Regulations, 2017

L.N. 161 of 2017

ANIMAL WELFARE ACT

(CAP. 439)

Protection of Animals Used for Scientific Purposes

Regulations, 2017

IN exercise of the powers conferred by article16 of the Animal

Welfare Act, the Minister for Sustainable Development, the

Environment and Climate Change has made the following

regulations:-

(1)

The title of these regulations is the Protection of

Animals Used for Scientific Purposes Regulations, 2017.

(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;

(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 Stricter national

maintain in force any provisions which ensure more extensive measures.

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

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 Department responsible for the

Veterinary Services of Malta which is designated by the Malta

government to carry out the obligations arising from these

regulations.

"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, Principle of

wherever possible, a scientifically satisfactory method or testing replacement,

reduction and

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

a procedure.

(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 Purposes of

procedures.

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

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-

Subject to sub-regulation (2), specimens of non- Non-human

human primates shall not be used in procedures, with the exception of primates.

those procedures meeting the following conditions

(a)

the procedure has one of the purposes referred to

(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) 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

(a)

the procedure has one of the purposes referred to

(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;

(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)

Bla ħsara għas-sub-regolament (2), kampjuni ta’

primati mhux umani m’għandhomx jintużaw fi proċeduri, bl-

eċċezzjoni tal-proċeduri li jilħqu l-kundizzjonijiet li ġejjin

(a)

il-proċedura

jkollha

wieħed

mill-finijiet

imsemmija

(i) fis-subparagrafi (b) (i) jew (ċ) tar-regolament

5 li huma magħmula bil-għan li jigu evitati, għall-

prevenzjoni, dijanjosi jew trattament ta’ kundizzjonijiet

kliniċi perikolużi jew li potenzjalment ikunu qegħdin

ipoġġu ħajjet il-bniedem fil-periklu; jew

(ii) is-subparagrafi (a) jew (e) tar-regolament 5; u

(b)

jkun hemm ġustifikazzjoni xjentifika kemm-il

darba l-fini tal-proċedura ma tkunx tista’ tintlaħaq bl-użu ta

speċi ħlief għal primati mhux umani u bl-użu ta’ speci mhux

imnissla fl-Anness

Iżda kondizzjoni klinika debilitanti għall-iskop ta'

dawn ir-regolamenti tfisser tnaqqis fil-kapaċità fiżika jew abiltà

psikoloġika li jiffunzjona.

(2) Kampjuni ta’ primati mhux umani, elenkati fl- Anness A li

jinsab fir-Regolament tal-Kunsill (KE) Nru 338/97, li ma jaqgħux

taħt l-iskop tal-Artikolu 7(1) ta’ dak ir-Regolament, m’għandhomx

jintużaw fi proċeduri ħlief għal dawk il-proċeduri li jilħqu l-

kundizzjonijiet li ġejjin

(a)

il-proċedura

jkollha

wieħed

mill-finijiet

imsemmija

(i) fis-subparagrafi (b)(i) u (ċ) tar-regolament 5,

tkun qiegħda ssir bil-ħsieb li jiġu evitati, għall-

prevenzjoni, dijanjosi jew trattament ta’ kundizzjonijiet

kliniċi perikolużi jew li potenzjalment ikunu qegħdin

ipoġġu ħajjet il-bniedem fil-periklu;

(ii) is-subparagrafu (e) tar-regolament 5; u

(b)

jkun hemm ġustifikazzjoni xjentifika kemm-il

darba l-fini tal-proċedura ma tkunx tista’ tintlaħaq bl-użu ta’

speċi ħlief għal primati mhux umani u bl-użu ta’ speċi mhux

elenkati f’dak l-Anness.

(3) Minkejja s-sub-regolamenti (1) u (2), xadini kbar ma

għandhomx jintużaw fi proċeduri, suġġett għall-użu tal-klawsola ta'

salvagwardja fir-regolament 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 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.

Stray and feral animals of domestic species shall Stray and feral

animals of

not be used in procedures.

domestic

species.

(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.

The competent authority in Malta shall ensure that Procedures.

procedures are carried out in a user’s establishment

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

The competent authority in Malta shall ensure that Choice of

a procedure is not carried out if another method or testing strategy for methods.

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

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

(a)

result in the deaths of as few animals as possible;

(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)

Annimali ta’ speċi domestika mingħajr sid

m’għandhomx jintużaw fi proċeduri.

(2) L-awtorità kompetenti tista' tagħti biss eżenzjonijiet mis-

subregolament (1) suġġett għall-kondizzjonijiet li ġejjin

(a)

hemm ħtieġa essenzjali għal studji li jikkonċernaw

is-saħħa u l-benesseri tal-annimali jew theddid serju għall-

ambjent jew għas-saħħa tal-bniedem jew tal-annimali; u

(b)

hemm ġustifikazzjoni xjentifika b'effett li l-iskop

tal-proċedura jista' jinkiseb biss bl-użu ta' annimal li jgħix fit-

triq jew annimal salvaġġ.

(1)

L-awtorità kompetenti f'Malta għandha tiżgura li l-

proċeduri jitwettqu fi stabbilmenti tal-utent

Iżda l-awtorità kompetenti tista’ tagħti eżenzjoni mill-

ewwel subregolament jekk ikun hemm ġustifikazzjoni xjentifika.

(2) Proċeduri jistgħu jitwettqu biss fil-qafas ta’ proġett.

(1)

L-awtorità kompetenti f'Malta għandha tiżgura li l-

proċedura ma titwettaqx jekk kemm-il darba metodu ieħor jew

strateġija oħra li twassal tar-riżultat mixtieq hija rikonoxxuta taħt il-

leġislazzjoni tal-Unjoni, li fihom ma jintużawx ta' annimal ħaj.

(2) Meta jkun hemm għażla bejn proċeduri, l-kriterji tal-

għażla għandhom ikunu bbażati billi tingħata importanza għall-ħtiġiet

li ġejjin

(a)

in-numru minimu ta’ annimali li għandhom

jintużaw;

(b)

l-użu ta’ annimali bl-inqas kapaċità li jħossu

wġigħ, tbatija, skomfort jew ħsara fit-tul;

(ċ)

jikkawżaw l-inqas uġigħ, tbatija, tensjoni skomfort

jew ħsara fit-tul;

u l-aktar riżultati sodisfaċenti li jkunu provduti.

(3) Il-mewt bħala l-punt ta’ tmiem ta’ proċedura għandha tiġi

evitata kemm jista’ jkun u tinbidel għal punti ta’ tmiem bikrija u

mhux krudili. Meta l-mewt bħala l-punt ta’ tmiem tkun inevitabbli, il-

proċedura għandha titfassal biex

(a)

tirriżulta fl-inqas imwiet possibbli ta’ annimali; u

(b)

tnaqqas id-dewmien u l-intensità ta’ tbatija għall-

annimal mill-inqas possibbli, u tiggarantixxi mewt b’inqas

uġigħ, kemm-il darba dan ikun teknikament u fiżikament

vijabbli u possibbli.

(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

(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.

(1)

A procedure shall be deemed to end when no End of the

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

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, Sharing organs

where appropriate, the establishment of programmes for the sharing and tissues.

of organs and tissues of animals killed.

The competent authority in Malta may allow animals used Setting free of

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

rehoming.

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 25.

(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 it

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

sub-regulation (2).

(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.

(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.

(1)

The competent authority in Malta shall ensure that Competence of

personnel.

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 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).

(1)

The competent authority in Malta shall ensure that Specific

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

personnel.

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.

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 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 Breeding

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

human primates.

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 Scheme for

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

setting free of

rehoming scheme in place that ensures socialisation of the animals 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 Animal records.

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

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 Care and

accommodation.

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

(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 by

inspections of all breeders, suppliers and users, including their the

authority.

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

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 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).

The competent authority of Malta shall ensure that Application for

an application for project authorisation is submitted by the user or the project

authorisation.

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

The project evaluation shall be performed with a Project

degree of detail appropriate for the type of project and shall verify evaluation.

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

(a)

an evaluation of the objectives of the project, the

predicted scientific benefits or educational value;

(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

(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.

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

(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)

Skont ir-regolament 38(2)(f), il-valutazzjoni

retrospettiva għandha titwettaq mill-awtorità kompetenti li għandha,

fuq il-bażi tad-dokumentazzjoni meħtieġa ppreżentata mill-utent,

tevalwa dan li ġej

(a)

jekk l-għanijiet tal-proġett ikunux intlaħqu;

(b)

il-ħsara il tkun ikkawżata lill-annimali, inkluż n-

numri u l-ispeċi ta 'annimali użati, u s-severità tal-proċeduri; u

(ċ)

l-elementi li jistgħu jikkontribwixxu għal

implimentazzjoni aqwa tar-rekwiżit tas-sostituzzjoni, it-tnaqqis

u r-raffinament.

(2) Il-proġetti kollha li jużaw primati mhux umani u proġetti li

jinvolvu proċedimenti li huma klassifikati bħala "severi", inklużi

dawk imsemmija fir-regolament 15(2), għandha ssirilhom

valutazzjoni retrospettiva.

(3) Bla ħsara għas-subregolament (2) u b'deroga mir-

regolament 38(2)(f), l-awtorità kompetenti f'Malta tista’ teżenta dawk

il-proġetti li jinvolvu biss proċeduri kklassifikati bħala "ħfief" jew

"mingħajr irkupru" mir-rekwiżit għal valutazzjoni retrospettiva.

(1)

The project authorisation shall be limited to Granting of

project

procedures which have been subject to

authorisation.

(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 that Authorisation

the decision regarding authorisation is taken and communicated to the decisions.

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.

(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,

amendment or renewal of the project authorisation is required for any renewal

withdrawal of a

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

authorisation.

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 Documentation.

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.

(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 Avoidance of

other Member States that are generated by procedures recognised by duplication

procedures.

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 for Veterinary Services, shall advise the animal-welfare

body on matters dealing with the acquisition, breeding,

accommodation, care and use of animals in procedures and ensure

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

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 Safeguard

scientifically justifiable grounds for believing it is essential to use clauses

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 Competent

authorities.

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

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.

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 regulation

(Macaca fascicularis)

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

Rhesus monkey (Macaca 5 years after the publication of the feasibility study referred to in regulation

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

mulatta)

Other species of non-

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

human primates

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

ANNEX III

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.

(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.

2.3. Noise

(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.

2.4. Alarm systems

(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.

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.

(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.

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 height

(cm )

(g)

(cm 2 )

(cm)

In stock and

up to 20

during procedures over 20 to 330

over 25 to 330

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 breeders

less than

Enclosure size

950 cm 2

Enclosure size

less than

1 500

1 500 cm

Table 1.2.

Rats

Body

Minimum enclosure

Floor area Minimum

Date referred to

weight

size

per animal enclosure

in regulation

(g)

(cm 2 )

(cm 2 )

height

33(2)

(cm)

In stock and during up to 200 800

1 January 2017

procedures ( 2 )

over 200

to 300

over 300

to 400

over 400

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

over 50 to 1 500

breeders ( )

Enclosure size

over 100

1 500

to 150

1 500 cm

over 150

1 500

to 200

Stock at

up to 100 2 500

over 100

2 500

breeders ( )

to 150

Enclosure size

over 150

2 500

2 500 cm 2

to 200

Table 1.3.

Gerbils

Minimum

Body

Floor area

Minimum

Date referred to in

weight

enclosure size

per animal

enclosure height regulation 33(2)

(g)

(cm 2 )

(cm 2 )

(cm)

In stock and

up to 40

1 200

1 January 2017

during procedures over 40

1 200

Breeding

1 200

Monogamous pair

or trio with

offspring

Table 1.4.

Hamsters

Body

Minimum

Floor area

Minimum

Date referred to in

weight

enclosure size

per animal

enclosure height regulation 33(2)

(g)

(cm 2 )

(cm 2 )

(cm)

In stock and

up to 60 800

1 January 2017

during procedures over 60 to 800

over 100

Breeding

Mother or

monogamous pair

with litter

Stock at breeders

less than

1 500

Table 1.5.

Guinea pigs

Body

Minimum

Floor area Minimumenclosure

Date referred to

weight

enclosure size

per animal height

in regulation

(cm 2 )

(cm 2 )

(g)

(cm)

33(2)

In stock and

up to 200 1 800

1 January 2017

during

over 200 1 800

procedures

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.

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 height Date referred to in

weight

socially harmonious animals

(cm)

regulation 33(2)

(kg)

(cm 2 )

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 weight Minimum enclosure Addition for nest

Minimum height Date referred to in

(kg)

size

boxes

(cm)

regulation 33(2)

(cm 2 )

(cm 2 )

less than 3

3 500

1 000

1 January 2017

from 3 to 5 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 2 )

(cm)

Weaning to 7 4 000

1 January 2017

weeks

From 7 to 10 4 000

1 200

weeks

Table 2.4.

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

indicated in Table 2.1.

Age in

Final body

Optimum size Optimum height from the

Date referred to in

weeks

weight

(cm x cm)

enclosure floor

regulation 33(2)

(kg)

(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.

Cats

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 33(2)

(m)

(m )

(m )

Minimum for one adult animal

1,5

0,5

1 January 2017

For each additional animal add 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 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 additional Minimum

Date referred to

(kg)

enclosure size

area for one or two animal add a

height

in regulation

(m 2 )

animals

minimum of

(m)

33(2)

(m 2 )

(m 2 )

up to 20

1 January 2017

over 20

Table 4.2.

Dogs - post-weaned stock

Weight of

Minimum

Minimum floor area/

Minimum

Date referred to in

dog

enclosure size

animal

height

regulation 33(2)

(kg)

(m 2 )

(m 2 )

(m)

up to 5

0,5

1 January 2017

over 5 to 10

1,0

over 10 to 15 4

1,5

over 15 to 20 4

over 20

5. Ferrets

Table 5.

Ferrets

Minimum

Minimum floor area

Minimum

Date referred to in

enclosure size

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 in

enclosures for 1or 2

per additional animal enclosure height regulation 33(2)

animals plus offspring up

over 5 months

(m)

to 5 months old

(m 3 )

(m 2 )

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.

Table 6.2.

Squirrel monkeys

Minimum floor area for Minimum volume per

Minimum

Date referred to in

1 or 2 animals

additional animal over 6 months enclosure height

regulation 33(2)

(m 2 )

of age

(m)

(m 3 )

2,0

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 to

in regulation

enclosure size enclosure

volume per

enclosure

(m 2 )

volume

animal

height

33(2)

(m 3 )

(m 3 )

(m)

Animals less

2,0

3,6

1,0

1,8

1 January 2017

than 3 yrs of

Animals from 3 2,0

3,6

1,8

1,8

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.

Table 6.4.

Baboons

Minimum

Minimum

Minimum

Minimum

Date referred to

enclosure size enclosure

volume per

enclosure

in regulation

(m 2 )

volume

animal

height

33(2)

(m 3 )

(m 3 )

(m)

Animals less

4,0

7,2

3,0

1,8

1 January 2017

than 4 yrs of

Animals from 4 7,0

12,6

6,0

1,8

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

Trough space for Trough space for Date referred to

Body

Minimum

Minimum floor

weight

enclosure size area/animal

ad-libitum feeding restricted feeding in regulation

(kg)

(m 2 )

(m 2 /animal)

of polled cattle

of polled cattle

33(2)

(m/animal)

(m/animal)

up to 100 2,50

2,30

0,10

0,30

1 January 2017

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

Table 7.2.

Sheep and goats

Body

Minimum

Minimum floor Minimum

Trough space Trough space

Date referred

weight

enclosure

area/animal

partition

for ad-libitum for restricted

to in

(kg)

size

height

feeding

feeding

regulation

(m /animal)

(m 2 )

(m)

(m/animal)

(m/animal)

33(2)

less than 1,0

0,7

1,0

0,10

0,25

1 January

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 per

Date referred to in

(kg)

enclosure size

area per animal

animal (in, thermoneutral

regulation 33(2)

(m 2 )

(m 2 /animal)

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

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 to

height

(m 2 /animal)

enclosure

in regulation

(m)

For each animal Foaling box/ height

33(2)

For each animal

held in groups of mare with foal (m)

held singly or in

groups of up to 3

4 or more

animals

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.

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 .

Body mass

Minimum

Minimum area Minimum

Minimum length Date referred to

(g)

enclosure size

per bird

height

of feed trough per in regulation

(m 2 )

(cm)

bird

33(2)

(m )

(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 to 2,00

0,11

1 800

over 1 800 to 2,00

0,13

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

.

Body

Minimum

Minimum area

Minimum

Minimum length of Date referred to in

mass

enclosure size

per bird

height

feed trough per bird regulation 33(2)

(kg)

(m 2 )

(m 2 )

(cm)

(cm)

Up to 0,3 2,00

0,13

1 January 2017

over 0,3 2,00

0,17

to 0,6

over 0,6 2,00

0,30

to 1

over 1 to 2,00

0,35

over 4 to 2,00

0,40

over 8 to 2,00

0,50

over 12

2,00

0,55

to 16

over 16

2,00

0,60

to 20

over 20

3,00

1,00

Table 8.3.

Quails

Body

Minimum

Area per

Area per

Minimum

Minimum

Date referred

mass

enclosure size bird pair-

additional bird height

length of

to in regulation

(g)

(m 2 )

housed

group-housed (cm)

trough per bird 33(2)

(m 2 )

(m 2 )

(cm)

Up to

1,00

0,5

0,10

1 January 2017

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

.

Body mass Minimum

Area per

Minimum

Minimum length of

Date referred to in

(g)

enclosure size

bird

height

feed trough per bird

Regulation 33(2)

(m 2 )

(m 2 )

(cm)

(cm)

Ducks

1 January 2017

Up to 300

2,00

0,10

Over 300 to 2,00

0,20

1 200

Over 1 200 2,00

0,25

to 3 500

Over 3 500 2,00

0,50

Geese

Up to 500

2,00

0,20

Over 500 to 2,00

0,33

2 000

Over 2 000 2,00

0,50

Table 8.5.

Ducks and geese: Minimum pond sizes

Area

Depth

(m 2 )

(cm)

Ducks

0,5

Geese

0,5

from 10 to 30

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 length Minimum length Date referred to

enclosure size height

of food trough

of perch per bird in Regulation

(m 2 )

(cm)

per bird

(cm)

33(2)

(cm)

Up to 6

1 January 2017

from 7 to 12 3

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

9. Amphibians

Table 9.1.

Aquatic urodeles

Body

Minimum water

Minimum water surface area Minimum water Date referred to in

length

surface area

for each additional animal in depth

Regulation 33(2)

(cm)

(cm 2 )

group-holding

(cm)

(cm 2 )

Up to 10

262,5

1 January 2017

over 10 to 525

over 15 to 875

over 20 to 1 837,5

Over 30

3 150

Table 9.2.

Aquatic anurans

Body

Minimum water

Minimum water surface area

Minimum water Date referred to in

length

surface area

for each additional animal in

depth

Regulation 33(2)

(cm)

(cm 2 )

group-holding

(cm)

(cm 2 )

Less than 160

1 January 2017

from 6 to

over 9 to

over 12

12,5

Table 9.3.

Semi-aquatic anurans

Body

Minimum

Minimum area for

Minimum

Minimum

Date referred to

length

enclosure size

each additional

enclosure

water depth

in Regulation

(cm)

(cm 2 )

animal in group

height

(cm)

33(2)

holding

(cm)

(cm 2 )

up to 5,0

1 500

1 January 2017

over 5,0 to 3 500

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 size each additional

in Regulation

enclosure

water depth

(cm)

(cm 2 )

animal in group-

height

(cm)

33(2)

holding

(cm)

(cm 2 )

Up to 5,0

1 500

1 January 2017

over 5,0 to 3 500

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 group- enclosure height

Regulation 33(2)

(cm)

(cm 2 )

holding

(cm)

(cm 2 )

up to 3,0

1 January 2017

Over 3,0

1 500

10. Reptiles

Table 10.1.

Aquatic chelonians

Body

Minimum water

Minimum water surface area Minimum water Date referred to in

length

surface area

for each additional animal in depth

Regulation 33(2)

(cm)

(cm 2 )

group holding

(cm)

(cm 2 )

up to 5

1 January 2017

Over 5 to 1 600

Over 10 to 3 500

Over 15 to 6 000

1 200

Over 20 to 10 000

2 000

Over 30

20 000

5 000

Table 10.2.

Terrestrial snakes

Body length Minimum floor Minimum area for each

Minimum

Date referred to in

(cm)

area

additional animal in group- enclosure height

Regulation 33(2)

holding

(cm)

(cm )

(cm 2 )

up to 30

1 January 2017

Over 30 to

Over 40 to

Over 50 to

1 200

Over 75

2 500

1 200

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.

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 correctly and to maintain normal behaviour. Fish shall be given an

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

conditions.

11.2. Oxygen, nitrogen compounds, 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. The concentrations of nitrogen compounds shall be kept low.

The pH level shall be adapted to the species and 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, lighting, noise

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

concerned and kept as stable as possible. Changes in temperature shall take place

gradually. Fish shall be maintained on an appropriate photoperiod. Noise levels

shall be kept to a minimum and, where possible, equipment causing noise or

vibration, such as power generators or filtration systems, shall be separate from the

fish-holding tanks.

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

transition from live to artificial diets. Handling of fish shall be kept to a minimum.

ANNEX IV

METHODS OF KILLING ANIMALS

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

methods

(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.

3. Table

Animals-

Fish Amphibian Reptiles Birds Rodents Rabbits Dogs, Large

Non-

remarks/

s

cats,

mammals human

methods

ferrets

primates

and

foxes

Anaesthetic

(1)

(1)

(1)

(1)

(1)

(1)

(1)

(1)

(1)

overdose

Captive bolt

(2)

Carbon dioxide

(3)

Cervical

(4)

(5)

(6)

dislocation

Concussion/

(7)

(8)

(9)

(10)

percussive blow

to the head

Decapitation

(11)

(12)

(13) (13)

(13)

(13)

(13)

(13)

Inert gases (Ar,

(14)

Shooting with a

(15)

(16)

(15)

free bullet with

rifles, guns and

ammunition

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.

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.

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.

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

methods.

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

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

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.

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;

(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;

(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.

€5.49