method à not animal experiment but it is up to the researcher to define
it does not limit the movement, that is not too heavy
RD2013
• Iden0fica0on
– See lecture minimally invasive procedures
– ! Not considered animal experiment
• Reference to animal experiment (approval number)
• Register in-out (weaned animals only)
Legisla(on
Exercise:
• Ta,ooing a number in a mouse’s ear for iden6fica6on purposes à this is not an animal
experiment, because marking an animal is not an animal experiment when it’s not invasive (so
it IS an animal experiment when it is invasive, and it exceeds the threshold)
• Anaesthe6ze a rat and carry out measurements on intes6nal func6on in intes6nal loops that
are clamped during the surgery (made ischemic). Kill the animal before it awakens with an
overdose of anesthe6cs à you perform a lot of experiments, while the animal is alive. So the
animal can experience pain, so it is an animal experiment.
• Humanely killing a chicken upon arrival to collect brain 6ssue à Not an animal experiment
• Sedate (via injec6on) a Bonobo and collect a blood sample to aid in the diagnosis of a possible
disease (it is feeling sick) and take some extra 100 ul for experimental purposes (gene analysis)
à you are using a bonobo, which is not allowed. So it is not an animal experiment
European level
• EU direc0ve 2010/63/EU
– The member states who signed and ra6fied the direc6ve must implement it into their
legisla6on.
– … EU direc6ve 1986/609/EEG
o was implemented in the law of 1986
o Led to a Royal Decree in 1993 (now replaced by RD 2013, which implemented
the changes because of 2010/63/EU)
• European; shared by many European countries
– Member states can ra6fy the direc6ve into na6onal legisla6on
– Implemented in the Belgian legisla6on in 1993
– Law was put in Royal Decree
EU direc6ve came up with a new direc6ve in 2010 which needs to be implemented in the law
Na0onal level (Belgium)
• Law animal welfare 1986
– More on the meta level: on every animal
• Royal Decree 30.11.01 Verbod op sommige dierproeven
• Royal Decree 29.05.13 Protec0on Laboratory animals incl annexes
• Decree 17.02.2017 Protec0on laboratory animals (changes)
• Decree 22.02.2017 Composi6on Vlaamse proefdierencommissie
• Vlaamse Codex Dierenwelzijn 2023
• Law
– Voted by parliament
– It takes a lot of 6me to change the law or to make up a new level
• Royal Decree
– Guideline on the law (but mandatory to follow)
– Decided via the federal parliament
– Decree = how the law should be put in prac6ce
• Decree = everything aaer 2013
– Guideline on the law (but mandatory to follow)
– Decided by the regional parliament
, • In 2014 animal welfare moved as a responsibility to the region level
– In 2014 responsibility for animal welfare was changed from federal level to the
different regions, therefore the royal was removed
o How the law of animal welfare is interpreted or put into prac6ce can be
differentent in flanders than in the french speaking part of Belgium
• We have an animal welfare law and how to interpret this law is decided by Flanders, Brussels
and the French speaking part of Belgium
• In 2024: Vlaamse Codes Dierenwelzijn
– Repeated what was men6oned in the previous decrees à will be implemented in
januari of 2025
In a nutshell: The protec6on of laboratory animals in Belgium/Flanders is basically ensured by the
Animal Welfare Law 1986 concerning the protec6on and welfare of animals and the Royal Decree of
1993 replaced by the Royal Decree of 2013 concerning the protec6on of laboratory animals.
à The legisla6on is the animal welfare law and everyhing is more detailed in the Decree
• Belgische grondwet / Consitu0on 2024
- Animals are sen6ent beings and their welfare should be protected.
- Note: all laws, decrees should comply with the cons6tu6on.
• The protec0on of laboratory animals in Belgium/Flanders is ensured by the Animal Welfare
Law 1986 concerning the protec0on and welfare of animals and the Royal Decree of 1993
replaced by the Royal Decree of 2013 concerning the protec0on of laboratory animals.
• Vlaamse Codex dierenwelzijn 2024 – starts 1/1/2025
- Sen6ence
- Vertebrates (unless specified)
Laboratory animal
Animal welfare law 1986
Art 3 - 15. Laboratory animal:
1. The living cephalopods used or intended for use in animal experiments, or which are
specifically kept so that their organs or 6ssues can be used for scien6fic purposes;
2. The living non-human vertebrates used or intended for use in animal experiments, or which
are kept specifically so that their organs or 6ssues may be used for scien6fic purposes,
including their self-feeding larval forms, as well as fetal forms of mammals from entry of the
last third of their normal development;
3. This defini6on also applies to animals used in animal experiments that are at an earlier stage
of development than the one in sec6on 15.2. if these animals are required to survive beyond
that stage of development and are in danger of suffering pain, suffering, distress or las0ng
harm aaer reaching that stage as a result of the animal experiments performed;
• What do we consider a laboratory animal?
– Cephalopods and non-human vertebrates à when these animals or their organs or
6ssues are used for experimental studies
o Drosophila is not a vertebrate = not a laboratory animal à you don’t need to
report that
– Dog as pet: animal welfare legisla6on but it is not a laboratory animal so certain
decrees you do not to take in considera6on
– self-feeding larval forms, as well as fetal forms of mammals from entry of the last third
of their normal development.
o Prior to the cell feeding phase: not a laboratory animal
– If you use a fetus, that is before the 3rd semester, but the animal survives beyond this
boarder (animal is for example born) à it is considered as a laboratory animal
,Art. 23. § 1. The Flemish Government can lay down rules regarding the origin of the experimental
animals and determine special condi6ons with regard to keeping laboratory animals of different
categories. The Flemish Government can also prescribe rules to determine and monitor the origin of
the animals. However, dogs and cats must be registered with an indica6on of their origin.
• In this animal welfare law, the local government can give more specifica6ons
– Flemish government: Demand that certain animal species very frequently used in
experiments should be purposed bred
o The animals should be purpose-bred by a breeder that has a license!
RD2013 annex 1
• All species that are listed here (slide 6) you should buy them by a licensed breeder, and they
should be breed to be used in an experiment
• These breeders should be licensed
– Standardized circumstances, some6mes training of animals à increase quality of
animals
• Use of monkeys is approved but they cannot be caught from the wild
– They should be of the F2 genera6on
o But grandparents can come from the wild
RD2013 Purpose bred
There is a need for certain species of vertebrate animals used in procedures to be bred specifically for
that purpose so that their gene6c, biological, and behavioral background is well-known to persons
undertaking the procedures. Such knowledge increases the scien0fic quality and reliability of the
results and decreases the variability, resul0ng in fewer procedures and reduced animal use.
• You wll have more standardiza6on
• Historical data
• Less variability à you will need to use less animals
• Increase the robustness of the study
• Exemp6on in case animals in annex 1 are not available in sufficient numbers
– but necessary to prove this and
– guarantee that animals were bred in good circumstances and
– guarantee that with these animals, the scien6fic goals can be met, and with the same
numbers of animals
– approval from the government necessary
• For every rule there must be an exemp6on
– In case that are not available in sufficient numbers
o First you need to find prove that you don’t have enough numbers and
contacted enough breeder
o Approval of governments
o Show where you are going to buy the animals à you need to show that the
companies treat the animals good, how they were breed…
o You need to show that you get equivalent results
o The companies also need to ask approval to the government
à you prove to the government why you need these animals, and that they are bred in good
circumstances
RD2013 - What about animals not listed in the annex?
• must not be purpose-bred, but bred by a licensed breeder, supplier
– This assures some kind of quality and reduces variability.
– except farm animals (no license necessary) (not purpose-bred, no licensed breeder)
, • (Art 5) Can endangered species be used? No
– Exemp6on possible
o Proof that no other animal (or alterna6ve method) can be used
o Only for purposes
§ Basic research
§ Applied research
§ Development of drugs
§ Preserva6on of species
• (Art 7) can animals be ‘caught’ in the wild? Yes but
– License should be requested and approved by the government and
o ‘proof’ that no other animals (or alterna6ve methods) can be used
o Caught by a competent person
• (Art 8) Can stray or ferral animals be used ? No
– Exemp6on possible
o Proof that the stray, ferral animal is the subject of the scien6fic ques6on
o And that no other animals (or alterna6ve methods) can be used
Animals taken from the wild
= a previously free-living animal that has been captured or otherwise brought under the control of man
• Catching, handling, restraining or transpor0ng animals should not be considered an animal
experiment (even if it exceeds the threshold, e.g. when the animals have to be sedated to do
so), unless the scien6fic procedures are aimed (at least in part) at inves6ga6ng the catching,
handling, restraining or transpor6ng of animals. Nevertheless, even when this does not
cons6tute an animal experiment, it may involve laboratory animals for which the most refined
methods must always be used to ensure the animals' welfare.
• Many iden0fica0on methods cause pain, but this is not a regulated procedure.
• Equipping the animals with a tracking device
– Using a non-invasive method (e.g. , backpack with GPS transmi,er a,ached, collar with
a transmi,er, leg ring with integrated transponder, etc.) is not an animal experiment,
except when the threshold is expected to be exceeded.
– Equipping the animals with a tracking device by an invasive method (e.g. , transmi,er
implanta6on, etc.) is considered an animal experiment if the threshold is exceeded
(which will usually be the case given the invasive nature of the method).
• Buy from breeder à bring to lab à experiments starts when you give injec6on
• If we are catching animals in the wild because it is important for the scien6fic ques6on when
does the experiment start?
– The catching, handling and the transport is not part of animal experiment
– The experiment starts when you do scien6fic experiment
• To tag an animal is not animal experiment
• Tracking
– Non-invasive method à not animal experiment but it is up to the researcher to define
it does not limit the movement, that is not too heavy
RD2013
• Iden0fica0on
– See lecture minimally invasive procedures
– ! Not considered animal experiment
• Reference to animal experiment (approval number)
• Register in-out (weaned animals only)
