PROTECTION OF ANIMALS FOR SCIENTIC PURPOSES REGULATIONS *

SUBSIDIARY LEGISLATION 439.13

PROTECTION OF ANIMALS

FOR SCIENTIC PURPOSES REGULATIONS *

16th April, 2013

LEGAL NOTICE 124 of 2013.

(1) The title of these regulations is the Protection of

Animals for Scientific Purposes Regulations.

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

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

purposes which establishes measures for the protection of animals

used for scientific or educational purposes. For this purpose, these

regulations provide 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.

(3) These regulations are being made for the safeguarding of

the public interest and public safety. Any requirements and

safeguard measures contained therein including those relating to

authorisations are made for overriding reasons relating to public

interest.

(1) Unless otherwise stated in these regulations, the

definitions in the Act shall apply.

(2) For the purpose of these regulations and unless the context

otherwise requires, the following definitions shall apply

"the Act" means the Animal Welfare Act;

"animal experiment" has the same meaning as that provided in

the Act;

"ani mal-w el fare bo dy" means a bod y set up by breeders,

suppliers and users in terms of regulation 27 with the aim to carry

out tasks as provided in terms of regulation 28;

"Animal Welfare Council” means the national committee as

established by articles 4, 5 and 6 of the Act for the protection of

animals used for scientific purposes in terms of these regulations;

"authorisation" means any authorisation which

*These regulations have been repealed by Legal Notice 138 of 2023.

(a) in relation to competent persons and their activities,

may be granted in terms of the Act, to such persons to

carry out a procedure or animal experiments, which

may only be performed by such competent persons, or

under the direct responsibility of such person and may

include any licence, warrant, permit, appointment,

concession or any decision concerning access to the

activity in question, or the exercise thereof; and

(b) in relation to breeders, suppliers, users and their

services means a permit, licence, appointment,

concession or any decision concerning access to the

service activity in question or the exercise thereof,

issued to such persons in terms of the Act and for the

term stipulated in these regulations;

"breeder" means any natural or legal person breeding animals

referred to in Schedule 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

economic remuneration or not;

"the Commission" means the European Commission;

"expert competent person" means the veterinarians or veterinary

surgeons responsible for procedures or any person or officer in

charge duly authorised to act on their behalf having adequate

knowledge and professional experience in terms of article 43 of the

Veterinary Services Act or as recognised by the Veterinary

Surgeons’ Council to exercise his duties and act on behalf of the

veterinarian;

Provided that competent personnel mentioned in regulation

24 shall, for the purpose of carrying out procedures, be at all times

supervised in terms of regulation 24(3) and conform with the

requirement set out in regulation 25(1)(c);

"debilitating clinical condition" means a reduction in an animal’s

normal physical and psychological ability to function;

"the Department" means the Department for Veterinary Services

in Malta as established by article 2 of the Act;

"the Director" has the same meaning as that provided under the

Act;

"endangered species" means those species listed in Annex A to

Council Regulation (EC) No 338/97 on the protection of species of

wild fauna and flora by regulating trade therein;

"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;

"final consumer" means any natural or legal person purchasing

animals and animal products subject to trade for his own use and

not for resale or retail purposes;

"genetically modified animal" means all animals having their

genes artificially added or removed from their DNA;

"intra-Community trade" means trade in animals and their

products between Member States including commercial activities

with the intention to make profit or gain;

"live cephalopods" means live animals of the cephalopoda class

including inter alia octopuses, squids, cuttlefish and nautiloids;

"M e m b e r St a t e" m e an s a s t a t e w h i c h i s a m e m b e r o f t h e

European Union;

"non-human primates" means all species of the primates order

excluding homo sapiens;

"non-human vertebrate animals" means all animals with a

backbone structure excluding homo sapiens;

"overriding reasons relating to public interest" means reasons

recognised as such in case law of the Court of Justice of the

European Union and which reasons present a justification for the

issue of an authorisation and, or the issue of a condition thereto

and, or to any other policy decision taken in terms of such

authorisation, when such authorisation, and, or condition and, or

policy decision thereto could not have been issued or taken under

normal circumstances but for such overriding reasons relating to

public interest which include the emergency circumstances referred

to in regulation 7(4);

"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. 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; the severity

classification of such procedures is set out in Schedule IX;

"project" means a programme of work having a defined scientific

objective and involving one or more procedures;

"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;

"specimen" has the same meaning as that provided under Council

Regulation (EC) No 338/97 on the protection of species of wild

fauna and flora by regulating trade therein;

"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 economic remuneration or not;

"TFEU" means the Treaty on the Functioning of the European

Union as amended by the Lisbon Treaty, 2009 as may be subject to

subsequent amendments;

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

procedures, whether for economic remuneration or not.

(1) 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, and

shall apply until the animals referred to in this sub-regulation have

been killed, rehomed or returned to a suitable habitat or husbandry

system. The elimination of pain, suffering, distress or lasting harm

by the successful use of anaesthesia, analgesia or other methods

shall not exclude the animal used in procedures from the scope of

these regulations.

(2)

These regulations shall also 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.

(3) Furthermore, these regulations shall apply to animals used

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

that referred to in sub-regulation (2)(a), 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.

(4) Without prejudice to sub-regulation (1), 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.

(5) These regulations shall apply without prejudice to the

Cosmetics Products Regulations.

(1) When the Department opts to maintain national laws

and regulations aimed at ensuring more extensive protection of

animals falling within the scope these regulations, it shall not

prohibit or impede the supply or use of animals bred or kept in

another Member State in accordance with these regulations, nor

shall it prohibit or impede the placing on the market of products

developed with the use of such animals in accordance with these

regulations, provided that such supply, use or breeding of animals

do not breach any other national laws regarding any prohibitions to

intra-Community trade, or any other Community laws or

regulations intended for the safeguarding and protection of human

and animal health.

(2) The Department 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.

(1) The Department shall establish and maintain a

monitoring system for the enforcement of

(a) a scientifically satisfactory method or testing strategy,

not entailing the use of live animals, to be used instead

of a procedure, wherever this is technically feasible

and possible;

(b) the reduction in the number of animals to be used in

procedures to a minimum without compromising the

objectives of the project; and

(c) breeding, accommodation and care, as well as

refinement of methods used in procedures, by

eliminating or reducing to the minimum any possible

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

(2) This regulation shall, as regards the choice of methods, be

implemented in accordance with regulation 14.

Procedures may only be carried out for the following

purposes

(a) basic research;

(b) 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 professional skills;

(g) forensic inquiries.

(1) The Department shall establish and maintain a

monitoring system for the enforcement of killing of animals with

minimum pain, suffering and distress, and such system shall

include that such 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 an establishment.

(2) In relation to animals listed in Schedule IV, the appropriate

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

(3) The Department may grant

exemptions

from

the

requirement in sub-regulation (2)

(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 may not be achieved by the

use of a method of killing set out in Schedule IV.

(4) Sub-regulations (1) and (2) 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 endangered species listed in Annex A to

Council Regulation (EC) No 338/97 on the protection of species of

wild fauna and flora by regulating trade therein, which do not fall

within the scope of Article 7(1) of such Regulation, shall not be

used in procedures, except for those procedures meeting the

following conditions

(a) the procedure has one of the purposes referred to in

regulation 6(b)(i), (c) or (e); and

(b) there is scientific justification to the effect that the

purpose of the procedure may not be achieved by the

use of species other than those listed in such Annex.

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

human primates.

(1)

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

primates shall not be used in procedures, except for those

procedures meeting the following conditions

(a) the procedure has one of the purposes referred to in

(i)

regulation 6(b)(i) or (c) 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) regulation 6(a) or (e); and

(b) there is scientific justification to the effect that the

purpose of the procedure may not be achieved by the

use of species other than non-human primates.

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

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

scope of Article 7(1) of such Regulation, shall not be used in

procedures, except for those procedures meeting the following

conditions

(a) the procedure has one of the purposes referred to in

(i)

regulation 6(b)(i) or (c) 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) regulation 6(e); and

(b) there is scientific justification to the effect that the

purpose of the procedure may not be achieved by the

use of species other than non-human primates and by

the use of species not listed in such Annex.

(1) Animals taken from the wild shall not be used in

procedures.

(2) The Department may grant exemptions from sub-regulation

(1) on the basis of scientific justification to the effect that the

purpose of the procedure may not 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. 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.

(4) The Department may grant exemptions from the

requirement in sub-regulation (3) of taking action to minimise the

suffering of the animal, if there is scientific justification.

(1) The Department shall establish and maintain a

mo nit ori ng and en fo rcem ent sy stem to ensure that animals

belonging to the species listed in Schedule I may only be used in

procedures where such animals have been bred for use in

procedures.

(2) Notwithstanding what is mentioned in sub-regulation (1), as

from the dates set out in Schedule II, the Department shall further

establish and maintain a monitoring and enforcement system to

ensure that non-human primates listed in Schedule I 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.

(3) The Department may grant exemptions from the

requirement in sub-regulation (1) on the basis of scientific

justification.

(1) Stray and feral animals of domestic species shall not

be used in procedures.

(2) The Department may only grant exemptions from sub-

regulation (1) provided that

(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 may be achieved only by the

use of a stray or a feral animal.

(1) The Department shall take all necessary administrative

measures to monitor and enforce procedures which shall be carried

out in a user’s establishment.

(2) The Department may grant an exemption from sub-

regulation (1) on the basis of scientific justification. Procedures

may be carried out only within the framework of a project.

(1) The Department shall establish and maintain a

monitoring and control system for the enforcement of a procedure

not to be carried out if another method or alternative testing

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

live animal, is recognised under other applicable EU legislation.

(2) When choosing between procedures, the selection criteria

shall be based taking into account the following requirements

(a) the minimum number of animals to be used;

(b) the use of animals with the lowest capacity to

experience pain, suffering, distress or lasting harm;

(c) the least pain, suffering, distress or lasting harm to be

caused; and

(d) the most satisfactory results provided or likely to be

provided.

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

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

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

designed so as to

(a) result in the least deaths of animals as possible; and

(b) reduce the duration and intensity of suffering to the

animal to the possible minimum and guarantee a

painless death, in so far as this is technically and

physically feasible and possible.

(1) The Department shall establish and maintain a

monitoring and control system for the enforcement of procedures

which shall be carried out under general or local anaesthesia, unless

it is inappropriate, and that analgesia or another appropriate method

shall be used to ensure that pain, suffering and distress are kept to a

minimum. Procedures involving serious injuries which 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 more traumatic to the animal

than the procedure itself; and

(b) whether anaesthesia is incompatible with the purpose

of the procedure.

(3) The Department shall further establish and maintain a

monitoring and enforcement system to ensure that animals are not

given any drug to stop or restrict their showing pain without an

adequate level of anaesthesia or analgesia. In such 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 Department shall establish and maintain a

monitoring and control system for the purpose of enforcing that all

procedures shall be classified as "non-recovery", "mild",

" m o d e r a t e " , o r " s e v e r e " o n a c a s e - b y - c a s e b a si s u si n g t h e

assignment criteria set out in Schedule IX.

(2) The Department shall establish and maintain a monitoring

and control system for the purpose of enforcing that a procedure is

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

likely to be long-lasting and may not be subject to improvement.

(1) The Department shall also establish and maintain a

monitoring and enforcement system to ensure that an animal

already used in one or more procedures shall not be reused,

provided there is a different animal on which a previous procedure

has not been carried out.

(2) Notwithstanding what is mentioned in sub-regulation (1),

and as a derogation thereof, an animal already used in one or more

procedures may be re-used provided the following conditions are

met

(a) the actual severity of the previous procedures was

"mild" or "moderate";

(b) it is shown 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.

(3) In exceptional circumstances and by way of derogation

from sub-regulation (2)(a), the Department, following a veterinary

examination of the animal, may allow the 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 further

observations need be made for that procedure or, as regards new

genetically modified animal lines, when the offsprings 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. 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 shall be kept alive, it shall receive care

and accommodation appropriate to its state of health.

The Department shall facilitate, where appropriate, the

establishment of programmes for the sharing of organs and tissues

of animals killed.

The Department shall allow animals used or intended to be

used in procedures to be rehomed, or returned to a suitable habitat

or husbandry system appropriate to the species, provided that the

following conditions are met

(a) the state of health of the animal permits so;

(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) The Department shall establish and maintain a

monitoring and enforcement system to ensure that all breeders,

suppliers and users of animals to be used for experimentation are

authorised and registered in terms of article 42 of the Act. Such

authorisation may only be granted for a limited period.

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 regulations 25(1) and 26.

(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 Department shall at all times 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 Department

shall take appropriate remedial action, or require such action to be

taken, or suspend or withdraw its authorisation.

(2) The Department shall, where the authorisation is suspended

or withdrawn, take all necessary measures to maintain the welfare

of the animals housed in the establishment to the extent that such

welfare is not adversely affected.

(1) The Department shall establish and maintain a

monitoring and control system to enforce 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, according 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

guarantee 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 Department shall also establish and maintain a

monitoring and control system to enforce compliance with the

relevant requirements set out in Schedule III.

(4) The design, construction and method of functioning of the

establishment shall ensure the maximum bio security to guarantee

that there will be no dispersion of biological or chemical material

or other residues into the surrounding environment.

(1) The Department shall establish and maintain a

monitoring and enforcement system to ensure that each breeder,

supplier and user has sufficient staff on site.

(2) The staff shall be adequately educated and well-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 for the purpose of paragraphs (a) and (d), the

staff shall be recognised as a competent person.

(3) Persons carrying out the functions referred to in sub-

regulation (2)(b) shall have received instruction in a scientific

order and authority relevant to the work being undertaken and shall

have specific knowledge on species. Staff carrying out functions

referred to in sub-regulation (2)(a), (c) or (d) shall be supervised in

the performance of their tasks until they have demonstrated the

requisite competence.

(4) The Department shall take all necessary administrative

measure by means of authorisation or otherwise, to ensure that the

requirements laid down in sub-regulation (3) are fulfilled.

(5) The Department shall publish, on the basis of the elements

set out in Schedule V, the minimum requirements with regard to

educatio n and training an d the req uirem en ts for obtainin g,

maintaining and demonstrating requisite competence for the

functions set out in sub-regulation (2).

(1) The Department shall establish and maintain a

monitoring and enforcement system to ensure that each breeder,

supplier and user has one or several persons on site who shall

(a) be responsible for overseeing the welfare and care of

the animals in the establishment;

(b) ensure that the staff dealing with animals have access

to specific information relating to the species kept 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 Department shall at all times guarantee that persons

mentioned in regulation 41(2)(b) shall

(a) eliminate any unnecessary pain, suffering, distress or

lasting harm that is being inflicted on an animal in the

course of a procedure;

(b) ensure that the projects are carried out in accordance

with the project authorisation in terms of regulation

37, or in the cases referred to in regulation 43, in

accordance with the application sent to the Department

in terms of regulation 38, or any decision taken by the

Department; and

(c) in the event of non-compliance, ensure that all

appropriate measures are taken to rectify such position

or mal-practice as the case may be. Such measures

taken for such rectification shall be recorded.

The Department shall at all times maintain a monitoring

and control system to enforce that each breeder, supplier and user

has a designated veterinarian with expertise in laboratory animal

medicine, or where it is more appropriate, an expert competent

person charged with advisory duties in relation to the well-being,

treatment and welfare of the animals.

(1) The Department shall establish and maintain a

monitoring and enforcement system to 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 competent person referred to in regulation 26.

(3)

Such body shall also

(a) as a primary task, focus on giving advice on animal-

welfare issues; the advice given by the animal-welfare

body shall be properly documented and open to

scrutiny during inspections;

(b) follow the development and outcome of projects at

establishment level; and

(c) foster a climate of care and provide tools for the

practical application and timely implementation of

recent technical and scientific developments in

relation to the principles of replacement, reduction and

refinement, in order to enhance the life-time

experience of the animals.

(1) Without prejudice to the provisions of regulation

27(3), 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

socialization of the animals to be rehomed.

(2) The Department shall establish a monitoring and

enforcement system to ensure that the records of any advice given

by the animal-welfare body and decisions taken regarding that

advice are kept for at least three years. The records shall be made

available to the Department upon its request.

The Department shall also establish and maintain a

monitoring system for the purpose of ensuring that breeders of non-

hum an primates have a strategy in place for increasing the

proportion of animals that are the offspring of non-human primates

that have been bred in captivity.

Where the Department allows rehoming, the breeders,

suppliers and users from which animals are intended to be rehomed

shall have a rehoming scheme in place that ensures socialization of

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

appropriate, a programme of rehabilitation shall be in place before

they are returned to their natural habitat.

(1) The Department shall establish a monitoring and

enforcement system to ensure 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 five years and made available to the Department

upon its request.

(1) The Department shall establish a monitoring and

enforcement system to ensure that all breeders, suppliers and users

keep the following information on each dog, cat and non-human

primate

(a) identification of each animal;

(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. The file shall be set up at

birth, or in the case of dogs, prior to the eruption of the lower pair

of permanent canine teeth, or prior to six months of age, whichever

comes first, 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 three years after the death or rehoming of the

animal, and shall be made available to the Department upon

request. 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 microchip shall be applied

and a record shall be maintained by the receiver.

(3) No unmarked dogs, cats or non-human primates, which are

weaned, shall be transferred, and the breeder, supplier or user shall

permanently mark any animal as soon as possible, in the least

painful manner possible and prior to its transfer.

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

of the Department, reasons for which an animal is unmarked.

(5) The provisions of this regulation shall apply without

prejudice to the Electronic Identification of Dogs Regulations.

(1) The Department shall, in so far as the care and

accommodation of animals is concerned, establish and maintain a

monitoring and enforcement system to 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 may

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 Department shall

further establish a monitoring and enforcement system to ensure

that the care and accommodation standards set out in Schedule III

are applied from the dates provided for therein.

(3) The Department may allow exemptions from the

requirements of sub-regulations (1)(c) and (2) on the basis of

scientific and animal-welfare justifications or animal-health

reasons.

(1) The Department shall carry out regular inspections of

all breeders, suppliers and users, including their establishments, to

verify compliance with the requirements of these regulations.

(2)

The Department 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). Nonetheless, breeders, suppliers and users of

non-human primates shall be inspected at least once a year.

(4) Records of all inspections shall be kept for at least five

years. An appropriate proportion of the inspections shall be carried

out without prior warning.

(1) The Department shall give all necessary assistance to

the experts of the Commission when carrying out inspections in

Malta.

(2) The Department shall take measures to take account of the

results of the controls inspections referred to in sub-regulation (1).

(1) Without prejudice to regulation 43, projects shall not

be carried out without prior authorisation from the Department, and

they shall be carried out in accordance with the authorisation or, in

the cases referred to in regulation 43, in accordance with the

application sent to the Department or any decision taken by the

Department.

(2) No project shall be carried out unless a favourable project

evaluation by the Department has been concluded in accordance

with regulation 39.

The Department shall establish a monitoring and

enforcement system to ensure that an application for a project

authorisation is submitted by the user or the person responsible for

the project. The application shall include at least the following

(a) the project proposal;

(b) a non-technical project summary; and

(c) information on the elements set out in Schedule VI.

(1) The project evaluation shall be performed with a

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

that the project meets the following criteria

(a) the project is justified from a scientific or educational

point of view or required by law;

(b) the purposes of the project justify the use of animals;

and

(c) the project is designed so as to enable procedures to be

carried out in the most humane and environmentally

sensitive manner possible.

(2) The project evaluation shall consist in particular of the

following

(a) an evaluation of the objectives of the project, the

predicted scientific benefits or educational value;

(b) an assessment of the compliance of the project with

the requirement of replacement, reduction and

refinement in procedures in terms of regulation 5;

(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 which

may ultimately benefit human beings, animals or the

environment;

(e) an assessment of any justification referred to in

regulations 7 to 13, 15, 17 and 34(3); and

(f)

a determination as to whether and when the project

should be assessed retrospectively.

(3) The Department carrying out the project evaluation shall

consider expertise in particular in the following areas

(a) the areas of scientific use for which animals shall be

used including replacement, reduction and refinement

in the respective areas in procedures in accordance

with regulation 5;

(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,

objective and non-discriminatory. Without prejudice to intellectual

prop erty righ ts, protectio n of data and the safeguarding of

confidential information, the project evaluation shall be performed

in an impartial manner and may integrate and include the opinion

of independent parties.

(1) The Department shall determine, in accordance with

regulation 39(2)(f), the retrospective assessment which shall be

carried out by the same Department, which shall, on the basis of the

necessary documentation submitted by the user, evaluate the

following

(a) whether the objectives of the project were achieved;

(b) the harm inflicted on animals, including the numbers

and species of animals used, and the severity of the

procedures; and

(c) any elements which 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 16(2), shall undergo a retrospective

assessment.

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

derogation from regulation 39(2)(f), the Department shall exempt

projects involving only procedures classified as "mild" or "non-

recovery" from the requirement for a retrospective assessment.

(1) The project authorisation

shall

be

limited

to

procedures which have been subject to

(a) a project evaluation; and

(b) the severity

classifications

assigned

to

those

procedures.

(2)

The project authorisation shall specify the following

(a) the user who undertakes the project;

(b) the persons responsible for the overall implementation

of the project and compliance of such implementation

with the project authorisation;

(c) the establishments in which the project will be

undertaken, where applicable;

(d) any specific conditions following the project

evaluation, including whether and when the project

shall be assessed retrospectively; and

(e) the designated veterinarian responsible for the overall

implementation of procedures and an expert competent

person where necessary.

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

exceeding five years.

(1) The Department shall take a decision regarding the

authorisation which shall be communicated to the applicant forty

working days at the latest from the receipt of the complete and

correct application. This period shall include the project

evaluation.

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

disciplinary nature of the project, the Department may extend the

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

period not exceeding fifteen 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 Department shall acknowledge to the applicant all

applications for authorisations immediately 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

Department shall immediately 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) When introducing a simplified administrative

procedure, the Department shall establish and maintain a

monitoring and control system to ensure that the following

provisions are met

(a) the application specifies elements referred to in

regulation 41(2)(a), (b), (c) and (e);

(b) a project evaluation is performed in accordance with

regulation 39; and

(c) the period referred to in regulation 42(1) is not

exceeded.

(2) If a project is changed in a way which may have a negative

impact o n animal welfare, the Department shall require an

additional project evaluation with a favourable outcome.

(3) Regulations 41(3), 42(3), and 45(3) and (4) shall apply

mutatis mutandis to projects which are allowed to be carried out in

accordance with this regulation.

(1) Without prejudice to intellectual property rights, data

protection and confidentiality of information, non-technical project

summaries shall provide and include 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 in procedures

in terms of regulation 5. The non-technical project

summary shall be anonymous and shall not contain the

names and addresses of the user and its personnel.

(2) In case of a project undergoing a retrospective assessment,

the Department shall establish a monitoring and enforcement

system to ensure that the non-technical project summary is updated

with the results of any retrospective assessment.

(3) The Department shall publish the non-technical project

summaries of authorised projects and any updates thereto.

(1) An amendment or renewal of the project authorisation

shall be required for any change of the project that may have a

negative impact on animal welfare as established and enforced by

the Department.

(2) Any amendment or renewal of a project authorisation shall

be subject to a further favourable outcome of the project

evaluation.

(3) The Department shall withdraw the project authorisation

where the project is not carried out in accordance with the project

authorisation, provided that the welfare of the animals used or

intended to be used in the project is not be adversely affected.

(4) The Department shall establish and publish conditions for

amendments and renewal of project authorisations.

(1) The Department shall establish a monitoring and

enforcement system to ensure that all relevant documentation,

including project authorisations and the result of the project

evaluation, is kept for at least three years from the expiry date of

the authorisation of the project or from the expiry of the period

referred to in regulation 42(1). Such documentation shall be made

available to the Department.

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

for projects which shall undergo retrospective assessment shall be

kept until the retrospective assessment has been completed.

The Department shall accept data from other competent

authorities which is generated by procedures recognised by

European Union legislation, unless further procedures need to be

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

safety or the environment.

(1) The Department 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 Department shall take such other

steps as it considers appropriate to encourage and promote research

in this field.

(2) The Department shall, at national level, encourage and

promote the development and validation of alternative approaches

and the dissemination of information thereon.

(3) Such validation studies shall be carried out by the National

Reference Laboratory referred to in Part A of Schedule VIII. The

tasks of such Laboratory are established under Part B of the

Schedule VIII.

The Union Reference Laboratory and its duties and tasks

shall be those referred to in Schedule VII.

(1) The Animal Welfare Council established for the

protection of animals used for scientific purposes 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 the animal-welfare body and

project evaluation and share best practice within the Union.

(1) The Department shall by 10 November 2018, and

every five years thereafter, send to the Commission the information

on the implementation of these regulations and in particular

regulations 11(1), 27, 29, 35, 39, 40, 44 and 47.

(2) The Department shall collect and publish, 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) The Department shall submit such statistical information to

the Commission by 10 November 2015 and every year thereafter.

(4) The Department shall submit to the Commission, on annual

basis, detailed information on exemptions granted under regulation

7(3)(a).

(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 4(2) and (3).

(2) Any right given to the Department under these regulations

to apply all such necessary measures prescribed in regulation 4(2)

an d (3 ), shall be given w ithou t prejudice t o oth er cri minal

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.

Schedule I

LIST OF ANIMALS REFERRED TO IN REGULATION 11

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)

Schedule II

LIST OF NON-HUMAN PRIMATES AND DATES REFERRED TO

IN REGULATION 11(1)

Species

Dates

Marmoset (Callithrix jacchus)

1 January 2013

C y n o m o l g u s m o n k e y ( M a c a c a 5 years after the publication of the feasibility

s t u d y r e f e r r e d t o i n r e g u l a t i o n 11 ( 1 ) ,

fascicularis)

provided the study does not recommend an

extended period

Rhesus monkey (Macaca mulatta)

5 years after the publication of the feasibility

s t u d y r e f e r r e d t o i n r e g u l a t i o n 11 ( 1 ) ,

provided the study does not recommend an

extended period

Other species of non-human primates 5 years after the publication of the feasibility

s t u d y r e f e r r e d t o i n r e g u l a t i o n 11 ( 1 ) ,

provided the study does not recommend an

extended period

Schedule 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 an impermeable 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 with immediate effect.

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 34(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 impermeable 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.

3.8. Cleaning

Cleaning schedules shall be established for each species to ensure that the

holdings and environments do not remain soiled and are not a source of ill health to

the animal.

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 weight

Minimum

Floor area Minimum

Date

(g)

enclosure size

per animal enclosure referred to in

(cm 2 )

(cm 2 )

height (cm) regulation

34(2)

I n s t o c k up to 20

1 January

and during

over 20 to 25 330

procedures

over 25 to 30 330

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.

S t o c k a t less than 20

breeders

Enclosure

size 950

cm 2

Enclosure less than 20

1 500

size 1500

cm 2

(*) Post-weaned mice may be kept at these higher stocking densities for the short period after

weaning until issue, provided that the animals are housed in larger enclosures with adequate

enrichment, and these housing conditions do not cause any welfare deficit such as increased

levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight

loss, or other physiological or behavioural stress responses.

Table 1.2

Rats

Body weight

Minimum

Floor area Minimum Date referred

(g)

enclosure size

per animal enclosure

to in

(cm 2 )

(cm 2 )

height (cm) regulation

34(2)

stock up to 200

January

and during

procedures over 200

to 800

(*)

over

to

to 1 500

over

over 600

Breeding

Mother and litter.

For

each

additional

adult

animal

permanently added

to the enclosure

add 400 cm 2

Stock at up to 50

1 500

breeders

over 50 to 100 1 500

(**)

Enclosure over 100

to 1 500

size 1 500 150

1 500

cm 2

over 150

to

Stock at up to 100

2 500

breeders

over 100

to 2 500

(**)

2 500

Enclosure

size 2 500 over 150

to

cm 2

(*) In long-term studies, if space allowances per individual animal fall below those indicated above

towards the end of such studies, priority shall be given to maintaining stable social structures.

(**) Post-weaned rats may be kept at these higher stocking densities for the short period after weaning

until issue, provided that the animals are housed in larger enclosures with adequate enrichment,

and these housing conditions do not cause any welfare deficit such as increased levels of

aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, or

other physiological or behavioural stress responses.

Table 1.3

Gerbils

Body weight

Minimum

Floor area Minimum Date referred

(g)

enclosure size

per animal enclosure

to in

(cm 2 )

(cm 2 )

height (cm) regulation

34(2)

stock up to 40

1 200

January

and during

procedures over 40

1 200

Breeding

1 200

Monogamous pair

or

trio

with

offspring

Table 1.4

Hamsters

Body weight

Minimum

Floor area Minimum Date referred

(g)

enclosure size

per animal enclosure

to in

(cm 2 )

(cm 2 )

height (cm) regulation

34(2)

stock up to 60

January

and during

procedures over 60 to 100 800

over 100

Breeding

Mother

or

monogamous pair

with litter

Stock

at less than 60

1 500

breeders

(*) Post-weaned hamsters may be kept at these higher stocking densities, for the short period after

weaning until issue provided that the animals are housed in larger enclosures with adequate

enrichment, and these housing conditions do not cause any welfare deficit such as increased

levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight

loss, or other physiological or behavioural stress responses.

Table 1.5

Guinea pigs

Body weight

Minimum

Floor area Minimum Date referred

(g)

enclosure size

per animal enclosure

to in

(cm 2 )

(cm 2 )

height (cm) regulation

34(2)

In

stock up to 200

1 800

January

and during

procedures over 200

to 1 800

1 800

over 300 to 450

2 500

to 2 500

over

over 700

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 55cm 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 500cm 2 as a minimum shall be added for each additional rabbit above a

number of six.

*Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming

purposes.

Final body weight Minimum floor area

Minimum height

Date referred to in

(kg)

for one or two

(cm)

regulation 34(2)

socially harmonious

animals (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 (kg)

Minimum

Addition for

Minimum

Date referred to in

enclosure size nest boxes

height (cm)

regulation 34(2)

(cm 2 )

(cm 2 )

less than 3

3 500

1 000

1 January 2017

from 3 to 5

4 200

1 2000

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

Minimum

Date referred to in

enclosure size area per animal height (cm)

regulation 34(2)

(cm 2 )

(cm 2 )

Weaning

to

7 4 000

1 January 2017

weeks

4 000

1 200

From 7 to 10

weeks

Table 2.4

Rabb its: Op tim al di men si on s fo r rai se d areas f or encl osures h av in g t he

dimensions indicated in Table 2.1.

Age in weeks

Final body

Optimum size

Optimum

Date referred to in

weight (kg)

(cm x cm) height from the

regulation 34(2)

enclosure floor

(cm)

over 10

less than 3

55 x 25

1 January 2017

from 3 to 5

55 x 30

over 5

60 x 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 rehomed 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.

Shelves (m 2 )

Height (m 2 )

Floor (*)

Date referred to in

(m )

regulation 34(2)

Minimum for 1.5

0.5

1 January 2017

one

adult

animal

For

each 0.75

0.25

-

additional

animal add

(*) Floor area excluding shelves.

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

undergoing procedures as defined in these regulations, if this separation is essential

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

4 hours at a time.

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

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

an additional compartment or raised area away from the puppies.

Weight

Minimum

Minimum floor For each

Minimum Date referred

(Kg)

enclosure

area animal add additional height (m)

to in

Size (m 2 )

for one or two animal add

regulation

animals (m 2 ) a Minimum

34(2)

of (m 2 )

Up to 20

January

Over 20

Table 4.2

Dogs-post weaned stock

Weight of Dog

Minimum

Minimum floor

Minimum

Date referred to

(Kg)

enclosure size

area/ animal

height

in regulation

(m 2 )

(m 2 )

(cm)

34(2)

Up to 5

0.5

1 January 2017

Over 5 to 10

1.0

Over 10 to 15

1.5

Over 15 to 20

Over 20

Table 5

Ferrets

Minimum

Minimum floor

Minimum

Date referred to

enclosure size area/ animal

enclosure

in regulation

(cm 2 )

(cm 2 )

height (cm)

34(2)

Animals up to 600g 4 500

1 500

1 January 2017

Animals over 600g 4 500

3 000

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

Minimum

Minimum

Date referred to

floor area of

volume per

enclosure

in regulation

enclosures for

additional

height

34(2)

1(*) or 2

animal over 5

(m) (**)

animals plus

months old

(m 3 )

offspring up

to 5 months

(m 2 )

Marmosets

0.5

0.2

1.5

1 January 2017

Tamarins

1.5

0.2

1.5

(*) Animals shall be kept single only in exceptional circumstances.

(**) The top of the enclosure shall be kept at least 1.8 m from the floor.

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 Minimum volume per

Minimum

Date referred to in

for 1 (*) or 2 animals additional animal over enclosure height

regulation 34(2)

(m 2 )

6 months of age (m 3 )

(m)

2.0

0.5

1.8

1 January 2017

(*) Animals should be kept singly only in exceptional circumstances.

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

months of age.

Table 6.3

Macaques and vervets (*)

Minimum Minimum

inimum

Minimum

Date referred in

enclosure enclosure

volume per

enclosure

regulation 34(2)

size (m 2 ) volume (m 3 ) animal (m 3 ) height (m)

Animals less 2.0

3.6

1.0

1.8

1 January 2017

than 3 years

of age (**)

Animals from 2.0

3.6

1.8

1.0

3 years of age

(***)

Animals held

3.5

2.0

for breeding

purposes

(****)

(*)

Animals should be kept singly only in exceptional circumstances.

(**)

An enclosure of minimum dimensions may hold up to three animals.

(***)

An enclosure of minimum dimensions may hold up to two animals.

(****) In breeding colonies no additional space/volume allowance is required for young animals up to

2 years of age housed with their mother.

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 in

enclosure enclosure volume per enclosure regulation 34(2)

size (m 2 ) volume (m 3 ) animal (m 3 ) height (m)

Animals less 4.0

7.2

3.0

1.8

1 January 2017

than 4 years

of age

Animals from 7.0

12.6

6.0

1.8

4 years of age

(**)

Animals held

12.0

2.0

for breeding

purposes

(***)

(*)

Animals shall be kept singly only in exceptional circumstances.

(**)

An enclosure of minimum dimensions may hold up to 2 animals.

(***)

In breeding colonies no additional space/volume allowance is required for young animals up to

2 years of age housed with their mothers.

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/EEC * and 91/630/EEC † .

Table 7.1

Cattle

Body weight

Minimum

Minimum Trough space Trough

Date referred

(Kg)

enclosure

floor area/

for ad-

space for in regulation

size (m 2 )

animal

libitium

restricted

(34)2

(m 2 /animal ) feeding of

feeding

polled cattle polled cattle

(m/animal) (m/animal)

Up to 100

2.50

2.30

0.10

0.30

1 January 2017

Over 100 to 200 4.25

3.40

0.15

0.50

Over 200 to 400 6.00

4.80

0.18

0.60

Over 400 to 600 9.00

7.50

0.21

0.70

Over 600 to 800 11.00

8.75

0.24

0.80

Over 800

16.00

10.00

0.30

1.00

Table 7.2

Sheep and goats

Body Weight Minimum Minimum Minimum Tough space Tough

Date

(Kg)

Enclosure Floor area/ partition

for ad-

Space for referred in

(m 2 )

animal

height

libitum

restricted regulation

(m 2 /animal )

(m)

feeding

feeding

34(2)

(m/animal) (m/animal)

Less than 20

1.0

0.7

1.0

0.10

0.25

1 January

Over 20 to 35 1.5

1.0

1.2

0.10

0.30

Over 35 to 60 2.0

1.5

1.2

0.12

0.40

Over 60

3.0

1.8

1.5

0.12

0.50

*Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of

calves

†Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of

pigs

Table 7.3

Pigs and Minipigs

Live Weight

Minimum

Minimum floor Minimum laying Date referred

(Kg)

Enclosure (*)

area per animal space per animal in regulation

(m 2 )

(m 2 /animal )

(in thermo

34(2)

neutral

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

(*) Pigs may be confined in smaller enclosures for short periods of time, for example by partitioning

the main enclosure using dividers, when justified on veterinary or experimental grounds , for

example where individual food is required .

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 height

Minimum Floor area/ animal

Minimum

Date

(m 2 /animal)

(m)

Enclosure referred in

height regulation

(m)

34(2)

For

e a c h For each animal Foaling box /

1 January

a n i m a l h e l d held in groups of m a r e

with

s i n g l y o r i n 4 or more animals foal

groups of up

to 3 animals

1.00 to 1.40

9.0

6.0

3.00

O v e r 1 . 4 0 t o 12.0

9.0

3.00

1.60

(2 x WH) 2 (*)

Over 1.60

16.0

3.00

(*) To ensure adequate space is provided, space allowances for each individual animal shall be based

on height to withers (WH).

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 † .

*Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying

hens

†Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the protection of chickens

kept for meat production

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

0.75m 2

Body Mass

Minimum Minimum area Minimum Minimum Date referred

Enclosure per bird (m 2 )

(g)

height

length of in regulation

size (m 2 )

(cm)

feed

34(2)

through

per bird

(cm)

Up to 200

1.00

0.025

January

Over 200 to 300 1.00

0.03

Over 300 to 600 1.00

0.05

Over 600 to 1200 2.00

0.09

Over 1200 to 1800 2.00

0.11

Over 1800 to 2400 2.00

0.13

Over 2400

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 0.75m 2 and a minimum height of 50cm

for birds below 0.6kg, 75cm for birds below 4kg, and 100cm for birds over 4kg.

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

allowances given in table 8.2.

Body Mass

Minimum Minimum area Minimum Minimum Date referred in

enclosure per bird (m 2 ) height (cm) length of regulation 34(2)

(kg)

size (m 2 )

feed

through per

bird (cm)

Up to 0.3

2.00

0.13

1 January 2017

Over 0.3 to 0.6 2.00

0.17

Over 0.6 to 1

2.00

0.30

Over 1 to 4

2.00

0.35

Over 4 to 8

2.00

0.40

Over 8 to 12

2.00

0.50

Over 12 to 16 2.00

0.55

Over 16 to 20 2.00

0.60

Over 20

3.00

1.00

Table 8.3

Quails

Body Mass Minimum Area per

Area per Minimum Minimum Data referred

(g)

enclosure bird pair- additional height (cm) length of in regulation

size (m 2 ) housed (m 2 ) bird group-

trough per

34(2)

housed (m 2 )

bird (cm)

Up to 150 1.00

0.5

0.10

1 January

Over 150

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

0.75m 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 bird Minimum

Minimum Data referred

(m 2 ) (*)

(g)

Enclosure

height (cm )

length of in regulation

Size (m 2 )

feed trough

34(2)

per bird

(cm)

Ducks

Up to 300

2.00

0.10

January

O v e r 3 0 0 t o 2.00

0.20

1200 (*)(**)

Over 1200 to 2.00

0.25

Over 3500 2.00

0.50

Geese

Up to 500

2.00

0.20

O v e r 5 0 0 t o 2.00

0.33

Over 2000 2.00

0.50

(*) This shall include a pond of minimum area 0.5m per 2m enclosure with a minimum depth of

30cm.The pond may contribute up to 50% of the minimum enclosure size.

(**) Pre-fledged birds may be held in enclosures with a minimum height of 75cm.

Table 8.5

Ducks and geese: Minimum pond sizes (*)

Area

Depth

(m 2 )

(cm)

Ducks

0.5

Geese

0.5

From 10 to 30

(*) Pond sizes are per 2m 2 enclosures. The pond may contribute up to 50% of the minimum enclosure

size.

Table 8.6

Pigeons

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

allow birds to perform short flights.

Group size

Minimum

Minimum

Minimum Minimum Date referred

enclosure

height

length of

length of in regulation

size (m 2 )

(cm)

food trough perch per

34(2)

per bird

bird (cm)

(cm)

Up to 6

1 January 2017

From 7 to 12 3

For

e a c h 0.15

additional bird

above 12

Table 8.7

Zebra finches

Enclosures shall be long and narrow (for example 2m by 1m) 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 0.5m 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

Date referred in

enclosure size

height

number of

regulation

(m 2 )

(cm)

feeders

34(2)

Up to 6

1.0

1 January 2017

7 to 12

1.5

13 to 20

2.0

For each additional bird 0.05

1 per 6 birds

above 20

Table 9.1

Aquatic urodeles

Body length (*)

Minimum

Minimum water

Minimum Date referred

(cm)

water surface

surface area for water depth in regulation

area (cm 2 )

each additional

(cm)

34(2)

animal in group-

holding

(cm 2 )

Up to 10

262.5

1 January 2017

Over 10 to 15

Over 15 to 20

Over 20 to 30

1 837.5

Over 30

(*) Measured from snout to vent.

Table 9.2

Aquatic anurans (*)

Body length (**)

Minimum

Minimum water

Minimum Date referred

(cm)

water surface

surface area for water depth

in 34(2)

area (cm 2 )

each additional

(cm)

animal in group

holding (cm 2 )

Less than 6

January

From 6 to 8

Over 9 to 12

Over 12

12.5

(*) These conditions apply to holding (i.e. husbandry) tanks but not to those tanks used for natural

mating and super-ovulation for reasons of efficiency, as the latter procedures require smaller

individual tanks. Space requirements determined for adults in the indicated size categories;

juveniles and tadpoles shall either be excluded, or dimensions altered according to the scaling

principle.

(**) Measured from snout to vent.

Table 9.3

Semi-aquatic anurans

Body length

Minimum Minimum water Minimum Minimum Date referred

(**) (cm)

water

surface area for enclosure water depth in regulation

surface area each additional height (***)

(cm)

34(2)

(cm 2 )

animal in group

(cm)

holding (cm 2 )

Up to 5.0

January

Over 5.0 to 7.53500

Over 7.5

Measured from snout to vent.

One third land division, two thirds water division sufficient for animals to submerge.

Measured from the surface of the land division up to the inner part of the top of the terrarium;

furthermore, the height of the enclosures shall be adapted to the interior design.

Table 9.4

Semi-terrestrial anurans

Body length

Minimum Minimum water Minimum Minimum Date referred

(**) (cm)

water

surface area for enclosure water depth in regulation

surface area each additional height (***)

(cm)

34(2)

(cm 2 )

animal in group

(cm)

holding (cm 2 )

Up to 5.0

1 500

1 January

Over 5.0 to 7.53 500

Over 7.5

4 000

Measured from snout to vent.

One third land division, two thirds water division sufficient for animals to submerge.

Measured from the surface of the land division up to the inner part of the top of the terrarium;

furthermore, the height of the enclosures shall be adapted to the interior design.

Table 9.5

Arboreal anurans

Body length (**)

Minimum

Minimum water

Minimum Date referred in

(cm)

water surface surface area for water depth regulation 34(2)

area (cm 2 )

each additional

(cm)

animal in group

holding

(cm 2 )

Up to 3.0

1 January 2017

Over 3.0

1 500

Measured from snout to vent.

One third land division, two thirds water division sufficient for animals to submerge.

Measured from the surface of the land division up to the inner part of the top of the terrarium;

furthermore, the height of the enclosures shall be adapted to the interior design.

10. Reptiles

Table 10.1

Aquatic chelonians

Body length (**)

Minimum

Minimum water

Minimum Date referred in

(cm)

floor area

surface area for water depth regulation 34(2)

(cm 2 )

each additional

(cm)

animal in group

holding (cm 2 )

Up to 5

1 January 2017

Over 5 to 10

1 600

Over 10 to 15

3 500

Over 15 to 20

6 000

1 200

Over 20 to 30

10 000

2 000

Over 35

20 000

5 000

(*) Measured in a straight line from the front edge to the back edge of the shell.

Table 10.2

Terrestrial snakes

Body length (**)

Minimum

Minimum area for Minimum Date referred to

(cm)

floor are

each additional

enclosure

in regulation

(cm 2 )

animal in group

height (**)

34(2)

holding (cm 2 )

(cm)

Up to 30

1 January 2017

Over 30 to 40

Over 40 to 50

Over 50 to 75

1 200

Over 75

2 500

1 200

(*) Measured from snout to vent.

(**) Measured from the surface o the land division up to the inner part of the top of the terrarium;

furthermore, the height of the enclosures shall be adapted to the interior design.

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.

Schedule 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

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 1 kg. Birds over 250 g shall be sedated.

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

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

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

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

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

10. Only to be used on neonates.

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

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.

Schedule V

LIST OF ELEMENTS REFERRED TO IN REGULATION 24(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 replacement, reduction and refinement.

11. Design of procedures and projects, where appropriate.

Schedule VI

LIST OF ELEMENTS REFERRED TO IN REGULATION 38(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.

Schedule VII

Part A - The Union Reference Laboratory

The Union Reference Laboratory referred to in regulation 49 is the Commission’s

Joint Research Centre.

Part B - Duties and tasks of the Union Reference Laboratory

1. 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.

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

alternative approaches.

Schedule VIII

Part A - The National Reference Laboratory

The National Reference Laboratory in Malta referred to in regulation 48 is the

National Veterinary Laboratory situated in Abattoir Street, Albertown, Marsa.

Part B - Tasks of the National Reference Laboratory

The National Reference Laboratory shall be responsible interalia and in particular

for the following

(a) carrying out of validation studies and coordinating the validation of

alternative approaches at national level;

(b) ensuring the promotion of alternative approaches and the dissemination

of information thereon;

(c) providing advice on the regulatory relevance and suitability and

development of alternative approaches proposed for validation as a

point of single contact for the purpose of exchange of information;

(d) contributing with other competent authorities in other Member States to

the development and validation of alternative approaches which could

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

procedures using animals in terms of regulation 48(1);

(e) setting up, maintaining and managing public databases and information

systems on alternative approaches and their state of development;

(f)

promoting dialogue between legislators, regulators, and all relevant

stakeholders, consumer organisations and animal-welfare groups in

particular, with a view to the development, validation, regulatory

acceptance, international recognition, and application of alternative

approaches.

Schedule IX

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

(a) type of manipulation, handling,

(b)

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,

(c) cumulative suffering within a procedure,

(d) 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

(a) type of species and genotype,

(b) maturity, age and gender of the animal,

(c) training experience of the animal with respect to the procedure,

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

procedures,

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

including refinement of housing, husbandry and care conditions,

(f)

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;

(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.