PROTECTION OF ANIMALS USED FOR SCIENTIFIC PURPOSES REGULATIONS

USED FOR SCIENTIFIC PURPOSES

SUBSIDIARY LEGISLATION 439.20

PROTECTION OF ANIMALS USED

FOR SCIENTIFIC PURPOSES REGULATIONS

30th May, 2017

LEGAL NOTICE 161 of 2017, as amended by Legal Notices 231 and 297

of 2025.

(1)

The title of these regulations is the Protection

of Animals Used for Scientific Purposes Regulations.

(2) The scope of these regulations is to transpose Directive

2010/63/EU on the protection of animals used for scientific purposes.

(3) These regulations establish measures for the protection

of animals used for scientific or educational purposes and establish

the following rules

(a)

the replacement and reduction of the use of

animals in procedures and the refinement of the breeding,

accommodation, care and use of animals in procedures;

(b)

the origin, breeding, marking, care and

accommodation and killing of animals;

(c)

the operations of breeders, suppliers and users;

(d)

the evaluation and authorisation of projects

involving the use of animals in procedures.

(4) (a)

These regulations shall apply where animals

are used or intended to be used in procedures, or bred specifically so

that their organs or tissues may be used for scientific purposes.

(b)

These regulations shall apply until the animals

referred to in the first sub-regulation have been killed,

rehomed or returned to a suitable habitat or husbandry system.

(c)

The elimination of pain, suffering, distress or

lasting harm by the successful use of anaesthesia, analgesia or

other methods shall not exclude the use of an animal in

procedures from the scope of these regulations.

(5)

These regulations shall apply to the following animals

(a)

live non-human vertebrate animals, including

(i)

independently feeding larval forms; and

(ii) foetal forms of mammals as from the last

third of their normal development;

USED FOR SCIENTIFIC PURPOSES

(b)

live cephalopods.

(6) These regulations shall apply to animals used in

procedures, which are at an earlier stage of development than that

referred to in paragraph (a) of sub-regulation 5, if the animal is to be

allowed to live beyond that stage of development and, as a result of

the procedures performed, is likely to experience pain, suffering,

distress or lasting harm after it has reached that stage of development.

(7)

These regulations shall not apply to the following

(a)

non-experimental agricultural practices;

(b)

non-experimental clinical veterinary practices;

(c)

veterinary clinical trials required for the

marketing authorisation of a veterinary medicinal product;

(d)

practices undertaken for the purposes of

recognised animal husbandry;

(e)

practices undertaken for the primary purpose of

identification of an animal;

(f)

practices not likely to cause pain, suffering,

distress or lasting harm equivalent to, or higher than, that

caused by the introduction of a needle in accordance with good

veterinary practice.

(8) These regulations shall apply without prejudice to those

regulation relating to cosmetic products.

(1)

The competent authority of Malta may not

maintain in force any provisions which ensure more extensive

protection of animals falling within the scope of these regulations.

(2) The competent authority shall apply all such necessary

administrative measures according to the requirements of these

regulations to ensure that there is no breach thereto, and also to

reduce the risk for final consumers and any additional risk to animals

and to the environment. Such measures shall be in conformity with

the requirements of the food chain and animal health.

(3) These measures shall include the direct confiscation of

the product, the suspension of the activities carried out by the

breeder, supplier or user of animals, being primarily responsible for

animal welfare, and the withdrawal, forfeiture or suspension of the

authorisation, licence or permit with regard to such activities when

these are creating a risk to final consumers and to the environment.

The application of administrative fines and effective and dissuasive

USED FOR SCIENTIFIC PURPOSES

penalties in terms of articles 45 and 47 of the Act shall also apply in

this regard.

For the purposes of these regulations, the following

definitions shall apply

"the Act" means the Animal Welfare Act.

"breeder" means any natural or legal person breeding animals

referred to in Annex I with a view to their use in procedures or for the

use of their tissue or organs for scientific purposes, or breeding other

animals primarily for those purposes, whether for profit or not;

"competent authority" means the Directorate responsible for

Animal Welfare which is designated to carry out the obligations arising

from these regulations;

"Director" means the Director for Animal Welfare;

"establishment" means any installation, building, group of

buildings or other premises and may include a place that is not

wholly enclosed or covered and mobile facilities;

"procedure" means any use, invasive or non-invasive, of an

animal for experimental or other scientific purposes, with known or

unknown outcome, or educational purposes, which may cause the

animal a level of pain, suffering, distress or lasting harm equivalent

to, or higher than, that caused by the introduction of a needle in

accordance with good veterinary practice

Provided that this includes any course of action

intended, or liable, to result in the birth or hatching of an animal or

the creation and maintenance of a genetically modified animal line in

any such condition, but excludes the killing of animals solely for the

use of their organs or tissues;

"project" means a programme of work having a defined

scientific objective and involving one or more procedures;

"supplier" means any natural or legal person, other than a

breeder, supplying animals with a view to their use in procedures or

for the use of their tissue or organs for scientific purposes, whether

for profit or not;

"user" means any natural or legal person using animals in

procedures, whether for profit or not.

(1)

The competent authority shall ensure that,

wherever possible, a scientifically satisfactory method or testing

strategy, not entailing the use of live animals, shall be used instead of

a procedure.

USED FOR SCIENTIFIC PURPOSES

(2) The competent authority shall ensure that the number of

animals used in projects is reduced to a minimum without

compromising the objectives of the project.

(3) The competent authority shall ensure refinement of

breeding, accommodation and care, and of methods used in

procedures, eliminating or reducing to the minimum any possible

pain, suffering, distress or lasting harm to the animals.

(4) This regulation shall, in the choice of methods, be

implemented in accordance with regulation 13.

Procedures may be carried out for the following

purposes only

(a)

basic research;

(b)

translational or applied research with any of the

following aims

(i)

the avoidance, prevention, diagnosis or

treatment of disease, ill-health or other abnormality or

their effects in human beings, animals or plants;

(ii) the assessment, detection, regulation or

modification of physiological conditions in human

beings, animals or plants; or

(iii) the welfare of animals and the

improvement of the production conditions for animals

reared for agricultural purposes;

(c)

for any of the aims in paragraph (b) in the

development, manufacture or testing of the quality,

effectiveness and safety of drugs, foodstuffs and feed-stuffs

and other substances or products;

(d)

protection of the natural environment in the

interests of the health or welfare of human beings or animals;

(e)

research aimed at preservation of the species;

(f)

higher education, or training for the

acquisition, maintenance or improvement of vocational skills;

(g)

forensic inquiries.

(1)

The competent authority shall ensure that

animals are killed with minimum pain, suffering and distress.

(2)

The competent authority shall ensure that animals are

USED FOR SCIENTIFIC PURPOSES

killed in the establishment of a breeder, supplier or user, by a

competent person

Provided that, in the case of a field study an animal may

be killed by a competent person outside of an establishment.

(3) In relation to the animals covered by Annex IV, the

appropriate method of killing as set out in that Annex shall be used.

(4) Competent authorities may grant exemptions from the

requirement in sub-regulation (3)

(a)

to allow the use of another method provided

that, on the basis of scientific evidence, the method is

considered to be at least as humane; or

(b)

when, on the basis of scientific justification,

the purpose of the procedure cannot be achieved by the use of

a method of killing set out in Annex IV.

(5) Sub-regulations (2) and (3) shall not apply where an

animal has to be killed in emergency circumstances for animal-

welfare,

public-health,

public-security,

animal-health

or

environmental reasons.

(1)

Specimens of those endangered species listed

in Annex A to Council Regulation (EC) No 338/97 of 9 December

1996 on the protection of species of wild fauna and flora by

regulating trade therein, which do not fall within the scope of

Regulation 7(1) of that Regulation, shall not be used in procedures,

with the exception of those procedures meeting the following

conditions

(a)

the procedure has one of the purposes referred

to in paragraphs (b)(i), (c) or (e) of regulation 5; and

(b)

there is scientific justification to the effect that

the purpose of the procedure cannot be achieved by the use of

species other than those listed in that Annex.

(2) Sub-regulation (1) shall not apply to any species of non-

human primates.

(1)

Subject to sub-regulation (2), specimens of

non-human primates shall not be used in procedures, with the

exception of those procedures meeting the following conditions

(a)

the procedure has one of the purposes referred

to in

(i)

paragraphs (b)(i) or (c) of regulation 5

USED FOR SCIENTIFIC PURPOSES

and is undertaken with a view to the avoidance,

prevention, diagnosis or treatment of debilitating or

potentially life-threatening clinical conditions in human

beings; or

(ii)

paragraphs (a) or (e) of regulation 5; and

(b)

there is scientific justification to the effect that

the purpose of the procedure cannot be achieved by the use of

species other than non-human primates

Provided that a debilitating clinical condition

for the purposes of these regulations means a reduction in a

person’s normal physical or psychological ability to function.

(2) Specimens of non-human primates listed in Annex A to

Regulation (EC) No 338/97, which do not fall within the scope of

Regulation 7(1) of that Regulation, shall not be used in procedures,

with the exception of those procedures meeting the following

conditions

(a)

the procedure has one of the purposes referred

to in

(i)

paragraphs (b)(i) or (c) of regulation 5

and is undertaken with a view to the avoidance,

prevention, diagnosis or treatment of debilitating or

potentially life-threatening clinical conditions in human

beings; or

(ii)

paragraph (e) of regulation 5;

and

(b)

there is scientific justification to the

effect that the purpose of the procedure cannot be

achieved by the use of species other than non-human

primates and by the use of species not listed in that

Annex

Provided that notwithstanding sub-regulations

(1) and (2), great apes shall not be used in procedures,

subject to the use of the safeguard clause in regulation

55(2).

(1)

Animals taken from the wild shall not be used

in procedures.

(2) The competent authority will grant exemptions from

sub-regulation (1) on the basis of scientific justification to the effect

USED FOR SCIENTIFIC PURPOSES

that the purpose of the procedure cannot be achieved by the use of an

animal which has been bred for use in procedures.

(3) The capture of animals in the wild shall be carried out

only by competent persons using methods which do not cause the

animals avoidable pain, suffering, distress or lasting harm

Provided that any animal found, at or after capture, to be

injured or in poor health shall be examined by a veterinarian or

another competent person and action shall be taken to minimise the

suffering of the animal. The competent authority may grant

exemptions from the requirement of taking action to minimise the

suffering of the animal if there is scientific justification.

(1)

The competent authority shall ensure that

animals belonging to the species listed in Annex I may only be used

in procedures where those animals have been bred for use in

procedures

Provided that from the dates set out in Annex II, the

competent authority shall ensure that non-human primates listed

therein may be used in procedures only where they are the offspring

of non-human primates which have been bred in captivity or where

they are sourced from self-sustaining colonies

Provided further that for the purposes of this regulation a

‘self-sustaining colony’ means a colony in which animals are bred

only within the colony or sourced from other colonies but not taken

from the wild, and where the animals are kept in a way that ensures

that they are accustomed to humans.

(2) The competent authority may grant exemptions from

sub-regulation (1) on the basis of scientific justification.

(1)

Stray and feral animals of domestic species

shall not be used in procedures.

(2) The competent authority may only grant exemptions

from sub-regulation (1) subject to the following conditions

(a)

there is an essential need for studies concerning

the health and welfare of the animals or serious threats to the

environment or to human or animal health; and

(b)

there is scientific justification to the effect that

the purpose of the procedure can be achieved only by the use

of a stray or a feral animal.

(1)

The competent authority in Malta shall ensure

that procedures are carried out in a user’s establishment

USED FOR SCIENTIFIC PURPOSES

Provided that the competent authority may grant an exemption

from the first sub-regulation on the basis of scientific justification.

(2) Procedures may be carried out only within the

framework of a project.

(1)

The competent authority in Malta shall ensure

that a procedure is not carried out if another method or testing

strategy for obtaining the result sought, not entailing the use of a live

animal, is recognised under the legislation of the Union.

(2) In choosing between procedures, those which to the

greatest extent meet the following requirements shall be selected

(a)

use the minimum number of animals;

(b)

involve animals with the lowest capacity to

experience pain, suffering, distress or lasting harm;

(c)

cause the least pain, suffering, distress or

lasting harm,

and are most likely to provide satisfactory results.

(3) Death as the end-point of a procedure shall be avoided

as far as possible and replaced by early and humane end-points.

Where death as the end-point is unavoidable, the procedure shall be

designed so as to

(a)

result in the deaths of as few animals as

possible; and

(b)

reduce the duration and intensity of suffering to

the animal to the minimum possible and, as far as possible,

ensure a painless death.

(1)

The competent authority in Malta shall ensure

that, unless it is inappropriate, procedures are carried out under

general or local anaesthesia, and that analgesia or another appropriate

method is used to ensure that pain, suffering and distress are kept to a

minimum

Provided that procedures that involve serious injuries

that may cause severe pain shall not be carried out without

anaesthesia.

(2) When deciding on the appropriateness of using

anaesthesia, the following shall be taken into account

(a)

whether anaesthesia is judged to be more

traumatic to the animal than the procedure itself; and

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(b)

whether anaesthesia is incompatible with the

purpose of the procedure.

(3) The competent authority in Malta shall ensure that

animals are not given any drug to stop or restrict their showing pain

without an adequate level of anaesthesia or analgesia and in these

cases, a scientific justification shall be provided, accompanied by the

details of the anaesthetic or analgesic regimen.

(4) An animal, which may suffer pain once anaesthesia has

worn off, shall be treated with pre-emptive and post-operative

analgesics or other appropriate pain-relieving methods provided that

it is compatible with the purpose of the procedure.

(5) As soon as the purpose of the procedure has been

achieved appropriate action shall be taken to minimise the suffering

of the animal.

(1)

The competent authority in Malta shall ensure

that all procedures are classified as ‘non-recovery’, ‘mild’,

‘moderate’, or ‘severe’ on a case-by-case basis using the assignment

criteria set out in Annex VIII.

(2) Subject to the use of the safeguard clause in regulation

55(3), the competent authority in Malta shall ensure that a procedure

is not performed if it involves severe pain, suffering or distress that is

likely to be long-lasting and cannot be ameliorated.

(1)

The competent authority in Malta shall ensure

that an animal already used in one or more procedures, when a

different animal on which no procedure has previously been carried

out could also be used, may only be reused in a new procedure

provided that the following conditions are met

(a)

the actual severity of the previous procedures

was ‘mild’ or ‘moderate’;

(b)

it is demonstrated that the animal’s general

state of health and well-being has been fully restored;

(c)

the further procedure is classified as ‘mild’,

‘moderate’ or ‘non-recovery’; and

(d)

it is in accordance with veterinary advice,

taking into account the lifetime experience of the animal.

(2) In exceptional circumstances, by way of derogation

from of sub-regulation (1)(a) and after a veterinary examination of

the animal, the competent authority may allow reuse of an animal,

provided the animal has not been used more than once in a procedure

entailing severe pain, distress or equivalent suffering.

USED FOR SCIENTIFIC PURPOSES

(1)

A procedure shall be deemed to end when no

further observations are to be made for that procedure or, as regards

new genetically modified animal lines, when the progeny are no

longer observed or expected to experience pain, suffering, distress or

lasting harm equivalent to, or higher than, that caused by the

introduction of a needle.

(2) At the end of a procedure, a decision to keep an animal

alive shall be taken by a veterinarian or by another competent person.

An animal shall be killed when it is likely to remain in moderate or

severe pain, suffering, distress or lasting harm.

(3) Where an animal is to be kept alive, it shall receive care

and accommodation appropriate to its state of health.

Malta together with other Member States shall facilitate,

where appropriate, the establishment of programmes for the sharing

of organs and tissues of animals killed.

The competent authority in Malta may allow animals

used or intended to be used in procedures to be rehomed, or returned

to a suitable habitat or husbandry system appropriate to the species,

provided that the following conditions are met

(a)

the state of health of the animal allows it;

(b)

there is no danger to public health, animal

health or the environment; and

(c)

appropriate measures have been taken to

safeguard the well-being of the animal.

(1)

All breeders, suppliers and users are to be

authorised by, and registered with, the competent authority. Such

authorisation may be granted for a limited period

Provided that authorisation shall be granted only if the breeder,

supplier or user and its establishment is in compliance with the

requirements of these regulations.

(2) The authorisation shall specify the person responsible

for ensuring compliance with the provisions of these regulations and

the person or persons referred to in regulation 24(1) and in regulation

(1)

Meta min irabbi, il-fornitur jew l-utent ma

jibqax jikkonforma mar-rekwiżiti stabbiliti f'dawn ir-regolamenti, l-

awtorità kompetenti għandha tieħu azzjoni xierqa ta' rimedju, jew

tirrikjedi li din l-azzjoni għandha tittieħed, jew tissospendi jew tirtira

l-awtorizzazzjoni tagħha.

(2) Hija l-awtorità kompetenti li għandha tiżgura ruħha li,

meta l-awtorizzazzjoni tkun ġiet sospiża jew irtirata, it-trattament

xieraq tal-annimali li jibqa’ miżmum fl-istabbiliment ma jintlaqatx

ħażin.

(1)

L-awtorità kompetenti ta' Malta għandha

tiżgura ruħha li l-istabbilimenti kollha ta' min irabbi, ta’ fornitur jew

ta’ utent ikollhom stallazzjonijiet u tagħmir adatti għall-ispeċi ta'

annimali miżmumin u, fejn il-proċeduri huma mwettqa, għat-twettiq

tal-proċeduri.

(2) Id-disinn, il-kostruzzjoni u l-metodi tal-operat tal-

installazzjonijiet u t-tagħmir imsemmijin fis-subregolament (1)

għandhom jiżguraw li l-proċeduri jitwettqu bl-aktar mod effettiv

possibbli, u jimmiraw li jiksbu riżultati affidabbli bl-użu ta’ numru

minimu ta' annimali u jikkawżaw l-inqas ammont ta' wġigħ, tbatija,

skomfort jew ħsara fit-tul.

JINTUŻAW GĦAL SKOPIJIET XJENTIFIĊI

(3) Għall-finijiet tal-implimentazzjoni tas-subregolamenti

(1) u (2), l-awtorità kompetenti ta' Malta għandha tiżgura li jkun

hemm konformità mar-rekwiżiti rilevanti kif stipulati fl-Anness III

(1)

L-awtorità kompetenti f'Malta għandha tiżgura

li kull min irabbi, kull fornitur u kull utent ikollhom biżżejjed

persunal fil-post.

(2) Il-persunal għandu jiġi edukat adegwatament u mħareġġ

tajjeb qabel ma jwettaq kwalunkwe waħda mill-funzjonijiet li ġejjin

(a)

twettiq ta' proċeduri fuq annimali;

(b)

tfassil ta’ proċeduri u proġetti;

(ċ)

jieħu ħsieb l-annimali; jew

(d)

qtil ta' annimali

Iżda persuni li jwettqu l-funzjonijiet imsemmijin fil-

paragrafu (b) għandhom ikunu rċevew tagħlim f'xi dixxiplina

xjentifika rilevanti għax-xogħol li qed iwettqu u għandu jkollhom

konoxxenza ta’ speċji speċifiċi

Iżda wkoll il-persunal li jwettaq il-funzjonijiet

imsemmija fil-paragrafi (a), (ċ) jew (d) għandu jiġi sorveljat fit-

twettiq tal-kompiti tiegħu sakemm ikun wera l-kompetenza rikjesta

Iżda wkoll l-awtorità kompetenti f'Malta għandha

tiżgura, li r-rekwiżiti stabbiliti f'dan il-paragrafu jkunu sodisfatti,

permezz ta’ awtorizzazzjoni jew b'mezzi oħra.

(3) L-awtorità kompetenti f'Malta għandha tippubblika, fuq

il-bażi tal-elementi stipulati fl-Anness V, ir-rekwiżiti minimi rigward

l-edukazzjoni u t-taħriġ u r-rekwiżiti għall-kisba, iż-żamma u wiri tal-

kompetenza meħtieġa għall-funzjonijiet stabbiliti fis-subregolament

(2).

(1)

L-awtorità kompetenti f'Malta għandha tiżgura

li kull min irabbi, kull fornitur u kull utent ikollhom persuna jew

diversi persuni fuq il-post li għandhom

(a)

ikunu responsabbli biex jissorveljaw

it-

trattament xieraq u l-kura tal-annimali fl-istabbiliment;

(b)

jiżguraw li l-persunal li jittratta mal-annimali

jkollu aċċess għall-informazzjoni speċifika dwar l-ispeċi

miżmuma fl-istabbiliment;

(ċ)

ikunu responsabbli biex jiżguraw li l-persunal

ikun edukat b’mod adatt, kompetenti u mħarreġ kontinwament

JINTUŻAW GĦAL SKOPIJIET XJENTIFIĊI

u li jkun sorveljat sakemm juri l-kompetenza meħtieġa.

(2) L-awtorità kompetenti f'Malta għandha tiżgura li l-

persuni msemmija fir-regolament 40(2)(b) għandhom

(a)

jiżguraw li kwalunkwe uġigħ bla bżonn, tbatija,

skonfort jew ħsara fit-tul li qed tiġi eżerċitata fuq l-annimali

matul l-proċess titwaqqaf; u

(b)

jiżgura li l-proġetti jitwettqu f'konformità mal-

awtorizzazzjoni tal-proġett jew, fil-każijiet imsemmija fir-

regolament 42, skont l-applikazzjoni mibgħuta lill-awtorità

kompetenti jew kwalunkwe deċiżjoni meħuda mill-awtorità

kompetenti, u jiżguraw li fil-każ ta' nuqqas ta' konformità, il-

miżuri adatti biex jirrattifikawha jittieħdu u jiġu rreġistrati.

(3) Renewal of the authorisation shall be required for any

significant change to the structure or the function of an establishment

of a breeder, supplier or user that could negatively affect animal

welfare.

(4)

The competent authority in Malta is to ensure itself that

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it is to be notified of any changes of the person or persons referred to

in sub-regulation (2).

21. (1)

Where a breeder, supplier or user no longer

complies with the requirements set out in these regulations, the

competent authority shall take appropriate remedial action, or require

such action to be taken, or suspend or withdraw its authorisation.

(2) It is the competent authority that shall ensure itself that,

where the authorisation is suspended or withdrawn, the welfare of the

animals housed in the establishment is not adversely affected.

22. (1)

The Maltese competent authority shall ensure

itself that all establishments of a breeder, supplier or user have

installations and equipment suited to the species of animals housed

and, where procedures are carried out, to the performance of the

procedures.

(2) The design, construction and method of functioning of

the installations and equipment referred to in sub-regulation (1) shall

ensure that the procedures are carried out as effectively as possible,

and aim at obtaining reliable results using the minimum number of

animals and causing the minimum degree of pain, suffering, distress

or lasting harm.

(3) For the purposes of implementation of sub-regulations

(1) and (2), the Maltese competent authority shall ensure that the

relevant requirements as set out in Annex III are complied with.

23. (1)

The competent authority in Malta shall ensure

that each breeder, supplier and user has sufficient staff on site.

(2) The staff shall be adequately educated and trained

before they perform any of the following functions

(a)

carrying out procedures on animals;

(b)

designing procedures and projects;

(c)

taking care of animals; or

(d)

killing animals

Provided that persons carrying out the functions referred

to in paragraph (b) shall have received instruction in a scientific

discipline relevant to the work being undertaken and shall have

species-specific knowledge

Provided further that staff carrying out functions

referred to in paragraphs (a), (c) or (d) shall be supervised in the

performance of their tasks until they have demonstrated the requisite

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competence.

The competent authority in Malta shall ensure, through

authorisation or by other means, that the requirements laid down in

this paragraph are fulfilled.

(3) The competent authority in Malta shall publish, on the

basis of the elements set out in Annex V, minimum requirements with

regard to education and training and the requirements for obtaining,

maintaining and demonstrating requisite competence for the

functions set out in sub-regulation (2).

24. (1)

The competent authority in Malta shall ensure

that each breeder, supplier and user has one or several persons on site

who shall

(a)

be responsible for overseeing the welfare and

care of the animals in the establishment;

(b)

ensure that the staff dealing with animals have

access to information specific to the species housed in the

establishment;

(c)

be responsible for ensuring that the staff are

adequately educated, competent and continuously trained and

that they are supervised until they have demonstrated the

requisite competence.

(2) The competent authority in Malta shall ensure that

persons specified in regulation 40(2)(b) shall

(a)

ensure that any unnecessary pain, suffering,

distress or lasting harm that is being inflicted on an animal in

the course of a procedure is stopped; and

(b)

ensure that the projects are carried out in

accordance with the project authorisation or, in the cases

referred to in regulation 42, in accordance with the application

sent to the competent authority or any decision taken by the

competent authority, and ensure that in the event of non-

compliance, the appropriate measures to rectify it are taken

and recorded.

25. The Maltese competent authority shall ensure that each

breeder, supplier and user has a designated veterinarian with

expertise in laboratory animal medicine, or a suitably qualified expert

where more appropriate, charged with advisory duties in relation to

the well-being and treatment of the animals.

(1)

The competent authority in Malta shall ensure

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that each breeder, supplier and user sets up an animal-welfare body.

(2) The animal-welfare body shall include at least the

person or persons responsible for the welfare and care of the animals

and, in the case of a user, a scientific member. The animal-welfare

body shall also receive input from the designated veterinarian or the

expert referred to in regulation 25.

(3) The competent authority in Malta may allow small

breeders, suppliers and users to fulfil the tasks laid down in

regulation 27(1) by other means.

(1)

The animal-welfare body shall, as a minimum,

carry out the following tasks

(a)

advise the staff dealing with animals on matters

related to the welfare of animals, in relation to their

acquisition, accommodation, care and use;

(b)

advise the staff on the application of the

requirement of replacement, reduction and refinement, and

keep it informed of technical and scientific developments

concerning the application of that requirement;

(c)

establish and review internal operational

processes as regards monitoring, reporting and follow-up in

relation to the welfare of animals housed or used in the

establishment;

(d)

follow the development and outcome of

projects, taking into account the effect on the animals used,

and identify and advise as regards elements that further

contribute to replacement, reduction and refinement; and

(e)

advise on rehoming schemes, including the

appropriate socialisation of the animals to be rehomed.

(2) The competent authority shall ensure that the records of

any advice given by the animal-welfare body and decisions taken

regarding that advice are kept for at least 3 years

Provided that the records shall be made available to the

competent authority upon request.

The competent authority in Malta shall ensure that

breeders of non-human primates have a strategy in place for

increasing the proportion of animals that are the offspring of non-

human primates that have been bred in captivity.

Where rehoming takes place, the breeders, suppliers and

users from which animals are intended to be rehomed shall have a

USED FOR SCIENTIFIC PURPOSES

rehoming scheme in place that ensures socialisation of the animals

that are rehomed. In the case of wild animals, where appropriate, a

programme of rehabilitation shall be in place before they are returned

to their habitat.

(1)

The competent authority in Malta shall ensure

that all breeders, suppliers and users keep records of at least the

following

(a)

the number and the species of animals bred,

acquired, supplied, used in procedures, set-free or rehomed;

(b)

the origin of the animals, including whether

they are bred for use in procedures;

(c)

the dates on which the animals are acquired,

supplied, released or rehomed;

(d)

from whom the animals are acquired;

(e)

the name and address of the recipient of

animals;

(f)

the number and species of animals which died

or were killed in each establishment. For animals that have

died, the cause of death shall, when known, be noted; and

(g)

in the case of users, the projects in which

animals are used.

(2) The records referred to in sub-regulation (1) shall be

kept for a minimum of 5 years and made available to the competent

authority upon request.

(1)

The competent authority shall ensure that all

breeders, suppliers and users keep the following information on each

dog, cat and non-human primate

(a)

identity;

(b)

place and date of birth, when available;

(c)

whether it is bred for use in procedures; and

(d)

in the case of a non-human primate, whether it

is the offspring of non-human primates that have been bred in

captivity.

(2) Each dog, cat and non-human primate shall have an

individual history file, which follows the animal as long as it is kept

for the purposes of these regulations

USED FOR SCIENTIFIC PURPOSES

Provided that the file shall be established at birth or as

soon as possible thereafter and shall cover any relevant reproductive,

veterinary and social information on the individual animal and the

projects in which it has been used.

(3) The information referred to in this regulation shall be

kept for a minimum of 3 years after the death or rehoming of the

animal and shall be made available to the competent authority upon

request

Provided that in the case of rehoming, relevant

veterinary care and social information from the individual history file

referred to in sub-regulation (2) shall accompany the animal.

(1)

Each dog, cat or non-human primate shall be

provided, at the latest at the time of weaning, with a permanent

individual identification mark in the least painful manner possible.

(2) Where a dog, cat or non-human primate is transferred

from one breeder, supplier or user to another before it is weaned, and

it is not practicable to mark it beforehand, a record, specifying in

particular its mother, must be maintained by the receiver until it is

marked.

(3) Where an unmarked dog, cat or non-human primate,

which is weaned, is received by a breeder, supplier or user it shall be

permanently marked as soon as possible and in the least painful

manner possible.

(4) The breeder, supplier and user shall provide, at the

request of the competent authority, reasons for which the animal is

unmarked.

(1)

The competent authority in Malta shall, as far

as the care and accommodation of animals is concerned, ensure that

(a)

all animals are provided with accommodation,

an environment, food, water and care which are appropriate to

their health and well-being;

(b)

any restrictions on the extent to which an

animal can satisfy its physiological and ethological needs are

kept to a minimum;

(c)

the environmental conditions in which animals

are bred, kept or used are checked daily;

(d)

arrangements are made to ensure that any

defect or avoidable pain, suffering, distress or lasting harm

discovered is eliminated as quickly as possible; and

USED FOR SCIENTIFIC PURPOSES

(e)

animals are transported under appropriate

conditions.

(2) For the purposes of sub-regulation (1), the competent

authority in Malta shall ensure that the care and accommodation

standards set out in Annex III are applied from the dates provided for

therein.

(3) The competent authority in Malta may allow exemptions

from the requirements of sub-regulations (1)(a) or (2) for scientific,

animal-welfare or animal-health reasons.

(1)

The competent authority shall carry out regular

inspections of all breeders, suppliers and users, including their

establishments, to verify compliance with the requirements of these

regulations.

(2) The competent authority shall adapt the frequency of

inspections on the basis of a risk analysis for each establishment,

taking account of

(a)

the number and species of animals housed;

(b)

the record of the breeder, supplier or user in

complying with the requirements of these regulations;

(c)

the number and types of projects carried out by

the user in question; and

(d)

any information that might indicate non-

compliance.

(3) Inspections shall be carried out on at least one third of

the users each year in accordance with the risk analysis referred to in

sub-regulation (2). However, breeders, suppliers and users of non-

human primates shall be inspected at least once a year.

(4) An appropriate proportion of the inspections shall be

carried out without prior warning.

(5)

Records of all inspections shall be kept for at least 5

years.

(1)

The competent authority in Malta shall give all

necessary assistance to the experts of the Commission in carrying out

their duty to undertake controls of the infrastructure and operation of

national inspections in Malta whenever there is due reason for

concern, taking into account, inter alia, the proportion of inspections

carried out without prior warning.

(2)

The competent authority in Malta shall take measures to

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take account of the results of the control referred to in sub-regulation

(1).

(1)

Without prejudice to regulation 42, projects are

not carried out without prior authorisation from the competent

authority of Malta, and that projects are carried out in accordance

with the authorisation or, in the cases referred to in regulation 42, in

accordance with the application sent to the competent authority or

any decision taken by the competent authority.

(2) The competent authority in Malta shall ensure that no

project is carried out unless a favourable project evaluation by the

competent authority has been received in accordance with regulation

(1)

L-awtorità kompetenti ta' Malta għandha

tiżgura li applikazzjoni għal awtorizzazzjoni tal-proġett tiġi

JINTUŻAW GĦAL SKOPIJIET XJENTIFIĊI

sottomessa mill-utent jew mill-persuna responsabbli għall-proġett. L-

applikazzjoni għandha tinkludi mill-inqas dan li ġej

(a)

il-proposta tal-proġett;

(b)

sommarju mhux tekniku tal-proġett; u

(c)

informazzjoni dwar l-elementi stipulati fl-

Anness VI.

(2) L-awtorità kompetenti f'Malta tista’ jirrinunzja għall-

ħtieġa fis-subregolament (1)(b) għal proġetti msemmijin fir-

regolament 42 (1).

37. (1)

The competent authority of Malta shall ensure

that an application for project authorisation is submitted by the user

or the person responsible for the project. The application shall

include at least the following

(a)

the project proposal;

(b)

a non-technical project summary; and

(c)

information on the elements set out in Annex

VI.

(2) The competent authority in Malta may waive the

requirement in paragraph (b) for projects referred to in regulation

42(1).

38. (1)

The project evaluation shall be performed with

a degree of detail appropriate for the type of project and shall verify

that the project meets the following criteria

(a)

the project is justified from a scientific or

educational point of view or required by law;

(b)

the purposes of the project justify the use of

animals; and

(c)

the project is designed so as to enable

procedures to be carried out in the most humane and

environmentally sensitive manner possible.

(2)

The project evaluation shall consist in particular of the

following

(a)

an evaluation of the objectives of the project,

the predicted scientific benefits or educational value;

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(b)

an assessment of the compliance of the project

with the requirement of replacement, reduction and

refinement;

(c)

an assessment and assignment

of

the

classification of the severity of procedures;

(d)

a harm-benefit analysis of the project, to assess

whether the harm to the animals in terms of suffering, pain and

distress is justified by the expected outcome taking into

account ethical considerations, and may ultimately benefit

human beings, animals or the environment;

(e)

an assessment of any justification referred to in

regulations 6 to 12, 14, 16 and 33; and

(f)

a determination as to whether and when the

project should be assessed retrospectively.

(3) The competent authority carrying out the project

evaluation shall consider expertise in particular in the following

areas

(a)

the areas of scientific use for which animals

will be used including replacement, reduction and refinement

in the respective areas;

(b)

experimental design, including statistics where

appropriate;

(c)

veterinary practice in laboratory animal science

or wildlife veterinary practice where appropriate;

(d)

animal husbandry and care, in relation to the

species that are intended to be used.

(4)

The project evaluation process shall be transparent

Provided that subject to safeguarding intellectual

property and confidential information, the project evaluation shall be

performed in an impartial manner and may integrate the opinion of

independent parties.

(1)

In accordance with regulation 38(2)(f), the

retrospective assessment shall be carried out by the competent

authority which shall, on the basis of the necessary documentation

submitted by the user, evaluate the following

(a)

whether the objectives of the project were

achieved;

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(b)

the harm inflicted on animals, including the

numbers and species of animals used, and the severity of the

procedures; and

(c)

any elements that may contribute to the further

implementation of the requirement of replacement, reduction

and refinement.

(2) All projects using non-human primates and projects

involving procedures classified as ‘severe’, including those referred

to in regulation 15(2), shall undergo a retrospective assessment.

(3) Without prejudice to sub-regulation (2) and by way of

derogation from regulation 38(2)(f), the competent authority in Malta

may exempt projects involving only procedures classified as ‘mild’

or ‘non-recovery’ from the requirement for a retrospective

assessment.

(1)

The project authorisation shall be limited to

procedures which have been subject to

(a)

a project evaluation; and

(b)

the severity classifications assigned to those

procedures.

(2)

The project authorisation shall specify the following

(a)

the user who undertakes the project;

(b)

the persons responsible for the overall

implementation of the project and its compliance with the

project authorisation;

(c)

the establishments in which the project will be

undertaken, where applicable; and

(d)

any specific conditions following the project

evaluation, including whether and when the project shall be

assessed retrospectively.

(3) Project authorisations shall be granted for a period not

exceeding 5 years.

(4) The competent authority in Malta may allow the

authorisation of multiple generic projects carried out by the same

user if such projects are to satisfy regulatory requirements or if such

projects use animals for production or diagnostic purposes with

established methods.

(1)

The competent authority in Malta shall ensure

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that the decision regarding authorisation is taken and communicated

to the applicant 40 working days at the latest from the receipt of the

complete and correct application. This period shall include the

project evaluation.

(2) When justified by the complexity or the multi-

disciplinary nature of the project, the competent authority may extend

the period referred to in sub-regulation (1) once, by an additional

period not exceeding 15 working days. The extension and its duration

shall be duly motivated and shall be notified to the applicant before

the expiry of the period referred to in sub-regulation (1).

(3) The competent authority shall acknowledge to the

applicant all applications for authorisations as quickly as possible,

and shall indicate the period referred to in sub-regulation (1) within

which the decision is to be taken.

(4) In the case of an incomplete or incorrect application, the

competent authority shall, as quickly as possible, inform the

applicant of the need to supply any additional documentation and of

any possible effects on the running of the applicable time period.

(1)

The competent authority in Malta may decide

to introduce a simplified administrative procedure for projects

containing procedures classified as ‘non-recovery’, ‘mild’ or

‘moderate’ and not using non-human primates, that are necessary to

satisfy regulatory requirements, or which use animals for production

or diagnostic purposes with established methods.

(2) When introducing a simplified administrative procedure,

the competent authority in Malta shall ensure that the following

provisions are met

(a)

the application specifies elements referred to in

regulation 40(2)(a), (b) and (c);

(b)

a project evaluation is performed in accordance

with regulation 38; and

(c)

that the period referred to in regulation 41(1) is

not exceeded.

(3) If a project is changed in a way that may have a negative

impact on animal welfare, the competent authority in Malta shall

require an additional project evaluation with a favourable outcome.

(4) Regulations 40(3) and (4), 41(3) and 44(3), (4) and (5)

shall apply mutatis mutandis to projects that are allowed to be carried

out in accordance with this regulation.

USED FOR SCIENTIFIC PURPOSES

(1)

Subject to safeguarding intellectual property

and confidential information, the non-technical project summary

shall provide the following

(a)

information on the objectives of the project,

including the predicted harm and benefits and the number and

types of animals to be used;

(b)

a demonstration of compliance with the

requirement of replacement, reduction and refinement.

(2) The non-technical project summary shall be anonymous

and shall not contain the names and addresses of the user and its

personnel.

(3) The competent authority in Malta may require the non-

technical project summary to specify whether a project is to undergo

a retrospective assessment and by what deadline. In such a case, the

competent authority shall ensure that the non-technical project

summary is updated with the results of any retrospective assessment.

(4) The competent authority shall publish the non-technical

project summaries of authorised projects and any updates thereto.

(1)

The competent authority in Malta shall ensure

that amendment or renewal of the project authorisation is required for

any change of the project that may have a negative impact on animal

welfare.

(2) Any amendment or renewal of a project authorisation

shall be subject to a further favourable outcome of the project

evaluation.

(3) The competent authority may withdraw the project

authorisation where the project is not carried out in accordance with

the project authorisation.

(4) Where a project authorisation is withdrawn, the welfare

of the animals used or intended to be used in the project must not be

adversely affected.

(5) The competent authority shall establish and publish

conditions for amendment and renewal of project authorisations.

(1)

The competent authority shall ensure that all

relevant documentation, including project authorisations and the

result of the project evaluation is kept for at least 3 years from the

expiry date of the authorisation of the project or from the expiry of

the period referred to in regulation 41(1) and shall be available to the

competent authority.

USED FOR SCIENTIFIC PURPOSES

(2) Without prejudice to sub-regulation (1), the

documentation for projects which have to undergo retrospective

assessment shall be kept until the retrospective assessment has been

completed.

The competent authority in Malta shall accept data from

other Member States that are generated by procedures recognised by

the legislation of the Union, unless further procedures need to be

carried out regarding that data for the protection of public health,

safety or the environment.

(1)

The competent authority shall contribute with

other competent authorities in other Member States to the

development and validation of alternative approaches which may

provide the same or higher levels of information as those obtained in

procedures using animals

Provided that such approaches do not involve the use of

animals, or the use of fewer animals, or which entail less painful

procedures on animals, and the competent authority shall take such

other steps as it considers appropriate to encourage and promote

research in this field.

(2) The competent authority shall, at national level, ensure

the promotion of alternative approaches and the dissemination of

information thereon.

(3) The competent authority shall nominate a single point of

contact to provide advice on the regulatory relevance and suitability

of alternative approaches proposed for validation.

(1)

The Animal Welfare Council established for

the protection of animals used for scientific purposes in conjunction

with the Director, shall advise the animal-welfare body on matters

relating to the acquisition, breeding, accommodation, care and use of

animals in scientific procedures and shall ensure the sharing of best

practice.

(2) The Animal Welfare Council shall further exchange

information on the operation of animal-welfare bodies and project

evaluation and share best practice within the Union.

(1)

Malta shall by 10 November 2018, and every 5

years thereafter, send the information on the implementation of these

Regulations and in particular regulations 10(1), 26, 28, 34, 38, 39, 43

and 46 to the Commission.

(2) The competent authority in Malta shall collect and make

publicly available, on an annual basis, statistical information on the

use of animals in procedures, including information on the actual

USED FOR SCIENTIFIC PURPOSES

severity of the procedures and on the origin and species of non-

human primates used in procedures.

(3) Malta shall submit that statistical information to the

Commission by 10 November 2015 and every year thereafter.

(4) Malta shall submit to the Commission, on annual basis,

detailed information on exemptions granted under regulation 6(4)(a).

(1)

Where the competent authority in Malta has

scientifically justifiable grounds for believing it is essential to use

non-human primates for the purposes referred to in regulation

8(1)(a)(i) with regard to human beings, but where the use is not

undertaken with a view to the avoidance, prevention, diagnosis or

treatment of debilitating or potentially life-threatening clinical

conditions, it may adopt a provisional measure allowing such use,

provided the purpose cannot be achieved by the use of species other

than non-human primates.

(2) Where the competent authority in Malta has grounds for

believing that action is essential for the preservation of the species or

in relation to an unexpected outbreak of a life-threatening or

debilitating clinical condition in human beings, it may adopt a

provisional measure allowing the use of great apes in procedures

having one of the purposes referred to in sub-regulations (b)(i), (c) or

(e) of regulation 5; provided that the purpose of the procedure cannot

be achieved by the use of species other than great apes or by the use

of alternative methods. However, the reference to regulation 5(b)(i)

shall not be taken to include the reference to animals and plants.

(3) Where, for exceptional and scientifically justifiable

reasons, the competent authority in Malta deems it necessary to allow

the use of a procedure involving severe pain, suffering or distress that

is likely to be long-lasting and cannot be ameliorated, as referred to

in regulation 15(2), it may adopt a provisional measure to allow such

procedure. The competent authority in Malta may decide not to allow

the use of non-human primates in such procedures.

(4) When the competent authority in Malta adopts a

provisional measure in accordance with sub-regulations 1, 2 or 3, it

shall immediately inform the Commission and the other Member

States thereof, giving reasons for its decision and submitting

evidence of the situation as described in sub-regulations 1, 2 and 3 on

which the provisional measure is based.

(1)

The competent authority in Malta shall be

responsible for the implementation of these regulations.

(2) The competent authority in Malta may designate bodies

other than public authorities for the implementation of specific tasks

USED FOR SCIENTIFIC PURPOSES

laid down in these regulations only if there is proof that the body

(a)

has the expertise and infrastructure required to

carry out the tasks; and

(b)

is free of any conflict of interests as regards the

performance of the tasks.

(3)

Bodies thus designated shall be considered

competent authorities for the purposes of these regulations.

(1)

Any person who fails to abide by these

regulations shall be guilty of an offence, and shall be liable to the

provisions and measures referred to in regulation 2(2) and 2(3).

(2) Any right given to the competent authority under these

regulations to apply all such necessary measures prescribed in

regulation 2(2) and 2(3), shall be given without prejudice to other

criminal procedures which may be taken under the Act or any other

law when a person commits an offence by failing to abide by these

regulations.

(1)

The competent authority in Malta shall not

apply laws, regulations and administrative provisions adopted in

accordance with regulations 36 to 45 to projects which have been

approved before 1 January 2013 and the duration of which does not

extend beyond 1 January 2018.

(2) Projects which have been approved before 1 January

2013 and the duration of which extends beyond 1 January 2018 shall

obtain project authorisation by 1 January 2018.

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ANNEX I

LIST OF ANIMALS REFERRED TO IN REGULATION 10

1. Mouse (Mus musculus)

2. Rat (Rattus norvegicus)

3. Guinea pig (Cavia porcellus)

4. Syrian (golden) hamster (Mesocricetus auratus)

5. Chinese hamster (Cricetulus griseus)

6. Mongolian gerbil (Meriones unguiculatus)

7. Rabbit (Oryctolagus cuniculus)

8. Dog (Canis familiaris)

9. Cat (Felis catus)

10. All species of non-human primates

11. Frog (Xenopus (laevis, tropicalis), Rana (temporaria, pipiens))

12. Zebra fish (Danio rerio)

ANNEX II

LIST OF NON-HUMAN PRIMATES AND DATES REFERRED TO IN THE

SECOND SUB-PARAGRAPH OF REGULATION 10(1)

Species

Dates

Marmoset (Callithrix 1 January 2013

jacchus)

Cynomolgus monkey 5 years after the publication of the feasibility study referred to in

(Macaca fascicularis) regulation 10(1), provided the study does not recommend an

extended period

Rhesus monkey

5 years after the publication of the feasibility study referred to in

(Macaca mulatta)

regulation 10(1), provided the study does not recommend an

extended period

Other species of non- 5 years after the publication of the feasibility study referred to in

human primates

regulation 10(1), provided the study does not recommend an

extended period

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Amended by: 

ANNEX III

L.N. 297 of 2025.

REQUIREMENTS FOR ESTABLISHMENTS AND FOR THE

CARE AND ACCOMMODATION OF ANIMALS

Section A: General section

1. The physical facilities

1.1.

Functions and general design

(a) All facilities shall be constructed so as to provide an environment which

takes into account the physiological and ethological needs of the species kept in them.

Facilities shall also be designed and managed to prevent access by unauthorised

persons and the ingress or escape of animals.

(b) Establishments shall have an active maintenance programme to prevent

and remedy any defect in buildings or equipment.

1.2.

Holding rooms

(a) Establishments shall have a regular and efficient cleaning schedule for the

rooms and shall maintain satisfactory hygienic standards.

(b) Walls and floors shall be surfaced with a material resistant to the heavy

wear and tear caused by the animals and the cleaning process. The material shall not be

detrimental to the health of the animals and shall be such that the animals cannot hurt

themselves. Additional protection shall be given to any equipment or fixtures so that

they are not damaged by the animals nor do they cause injury to the animals

themselves.

(c) Species that are incompatible, for example predator and prey, or animals

requiring different environmental conditions, shall not be housed in the same room nor,

in the case of predator and prey, within sight, smell or sound of each other.

1.3.

General and special purpose procedure rooms

(a) Establishments shall, where appropriate, have available laboratory

facilities for the carrying out of simple diagnostic tests, post-mortem examinations,

and/or the collection of samples that are to be subjected to more extensive laboratory

investigations elsewhere. General and special purpose procedure rooms shall be

available for situations where it is undesirable to carry out the procedures or

observations in the holding rooms.

(b) Facilities shall be provided to enable newly-acquired animals to be

isolated until their health status can be determined and the potential health risk to

established animals assessed and minimised.

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(c)

There shall be accommodation for the separate housing of sick or injured

animals.

1.4.

Service rooms

(a) Store-rooms shall be designed, used and maintained to safeguard the

quality of food and bedding. These rooms shall be vermin and insect-proof, as far as

possible. Other materials, which may be contaminated or present a hazard to animals or

staff, shall be stored separately.

(b) The cleaning and washing areas shall be large enough to accommodate the

installations necessary to decontaminate and clean used equipment. The cleaning

process shall be arranged so as to separate the flow of clean and dirty equipment to

prevent the contamination of newly-cleaned equipment.

(c) Establishments shall provide for the hygienic storage and safe disposal of

carcasses and animal waste.

(d) Where surgical procedures under aseptic conditions are required there

shall be provision for one or more than one suitably equipped room, and facilities

provided for postoperative recovery.

2. The environment and control thereof

2.1.

Ventilation and temperature

(a) Insulation, heating and ventilation of the holding room shall ensure that

the air circulation, dust levels, and gas concentrations are kept within limits that are not

harmful to the animals housed.

(b) Temperature and relative humidity in the holding rooms shall be adapted

to the species and age groups housed. The temperature shall be measured and logged on

a daily basis.

(c) Animals shall not be restricted to outdoor areas under climatic conditions

which may cause them distress.

2.2.

Lighting

(a) Where natural light does not provide an appropriate light/dark cycle,

controlled lighting shall be provided to satisfy the biological requirements of the

animals and to provide a satisfactory working environment.

(b) Illumination shall satisfy the needs for the performance of husbandry

procedures and inspection of the animals.

(c)

Regular photoperiods and intensity of light adapted to the species shall be

provided.

(d) When keeping albino animals, the lighting shall be adjusted to take into

account their sensitivity to light.

USED FOR SCIENTIFIC PURPOSES

2.3.

Noise and vibration

(a)

Noise levels including ultrasound, shall not adversely affect animal

welfare.

(b) Establishments shall have alarm systems that sound outside the sensitive

hearing range of the animals, where this does not conflict with their audibility to human

beings.

(c) Holding rooms shall where appropriate be provided with noise insulation

and absorption materials.

(d) For aquatic animals, equipment causing noise or vibration, such as power

generators or filtration systems shall not adversely affect animal welfare.

2.4.

Alarm systems and contingency plans

(a) Establishments relying on electrical or mechanical equipment for

environmental control and protection, shall have a stand-by system to maintain

essential services and emergency lighting systems as well as to ensure that alarm

systems themselves do not fail to operate.

(b) Heating and ventilation systems shall be equipped with monitoring devices

and alarms.

(c)

Clear instructions on emergency procedures shall be prominently

displayed.

(d) Effective contingency plans shall be in place to ensure the health and

welfare of the animals in the case of a failure of essential husbandry systems.

3. Care of animals

3.1.

Health

(a) Establishments shall have a strategy in place to ensure that a health status

of the animals is maintained that safeguards animal welfare and meets scientific

requirements. This strategy shall include regular health monitoring, a microbiological

surveillance programme and plans for dealing with health breakdowns and shall define

health parameters and procedures for the introduction of new animals.

(b) Animals shall be checked at least daily by a competent person. These

checks shall ensure that all sick or injured animals are identified and appropriate action

is taken.

3.2.

Animals taken from the wild

(a) Transport containers and means of transport adapted to the species

concerned shall be available at capture sites, in case animals need to be moved for

examination or treatment.

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(b) Special consideration shall be given and appropriate measures taken for

the acclimatisation, quarantine, housing, husbandry, care of animals taken from the

wild and, as appropriate, provisions for setting them free at the end of procedures.

3.3.

Housing and enrichment

(a)

Housing

Animals, except those which are naturally solitary, shall be socially housed in

stable groups of compatible individuals. In cases where single housing is allowed in

accordance with regulation 33(3) the duration shall be limited to the minimum period

necessary and visual, auditory, olfactory and/or tactile contact shall be maintained. The

introduction or re-introduction of animals to established groups shall be carefully

monitored to avoid problems of incompatibility and disrupted social relationships.

(b)

Enrichment

All animals shall be provided with space of sufficient complexity to allow

expression of a wide range of normal behaviour. They shall be given a degree of control

and choice over their environment to reduce stress-induced behaviour. Establishments

shall have appropriate enrichment techniques in place, to extend the range of activities

available to the animals and increase their coping activities including physical exercise,

foraging, manipulative and cognitive activities, as appropriate to the species.

Environmental enrichment in animal enclosures shall be adapted to the species and

individual needs of the animals concerned. The enrichment strategies in establishments

shall be regularly reviewed and updated.

(c)

Animal enclosures

Animal enclosures shall not be made out of materials detrimental to the health of

the animals. Their design and construction shall be such that no injury to the animals is

caused. Unless they are disposable, they shall be made from materials that will

withstand cleaning and decontamination techniques. The design of animal enclosure

floors shall be adapted to the species and age of the animals and be designed to

facilitate the removal of excreta.

3.4.

Feeding

(a) The form, content and presentation of the diet shall meet the nutritional

and behavioural needs of the animal.

(b) The animals’ diet shall be palatable and non-contaminated. In the selection

of raw materials, production, preparation and presentation of feed, establishments shall

take measures to minimise chemical, physical and microbiological contamination.

(c) Packing, transport and storage shall be such as to avoid contamination,

deterioration or destruction. All feed hoppers, troughs or other utensils used for feeding

shall be regularly cleaned and, if necessary, sterilised.

(d) Each animal shall be able to access the food, with sufficient feeding space

provided to limit competition.

USED FOR SCIENTIFIC PURPOSES

3.5.

Watering

(a)

Uncontaminated drinking water shall always be available to all animals.

(b) When automatic watering systems are used, they shall be regularly

checked, serviced and flushed to avoid accidents. If solid-bottomed cages are used, care

shall be taken to minimise the risk of flooding.

(c) Provision shall be made to adapt the water supply for aquaria and tanks to

the needs and tolerance limits of the individual fish, amphibian and reptile species.

3.6.

Resting and sleeping areas

(a) Bedding materials or sleeping structures adapted to the species shall

always be provided, including nesting materials or structures for breeding animals.

(b) Within the animal enclosure, as appropriate to the species, a solid,

comfortable resting area for all animals shall be provided. All sleeping areas shall be

kept clean and dry.

3.7.

Handling

Establishments shall set up habituation and training programmes suitable for the

animals, the procedures and length of the project.

Section B: Species-specific section

1. Mice, rats, gerbils, hamsters and guinea pigs

In this and subsequent tables for mice, rats, gerbils, hamsters and guinea pigs,

‘enclosure height’ means the vertical distance between the enclosure floor and the top

of the enclosure and this height applies over more than 50 % of the minimum enclosure

floor area prior to the addition of enrichment devices.

When designing procedures, consideration shall be given to the potential growth

of the animals to ensure adequate space is provided (as detailed in Tables 1.1 to 1.5) for

the duration of the study.

Table 1.1.

Mice

Body

Minimum enclosure size

Floor area Minimum

weight

per animal enclosure

(cm )

(g)

(cm 2 )

height

(cm)

USED FOR SCIENTIFIC PURPOSES

In stock and

up to 20

during

over 20

procedures

to 25

over 25

to 30

over 30

Breeding

For a monogamous pair

(outbred/inbred) or a trio

(inbred). For each additional

female plus litter 180 cm 2 shall

be added.

Stock at

less than 950

breeders

Enclosure size

950 cm 2

Enclosure size

less than 1 500

1 500 cm

Table 1.2.

Rats

Body

Minimum

Floor area Minimum

Date referred

weight

enclosure size

per

enclosure

to in

(cm 2 )

(g)

animal

height

regulation

(cm)

33(2)

(cm )

USED FOR SCIENTIFIC PURPOSES

In stock and

up to

1 January

during

procedures ( 2 )

over 200 800

to 300

over 300 800

to 400

over 400 800

to 600

over 600 1 500

Breeding

Mother and litter.

For each additional

adult animal

permanently added

to the enclosure add

400 cm 2

Stock at

up to 50 1 500

breeders ( 3 )

over 50

1 500

to 100

Enclosure size

over 100 1 500

1 500 cm 2

to 150

over 150 1 500

to 200

Stock at

up to

2 500

breeders ( )

over 100 2 500

to 150

Enclosure size

2 500 cm 2

over 150 2 500

to 200

USED FOR SCIENTIFIC PURPOSES

Table 1.3.

Gerbils

Body

Minimum

Floor area Minimum

Date referred to

weight

enclosure size

per animal enclosure

in regulation

(g)

(cm 2 )

(cm 2 )

height

33(2)

(cm)

In stock and

up to 40 1 200

1 January 2017

during

over 40

1 200

procedures

Breeding

1 200

Monogamous

pair or trio with

offspring

Table 1.4.

Hamsters

Body

Minimum

Floor area Minimum

Date referred to

weight

enclosure size

per animal enclosure

in regulation

(cm 2 )

(cm 2 )

(g)

height

33(2)

(cm)

In stock and

up to 60 800

1 January 2017

during

over 60

procedures

to 100

over 100 800

Breeding

Mother or

monogamous

pair with litter

Stock at

less than 1 500

breeders

USED FOR SCIENTIFIC PURPOSES

Table 1.5.

Guinea pigs

Body

Minimum

Floor

Minimum

Date referred

weight

enclosure size

area per

enclosure height

to in

(g)

(cm 2 )

animal

(cm)

regulation

33(2)

(cm 2 )

In stock and

up to

1 800

1 January

during

procedures

over 200 1 800

to 300

over 300 1 800

to 450

over 450 2 500

to 700

over 700 2 500

Breeding

2 500

Pair with litter.

For each

additional

breeding

female add

1 000 cm 2

2. Rabbits

During agricultural research, when the aim of the project requires that the

animals are kept under similar conditions to those under which commercial farm

animals are kept, the keeping of the animals shall at least follow the standards laid

down in Directive 98/58/EC.

A raised area shall be provided within the enclosure. This raised area must allow

the animal to lie and sit and easily move underneath, and shall not cover more than

40 % of the floor space. When for scientific or veterinary reasons a raised area cannot

be used, the enclosure shall be 33 % larger for a single rabbit and 60% larger for two

rabbits. Where a raised area is provided for rabbits of less than 10 weeks of age, the size

of the raised area shall be at least of 55 cm by 25cm and the height above the floor shall

be such that the animals can make use of it.

USED FOR SCIENTIFIC PURPOSES

Table 2.1.

Rabbits over 10 weeks of age

Table 2.1 is to be used for both cages and pens. The additional floor area is as a

minimum 3 000 cm 2 per rabbit for the third, the fourth, the fifth and the sixth rabbit,

while 2 500 cm 2 as a minimum shall be added for each additional rabbit above a

number of six.

Final body

Minimum floor area for one or two Minimum

Date referred to in

weight

socially harmonious animals

height

regulation 33(2)

(kg)

(cm 2 )

(cm)

less than 3

3 500

1 January 2017

from 3 to 5

4 200

over 5

5 400

Table 2.2.

Doe plus litter

Doe

Minimum

Addition for nest Minimum

Date referred to in

weight

enclosure size

boxes

height

regulation 33(2)

(kg)

(cm 2 )

(cm)

(cm )

less than 3 3 500

1 000

1 January 2017

from 3 to 4 200

1 200

over 5

5 400

1 400

Table 2.3.

Rabbits less than 10 weeks of age

Table 2.3 is to be used for both cages and pens.

Age

Minimum

Minimum floor area Minimum

Date referred to in

enclosure size

per animal

height

regulation 33(2)

(cm 2 )

(cm)

(cm )

Weaning to 4 000

1 January 2017

7 weeks

From 7 to

4 000

1 200

10 weeks

USED FOR SCIENTIFIC PURPOSES

Table 2.4.

Rabbits: Optimal dimensions for raised areas for enclosures having the dimensions

indicated in Table 2.1.

Age in

Final body

Optimum

Optimum height from

Date referred to in

weeks

weight

size

the enclosure floor

regulation 33(2)

(kg)

(cm x cm)

(cm)

over 10

less than 3

55 × 25

1 January 2017

from 3 to 5

55 × 30

over 5

60 × 35

3. Cats

Cats shall not be single-housed for more than 24 hours at a time. Cats that are

repeatedly aggressive towards other cats shall be housed singly only if a compatible

companion cannot be found. Social stress in all pair- or group-housed individuals shall

be monitored at least weekly. Females with kittens under four weeks of age or in the

last two weeks of pregnancy may be housed singly.

Table 3.

The minimum space in which a queen and litter may be held is the space for a

single cat, which shall be gradually increased so that by 4 months of age litters have

been rehoused following the space requirements for adults.

Areas for feeding and for litter trays shall not be less than 0,5 metres apart and

shall not be interchanged.

Floor Shelves Height Date referred to in regulation

(m 2 )

(m 2 )

(m)

33(2)

Minimum for one adult

1,5

0,5

1 January 2017

animal

For each additional animal

0,75

0,25

-

4. Dogs

Dogs shall where possible be provided with outside runs. Dogs shall not be

single-housed for more than 4 hours at a time.

The internal enclosure shall represent at least 50 % of the minimum space to be

made available to the dogs, as detailed in Table 4.1.

The space allowances detailed below are based on the requirements of beagles,

but giant breeds such as St Bernards or Irish wolfhounds shall be provided with

allowances significantly in excess of those detailed in Table 4.1. For breeds other than

USED FOR SCIENTIFIC PURPOSES

the laboratory beagle, space allowances shall be determined in consultation with

veterinary staff.

Table 4.1.

Dogs

Dogs that are pair or group housed may each be constrained to half the total

space provided (2 m 2 for a dog under 20 kg, 4 m 2 for a dog over 20 kg) while they are

undergoing procedures as defined in this Directive, if this separation is essential for

scientific purposes. The period for which a dog is so constrained shall not exceed 4

hours at a time.

A nursing bitch and litter shall have the same space allowance as a single bitch of

equivalent weight. The whelping pen shall be designed so that the bitch can move to an

additional compartment or raised area away from the puppies.

Weight

Minimum

Minimum floor For each

Minimum

Date referred

(kg)

enclosure

area for one or additional

height

to in regulation

size

two animals

animal add a

(m)

33(2)

(m 2 )

minimum of

(m )

(m 2 )

up to 20 4

1 January 2017

over 20

Table 4.2.

Dogs - post-weaned stock

Weight of

Minimum

Minimum floor

Minimum

Date referred to in

dog

enclosure size

area/animal

height

regulation 33(2)

(kg)

(m 2 )

(m 2 )

(m)

up to 5

0,5

1 January 2017

over 5 to 10 4

1,0

over 10 to

1,5

over 15 to

over 20

USED FOR SCIENTIFIC PURPOSES

5. Ferrets

Table 5.

Ferrets

Minimum

Minimum floor

Minimum

Date referred to in

enclosure size

area per animal

height

regulation 33(2)

(cm 2 )

(cm 2 )

(cm)

Animals up to 4 500

1 500

1 January 2017

600 g

Animals over 4 500

3 000

600 g

Adult males

6 000

6 000

Jill and litter

5 400

5 400

6. Non-human primates

Young non-human primates shall not be separated from their mothers until they

are, depending on the species, 6 to 12 months old.

The environment shall enable non-human primates to carry out a complex daily

programme of activity. The enclosure shall allow non-human primates to adopt as wide

a behavioural repertoire as possible, provide it with a sense of security, and a suitably

complex environment to allow the animal to run, walk, climb and jump.

Table 6.1.

Marmosets and tamarins

Minimum floor area of

Minimum volume

Minimum

Date referred to

enclosures for 1or 2

per additional

enclosure

in regulation

animals plus offspring

animal over 5

height

33(2)

up to 5 months old

months

(m)

(m 2 )

(m 3 )

Marmosets

0,5

0,2

1,5

1 January 2017

Tamarins

1,5

0,2

1,5

For marmosets and tamarins, separation from the mother shall not take place

before 8 months of age.

USED FOR SCIENTIFIC PURPOSES

Table 6.2.

Squirrel monkeys

Minimum floor area

Minimum volume per

Minimum

Date referred to in

for 1 or 2 animals

additional animal over 6

enclosure height regulation 33(2)

months of age

(m)

(m 3 )

0,5

1,8

1 January 2017

For squirrel monkeys, separation from the mother shall not take place before 6

months of age.

Table 6.3.

Macaques and vervets

Minimum

Minimum

Minimum

Minimum

Date referred

enclosure

enclosure

volume per

enclosure

to in

size

volume

animal

height

regulation

(m 2 )

(m 3 )

(m 3 )

(m)

33(2)

Animals less 2,0

3,6

1,0

1,8

1 January

than 3 yrs of

Animals from 2,0

3,6

1,8

1,8

3 yrs of age

Animals held

3,5

2,0

for breeding

purposes

For macaques and vervets, separation from the mother shall not take place before

8 months of age.

USED FOR SCIENTIFIC PURPOSES

Table 6.4.

Baboons

Minimum

Minimum

Minimum

Minimum

Date referred

enclosure

enclosure

volume per

enclosure

to in

size

volume

animal

height

regulation

(m)

33(2)

(m 2 )

(m 3 )

(m 3 )

Animals less 4,0

7,2

3,0

1,8

1 January

than 4 yrs of

age

Animals from 7,0

12,6

6,0

1,8

4 yrs of age

Animals held

12,0

2,0

for breeding

purposes

For baboons, separation from the mother shall not take place before 8 months of

age.

7. Farm animals

During agricultural research, when the aim of the project requires that the

animals are kept under similar conditions to those under which commercial farm

animals are kept, the keeping of the animals shall comply at least with the standards

laid down in Directives 98/58/EC, 91/629/EC and 91/630/EEC.

Table 7.1.

Cattle

Body

Minimum

Minimum

Trough space

Trough space

Date referred

weight

enclosure

floor area/

for ad-libitum

for restricted

to in

(kg)

size

animal

feeding of

feeding of

regulation

(m 2 )

(m 2 /animal)

polled cattle

polled cattle

33(2)

(m/animal)

(m/animal)

up to

2,50

2,30

0,10

0,30

1 January

over 100 4,25

3,40

0,15

0,50

to 200

over 200 6,00

4,80

0,18

0,60

to 400

over 400 9,00

7,50

0,21

0,70

to 600

over 600 11,00

8,75

0,24

0,80

to 800

over 800 16,00

10,00

0,30

1,00

USED FOR SCIENTIFIC PURPOSES

Table 7.2.

Sheep and goats

Body

Minimum

Minimum

Minimum

Trough

Trough

Date

weight

enclosure

floor area/

partition

space for ad- space for

referred to

(kg)

size

animal

height

libitum

restricted

in

(m 2 )

(m 2 /animal)

(m)

feeding

feeding

regulation

(m/animal) (m/animal)

33(2)

less

1,0

0,7

1,0

0,10

0,25

1 January

than 20

over 20 1,5

1,0

1,2

0,10

0,30

to 35

over 35 2,0

1,5

1,2

0,12

0,40

to 60

over 60 3,0

1,8

1,5

0,12

0,50

Table 7.3.

Pigs and minipigs

Live weight

Minimum

Minimum floor Minimum lying space

Date referred to

(kg)

enclosure size area per animal per animal (in,

in regulation

(m 2 )

(m 2 /animal)

thermoneutral

33(2)

conditions)

(m 2 /animal)

Up to 5

2,0

0,20

0,10

1 January 2017

over 5 to 10

2,0

0,25

0,11

over 10 to 20

2,0

0,35

0,18

over 20 to 30

2,0

0,50

0,24

over 30 to 50

2,0

0,70

0,33

over 50 to 70

3,0

0,80

0,41

over 70 to 100

3,0

1,00

0,53

over 100 to 150 4,0

1,35

0,70

over 150

5,0

2,50

0,95

Adult

7,5

1,30

(conventional)

boars

USED FOR SCIENTIFIC PURPOSES

Table 7.4.

Equines

The shortest side shall be a minimum of 1,5 times the wither height of the

animal. The height of indoor enclosures shall allow animals to rear to their full height.

Wither

Minimum floor area/animal

Minimum

Date referred

height

enclosure

to in regulation

(m /animal)

(m)

Foaling box/ height

33(2)

For each animal For each

(m)

held singly or in animal held in mare with

groups of up to groups of 4 or foal

3 animals

more animals

1,00 to

9,0

6,0

3,00

1 January 2017

1,40

over 1,40 12,0

9,0

3,00

to 1,60

(2 × WH) 2

over 1,60 16,0

3,00

8. Birds

During agricultural research, when the aim of the project requires that the

animals are kept under similar conditions to those under which commercial farm

animals are kept, the keeping of the animals shall comply at least with the standards

laid down in Directives 98/58/EC, 1999/74/EC and 2007/43/EC.

When housing birds taken from the wild, the space allowance provided for in

tables 8.1 to 8.10 shall apply whenever the birds are held for periods of more than 24

hours. When birds are held for shorter periods of time, appropriate measures shall be

taken to minimise, as far as possible, any risks to animal welfare.

Table 8.1.

Domestic fowl

Where these minimum enclosure sizes cannot be provided for scientific reasons,

the duration of the confinement shall be justified by the experimenter in consultation

with veterinary staff. In such circumstances, birds can be housed in smaller enclosures

containing appropriate enrichment and with a minimum floor area of 0,75 m 2

USED FOR SCIENTIFIC PURPOSES

.

Body mass

Minimum

Minimum

Minimum

Minimum

Date referred to

(g)

enclosure

area per bird height

length of feed

in regulation

size

(m 2 )

(cm)

trough per bird

33(2)

(m 2 )

(cm)

Up to 200

1,00

0,025

1 January 2017

over 200 to

1,00

0,03

over 300 to

1,00

0,05

over 600 to

2,00

0,09

1 200

over 1 200

2,00

0,11

to 1 800

over 1 800

2,00

0,13

to 2 400

over 2 400

2,00

0,21

Table 8.2.

Domestic turkeys

All enclosure sides shall be at least 1,5 m long. Where these minimum enclosures sizes

cannot be provided for scientific reasons, the duration of the confinement shall be

justified by the experimenter in consultation with veterinary staff. In such

circumstances, birds can be housed in smaller enclosures containing appropriate

enrichment and with a minimum floor area of 0,75 m 2 and a minimum height of 50 cm

for birds below 0,6 kg, 75 cm for birds below 4 kg, and 100 cm for birds over 4 kg.

These can be used to house small groups of birds in accordance with the space

allowances given in table 8.2

USED FOR SCIENTIFIC PURPOSES

.

Minimum length Date 

Body mass

Minimum

Minimum

Minimum

(kg)

enclosure

area per bird height

of feed trough referred to in

size

(m 2 )

(cm)

per bird

regulation

(cm)

33(2)

(m 2 )

Up to 0,3

2,00

0,13

1 January

over 0,3 to 0,6 2,00

0,17

over 0,6 to 1

2,00

0,30

over 1 to 4

2,00

0,35

over 4 to 8

2,00

0,40

over 8 to 12

2,00

0,50

over 12 to 16

2,00

0,55

over 16 to 20

2,00

0,60

over 20

3,00

1,00

Table 8.3.

Quails

Body

Minimum

Area per Area per

Minimum

Minimum

Date referred

mass

enclosure

bird pair- additional

height

length of

to in

(g)

size

housed

bird group-

(cm)

trough per

regulation

(m 2 )

housed

bird

33(2)

(m )

(m 2 )

(cm)

Up to

1,00

0,5

0,10

1 January

Over

1,00

0,6

0,15

Table 8.4.

Ducks and geese

Where these minimum enclosures sizes cannot be provided for scientific reasons, the

duration of the confinement shall be justified by the experimenter in consultation with

veterinary staff. In such circumstances, birds can be housed in smaller enclosures

containing appropriate enrichment and with a minimum floor area of 0,75 m 2 . These

can be used to house small groups of birds in accordance with the space allowances

given in table 8.4

USED FOR SCIENTIFIC PURPOSES

.

Minimum length Date 

Body

Minimum

Area per Minimum

mass

enclosure size bird

height

of feed trough per referred to in

(g)

(cm)

bird

Regulation 33(2)

(m )

(m )

(cm)

Ducks

1 January 2017

Up to 300 2,00

0,10

Over 300 2,00

0,20

to 1 200

Over

2,00

0,25

1 200 to

3 500

Over

2,00

0,50

3 500

Geese

Up to 500 2,00

0,20

Over 500 2,00

0,33

to 2 000

Over

2,00

0,50

2 000

Table 8.5.

Ducks and geese: Minimum pond sizes

Area

Depth

(m 2 )

(cm)

Ducks

0,5

Geese

0,5

from 10 to 30

USED FOR SCIENTIFIC PURPOSES

Table 8.6.

Pigeons

Enclosures shall be long and narrow (for example 2 m by 1 m) rather than square

to allow birds to perform short flights.

Group size Minimum

Minimum

Minimum

Minimum

Date referred to

enclosure

height

length of food

length of perch in Regulation

size

(cm)

trough per bird

per bird

33(2)

(m 2 )

(cm)

(cm)

Up to 6

1 January 2017

from 7 to

for each

0,15

additional

bird above

Table 8.7.

Zebra finches

Enclosures shall be long and narrow (for example 2 m by 1 m) to enable birds to

perform short flights. For breeding studies, pairs may be housed in smaller enclosures

containing appropriate enrichment with a minimum floor area of 0,5 m 2 and a

minimum height of 40 cm. The duration of the confinement shall be justified by the

experimenter in consultation with veterinary staff.

Group size

Minimum

Minimum

Minimum number Date referred to in

enclosure size

height

of feeders

Regulation 33(2)

(m 2 )

(cm)

Up to 6

1,0

1 January 2017

7 to 12

1,5

13 to 20

2,0

for each

0,05

1 per 6 birds

additional bird

above 20

Table 8.8.

Starlings

Group size

Minimum

Minimum

Minimum length of

Minimum

enclosure

height

food trough per

length of perch

size

bird

per bird

(cm)

(cm)

(cm)

(m )

USED FOR SCIENTIFIC PURPOSES

up to 6

2,0

7 to 12

4,0

13 to 20

6,0

for each

0.25

additional bird

between 21 and

for each

0,15

additional bird

above 50 in

number

Table 8.9.

House sparrows

Group size in the

Group size in the

Minimum

Minimum

absence of visual

presence of visual

enclosure size

height

barriers

barriers

(m 2 )

(cm)

up to 10

up to 15

2,4

11 to 20

16 to 35

4,8

21 to 30

36 to 60

7,3

for each additional

for each additional

0,11

bird above 30 in

bird above 60 in

number

number

Table 8.10.

Great tit and Blue tit

Group size

Minimum

Minimum

Minimum

Minimum

enclosure size

height

number of

length of perch

per bird

feeders

per bird

(cm)

(m 2 )

(cm)

2-10 (single sex)

1 female + 1 male

USED FOR SCIENTIFIC PURPOSES

9. Amphibians

Table 9.1.

Aquatic urodeles

Body

Minimum water Minimum water surface

Minimum

Date referred to in

length

surface area

area for each additional

water depth

Regulation 33(2)

(cm)

animal in group-holding

(cm)

(cm )

(cm 2 )

Up to 10 262,5

1 January 2017

over 10

to 15

over 15

to 20

over 20

1 837,5

to 30

Over 30 3 150

Table 9.2.

Aquatic anurans

Body

Minimum water Minimum water surface

Minimum

Date referred to in

length

surface area

area for each additional

water depth

Regulation 33(2)

(cm)

animal in group-holding

(cm)

(cm )

(cm 2 )

Less than 160

1 January 2017

from 6 to 300

over 9 to 600

over 12

12,5

USED FOR SCIENTIFIC PURPOSES

Table 9.3.

Semi-aquatic anurans

Body

Minimum

Minimum area for Minimum

Minimum

Date referred to

length

enclosure

each additional

enclosure

water depth

in Regulation

(cm)

size

animal in group height

(cm)

33(2)

(cm 2 )

holding

(cm)

(cm 2 )

up to 5,0 1 500

1 January 2017

over 5,0 3 500

to 7,5

Over 7,5 4 000

Table 9.4.

Semi-terrestrial anurans

Body

Minimum

Minimum area for Minimum

Minimum

Date referred to

length

enclosure

each additional

enclosure

water depth

in Regulation

(cm)

size

animal in group- height

(cm)

33(2)

(cm 2 )

holding

(cm)

(cm 2 )

Up to 5,0 1 500

1 January 2017

over 5,0 3 500

to 7,5

over 7,5 4 000

Table 9.5.

Arboreal anurans

Body

Minimum

Minimum area for each

Minimum

Date referred to in

length

enclosure size

additional animal in

enclosure

Regulation 33(2)

(cm)

(cm 2 )

group-holding

height

(cm 2 )

(cm)

up to 3,0 900

1 January 2017

Over 3,0 1 500

USED FOR SCIENTIFIC PURPOSES

10. Reptiles

Table 10.1.

Aquatic chelonians

Body

Minimum water Minimum water surface

Minimum

Date referred to in

length

surface area

area for each additional

water depth

Regulation 33(2)

(cm)

animal in group holding

(cm)

(cm )

(cm 2 )

up to 5

1 January 2017

Over 5 to 1 600

Over 10 3 500

to 15

Over 15 6 000

1 200

to 20

Over 20 10 000

2 000

to 30

Over 30 20 000

5 000

Table 10.2.

Terrestrial snakes

Body

Minimum

Minimum area for each

Minimum

Date referred to in

length

floor area

additional animal in

enclosure

Regulation 33(2)

(cm)

(cm 2 )

group-holding

height

(cm 2 )

(cm)

up to 30

1 January 2017

Over 30 to 400

Over 40 to 600

Over 50 to 1 200

Over 75

2 500

1 200

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11. Fish

11.1. Water supply and quality

Adequate water supply of suitable quality shall be provided at all times. Water

flow in re-circulatory systems or filtration within tanks shall be sufficient to ensure that

water quality parameters are maintained within acceptable levels, according to the

characteristics of the husbandry system, and according to the requirements of the

species and their life stage requirements. Water supply shall be filtered or treated to

remove substances harmful to fish, where necessary. Water-quality parameters shall at

all times be within the acceptable range that sustains normal activity and physiology for

a given species and stage of development. The water flow shall be appropriate to enable

fish to swim naturally and to maintain normal behaviour. Fish shall be given an

appropriate time for acclimatisation and adaptation to changes in water-quality

conditions. Appropriate measures shall be taken to minimise sudden changes in the

different parameters affecting water quality. Appropriate water flow and the water level

shall be ensured and monitored.

11.2. Oxygen, nitrogen compounds, carbon dioxide, pH, and salinity

Oxygen concentration shall be appropriate to the species and to the context in

which the fish are held. Where necessary, supplementary aeration of tank water shall be

provided, depending on the husbandry system. The concentrations of carbon dioxide

and of nitrogen compounds, namely ammonia, nitrite and nitrate, shall be kept below

harmful levels. Water quality shall be monitored using a defined testing schedule at a

sufficient frequency to detect changes in these critical parameters and action shall be

taken to mitigate such changes.

The pH level shall be adapted to the species and monitored to be kept as stable as

possible. The salinity shall be adapted to the requirements of the fish species and to the

life stage of the fish. Changes in salinity shall take place gradually.

11.3. Temperature and lighting

Temperature shall be maintained within the optimal range for the fish species and

their stages of development and kept as stable as possible. Changes in temperature shall

take place gradually. Fish shall be maintained on an appropriate photoperiod.

11.4. Stocking density and environmental complexity

The stocking density of fish shall be based on the total needs of the fish in

respect of environmental conditions, health and welfare. Fish shall have sufficient

water volume for normal swimming, taking account of their size, age, health and

feeding method. Fish shall be provided with an appropriate environmental enrichment,

such as hiding places or bottom substrate, unless behavioural traits suggest none is

required.

11.5. Feeding and handling

Fish shall be fed a diet suitable for the fish at an appropriate feeding rate and

frequency. Particular attention shall be given to feeding of larval fish during any

USED FOR SCIENTIFIC PURPOSES

transition from live to artificial diets. If feed withdrawal is necessary for non-

procedural reasons (e.g. transport), the duration shall be kept as short as possible and

take into account the fish size and water temperature.

Where possible, fish shall be handled without removal from the water. Handling of

fish both in and outside of the water shall be kept to a minimum and equipment in

direct contact with the fish shall be moistened. Fish shall not be handled at the outer

limits of the water temperature ranges that they may tolerate.

11.6. Zebrafish

1.6.1. Water Quality

Table 11.1

Water parameter requirements in zebrafish housing systems

Water parameters

Minimum-maximum requirements

Temperature

24-29°C

150-1700 μS/cm 2

Conductivity

Total Alkanility

40-250 mg/L CaCO 3

pH

6,5-8

Nitrogen

NH 3 /NH 4 +< 0,1 (*2) mg/L, NO 2 - < 0,3 mg/L, NO 3 -

compounds

< 25 mg/L

Dissolved oxygen

> 5 mg/L

11.6.2. Lighting

During the light phase, the light levels shall be constant, except during short dawn

and dusk transitions. Dark phase shall be completely dark.

11.6.3. Stocking density and environmental complexity

Water volumes smaller than 1 litre shall not be used for adult zebrafish. Stocking

densities shall not exceed 10 adult fish for every litre. The tank size and shape shall allow

the fish to express their natural behaviours and swimming activities.

Prolonged single housing shall be avoided. *

12. Cephalopods

12.1. Water supply and quality

Adequate water supply of suitable quality shall be provided at all times.

The tank design and water flow rate shall meet the needs of the animal including

appropriate oxygenation delivered in relation to its size, life stage and behavioural needs.

* 2 or below detection limit. 0,1 mg/L indicates the total amount of ammonia, NH 3 /

NH 4 + . This corresponds to 0,002 mg/L of NH 3 at 28 °C and pH 7,5.

USED FOR SCIENTIFIC PURPOSES

Water temperature, salinity, pH, and nitrogen compound levels shall be appropriate to the

needs of species and life forms. Escapes and the inadvertent introduction of foreign

elements shall be prevented through the use of covers where necessary.

Cephalopods shall be given appropriate time for acclimatisation and adaptation to

changes in water quality conditions.

12.2. Lighting

Light intensity and photoperiod shall satisfy the requirements of the species.

12.3. Diet

Cephalopods shall be provided with a feeding regime appropriate to the species, their

developmental stage and behavioural needs.

12.4. Enrichment and handling

Cephalopods shall be provided with the appropriate and sufficient amount of

physical, cognitive and sensory stimuli to enable a wide range of species specific

behaviours. Housing conditions shall take into account species specific social needs

(i.e. group- or solitary-living habits of the species). Shelters shall be provided,

whenever appropriate for the species.

Where possible, cephalopods shall be handled without taking them out from the

water. Handling of cephalopods in and outside of the water shall be kept to a minimum

and equipment in direct contact with animals shall be moistened.

Table 12.1

Cephalopods

Family

Group

Body

Minimum

Minimum water

Minimum

length

water

surface area for

water depth

surface area

each additional

(cm)

(cm)

animal in

(cm 2 )

group-holding

(cm 2 )

Sepiidae

Cuttlefish

up to 2

>2 to 6

>6 to 12

>12

Sepiolidae

Sepiolids

up to 1

>1 to 3

>3

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Loliginidae

Squid

up to 15

>15 to 25

>25

Octopodidae

Octopus

up to 10

>10 to 20

>20

Amended by: 

ANNEX IV

L.N. 297 of

METHODS OF KILLING ANIMALS

2025.

1. In the process of killing animals, methods listed in the table below shall be

used.

Methods other than those listed in the table may be used

(a) on unconscious animals, providing the animal does not regain

consciousness before death;

(b) on animals used in agricultural research, when the aim of the project

requires that the animals are kept under similar conditions to those under which

commercial farm animals are kept; these animals may be killed in accordance with the

requirements laid down in Annex I to Council Regulation (EC) No 1099/2009 of 24

September 2009 on the protection of animals at the time of killing.

2. The killing of animals shall be completed by one of the following instances

(a)

a confirmation of permanent cessation of the circulation;

(b)

destruction of the brain;

(c)

dislocation of the neck;

(d)

exsanguination; or

(e)

confirmation of the onset of rigor mortis.

Methods of confirmation of death shall be appropriate for the species to be killed.

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3. Table

Requirements

1. Shall, where appropriate, be used with prior sedation.

2. Only to be used on large reptiles.

3. Only to be used in gradual fill. Not to be used for foetal and neonate

rodents.

4. Only to be used for birds under 1kg. Birds over 250g shall be sedated.

5. Only to be used for rodents under 1kg. Rodents over 150 g shall be

sedated.

6. Only to be used for rabbits under 1kg. Rabbits over 150g shall be sedated.

7. Only to be used for birds under 5kg.

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8. Only to be used for rodents under 1kg.

9. Only to be used for rabbits under 5kg.

10. Only to be used on neonates.

11. Only to be used for birds under 250g.

12. Only to be used if other methods are not possible.

13. Specialised equipment required.

14. Only to be used on pigs.

15. Only to be used in field conditions by experienced marksmen.

16. Only to be used in field conditions by experienced marksmen when other

methods are not possible.

17. To be used only for zebrafish (Danio rerio) ≥ 16 days post fertilisation

(dpf) and with a maximum body length of 5cm. Temperature of hypothermic

shock shall be ≤ 4°C and the temperature difference from holding

temperature shall be ≥ 20°C. The fish shall not have direct contact with the

ice. Minimum exposure time shall be 5 minutes.

ANNEX V

LIST OF ELEMENTS REFERRED TO IN REGULATION 23(3)

1. National legislation in force relevant to the acquisition, husbandry, care

and use of animals for scientific purposes.

2. Ethics in relation to human-animal relationship, intrinsic value of life and

arguments for and against the use of animals for scientific purposes.

3. Basic and appropriate species-specific biology in relation to anatomy,

physiological features, breeding, genetics and genetic alteration.

4. Animal behaviour, husbandry and enrichment.

5. Species-specific methods of handling and procedures, where appropriate.

6. Animal health management and hygiene.

7. Recognition of species-specific distress, pain and suffering of most

common laboratory species.

8. Anaesthesia, pain relieving methods and killing.

9. Use of humane end-points.

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10. Requirement of rures and projects, where appropriate.

ANNEX VI

LIST OF ELEMENTS REFERRED TO IN REGULATION 37(1)(c)

1. Relevance and justification of the following

(a)

use of animals including their origin, estimated numbers, species

and life stages;

(b)

procedures.

2. Application of methods to replace, reduce and refine the use of animals in

procedures.

3. The planned use of anaesthesia, analgesia and other pain relieving

4. Reduction, avoidance and alleviation of any form of animal suffering,

from birth to death where appropriate.

5. Use of humane end-points.

6. Experimental or observational strategy and statistical design to minimise

animal numbers, pain, suffering, distress and environmental impact where appropriate.

7. Reuse of animals and the accumulative effect thereof on the animals.

8. The proposed severity classification of procedures.

9. Avoidance of unjustified duplication of procedures where appropriate.

10. Housing, husbandry and care conditions for the animals.

11. Methods of killing.

12. Competence of persons involved in the project.

ANNEX VII

DUTIES AND TASKS OF THE UNION REFERENCE LABORATORY

1. The Union Reference Laboratory referred to in regulation 48 is the

Commission’s Joint Research Centre.

2. The Union Reference Laboratory shall be responsible, in particular, for

(a)

coordinating and promoting the development and use of

alternatives to procedures including in the areas of basic and applied research

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and regulatory testing;

(b)

coordinating the validation of alternative approaches at Union

level;

(c)

acting as a focal point for the exchange of information on the

development of alternative approaches;

(d)

setting up, maintaining and managing public databases and

information systems on alternative approaches and their state of development;

(e)

promoting dialogue between legislators, regulators, and all

relevant stakeholders, in particular, industry, biomedical scientists, consumer

organisations and animal-welfare groups, with a view to the development,

validation, regulatory acceptance, international recognition, and application of

alternative approaches.

3. The Union Reference Laboratory shall participate in the validation of

alternative approaches.

ANNEX VIII

SEVERITY CLASSIFICATION OF PROCEDURES

The severity of a procedure shall be determined by the degree of pain, suffering,

distress or lasting harm expected to be experienced by an individual animal during the

course of the procedure.

Section I

Severity categories

Non-recovery

Procedures which are performed entirely under general anaesthesia from which

the animal shall not recover consciousness shall be classified as ‘non-recovery’.

Mild

Procedures on animals as a result of which the animals are likely to experience

short-term mild pain, suffering or distress, as well as procedures with no significant

impairment of the well-being or general condition of the animals shall be classified as

‘mild’.

Moderate

Procedures on animals as a result of which the animals are likely to experience

short-term moderate pain, suffering or distress, or long-lasting mild pain, suffering or

distress as well as procedures that are likely to cause moderate impairment of the well-

being or general condition of the animals shall be classified as ‘moderate’.

Severe

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Procedures on animals as a result of which the animals are likely to experience

severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as

well as procedures, that are likely to cause severe impairment of the well-being or

general condition of the animals shall be classified as ‘severe’.

Section II

Assignment criteria

The assignment of the severity category shall take into account any intervention

or manipulation of an animal within a defined procedure. It shall be based on the most

severe effects likely to be experienced by an individual animal after applying all

appropriate refinement techniques.

When assigning a procedure to a particular category, the type of procedure and a

number of other factors shall be taken into account. All these factors shall be

considered on a case-by-case basis.

The factors related to the procedure shall include

-

type of manipulation, handling,

-

nature of pain, suffering, distress or lasting harm caused by (all

elements of) the procedure, and its intensity, the duration, frequency

and multiplicity of techniques employed,

-

cumulative suffering within a procedure,

-

prevention from expressing natural behaviour including restrictions

on the housing, husbandry and care standards.

Examples are given in Section III of procedures assigned to each of the severity

categories on the basis of factors related to the type of the procedure alone. They shall

provide the first indication as to what classification would be the most appropriate for a

certain type of procedure.

However, for the purposes of the final severity classification of the procedure,

the following additional factors, assessed on a case-by-case basis, shall also be taken

into account

-

type of species and genotype,

-

maturity, age and gender of the animal,

-

training experience of the animal with respect to the procedure,

-

if the animal is to be reused, the actual severity of the previous

procedures,

-

the methods used to reduce or eliminate pain, suffering and distress,

including refinement of housing, husbandry and care conditions,

-

humane end-points.

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Section III

Examples of different types of procedure assigned to each of the severity

categories on the basis of factors related to the type of the procedure

1. Mild

(a)

administration of anaesthesia except for the sole purpose of killing;

(b) pharmacokinetic study where a single dose is administered and a limited

number of blood samples are taken (totalling < 10 % of circulating volume) and the

substance is not expected to cause any detectable adverse effect;

(c) non-invasive imaging of animals (e.g. MRI) with appropriate sedation or

anaesthesia;

(d) superficial procedures, e.g. ear and tail

biopsies,

non-surgical

subcutaneous implantation of mini-pumps and transponders;

(e) application of external telemetry devices that cause only minor impairment

to the animals or minor interference with normal activity and behaviour;

(f)

administration of substances by subcutaneous, intramuscular,

intraperitoneal routes, gavage and intravenously via superficial blood vessels, where

the substance has no more than mild impact on the animal, and the volumes are within

appropriate limits for the size and species of the animal;

(g) induction of tumours, or spontaneous tumours, that cause no detectable

clinical adverse effects (e.g. small, subcutaneous, non-invasive nodules);

(h) breeding of genetically altered animals, which is expected to result in a

phenotype with mild effects;

(i)

feeding of modified diets, that do not meet all of the animals’ nutritional

needs and are expected to cause mild clinical abnormality within the time-scale of the

study;

(j)

short-term (<24h) restraint in metabolic cages;

(k) studies involving short-term deprivation of social partners, short-term

solitary caging of adult rats or mice of sociable strains;

(l)

models which expose animals to noxious stimuli which are briefly

associated with mild pain, suffering or distress, and which the animals can successfully

avoid;

(m) a combination or accumulation of the following examples may result in

classification as ‘mild’

(i)

assessing body composition by non-invasive measures and with

minimal restraint;

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(ii)

monitoring ECG with non-invasive techniques with minimal or

no restraint of habituated animals;

(iii)

application of external telemetry devices that are expected to

cause no impairment to socially adapted animals and do not interfere with

normal activity and behaviour;

(iv)

breeding genetically altered animals which are expected to have

no clinically detectable adverse phenotype;

(v)

adding inert markers in the diet to follow passage of digesta;

(vi)

withdrawal of food for < 24h in adult rats;

(vii)

open field testing.

2. Moderate

(a) frequent application of test substances which produce moderate clinical

effects, and withdrawal of blood samples (> 10 % of circulating volume) in a conscious

animal within a few days without volume replacement;

(b) acute dose-range finding studies, chronic toxicity/carcinogenicity tests,

with non-lethal end-points;

(c) surgery under general anaesthesia and appropriate analgesia, associated

with post surgical pain, suffering or impairment of general condition. Examples

include: thoracotomy, craniotomy, laparotomy, orchidectomy, lymphadenectomy,

thyroidectomy, orthopaedic surgery with effective stabilisation and wound

management, organ transplantation with effective management of rejection, surgical

implantation of catheters, or biomedical devices (e.g. telemetry transmitters,

minipumps etc.);

(d) models of induction of tumours, or spontaneous tumours, that are expected

to cause moderate pain or distress or moderate interference with normal behaviour;

(e) irradiation or chemotherapy with a sublethal dose, or with an otherwise

lethal dose but with reconstitution of the immune system. Adverse effects would be

expected to be mild or moderate and would be short-lived (<5 days);

(f)

breeding of genetically altered animals which are expected to result in a

phenotype with moderate effects;

(g)

creation of genetically altered animals through surgical procedures;

(h) use of metabolic cages involving moderate restriction of movement over a

prolonged period (up to 5 days);

(i)

studies with modified diets that do not meet all of the animals’ nutritional

needs and are expected to cause moderate clinical abnormality within the time-scale of

the study;

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(j)

withdrawal of food for 48 hours in adult rats;

(k) evoking escape and avoidance reactions where the animal is unable to

escape or avoid the stimulus, and are expected to result in moderate distress.

3. Severe

(a) toxicity testing where death is the end-point, or fatalities are to be

expected and severe pathophysiological states are induced. For example, single dose

acute toxicity testing (see OECD testing guidelines);

(b) testing of device where failure may cause severe pain, distress or death of

the animal (e.g. cardiac assist devices);

(c) vaccine potency testing characterised by persistent impairment of the

animal’s condition, progressive disease leading to death, associated with long-lasting

moderate pain, distress or suffering;

(d) irradiation or chemotherapy with a lethal dose without reconstitution of

the immune system, or reconstitution with production of graft versus host disease;

(e) models with induction of tumours, or with spontaneous tumours, that are

expected to cause progressive lethal disease associated with long-lasting moderate pain,

distress or suffering. For example tumours causing cachexia, invasive bone tumours,

tumours resulting in metastatic spread, and tumours that are allowed to ulcerate;

(f)

surgical and other interventions in animals under general anaesthesia

which are expected to result in severe or persistent moderate postoperative pain,

suffering or distress or severe and persistent impairment of the general condition of the

animals. Production of unstable fractures, thoracotomy without adequate analgesia, or

trauma to produce multiple organ failure;

(g) organ transplantation where organ rejection is likely to lead to severe

distress or impairment of the general condition of the animals (e.g.

xenotransplantation);

(h) breeding animals with genetic disorders that are expected to experience

severe and persistent impairment of general condition, for example Huntington’s

disease, Muscular dystrophy, chronic relapsing neuritis models;

(i)

use of metabolic cages involving severe restriction of movement over a

prolonged period;

(j)

inescapable electric shock (e.g. to produce learned helplessness);

(k) complete isolation for prolonged periods of social species e.g. dogs and

non-human primates;

(l)

immobilisation stress to induce gastric ulcers or cardiac failure in rats;

(m)

forced swim or exercise tests with exhaustion as the end-point.

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