L.N. 124 of 2013 ANIMAL WELFARE ACT (CAP. 439) Protection ...

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L.N. 124 of 2013

ANIMAL WELFARE ACT(CAP. 439)

Protection of Animals for Scientific Purposes Regulations, 2013

IN exercise of the powers conferred by Part XI of the AnimalWelfare Act, the Minister for Sustainable Development, theEnvironment and Climate Change has made the followingregulations:-

Citation and scope.

1. (1) The title of these regulations is the Protection ofAnimals for Scientific Purposes Regulations, 2013.

(2) The scope of these regulations is to transpose Directive2010/63/EU on the protection of animals used for scientific purposeswhich establishes measures for the protection of animals used forscientific or educational purposes. For this purpose, these regulationsprovide the following rules:

(a) the replacement and reduction of the use of animalsin procedures and the refinement of the breeding,accommodation, care and use of animals in procedures;

(b) the origin, breeding, marking, care andaccommodation and killing of animals;

(c) the operations of breeders, suppliers and users;

(d) the evaluation and authorisation of projectsinvolving the use of animals in procedures.

(3) These regulations are being made for the safeguarding ofthe public interest and public safety. Any requirements and safeguardmeasures contained therein including those relating to authorisationsare made for overriding reasons relating to public interest.

Interpretation. 2. (1) Unless otherwise stated in these regulations, thedefinitions in the Act shall apply.

(2) For the purpose of these regulations and unless the contextotherwise requires, the following definitions shall apply:

Cap. 439. "the Act" means the Animal Welfare Act;

"animal experiment" has the same meaning as that provided inthe Act;

VERŻJONI ELETTRONIKA

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"animal-welfare body" means a body set up by breeders,suppliers and users in terms of regulation 27 with the aim to carry outtasks as provided in terms of regulation 28;

"Animal Welfare Council” means the national committee asestablished by articles 4, 5 and 6 of the Act for the protection ofanimals used for scientific purposes in terms of these regulations;

"authorisation" means any authorisation which:

(a) in relation to competent persons and theiractivities, may be granted in terms of the Act, to such persons tocarry out a procedure or animal experiments, which may only beperformed by such competent persons, or under the directresponsibility of such person and may include any licence,warrant, permit, appointment, concession or any decisionconcerning access to the activity in question, or the exercisethereof; and

(b) in relation to breeders, suppliers, users and theirservices means a permit, licence, appointment, concession orany decision concerning access to the service activity inquestion or the exercise thereof, issued to such persons in termsof the Act and for the term stipulated in these regulations;

"breeder" means any natural or legal person breeding animalsreferred to in Schedule I with a view to their use in procedures or forthe use of their tissue or organs for scientific purposes, or breedingother animals primarily for those purposes, whether for economicremuneration or not;

"the Commission" means the European Commission;

Cap. 437.

"expert competent person" means the veterinarians or veterinarysurgeons responsible for procedures or any person or officer in chargeduly authorised to act on their behalf having adequate knowledge andprofessional experience in terms of article 43 of the VeterinaryServices Act or as recognised by the Veterinary Surgeons’ Council toexercise his duties and act on behalf of the veterinarian;

Provided that competent personnel mentioned in regulation24 shall, for the purpose of carrying out procedures, be at all timessupervised in terms of regulation 24(3) and conform with therequirement set out in regulation 25(1)(c);

"debilitating clinical condition" means a reduction in ananimal’s normal physical and psychological ability to function;


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"the Department" means the Department for Veterinary Servicesin Malta as established by article 2 of the Act;

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

"endangered species" means those species listed in Annex A toCouncil Regulation (EC) No 338/97 on the protection of species ofwild fauna and flora by regulating trade therein;

"establishment" means any installation, building, group ofbuildings or other premises and may include a place that is not whollyenclosed or covered and mobile facilities;

"final consumer" means any natural or legal person purchasinganimals and animal products subject to trade for his own use and notfor resale or retail purposes;

"genetically modified animal" means all animals having theirgenes artificially added or removed from their DNA;

"intra-Community trade" means trade in animals and theirproducts between Member States including commercial activitieswith the intention to make profit or gain;

"live cephalopods" means live animals of the cephalopoda classincluding inter alia octopuses, squids, cuttlefish and nautiloids;

"Member State" means a state which is a member of theEuropean Union;

"non-human primates" means all species of the primates orderexcluding homo sapiens;

"non-human vertebrate animals" means all animals with abackbone structure excluding homo sapiens;

"overriding reasons relating to public interest" means reasonsrecognised as such in case law of the Court of Justice of the EuropeanUnion and which reasons present a justification for the issue of anauthorisation and, or the issue of a condition thereto and, or to anyother policy decision taken in terms of such authorisation, when suchauthorisation, and, or condition and, or policy decision thereto couldnot have been issued or taken under normal circumstances but forsuch overriding reasons relating to public interest which include theemergency circumstances referred to in regulation 7(4);

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


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animal for experimental or other scientific purposes, with known orunknown outcome, or educational purposes, which may cause theanimal a level of pain, suffering, distress or lasting harm equivalentto, or higher than, that caused by the introduction of a needle inaccordance with good veterinary practice. This includes any course ofaction intended, or liable, to result in the birth or hatching of ananimal or the creation and maintenance of a genetically modifiedanimal line in any such condition, but excludes the killing of animalssolely for the use of their organs or tissues; the severity classificationof such procedures is set out in Schedule IX;

"project" means a programme of work having a definedscientific objective and involving one or more procedures;

"self-sustaining colony" means a colony in which animals arebred only within the colony or sourced from other colonies but nottaken from the wild, and where the animals are kept in a way thatensures that they are accustomed to humans;

"specimen" has the same meaning as that provided underCouncil Regulation (EC) No 338/97 on the protection of species ofwild fauna and flora by regulating trade therein;

"supplier" means any natural or legal person, other than abreeder, supplying animals with a view to their use in procedures orfor the use of their tissue or organs for scientific purposes, whetherfor economic remuneration or not;

"TFEU" means the Treaty on the Functioning of the EuropeanUnion as amended by the Lisbon Treaty, 2009 as may be subject tosubsequent amendments;

"user" means any natural or legal person using animals inprocedures, whether for economic remuneration or not.

Applicability.3. (1) These regulations shall apply where animals areused or intended to be used in procedures, or bred specifically so thattheir organs or tissues may be used for scientific purposes, and shallapply until the animals referred to in this sub-regulation have beenkilled, rehomed or returned to a suitable habitat or husbandry system.The elimination of pain, suffering, distress or lasting harm by thesuccessful use of anaesthesia, analgesia or other methods shall notexclude the animal used in procedures from the scope of theseregulations.

(2) These regulations shall also apply to the followinganimals:


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(a) live non-human vertebrate animals, including:

(i) independently feeding larval forms; and

(ii) foetal forms of mammals as from the lastthird of their normal development;

(b) live cephalopods.

(3) Furthermore, these regulations shall apply to animals usedin procedures, which are at an earlier stage of development than thatreferred to in sub-regulation (2)(a), if the animal is to be allowed tolive beyond that stage of development and, as a result of theprocedures performed, is likely to experience pain, suffering, distressor lasting harm after it has reached that stage of development.

(4) Without prejudice to sub-regulation (1), these regulationsshall not apply to the following:

(a) non-experimental agricultural practices;

(b) non-experimental clinical veterinary practices;

(c) veterinary clinical trials required for the marketingauthorisation of a veterinary medicinal product;

(d) practices undertaken for the purposes of recognisedanimal husbandry;

(e) practices undertaken for the primary purpose ofidentification of an animal;

(f) practices not likely to cause pain, suffering,distress or lasting harm equivalent to, or higher than, that causedby the introduction of a needle in accordance with goodveterinary practice.

S.L. 427.58(5) These regulations shall apply without prejudice to the

Cosmetics Products Regulations.

National measures.

4. (1) When the Department opts to maintain nationallaws and regulations aimed at ensuring more extensive protection ofanimals falling within the scope these regulations, it shall not prohibitor impede the supply or use of animals bred or kept in anotherMember State in accordance with these regulations, nor shall itprohibit or impede the placing on the market of products developedwith the use of such animals in accordance with these regulations,provided that such supply, use or breeding of animals do not breach


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any other national laws regarding any prohibitions to intra-Community trade, or any other Community laws or regulationsintended for the safeguarding and protection of human and animalhealth.

(2) The Department shall apply all such necessaryadministrative measures according to the requirements of theseregulations to ensure that there is no breach thereto, and also toreduce the risk for final consumers and any additional risk to animalsand to the environment. Such measures shall be in conformity withthe requirements of the food chain and animal health.

(3) These measures shall include the direct confiscation of theproduct, the suspension of the activities carried out by the breeder,supplier or user of animals, being primarily responsible for animalwelfare, and the withdrawal, forfeiture or suspension of theauthorisation, licence or permit with regard to such activities whenthese are creating a risk to final consumers and to the environment.The application of administrative fines and effective and dissuasivepenalties in terms of articles 45 and 47 of the Act shall also apply inthis regard.

Principle of replacement, reduction and refinement.

5. (1) The Department shall establish and maintain amonitoring system for the enforcement of:

(a) a scientifically satisfactory method or testingstrategy, not entailing the use of live animals, to be used insteadof a procedure, wherever this is technically feasible andpossible;

(b) the reduction in the number of animals to be usedin procedures to a minimum without compromising theobjectives of the project; and

(c) breeding, accommodation and care, as well asrefinement of methods used in procedures, by eliminating orreducing to the minimum any possible pain, suffering, distressor lasting harm to the animals.

(2) This regulation shall, as regards the choice of methods, beimplemented in accordance with regulation 14.

Purposes of procedures.

6. Procedures may only be carried out for the followingpurposes:

(a) basic research;

(b) applied research with any of the following aims:


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(i) the avoidance, prevention, diagnosis ortreatment of disease, ill-health or other abnormality ortheir effects in human beings, animals or plants;

(ii) the assessment, detection, regulation ormodification of physiological conditions in human beings,animals or plants; or

(iii) the welfare of animals and the improvementof the production conditions for animals reared foragricultural purposes;

(c) for any of the aims in paragraph (b) in thedevelopment, manufacture or testing of the quality,effectiveness and safety of drugs, foodstuffs and feed-stuffs andother substances or products;

(d) protection of the natural environment in theinterests 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.

Methods of killing.

7. (1) The Department shall establish and maintain amonitoring system for the enforcement of killing of animals withminimum pain, suffering and distress, and such system shall includethat such animals are killed in the establishment of a breeder, supplieror user, by a competent person, provided that in the case of a fieldstudy an animal may be killed by a competent person outside anestablishment.

(2) In relation to animals listed in Schedule IV, the appropriatemethod of killing as set out in that Schedule shall be used.

(3) The Department may grant exemptions from therequirement in sub-regulation (2):

(a) to allow the use of another method provided that,on the basis of scientific evidence, the method is considered tobe at least as humane; or

(b) when, on the basis of scientific justification, thepurpose of the procedure may not be achieved by the use of amethod of killing set out in Schedule IV.


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(4) Sub-regulations (1) and (2) shall not apply where ananimal has to be killed in emergency circumstances for animal-welfare, public-health, public-security, animal-health orenvironmental reasons.

Endangered species.

8. (1) Specimens of endangered species listed in AnnexA to Council Regulation (EC) No 338/97 on the protection of speciesof wild fauna and flora by regulating trade therein, which do not fallwithin the scope of Article 7(1) of such Regulation, shall not be usedin procedures, except for those procedures meeting the followingconditions:

(a) the procedure has one of the purposes referred to inregulation 6(b)(i), (c) or (e); and

(b) there is scientific justification to the effect that thepurpose of the procedure may not be achieved by the use ofspecies other than those listed in such Annex.

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

Non-human primates.

9. (1) Subject to sub-regulation (2), specimens of non-human primates shall not be used in procedures, except for thoseprocedures meeting the following conditions:

(a) the procedure has one of the purposes referred toin:

(i) regulation 6(b)(i) or (c) and is undertakenwith a view to the avoidance, prevention, diagnosis ortreatment of debilitating or potentially life-threateningclinical conditions in human beings; or

(ii) regulation 6(a) or (e); and

(b) there is scientific justification to the effect that thepurpose of the procedure may not be achieved by the use ofspecies other than non-human primates.

(2) Specimens of non-human primates listed in Annex A toCouncil Regulation (EC) No 338/97, which do not fall within thescope of Article 7(1) of such Regulation, shall not be used inprocedures, except for those procedures meeting the followingconditions:

(a) the procedure has one of the purposes referred toin:


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(i) regulation 6(b)(i) or (c) and is undertakenwith a view to the avoidance, prevention, diagnosis ortreatment of debilitating or potentially life-threateningclinical conditions in human beings; or

(ii) regulation 6(e); and

(b) there is scientific justification to the effect that thepurpose of the procedure may not be achieved by the use ofspecies other than non-human primates and by the use ofspecies not listed in such Annex.

Animals taken from the wild.

10. (1) Animals taken from the wild shall not be used inprocedures.

(2) The Department may grant exemptions from sub-regulation (1) on the basis of scientific justification to the effect thatthe purpose of the procedure may not be achieved by the use of ananimal which has been bred for use in procedures.

(3) The capture of animals in the wild shall be carried out onlyby competent persons using methods which do not cause the animalsavoidable pain, suffering, distress or lasting harm. Any animal found,at or after capture, to be injured or in poor health shall be examinedby a veterinarian or another competent person and action shall betaken to minimise the suffering of the animal.

(4) The Department may grant exemptions from therequirement in sub-regulation (3) of taking action to minimise thesuffering of the animal, if there is scientific justification.

Animals bred for use in procedures.

11. (1) The Department shall establish and maintain amonitoring and enforcement system to ensure that animals belongingto the species listed in Schedule I may only be used in procedureswhere 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 furtherestablish and maintain a monitoring and enforcement system toensure that non-human primates listed in Schedule I may be used inprocedures only where they are the offspring of non-human primateswhich have been bred in captivity or where they are sourced fromself-sustaining colonies.

(3) The Department may grant exemptions from therequirement in sub-regulation (1) on the basis of scientificjustification.


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Stray and feral animals of domestic species.

12. (1) Stray and feral animals of domestic species shallnot 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 thehealth and welfare of the animals or serious threats to theenvironment or to human or animal health; and

(b) there is scientific justification to the effect that thepurpose of the procedure may be achieved only by the use of astray or a feral animal.

Procedures.13. (1) The Department shall take all necessaryadministrative measures to monitor and enforce procedures whichshall 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 maybe carried out only within the framework of a project.

Choice of methods.

14. (1) The Department shall establish and maintain amonitoring and control system for the enforcement of a procedure notto be carried out if another method or alternative testing strategy forobtaining the result sought, not entailing the use of a live animal, isrecognised under other applicable EU legislation.

(2) When choosing between procedures, the selection criteriashall 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 toexperience pain, suffering, distress or lasting harm;

(c) the least pain, suffering, distress or lasting harm tobe caused; and

(d) the most satisfactory results provided or likely tobe provided.

(3) Death as the end-point of a procedure shall be avoided asfar as possible and replaced by early and humane end-points. Wheredeath as the end-point is unavoidable, the procedure shall be designedso as to:

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


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(b) reduce the duration and intensity of suffering to theanimal to the possible minimum and guarantee a painless death,in so far as this is technically and physically feasible andpossible.

Anaesthesia. 15. (1) The Department shall establish and maintain amonitoring and control system for the enforcement of procedureswhich shall be carried out under general or local anaesthesia, unless itis inappropriate, and that analgesia or another appropriate methodshall be used to ensure that pain, suffering and distress are kept to aminimum. Procedures involving serious injuries which may causesevere pain shall not be carried out without anaesthesia.

(2) When deciding on the appropriateness of usinganaesthesia, the following shall be taken into account:

(a) whether anaesthesia is more traumatic to theanimal than the procedure itself; and

(b) whether anaesthesia is incompatible with thepurpose of the procedure.

(3) The Department shall further establish and maintain amonitoring and enforcement system to ensure that animals are notgiven any drug to stop or restrict their showing pain without anadequate level of anaesthesia or analgesia. In such cases, a scientificjustification shall be provided, accompanied by the details of theanaesthetic or analgesic regimen.

(4) An animal, which may suffer pain once anaesthesia hasworn off, shall be treated with pre-emptive and post-operativeanalgesics or other appropriate pain-relieving methods provided thatit is compatible with the purpose of the procedure.

(5) As soon as the purpose of the procedure has been achievedappropriate action shall be taken to minimise the suffering of theanimal.

Classification of severity of procedures.

16. The Department shall establish and maintain a monitoringand control system for the purpose of enforcing that all proceduresshall be classified as "non-recovery", "mild", "moderate", or "severe"on a case-by-case basis using the assignment criteria set out inSchedule IX.

(2) The Department shall establish and maintain a monitoringand control system for the purpose of enforcing that a procedure isnot performed if it involves severe pain, suffering or distress that islikely to be long-lasting and may not be subject to improvement.


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Reuse of animals in procedures.

17. (1) The Department shall also establish and maintain amonitoring and enforcement system to ensure that an animal alreadyused in one or more procedures shall not be reused, provided there isa different animal on which a previous procedure has not been carriedout.

(2) Notwithstanding what is mentioned in sub-regulation (1),and as a derogation thereof, an animal already used in one or moreprocedures 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 healthand 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 takinginto account the lifetime experience of the animal.

(3) In exceptional circumstances and by way of derogationfrom sub-regulation (2)(a), the Department, following a veterinaryexamination of the animal, may allow the reuse of an animal,provided the animal has not been used more than once in a procedureentailing severe pain, distress or equivalent suffering.

Termination of procedure.

18. (1) A procedure shall be deemed to end when nofurther observations need be made for that procedure or, as regardsnew genetically modified animal lines, when the offsprings are nolonger observed or expected to experience pain, suffering, distress orlasting harm equivalent to, or higher than, that caused by theintroduction of a needle.

(2) At the end of a procedure, a decision to keep an animalalive shall be taken by a veterinarian. An animal shall be killed whenit is likely to remain in moderate or severe pain, suffering, distress orlasting harm.

(3) Where an animal shall be kept alive, it shall receive careand accommodation appropriate to its state of health.

Sharing organs and tissues.

19. The Department shall facilitate, where appropriate, theestablishment of programmes for the sharing of organs and tissues ofanimals killed.


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Setting free of animals and rehoming.

20. The Department shall allow animals used or intended to beused in procedures to be rehomed, or returned to a suitable habitat orhusbandry system appropriate to the species, provided that thefollowing conditions are met:

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

(b) there is no danger to public health, animal health orthe environment; and

(c) appropriate measures have been taken to safeguardthe well-being of the animal.

Authorisation of breeders, suppliers and users.

21. (1) The Department shall establish and maintain amonitoring and enforcement system to ensure that all breeders,suppliers and users of animals to be used for experimentation areauthorised and registered in terms of article 42 of the Act. Suchauthorisation may only be granted for a limited period. Authorisationshall be granted only if the breeder, supplier or user and itsestablishment is in compliance with the requirements of theseregulations.

(2) The authorisation shall specify the person responsible forensuring compliance with the provisions of these regulations and theperson or persons referred to in regulations 25(1) and 26.

(3) Renewal of the authorisation shall be required for anysignificant change to the structure or the function of an establishmentof a breeder, supplier or user that could negatively affect animalwelfare.

(4) The Department shall at all times be notified of anychanges of the person or persons referred to in sub-regulation (2).

Suspension, withdrawal, or cancellation of an authorisation.

22. (1) Where a breeder, supplier or user no longercomplies with the requirements set out in these regulations, theDepartment shall take appropriate remedial action, or require suchaction to be taken, or suspend or withdraw its authorisation.

(2) The Department shall, where the authorisation issuspended or withdrawn, take all necessary measures to maintain thewelfare of the animals housed in the establishment to the extent thatsuch welfare is not adversely affected.

Requirements for installations and equipment.

23. (1) The Department shall establish and maintain amonitoring and control system to enforce that all establishments of abreeder, supplier or user have installations and equipment suited tothe species of animals housed and, where procedures are carried out,


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according to the performance of the procedures.

(2) The design, construction and method of functioning of theinstallations and equipment referred to in sub-regulation (1) shallguarantee that the procedures are carried out as effectively aspossible, and aim at obtaining reliable results using the minimumnumber 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 amonitoring and control system to enforce compliance with therelevant requirements set out in Schedule III.

(4) The design, construction and method of functioning of theestablishment shall ensure the maximum bio security to guaranteethat there will be no dispersion of biological or chemical material orother residues into the surrounding environment.

Competence of personnel.

24. (1) The Department shall establish and maintain amonitoring 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-trainedbefore 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), thestaff 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 orderand authority relevant to the work being undertaken and shall havespecific knowledge on species. Staff carrying out functions referredto in sub-regulation (2)(a), (c) or (d) shall be supervised in theperformance of their tasks until they have demonstrated the requisitecompetence.

(4) The Department shall take all necessary administrativemeasure by means of authorisation or otherwise, to ensure that therequirements laid down in sub-regulation (3) are fulfilled.


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(5) The Department shall publish, on the basis of the elementsset out in Schedule V, the minimum requirements with regard toeducation and training and the requirements for obtaining,maintaining and demonstrating requisite competence for the functionsset out in sub-regulation (2).

Specific requirements for personnel.

25. (1) The Department shall establish and maintain amonitoring 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 careof the animals in the establishment;

(b) ensure that the staff dealing with animals haveaccess to specific information relating to the species kept in theestablishment;

(c) be responsible for ensuring that the staff areadequately educated, competent and continuously trained andthat they are supervised until they have demonstrated therequisite competence.

(2) The Department shall at all times guarantee that personsmentioned in regulation 41(2)(b) shall:

(a) eliminate any unnecessary pain, suffering, distressor lasting harm that is being inflicted on an animal in the courseof a procedure;

(b) ensure that the projects are carried out inaccordance with the project authorisation in terms of regulation37, or in the cases referred to in regulation 43, in accordancewith the application sent to the Department in terms ofregulation 38, or any decision taken by the Department; and

(c) in the event of non-compliance, ensure that allappropriate measures are taken to rectify such position or mal-practice as the case may be. Such measures taken for suchrectification shall be recorded.

Designated veterinarian.

26. The Department shall at all times maintain a monitoringand control system to enforce that each breeder, supplier and user hasa designated veterinarian with expertise in laboratory animalmedicine, or where it is more appropriate, an expert competent personcharged with advisory duties in relation to the well-being, treatmentand welfare of the animals.

Animal-welfare body.

27. (1) The Department shall establish and maintain a


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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 personor persons responsible for the welfare and care of the animals and, inthe case of a user, a scientific member. The animal-welfare body shallalso receive input from the designated veterinarian or the expertcompetent person referred to in regulation 26.

(3) Such body shall also:

(a) as a primary task, focus on giving advice onanimal-welfare issues; the advice given by the animal-welfarebody shall be properly documented and open to scrutiny duringinspections;

(b) follow the development and outcome of projects atestablishment level; and

(c) foster a climate of care and provide tools for thepractical application and timely implementation of recenttechnical and scientific developments in relation to theprinciples of replacement, reduction and refinement, in order toenhance the life-time experience of the animals.

Tasks of the animal-welfare body.

28. (1) Without prejudice to the provisions of regulation27(3), the animal-welfare body shall, as a minimum, carry out thefollowing tasks:

(a) advise the staff dealing with animals on mattersrelated to the welfare of animals, in relation to their acquisition,accommodation, care and use;

(b) advise the staff on the application of therequirement of replacement, reduction and refinement, and keepit informed of technical and scientific developments concerningthe application of that requirement;

(c) establish and review internal operational processesas regards monitoring, reporting and follow-up in relation to thewelfare 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 identifyand advise as regards elements that further contribute toreplacement, reduction and refinement; and

(e) advise on rehoming schemes, including the


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appropriate socialization of the animals to be rehomed.

(2) The Department shall establish a monitoring andenforcement system to ensure that the records of any advice given bythe animal-welfare body and decisions taken regarding that advice arekept for at least three years. The records shall be made available tothe Department upon its request.

Breeding strategy for non-human primates.

29. The Department shall also establish and maintain amonitoring system for the purpose of ensuring that breeders of non-human primates have a strategy in place for increasing the proportionof animals that are the offspring of non-human primates that havebeen bred in captivity.

Scheme for rehoming or setting free of animals.

30. Where the Department allows rehoming, the breeders,suppliers and users from which animals are intended to be rehomedshall have a rehoming scheme in place that ensures socialization ofthe animals that are rehomed. In the case of wild animals, whereappropriate, a programme of rehabilitation shall be in place beforethey are returned to their natural habitat.

Animal records. 31. (1) The Department shall establish a monitoring andenforcement system to ensure all breeders, suppliers and users keeprecords 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 theyare 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 orwere 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 animalsare used.

(2) The records referred to in sub-regulation (1) shall be keptfor a minimum of five years and made available to the Departmentupon its request.


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Information on dogs, cats and non-human primates.

32. (1) The Department shall establish a monitoring andenforcement system to ensure that all breeders, suppliers and userskeep the following information on each dog, cat and non-humanprimate:

(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 isthe offspring of non-human primates that have been bred incaptivity.

(2) Each dog, cat and non-human primate shall have anindividual history file, which follows the animal as long as it is keptfor 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 ofpermanent canine teeth, or prior to six months of age, whichevercomes first, and shall cover any relevant reproductive, veterinary andsocial information on the individual animal and the projects in whichit has been used.

(3) The information referred to in this regulation shall be keptfor a minimum of three years after the death or rehoming of theanimal, and shall be made available to the Department upon request.In the case of rehoming, relevant veterinary care and socialinformation from the individual history file referred to in sub-regulation (2) shall accompany the animal.

Marking and identification of dogs, cats and non-human primates.

33. (1) Each dog, cat or non-human primate shall beprovided, at the latest at the time of weaning, with a permanentindividual identification mark in the least painful manner possible.

(2) Where a dog, cat or non-human primate is transferred fromone breeder, supplier or user to another before it is weaned, and it isnot practicable to mark it beforehand a microchip shall be applied anda record shall be maintained by the receiver.

(3) No unmarked dogs, cats or non-human primates, which areweaned, shall be transferred, and the breeder, supplier or user shallpermanently mark any animal as soon as possible, in the least painfulmanner possible and prior to its transfer.

(4) The breeder, supplier and user shall provide, at the requestof the Department, reasons for which an animal is unmarked.


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S.L. 437.101(5) The provisions of this regulation shall apply without

prejudice to the Electronic Identification of Dogs Regulations.

Care and accommodation.

34. (1) The Department shall, in so far as the care andaccommodation of animals is concerned, establish and maintain amonitoring and enforcement system to ensure that:

(a) all animals are provided with accommodation, anenvironment, food, water and care which are appropriate to theirhealth and well-being;

(b) any restrictions on the extent to which an animalmay satisfy its physiological and ethological needs are kept to aminimum;

(c) the environmental conditions in which animals arebred, kept or used are checked daily;

(d) arrangements are made to ensure that any defect oravoidable pain, suffering, distress or lasting harm discovered iseliminated as quickly as possible; and

(e) animals are transported under appropriateconditions.

(2) For the purposes of sub-regulation (1), the Departmentshall further establish a monitoring and enforcement system to ensurethat the care and accommodation standards set out in Schedule III areapplied from the dates provided for therein.

(3) The Department may allow exemptions from therequirements of sub-regulations (1)(c) and (2) on the basis ofscientific and animal-welfare justifications or animal-health reasons.

Inspections by the Department.

35. (1) The Department shall carry out regular inspectionsof all breeders, suppliers and users, including their establishments, toverify compliance with the requirements of these regulations.

(2) The Department shall adapt the frequency of inspectionson the basis of a risk analysis for each establishment, taking accountof:

(a) the number and species of animals housed;

(b) the record of the breeder, supplier or user incomplying with the requirements of these regulations;

(c) the number and types of projects carried out by theuser in question; and


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(d) any information that might indicate non-compliance.

(3) Inspections shall be carried out on at least one third of theusers 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 fiveyears. An appropriate proportion of the inspections shall be carriedout without prior warning.

Controls inspections by experts of the Commission.

36. (1) The Department shall give all necessary assistanceto the experts of the Commission when carrying out inspections inMalta.

(2) The Department shall take measures to take account of theresults of the controls inspections referred to in sub-regulation (1).

Requirements for projects authorisation.

37. (1) Without prejudice to regulation 43, projects shallnot 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 theapplication sent to the Department or any decision taken by theDepartment.

(2) No project shall be carried out unless a favourable projectevaluation by the Department has been concluded in accordance withregulation 39.

Application for project authorisation.

38. The Department shall establish a monitoring andenforcement system to ensure that an application for a projectauthorisation is submitted by the user or the person responsible forthe 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.

Project evaluation.

39. (1) The project evaluation shall be performed with adegree of detail appropriate for the type of project and shall verifythat the project meets the following criteria:

(a) the project is justified from a scientific oreducational point of view or required by law;

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


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animals; and

(c) the project is designed so as to enable proceduresto be carried out in the most humane and environmentallysensitive manner possible.

(2) The project evaluation shall consist in particular of thefollowing:

(a) an evaluation of the objectives of the project, thepredicted scientific benefits or educational value;

(b) an assessment of the compliance of the project withthe requirement of replacement, reduction and refinement inprocedures in terms of regulation 5;

(c) an assessment and assignment of the classificationof the severity of procedures;

(d) a harm-benefit analysis of the project, to assesswhether the harm to the animals in terms of suffering, pain anddistress is justified by the expected outcome taking into accountethical considerations, and which may ultimately benefit humanbeings, animals or the environment;

(e) an assessment of any justification referred to inregulations 7 to 13, 15, 17 and 34(3); and

(f) a determination as to whether and when the projectshould be assessed retrospectively.

(3) The Department carrying out the project evaluation shallconsider expertise in particular in the following areas:

(a) the areas of scientific use for which animals shallbe used including replacement, reduction and refinement in therespective areas in procedures in accordance with regulation 5;

(b) experimental design, including statistics whereappropriate;

(c) veterinary practice in laboratory animal science orwildlife veterinary practice where appropriate;

(d) animal husbandry and care, in relation to thespecies that are intended to be used.

(4) The project evaluation process shall be transparent,


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objective and non-discriminatory. Without prejudice to intellectualproperty rights, protection of data and the safeguarding ofconfidential information, the project evaluation shall be performed inan impartial manner and may integrate and include the opinion ofindependent parties.

Retrospective assessment.

40. (1) The Department shall determine, in accordancewith regulation 39(2)(f), the retrospective assessment which shall becarried out by the same Department, which shall, on the basis of thenecessary documentation submitted by the user, evaluate thefollowing:

(a) whether the objectives of the project wereachieved;

(b) the harm inflicted on animals, including thenumbers and species of animals used, and the severity of theprocedures; and

(c) any elements which may contribute to the furtherimplementation of the requirement of replacement, reductionand refinement.

(2) All projects using non-human primates and projectsinvolving procedures classified as "severe", including those referredto in regulation 16(2), shall undergo a retrospective assessment.

(3) Without prejudice to sub-regulation (2) and by way ofderogation from regulation 39(2)(f), the Department shall exemptprojects involving only procedures classified as "mild" or "non-recovery" from the requirement for a retrospective assessment.

Granting of project authorisation.

41. (1) The project authorisation shall be limited toprocedures which have been subject to:

(a) a project evaluation; and

(b) the severity classifications assigned to thoseprocedures.

(2) The project authorisation shall specify the following:

(a) the user who undertakes the project;

(b) the persons responsible for the overallimplementation of the project and compliance of suchimplementation with the project authorisation;


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(c) the establishments in which the project will beundertaken, where applicable;

(d) any specific conditions following the projectevaluation, including whether and when the project shall beassessed retrospectively; and

(e) the designated veterinarian responsible for theoverall implementation of procedures and an expert competentperson where necessary.

(3) Project authorisations shall be granted for a period notexceeding five years.

Authorisation decisions.

42. (1) The Department shall take a decision regarding theauthorisation which shall be communicated to the applicant fortyworking days at the latest from the receipt of the complete and correctapplication. 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 theperiod referred to in sub-regulation (1) once, by an additional periodnot exceeding fifteen working days. The extension and its durationshall be duly motivated and shall be notified to the applicant beforethe expiry of the period referred to in sub-regulation (1).

(3) The Department shall acknowledge to the applicant allapplications for authorisations immediately as possible, and shallindicate the period referred to in sub-regulation (1) within which thedecision is to be taken.

(4) In the case of an incomplete or incorrect application, theDepartment shall immediately inform the applicant of the need tosupply any additional documentation and of any possible effects onthe running of the applicable time period.

Simplified administrative procedure.

43. (1) When introducing a simplified administrativeprocedure, the Department shall establish and maintain a monitoringand control system to ensure that the following provisions are met:

(a) the application specifies elements referred to inregulation 41(2)(a), (b), (c) and (e);

(b) a project evaluation is performed in accordancewith regulation 39; and

(c) the period referred to in regulation 42(1) is notexceeded.


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(2) If a project is changed in a way which may have a negativeimpact on animal welfare, the Department shall require an additionalproject evaluation with a favourable outcome.

(3) Regulations 41(3), 42(3), and 45(3) and (4) shall applymutatis mutandis to projects which are allowed to be carried out inaccordance with this regulation.

Non-technical project summaries.

44. (1) Without prejudice to intellectual property rights,data protection and confidentiality of information, non-technicalproject summaries shall provide and include the following:

(a) information on the objectives of the project,including the predicted harm and benefits and the number andtypes of animals to be used;

(b) a demonstration of compliance with therequirement of replacement, reduction and refinement inprocedures in terms of regulation 5. The non-technical projectsummary shall be anonymous and shall not contain the namesand 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 systemto ensure that the non-technical project summary is updated with theresults of any retrospective assessment.

(3) The Department shall publish the non-technical projectsummaries of authorised projects and any updates thereto.

Amendment, renewal and withdrawal of a project authorisation.

45. (1) An amendment or renewal of the projectauthorisation shall be required for any change of the project that mayhave a negative impact on animal welfare as established and enforcedby the Department.

(2) Any amendment or renewal of a project authorisation shallbe subject to a further favourable outcome of the project evaluation.

(3) The Department shall withdraw the project authorisationwhere the project is not carried out in accordance with the projectauthorisation, provided that the welfare of the animals used orintended to be used in the project is not be adversely affected.

(4) The Department shall establish and publish conditions foramendments and renewal of project authorisations.

Documentation.46. (1) The Department shall establish a monitoring andenforcement system to ensure that all relevant documentation,


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including project authorisations and the result of the projectevaluation, is kept for at least three years from the expiry date of theauthorisation of the project or from the expiry of the period referredto in regulation 42(1). Such documentation shall be made available tothe Department.

(2) Without prejudice to sub-regulation (1), the documentationfor projects which shall undergo retrospective assessment shall bekept until the retrospective assessment has been completed.

Duplication of procedures.

47. The Department shall accept data from other competentauthorities which is generated by procedures recognised by EuropeanUnion legislation, unless further procedures need to be carried outregarding such data for the protection of public health, safety or theenvironment.

National Reference Laboratory and alternative approaches.

48. (1) The Department shall contribute with othercompetent authorities in other Member States to the development andvalidation of alternative approaches which may provide the same orhigher levels of information as those obtained in procedures usinganimals:

Provided that such approaches do not involve the use ofanimals, or the use of fewer animals, or which entail less painfulprocedures on animals, and the Department shall take such other stepsas it considers appropriate to encourage and promote research in thisfield.

(2) The Department shall, at national level, encourage andpromote the development and validation of alternative approachesand the dissemination of information thereon.

(3) Such validation studies shall be carried out by the NationalReference Laboratory referred to in Part A of Schedule VIII. Thetasks of such Laboratory are established under Part B of the ScheduleVIII.

Union Reference Laboratory.

49. The Union Reference Laboratory and its duties and tasksshall be those referred to in Schedule VII.

Animal Welfare Council for the protection of animals used for scientific purposes.

50. (1) The Animal Welfare Council established for theprotection of animals used for scientific purposes shall advise theanimal-welfare body on matters dealing with the acquisition,breeding, accommodation, care and use of animals in procedures andensure sharing of best practice.

(2) The Animal Welfare Council shall further exchangeinformation on the operation of the animal-welfare body and project


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evaluation and share best practice within the Union.

Reporting.51. (1) The Department shall by 10 November 2018, andevery five years thereafter, send to the Commission the informationon the implementation of these regulations and in particularregulations 11(1), 27, 29, 35, 39, 40, 44 and 47.

(2) The Department shall collect and publish, on an annualbasis, statistical information on the use of animals in procedures,including information on the actual severity of the procedures and onthe origin and species of non-human primates used in procedures.

(3) The Department shall submit such statistical informationto the Commission by 10 November 2015 and every year thereafter.

(4) The Department shall submit to the Commission, onannual basis, detailed information on exemptions granted underregulation 7(3)(a).

Offences and penalties.

52. (1) Any person who fails to abide by these regulationsshall be guilty of an offence, and shall be liable to the provisions andmeasures referred to in regulation 4(2) and (3).

(2) Any right given to the Department under these regulationsto apply all such necessary measures prescribed in regulation 4(2) and(3), shall be given without prejudice to other criminal procedureswhich may be taken under the Act or any other law when a personcommits an offence by failing to abide by these regulations.


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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 TOIN REGULATION 11(1)

Species Dates Marmoset (Callithrix jacchus) 1 January 2013 Cynomolgus monkey (Macaca fascicularis) 5 years after the publication of the feasibility

study referred to in regulation 11(1),provided the study does not recommend anextended period

Rhesus monkey (Macaca mulatta) 5 years after the publication of the feasibilitystudy referred to in regulation 11(1),provided the study does not recommend anextended period

Other species of non-human primates 5 years after the publication of the feasibilitystudy referred to in regulation 11(1),provided the study does not recommend anextended period


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Schedule III

REQUIREMENTS FOR ESTABLISHMENTS AND FOR THE CAREAND 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 anenvironment which takes into account the physiological and ethologicalneeds of the species kept in them. Facilities shall also be designed andmanaged to prevent access by unauthorised persons and the ingress or escapeof animals.

(b) Establishments shall have an active maintenance programme toprevent and remedy any defect in buildings or equipment.

1.2. Holding rooms

(a) Establishments shall have a regular and efficient cleaningschedule for the rooms and shall maintain satisfactory hygienic standards.

(b) Walls and floors shall be surfaced with an impermeable materialresistant to the heavy wear and tear caused by the animals and the cleaningprocess. The material shall not be detrimental to the health of the animals andshall be such that the animals cannot hurt themselves. Additional protectionshall be given to any equipment or fixtures so that they are not damaged bythe animals nor do they cause injury to the animals themselves.

(c) Species that are incompatible, for example predator and prey, oranimals requiring different environmental conditions, shall not be housed inthe same room nor, in the case of predator and prey, within sight, smell orsound of each other.

1.3. General and special purpose procedure rooms

(a) Establishments shall, where appropriate, have availablelaboratory facilities for the carrying out of simple diagnostic tests, post-mortem examinations, and/or the collection of samples that are to besubjected to more extensive laboratory investigations elsewhere. General andspecial purpose procedure rooms shall be available for situations where it isundesirable to carry out the procedures or observations in the holding rooms.

(b) Facilities shall be provided to enable newly-acquired animals tobe isolated until their health status can be determined and the potential health


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risk to established animals assessed and minimised.

(c) There shall be accommodation for the separate housing of sickor injured animals.

1.4. Service rooms

(a) Store-rooms shall be designed, used and maintained tosafeguard the quality of food and bedding. These rooms shall be vermin andinsect-proof, as far as possible. Other materials, which may be contaminatedor present a hazard to animals or staff, shall be stored separately.

(b) The cleaning and washing areas shall be large enough toaccommodate the installations necessary to decontaminate and clean usedequipment. The cleaning process shall be arranged so as to separate the flowof clean and dirty equipment to prevent the contamination of newly-cleanedequipment.

(c) Establishments shall provide for the hygienic storage and safedisposal of carcasses and animal waste.

(d) Where surgical procedures under aseptic conditions are requiredthere 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 shallensure that the air circulation, dust levels, and gas concentrations are keptwithin limits that are not harmful to the animals housed.

(b) Temperature and relative humidity in the holding rooms shall beadapted to the species and age groups housed. The temperature shall bemeasured and logged on a daily basis.

(c) Animals shall not be restricted to outdoor areas under climaticconditions which may cause them distress.

2.2. Lighting

(a) Where natural light does not provide an appropriate light/darkcycle, controlled lighting shall be provided to satisfy the biologicalrequirements of the animals and to provide a satisfactory workingenvironment.

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


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husbandry procedures and inspection of the animals.

(c) Regular photoperiods and intensity of light adapted to thespecies shall be provided.

(d) When keeping albino animals, the lighting shall be adjusted totake into account their sensitivity to light.

2.3. Noise

(a) Noise levels including ultrasound, shall not adversely affectanimal welfare.

(b) Establishments shall have alarm systems that sound outside thesensitive hearing range of the animals, where this does not conflict with theiraudibility to human beings.

(c) Holding rooms shall where appropriate be provided with noiseinsulation and absorption materials.

2.4. Alarm systems

(a) Establishments relying on electrical or mechanical equipmentfor environmental control and protection, shall have a stand-by system tomaintain essential services and emergency lighting systems as well as toensure that alarm systems themselves do not fail to operate.

(b) Heating and ventilation systems shall be equipped withmonitoring devices and alarms.

(c) Clear instructions on emergency procedures shall beprominently displayed.

3. Care of animals

3.1. Health

(a) Establishments shall have a strategy in place to ensure that ahealth status of the animals is maintained that safeguards animal welfare andmeets scientific requirements. This strategy shall include regular healthmonitoring, a microbiological surveillance programme and plans for dealingwith health breakdowns and shall define health parameters and proceduresfor 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 andappropriate action is taken with immediate effect.


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3.2. Animals taken from the wild

(a) Transport containers and means of transport adapted to thespecies concerned shall be available at capture sites, in case animals need tobe moved for examination or treatment.

(b) Special consideration shall be given and appropriate measurestaken for the acclimatisation, quarantine, housing, husbandry, care of animalstaken from the wild and, as appropriate, provisions for setting them free atthe end of procedures.

3.3. Housing and enrichment

(a) Housing

Animals, except those which are naturally solitary, shall be sociallyhoused in stable groups of compatible individuals. In cases where singlehousing is allowed in accordance with regulation 34(3) the duration shall belimited to the minimum period necessary and visual, auditory, olfactory and/or tactile contact shall be maintained. The introduction or re-introduction ofanimals to established groups shall be carefully monitored to avoid problemsof incompatibility and disrupted social relationships.

(b) Enrichment

All animals shall be provided with space of sufficient complexity toallow expression of a wide range of normal behaviour. They shall be given adegree of control and choice over their environment to reduce stress-inducedbehaviour. Establishments shall have appropriate enrichment techniques inplace, to extend the range of activities available to the animals and increasetheir coping activities including physical exercise, foraging, manipulativeand cognitive activities, as appropriate to the species. Environmentalenrichment in animal enclosures shall be adapted to the species andindividual needs of the animals concerned. The enrichment strategies inestablishments shall be regularly reviewed and updated.

(c) Animal enclosures

Animal enclosures shall not be made out of materials detrimental to thehealth of the animals. Their design and construction shall be such that noinjury to the animals is caused. Unless they are disposable, they shall bemade from impermeable materials that will withstand cleaning anddecontamination techniques. The design of animal enclosure floors shall beadapted to the species and age of the animals and be designed to facilitate theremoval of excreta.

3.4. Feeding


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(a) The form, content and presentation of the diet shall meet thenutritional and behavioural needs of the animal.

(b) The animals’ diet shall be palatable and non-contaminated. Inthe selection of raw materials, production, preparation and presentation offeed, establishments shall take measures to minimise chemical, physical andmicrobiological contamination.

(c) Packing, transport and storage shall be such as to avoidcontamination, deterioration or destruction. All feed hoppers, troughs orother utensils used for feeding shall be regularly cleaned and, if necessary,sterilised.

(d) Each animal shall be able to access the food, with sufficientfeeding space provided to limit competition.

3.5. Watering

(a) Uncontaminated drinking water shall always be available to allanimals.

(b) When automatic watering systems are used, they shall beregularly checked, serviced and flushed to avoid accidents. If solid-bottomedcages are used, care shall be taken to minimise the risk of flooding.

(c) Provision shall be made to adapt the water supply for aquariaand tanks to the needs and tolerance limits of the individual fish, amphibianand reptile species.

3.6. Resting and sleeping areas

(a) Bedding materials or sleeping structures adapted to the speciesshall always be provided, including nesting materials or structures forbreeding animals.

(b) Within the animal enclosure, as appropriate to the species, asolid, comfortable resting area for all animals shall be provided. All sleepingareas shall be kept clean and dry.

3.7. Handling

Establishments shall set up habituation and training programmes suitable forthe animals, the procedures and length of the project.

3.8. Cleaning

Cleaning schedules shall be established for each species to ensure that theholdings and environments do not remain soiled and are not a source of ill health


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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 thetop of the enclosure and this height applies over more than 50% of the minimumenclosure floor area prior to the addition of enrichment devices.

When designing procedures, consideration shall be given to the potentialgrowth of the animals to ensure adequate space is provided (as detailed in Tables1.1 to 1.5) for the duration of the study.

Table 1.1.

Mice

(*) Post-weaned mice may be kept at these higher stocking densities for the short period after weaninguntil issue, provided that the animals are housed in larger enclosures with adequate enrichment, andthese 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 physiologicalor behavioural stress responses.

Body weight (g) Minimum enclosure size

(cm2)

Floor area per animal

(cm2)

Minimum enclosure

height (cm)

Date referred to in regulation

34(2)In stockand duringprocedures

up to 20

over 20 to 25

over 25 to 30

over 30

330

330

330

330

60

70

80

100

12

12

12

12

1 January 2017

Breeding 330

For a monogamous pair (outbred/

inbred) or a trio (inbred). For each additional female plus litter 180 cm2

shall be added.

12

Stock atbreeders(*)

Enclosuresize 950cm2

less than 20 950 40 12

Enclosuresize 1500cm2

less than 20 1 500 30 12


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Table 1.2

Rats

(*) In long-term studies, if space allowances per individual animal fall below those indicated abovetowards 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 weaninguntil issue, provided that the animals are housed in larger enclosures with adequate enrichment, andthese 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 physiologicalor behavioural stress responses.


(cm2)


(cm2)

Minimum enclosure

height (cm)


34(2)In stockand duringprocedures(*)

up to 200

over 200 to 300

over 300 to 400

over 400 to 600

over 600

800

800

800

800

1 500

200

250

350

450

600

18

18

18

18

18

1 January 2017

Breeding 800

Mother and litter.

For each additionaladult animalpermanently addedto the enclosureadd 400 cm2

18

Stock atbreeders(**)

Enclosuresize 1 500cm2

up to 50

over 50 to 100

over 100 to 150

over 150 to 200

1 500

1 500

1 500

1 500

100

125

150

175

18

18

18

18Stock atbreeders(**)

Enclosuresize 2 500cm2

up to 100

over 100 to 150

over 150 to 200

2 500

2 500

2 500

100

125

150

18

18

18


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Table 1.3

Gerbils

Table 1.4

Hamsters

(*) Post-weaned hamsters may be kept at these higher stocking densities, for the short period afterweaning until issue provided that the animals are housed in larger enclosures with adequateenrichment, and these housing conditions do not cause any welfare deficit such as increased levels ofaggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, or otherphysiological or behavioural stress responses.


(cm2)


(cm2)

Minimum enclosure

height (cm)



up to 40

over 40

1 200

1 200

150

250

18

18

1 January 2017

Breeding 1 200

Monogamous pairor trio withoffspring

18


(cm2)


(cm2)

Minimum enclosure

height (cm)



up to 60

over 60 to 100

over 100

800

800

800

150

200

250

14

14

14

1 January 2017

Breeding 800

Mother ormonogamous pairwith litter

14

Stock atbreeders(*)

less than 60 1 500 100 14


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Table 1.5

Guinea pigs

2. Rabbits

During agricultural research, when the aim of the project requires that theanimals are kept under similar conditions to those under which commercial farmanimals are kept, the keeping of the animals shall at least follow the standards laiddown in Directive 98/58/EC*.

A raised area shall be provided within the enclosure. This raised area mustallow the animal to lie and sit and easily move underneath, and shall not covermore than 40% of the floor space. When for scientific or veterinary reasons araised area cannot be used, the enclosure shall be 33% larger for a single rabbit and60% larger for two rabbits. Where a raised area is provided for rabbits of less than10 weeks of age, the size of the raised area shall be at least of 55cm by 25cm andthe 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 asa minimum 3 000 cm2 per rabbit for the third, the fourth, the fifth and the sixthrabbit, while 2 500cm2 as a minimum shall be added for each additional rabbit


(cm2)


(cm2)

Minimum enclosure

height (cm)



up to 200

over 200 to 300

over 300 to 450

over 450 to 700

over 700

1 800

1 800

1 800

2 500

2 500

200

350

500

700

900

23

23

23

23

23

1 January 2017

Breeding 2 500

Pair with litter.

For each additionalbreeding femaleadd 1 000 cm2

23

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


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above a number of six.

Table 2.2.

Doe plus litter

Table 2.3

Rabbits less than 10 weeks of age

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

Table 2.4

Rabbits: Optimal dimensions for raised areas for enclosures having thedimensions indicated in Table 2.1.

Final body weight (kg) Minimum floor area for one or two socially harmonious animals

(cm2)

Minimum height (cm) Date referred to in regulation 34(2)

less than 3

from 3 to 5

over 5

3 500

4 200

5 400

45

45

60

1 January 2017

Doe weight (kg) Minimum enclosure size

(cm2)

Addition for nest boxes (cm2)

Minimum height (cm)

Date referred to in regulation 34(2)

less than 3

from 3 to 5

over 5

3 500

4 200

5 400

1 000

1 2000

1 400

45

45

60

1 January 2017

Age Minimum enclosure size

(cm2)

Minimum floor area per animal

(cm2)

Minimum height (cm)


Weaning to 7weeks

From 7 to 10weeks

4 000

4 000

800

1 200

40

40

1 January 2017

Age in weeks Final body weight (kg)

Optimum size(cm x cm)

Optimum height from the

enclosure floor (cm)


over 10 less than 3

from 3 to 5

over 5

55 x 25

55 x 30

60 x 35

25

25

30

1 January 2017


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3. Cats

Cats shall not be single-housed for more than 24 hours at a time. Cats that arerepeatedly aggressive towards other cats shall be housed singly only if acompatible companion cannot be found. Social stress in all pair- or group-housedindividuals shall be monitored at least weekly. Females with kittens under fourweeks 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 asingle cat, which shall be gradually increased so that by 4 months of age littershave been rehomed following the space requirements for adults.

Areas for feeding and for litter trays shall not be less than 0.5 metres apartand shall not be interchanged.

4. Dogs

Dogs shall where possible be provided with outside runs. Dogs shall not besingle-housed for more than 4 hours at a time.

The internal enclosure shall represent at least 50% of the minimum space tobe made available to the dogs, as detailed in Table 4.1.

The space allowances detailed below are based on the requirements ofbeagles, but giant breeds such as St Bernards or Irish wolfhounds shall be providedwith allowances significantly in excess of those detailed in Table 4.1. For breedsother than the laboratory beagle, space allowances shall be determined inconsultation with veterinary staff.

Table 4.1.

Dogs

Dogs that are pair or group housed may each be constrained to half the totalspace provided (2m2 for a dog under 20 kg, 4m2 for a dog over 20 kg) while theyare undergoing procedures as defined in these regulations, if this separation isessential for scientific purposes. The period for which a dog is so constrained shall

Floor (*)(m2)

Shelves (m2) Height (m2) Date referred to in regulation 34(2)

Minimum forone adult animal

1.5 0.5 2 1 January 2017

For eachadditionalanimal add

0.75 0.25 -

(*) Floor area excluding shelves.


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not exceed 4 hours at a time.

A nursing bitch and litter shall have the same space allowance as a singlebitch of equivalent weight. The whelping pen shall be designed so that the bitchcan move to an additional compartment or raised area away from the puppies.

Table 4.2

Dogs-post weaned stock

Table 5

Ferrets

6. Non-human primates

Young non-human primates shall not be separated from their mothers untilthey are, depending on the species, 6 to 12 months old.

The environment shall enable non-human primates to carry out a complexdaily programme of activity. The enclosure shall allow non-human primates toadopt as wide a behavioural repertoire as possible, provide it with a sense ofsecurity, and a suitably complex environment to allow the animal to run, walk,climb and jump.

Weight(Kg)

Minimum enclosureSize (m2)

Minimum floor area animal add for one or two animals (m2)

For each additional

animal add a Minimum of

(m2)

Minimum height (m)


34(2)

Up to 20

Over 20

4

8

4

8

2

4

2

2

1 January 2017

Weight of Dog(Kg)

Minimum enclosure size (m2)

Minimum floor area/ animal (m2)

Minimum height (cm)


34(2)Up to 5 4 0.5 2 1 January 2017Over 5 to 10 4 1.0 2Over 10 to 15 4 1.5 2Over 15 to 20 4 2 2Over 20 8 4 2

Minimum enclosure size

(cm2)

Minimum floor area/ animal

(cm2)

Minimum enclosure height

(cm)


Animals up to 600g 4 500 1 500 50 1 January 2017Animals over 600g 4 500 3 000 50Adult males 6 000 6 000 50

Jill and Litter 5 400 5 400 50


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Table 6.1

Marmosets and tamarins

(*) 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 placebefore 8 months of age.

Table 6.2

Squirrel monkeys

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

For squirrel monkeys, separation from the mother shall not take place before6 months of age.

Table 6.3

Macaques and vervets (*)

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

Minimum floor area of enclosures

for 1(*) or 2 animals plus

offspring up to 5 months (m2)

Minimum volume per additional

animal over 5 months old (m3)


(m) (**)


34(2)

Marmosets 0.5 0.2 1.5 1 January 2017Tamarins 1.5 0.2 1.5

Minimum Floor area for 1 (*) or 2 animals (m2)

Minimum volume per additional animal over 6

months of age (m3)

Minimum enclosure height (m)


2.0 0.5 1.8 1 January 2017


Minimum enclosure

volume (m3)

Minimum volume per

animal (m3)

Minimum enclosure height (m)

Date referred in regulation 34(2)

Animals lessthan 3 years ofage (**)

2.0 3.6 1.0 1.8 1 January 2017

Animals from3 years of age(***)

2.0 3.6 1.8 1.0

Animals heldfor breedingpurposes(****)

3.5 2.0


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(**) 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 2years of age housed with their mother.

For macaques and vervets, separation from the mother shall not take placebefore 8 months of age.

Table 6.4

Baboons

(*) 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 2years of age housed with their mothers.

For baboons, separation from the mother shall not take place before 8 monthsof age.

7. Farm animals

During agricultural research, when the aim of the project requires that theanimals are kept under similar conditions to those under which commercial farmanimals are kept, the keeping of the animals shall comply at least with thestandards laid down in Directives 98/58/EC, 91/629/EEC* and 91/630/EEC**.


Minimum enclosure

volume (m3)

Minimum volume per animal (m3)

Minimum enclosure

height (m)


Animals lessthan 4 years ofage

4.0 7.2 3.0 1.8 1 January 2017

Animals from4 years of age(**)

7.0 12.6 6.0 1.8

Animals heldfor breedingpurposes (***)

12.0 2.0

*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


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Table 7.1

Cattle

Table 7.2

Sheep and goats

Table 7.3

Pigs and Minipigs

(*) Pigs may be confined in smaller enclosures for short periods of time, for example by partitioning themain enclosure using dividers, when justified on veterinary or experimental grounds , for examplewhere individual food is required .

Body weight(Kg)


Minimum floor area/animal(m2/animal )

Trough space for ad-libitium

feeding of polled cattle (m/animal)

Trough space for restricted

feeding polled cattle

(m/animal)

Date referred in regulation (34)2

Up to 100 2.50 2.30 0.10 0.30 1 January 2017Over 100 to 200 4.25 3.40 0.15 0.50Over 200 to 400 6.00 4.80 0.18 0.60Over 400 to 600 9.00 7.50 0.21 0.70

Over 600 to 800 11.00 8.75 0.24 0.80Over 800 16.00 10.00 0.30 1.00

Body Weight(Kg)

Minimum Enclosure

(m2)

Minimum Floor area/

animal(m2/animal )

Minimum partition height

(m)

Tough space for ad-libitum

feeding(m/animal)

Tough Space for restricted

feeding(m/animal)

Date referred in regulation

34(2)Less than 20 1.0 0.7 1.0 0.10 0.25 1 January

2017Over 20 to 35 1.5 1.0 1.2 0.10 0.30Over 35 to 60 2.0 1.5 1.2 0.12 0.40Over 60 3.0 1.8 1.5 0.12 0.50

Live Weight(Kg)

Minimum Enclosure (*)

(m2)

Minimum floor area per animal

(m2/animal )

Minimum laying space per animal

(in thermo neutral conditions

(m2/animal)


Up to 5 2.0 0.20 0.10 1 January 2017Over 5 to 10 2.0 0.25 0.11Over 10 to 20 2.0 0.35 0.18Over 20 to 30 2.0 0.50 0.24Over 30 to 50 2.0 0.70 0.33Over 50 to 70 3.0 0.80 0.41Over 70 to 100 3.0 1.00 0.53Over 100 to 150 4.0 1.35 0.70Over 150 5.0 2.50 0.95Adult(conventional)boars

7.5 1.30


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Table 7.4

Equines

The shortest side shall be a minimum of 1.5 times the wither height of theanimal. The height of indoor enclosures shall allow animals to rear to their fullheight.

(*) To ensure adequate space is provided, space allowances for each individual animal shall be based onheight to withers (WH).

8. Birds

During agricultural research, when the aim of the project requires that theanimals are kept under similar conditions to those under which commercial farmanimals are kept, the keeping of the animals shall comply at least with thestandards laid down in Directives 98/58/EC, 1999/74/EC* and 2007/43/EC**.

Table 8.1

Domestic fowl

Where these minimum enclosure sizes cannot be provided for scientificreasons, the duration of the confinement shall be justified by the experimenter inconsultation with veterinary staff. In such circumstances, birds can be housed insmaller enclosures containing appropriate enrichment and with a minimum floorarea of 0.75m2

Wither height(m)

Minimum Floor area/ animal(m2/animal)

Minimum Enclosure

height(m)


34(2)For each animal held singly or in groups of up to

3 animals

For each animal held in groups of 4

or more animals

Foaling box / mare with foal

1 January 2017

1.00 to 1.40 9.0 6.0 16 3.00Over 1.40 to 1.60 12.0 9.0 20 3.00Over 1.60 16.0 (2 x WH)2 (*) 20 3.00

*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


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Table 8.2

Domestic Turkeys

All enclosure sides shall be at least 1.5 m long. Where these minimumenclosures sizes cannot be provided for scientific reasons, the duration of theconfinement shall be justified by the experimenter in consultation with veterinarystaff. In such circumstances, birds can be housed in smaller enclosures containingappropriate enrichment and with a minimum floor area of 0.75m2 and a minimumheight of 50cm for birds below 0.6kg, 75cm for birds below 4kg, and 100cm forbirds over 4kg. These can be used to house small groups of birds in accordancewith the space allowances given in table 8.2.

Table 8.3

Quails

Body Mass (g)

Minimum Enclosure size

(m2)

Minimum area per bird (m2)

Minimum height(cm)

Minimum length of

feed through per bird (cm)


34(2)

Up to 200 1.00 0.025 30 3 1 January 2017Over 200 to 300 1.00 0.03 30 3Over 300 to 600 1.00 0.05 40 7Over 600 to 1200 2.00 0.09 50 15Over 1200 to 1800 2.00 0.11 75 15Over 1800 to 2400 2.00 0.13 75 15Over 2400 2.00 0.21 75 15

Body Mass(kg)


Minimum area per bird (m2)

Minimum height (cm)

Minimum length of

feed through per bird (cm)


Up to 0.3 2.00 0.13 50 3 1 January 2017Over 0.3 to 0.6 2.00 0.17 50 7Over 0.6 to 1 2.00 0.30 100 15Over 1 to 4 2.00 0.35 100 15Over 4 to 8 2.00 0.40 100 15Over 8 to 12 2.00 0.50 150 20Over 12 to 16 2.00 0.55 150 20Over 16 to 20 2.00 0.60 150 20Over 20 3.00 1.00 150 20

Body Mass(g)


Area per bird pair-housed

(m2)

Area per additional

bird group-housed (m2)

Minimum height (cm)

Minimum length of

trough per bird (cm)

Data referred in regulation

34(2)

Up to 150 1.00 0.5 0.10 20 4 1 January 2017Over 150 1.00 0.6 0.15 30 4


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Table 8.4

Ducks and geese

Where these minimum enclosures sizes cannot be provided for scientificreasons, the duration of the confinement shall be justified by the experimenter inconsultation with veterinary staff. In such circumstances, birds can be housed insmaller enclosures containing appropriate enrichment and with a minimum floorarea of 0.75m2 . These can be used to house small groups of birds in accordancewith the space allowances given in table 8.4.

(*) This shall include a pond of minimum area 0.5m2 per 2m2 enclosure with a minimum depth of30cm.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 (*)

(*) Pond sizes are per 2m2 enclosures. The pond may contribute up to 50% of the minimum enclosuresize.

Body Mass(g)

Minimum Enclosure Size (m2)

Area per bird (m2) (*)

Minimum height (cm )

Minimum length of

feed trough per bird

(cm)

Data referred in regulation 34(2)

Ducks Up to 300 2.00 0.10 50 10 1 January 2017Over 300 to 1200(*)(**)

2.00 0.20 200 10

Over 1200 to 3500 2.00 0.25 200 15Over 3500 2.00 0.50 200 15Geese Up to 500 2.00 0.20 200 10Over 500 to 2000 2.00 0.33 200 15Over 2000 2.00 0.50 200 15

Area(m2)

Depth(cm)

Ducks 0.5 30Geese 0.5 From 10 to 30


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Table 8.6

Pigeons

Enclosures shall be long and narrow (for example 2m by 1m) rather thansquare to allow birds to perform short flights.

Table 8.7

Zebra finches

Enclosures shall be long and narrow (for example 2m by 1m) to enable birdsto perform short flights. For breeding studies, pairs may be housed in smallerenclosures containing appropriate enrichment with a minimum floor area of 0.5m2

and a minimum height of 40 cm. The duration of the confinement shall be justifiedby the experimenter in consultation with veterinary staff.

Table 9.1

Aquatic urodeles

(*) Measured from snout to vent.

Group size Minimum enclosure size (m2)

Minimum height(cm)

Minimum length of food

trough per bird (cm)

Minimum length of perch per bird (cm)


Up to 6 2 200 5 30 1 January 2017From 7 to 12 3 200 5 30For each additionalbird above 12

0.15 200 5 30

Group size Minimum enclosure size

(m2)

Minimum height(cm)

Minimum number of

feeders


Up to 6 1.0 100 2 1 January 20177 to 12 1.5 200 213 to 20 2.0 200 3For each additional bird above20

0.05 1 per 6 birds

Body length (*)(cm)

Minimum water surface

area (cm2)

Minimum water surface area for each additional animal in

group-holding(cm2)

Minimum water depth(cm)


Up to 10 262.5 50 13 1 January 2017Over 10 to 15 525 110 13Over 15 to 20 875 200 15Over 20 to 30 1 837.5 440 15Over 30 3150 800 20


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Table 9.2

Aquatic anurans (*)

(*) These conditions apply to holding (i.e. husbandry) tanks but not to those tanks used for natural matingand 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 shalleither be excluded ,or dimensions altered according to the scaling principle.

(**) Measured from snout to vent.

Table 9.3

Semi-aquatic anurans


(**) 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 (**) (cm) Minimum water surface area

(cm2)

Minimum water surface area for each additional animal in group holding (cm2)

Minimum water depth (cm)

Date referred in 34(2)

Less than 6 160 40 6 1 January 2017From 6 to 8 300 75 8Over 9 to 12 600 150 10Over 12 920 230 12.5

Body length (**) (cm)


area (cm2)


Minimum enclosure

height (***)(cm)

Minimum water depth

(cm)


34(2)

Up to 5.0 1500 200 20 10 1 January 2017Over 5.0 to 7.5 3500 500 30 10Over 7.5 4000 700 30 15

Body length (**) (cm)


area (cm2)


Minimum enclosure

height (***)(cm)

Minimum water depth

(cm)


34(2)

Up to 5.0 1 500 200 20 10 1 January 2017Over 5.0 to 7.5 3 500 500 30 10Over 7.5 4 000 700 30 15


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Table 9.5

Arboreal anurans




10. Reptiles

Table 10.1

Aquatic chelonians

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

Table 10.2

Terrestrial snakes


Body length (**)(cm)


area (cm2)

Minimum water surface area for each additional animal in

group holding(cm2)

Minimum water depth(cm)


Up to 3.0 900 100 30 1 January 2017Over 3.0 1 500 200 30


Minimum floor area (cm2)


Minimum water depth (cm)


Up to 5 600 100 10 1 January 2017Over 5 to 10 1 600 300 15Over 10 to 15 3 500 600 20Over 15 to 20 6 000 1 200 30Over 20 to 30 10 000 2 000 35Over 35 20 000 5 000 40


Minimum floor are (cm2)

Minimum area for each additional animal in group holding (cm2)


(**)(cm)


34(2)

Up to 30 300 150 10 1 January 2017Over 30 to 40 400 200 12Over 40 to 50 600 300 15Over 50 to 75 1 200 600 20Over 75 2 500 1 200 28


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(**) 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 toensure 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 thatsustains normal activity and physiology for a given species and stage ofdevelopment. The water flow shall be appropriate to enable fish to swim correctlyand to maintain normal behaviour. Fish shall be given an appropriate time foracclimatisation 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 inwhich the fish are held. Where necessary, supplementary aeration of tank watershall 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 lifestage 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 speciesconcerned and kept as stable as possible. Changes in temperature shall take placegradually. Fish shall be maintained on an appropriate photoperiod. Noise levelsshall be kept to a minimum and, where possible, equipment causing noise orvibration, such as power generators or filtration systems, shall be separate from thefish-holding tanks.

11.4. Stocking density and environmental complexity

The stocking density of fish shall be based on the total needs of the fish inrespect of environmental conditions, health and welfare. Fish shall have sufficientwater volume for normal swimming, taking account of their size, age, health andfeeding method. Fish shall be provided with an appropriate environmentalenrichment, such as hiding places or bottom substrate, unless behavioural traitssuggest none is required.


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11.5. Feeding and handling

Fish shall be fed a diet suitable for the fish at an appropriate feeding rate andfrequency. Particular attention shall be given to feeding of larval fish during anytransition 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 shallbe used.

Methods other than those listed in the table may be used:

(a) on unconscious animals, providing the animal does not regainconsciousness before death;

(b) on animals used in agricultural research, when the aim of theproject requires that the animals are kept under similar conditions to thoseunder which commercial farm animals are kept; these animals may be killedin accordance with the requirements laid down in Annex I to CouncilRegulation (EC) No 1099/2009 of 24 September 2009 on the protection ofanimals at the time of killing.

2. The killing of animals shall be completed by one of the followingmethods:

(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


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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 neonaterodents.

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 besedated.

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

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.


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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 whenother 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, careand use of animals for scientific purposes.

2. Ethics in relation to human-animal relationship, intrinsic value of lifeand 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, whereappropriate.

6. Animal health management and hygiene.

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


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(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 animalsin procedures.

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

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 tominimise animal numbers, pain, suffering, distress and environmental impactwhere 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 theCommission’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 ofalternatives to procedures including in the areas of basic and applied researchand regulatory testing;


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(b) coordinating the validation of alternative approaches at Unionlevel;

(c) acting as a focal point for the exchange of information on thedevelopment of alternative approaches;

(d) setting up, maintaining and managing public databases andinformation systems on alternative approaches and their state ofdevelopment;

(e) promoting dialogue between legislators, regulators, and allrelevant stakeholders, in particular, industry, biomedical scientists, consumerorganisations and animal-welfare groups, with a view to the development,validation, regulatory acceptance, international recognition, and applicationof alternative approaches.

2. The Union Reference Laboratory shall participate in the validation ofalternative approaches.

Schedule VIII

Part A - The National Reference Laboratory

The National Reference Laboratory in Malta referred to in regulation 48 isthe 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 inparticular for the following:

(a) carrying out of validation studies and coordinating thevalidation of alternative approaches at national level;

(b) ensuring the promotion of alternative approaches and thedissemination of information thereon;

(c) providing advice on the regulatory relevance and suitability anddevelopment of alternative approaches proposed for validation as a point ofsingle contact for the purpose of exchange of information;

(d) contributing with other competent authorities in other MemberStates to the development and validation of alternative approaches whichcould provide the same or higher levels of information as those obtained inprocedures using animals in terms of regulation 48(1);


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(e) setting up, maintaining and managing public databases andinformation systems on alternative approaches and their state ofdevelopment;

(f) promoting dialogue between legislators, regulators, and allrelevant stakeholders, consumer organisations and animal-welfare groups inparticular, 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 individualanimal during the course of the procedure.

Section I: Severity categories

Non-recovery:

Procedures which are performed entirely under general anaesthesia fromwhich 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 toexperience short-term mild pain, suffering or distress, as well as procedures withno significant impairment of the well-being or general condition of the animalsshall be classified as ‘mild’.

Moderate:

Procedures on animals as a result of which the animals are likely toexperience short-term moderate pain, suffering or distress, or long-lasting mildpain, suffering or distress as well as procedures that are likely to cause moderateimpairment of the well-being or general condition of the animals shall be classifiedas ‘moderate’.

Severe:

Procedures on animals as a result of which the animals are likely toexperience severe pain, suffering or distress, or long- lasting moderate pain,suffering or distress as well as procedures, that are likely to cause severe


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impairment of the well- being or general condition of the animals shall beclassified as ‘severe’.

Section II: Assignment criteria

The assignment of the severity category shall take into account anyintervention or manipulation of an animal within a defined procedure. It shall bebased on the most severe effects likely to be experienced by an individual animalafter applying all appropriate refinement techniques.

When assigning a procedure to a particular category, the type of procedureand a number of other factors shall be taken into account. All these factors shall beconsidered 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 (allelements of) the procedure, and its intensity, the duration, frequency andmultiplicity of techniques employed,

(c) cumulative suffering within a procedure,

(d) prevention from expressing natural behaviour includingrestrictions on the housing, husbandry and care standards.

Examples are given in Section III of procedures assigned to each of theseverity categories on the basis of factors related to the type of the procedurealone. They shall provide the first indication as to what classification would be themost appropriate for a certain type of procedure.

However, for the purposes of the final severity classification of theprocedure, the following additional factors, assessed on a case-by-case basis, shallalso 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 previousprocedures,

(e) the methods used to reduce or eliminate pain, suffering anddistress, including refinement of housing, husbandry and care conditions,


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(f) humane end-points.

Section III:

Examples of different types of procedure assigned to each of the severitycategories on the basis of factors related to the type of the procedure.

1. Mild:

(a) administration of anaesthesia except for the sole purpose ofkilling;

(b) pharmacokinetic study where a single dose is administered and alimited number of blood samples are taken (totalling < 10 % of circulatingvolume) and the substance is not expected to cause any detectable adverseeffect;

(c) non-invasive imaging of animals (e.g. MRI) with appropriatesedation or anaesthesia;

(d) superficial procedures, e.g. ear and tail biopsies, non-surgicalsubcutaneous implantation of mini-pumps and transponders;

(e) application of external telemetry devices that cause only minorimpairment to the animals or minor interference with normal activity andbehaviour;

(f) administration of substances by subcutaneous, intramuscular,intraperitoneal routes, gavage and intravenously via superficial bloodvessels, 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 theanimal;

(g) induction of tumours, or spontaneous tumours, that cause nodetectable clinical adverse effects (e.g. small, subcutaneous, non-invasivenodules);

(h) breeding of genetically altered animals, which is expected toresult 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 withinthe 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;


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(l) models which expose animals to noxious stimuli which arebriefly associated with mild pain, suffering or distress, and which the animalscan successfully avoid;

(m) a combination or accumulation of the following examples mayresult in classification as ‘mild’:

(i) assessing body composition by non-invasive measures andwith minimal restraint;

(ii) monitoring ECG with non-invasive techniques withminimal or no restraint of habituated animals;

(iii) application of external telemetry devices that are expectedto cause no impairment to socially adapted animals and do not interferewith normal activity and behaviour;

(iv) breeding genetically altered animals which are expected tohave no clinically detectable adverse phenotype;

(v) adding inert markers in the diet to follow passage ofdigesta;

(vi) withdrawal of food for < 24h in adult rats;

(vii) open field testing.

2. Moderate:

(a) frequent application of test substances which produce moderateclinical effects, and withdrawal of blood samples (> 10% of circulatingvolume) in a conscious animal within a few days without volumereplacement;

(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 generalcondition. Examples include: thoracotomy, craniotomy, laparotomy,orchidectomy, lymphadenectomy, thyroidectomy, orthopaedic surgery witheffective stabilisation and wound management, organ transplantation witheffective management of rejection, surgical implantation of catheters, orbiomedical devices (e.g. telemetry transmitters, minipumps etc.);

(d) models of induction of tumours, or spontaneous tumours, thatare expected to cause moderate pain or distress or moderate interference withnormal behaviour;


B 1710

(e) irradiation or chemotherapy with a sublethal dose, or with anotherwise lethal dose but with reconstitution of the immune system. Adverseeffects would be expected to be mild or moderate and would be short-lived (<5 days);

(f) breeding of genetically altered animals which are expected toresult in a phenotype with moderate effects;

(g) creation of genetically altered animals through surgicalprocedures;

(h) use of metabolic cages involving moderate restriction ofmovement 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 abnormalitywithin 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 isunable to escape or avoid the stimulus, and are expected to result in moderatedistress.

3. Severe:

(a) toxicity testing where death is the end-point, or fatalities are tobe expected and severe pathophysiological states are induced. For example,single dose acute toxicity testing;

(b) testing of device where failure may cause severe pain, distressor death of the animal (e.g. cardiac assist devices);

(c) vaccine potency testing characterised by persistent impairmentof the animal’s condition, progressive disease leading to death, associatedwith long-lasting moderate pain, distress or suffering;

(d) irradiation or chemotherapy with a lethal dose withoutreconstitution of the immune system, or reconstitution with production ofgraft 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 causingcachexia, invasive bone tumours, tumours resulting in metastatic spread, andtumours that are allowed to ulcerate;

(f) surgical and other interventions in animals under general


B 1711

anaesthesia which are expected to result in severe or persistent moderatepostoperative pain, suffering or distress or severe and persistent impairmentof the general condition of the animals. Production of unstable fractures,thoracotomy without adequate analgesia, or trauma to produce multipleorgan failure;

(g) organ transplantation where organ rejection is likely to lead tosevere distress or impairment of the general condition of the animals (e.g.xenotransplantation);

(h) breeding animals with genetic disorders that are expected toexperience severe and persistent impairment of general condition, forexample Huntington’s disease, Muscular dystrophy, chronic relapsingneuritis models;

(i) use of metabolic cages involving severe restriction of movementover a prolonged period;

(j) inescapable electric shock (e.g. to produce learnedhelplessness);

(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 failurein rats;

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


B 1590

_________________________________________________________________________________________________________________________Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

Mitbugħ fl-Istamperija tal-Gvern fuq karta riċiklata — Printed at the Government Printing Press on recycled paper

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L.N. 124 of 2013 ANIMAL WELFARE ACT (CAP. 439) Protection ...

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