S.I. No. 543/2012 - European Union (Protection of Animals used for Scientific Purposes) Regulations 2012

ARRANGEMENTS OF REGULATIONS

PART 1 Preliminary

1.

2.

3.

4.

5.

PART 2 General Provisions

6.

7.

8.

9.

10.

11.

PART 3 Restrictions in relation to certain animals

12.

13.

14.

15.

16.

PART 4 Procedures

17.

18.

19.

20.

21.

22.

23.

PART 5 Authorisation of projects

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

34.

PART 6 Authorisation of breeders, suppliers and users

35.

36.

37.

38.

39.

40.

41.

42.

PART 7 Personnel

43.

44.

45.

46.

47.

48.

49.

50.

PART 8 Authorisation of individuals

51.

52.

53.

54.

55.

56.

57.

58.

PART 9 National Committee

59.

60.

61.

62.

PART 10 Records and information

63.

64.

65.

66.

67.

68.

69.

70.

PART 11 Enforcement, offences and penalties

71.

72.

73.

74.

75.

76.

77.

78.

79.

80.

81.

82.

83.

84.

85.

86.

PART 12 Transitional provisions and provisional measures

87.

88.

PART 13 Repeals and revocations

89.

90.

SCHEDULE Certificate of result of test, examination or analysis of sample, etc.

S.I. No. 543 of 2012

EUROPEAN UNION (PROTECTION OF ANIMALS USED FOR SCIENTIFIC PURPOSES) REGULATIONS 2012

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 1st January, 2013.

I, JAMES REILLY, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), for the purpose of giving effect to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010¹ and for the purpose of giving full effect to Commission Implementing Decision 2012/707/EU of 14 November 2012² , hereby make the following regulations:

PART 1 PRELIMINARY

Citation

Commencement

Interpretation

“Act” means the Irish Medicines Board Act 1995 , as amended by s. 197 of the Finance Act 1999 (No. 2 of 1999), Regulation 3 of the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ), Regulation 2 of the European Communities (Medical Devices) (Amendment) Regulations 2001 ( S.I. No. 444 of 2001 ), Regulation 3 of the European Communities (Medical Devices) (Amendment) Regulations 2002 ( S.I. No. 576 of 2002 ), the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006) and the European Communities (Amendment of the Medicines Board Act 1995) Regulations 2007 ( S.I. No. 542 of 2007 );

“activity” means any activity relating to—

• (a) the use of an animal in a procedure,

• (b) the breeding, supply, care or accommodation of an animal used, or intended to be used, in a procedure, or

• (c) the breeding, supply, care or accommodation of an animal specifically so that its organs or tissues may be used for scientific purposes;

“animal” means—

• (a) any live non-human vertebrate animal, including—

• (i) an independently feeding larval form,

• (ii) a foetal form of mammal as from the last third of its normal development,

• (b) any animal at an earlier stage of development than that referred to in subparagraph (a), where the animal is to be allowed to live beyond that stage of development and, as a result of the procedures performed, is likely to experience pain, suffering, distress or lasting harm after it has reached that stage of development; or

• (c) any live cephalopod;

“animal care and welfare officer” means a person designated by a breeder, supplier or user pursuant to Regulation 45;

“animal welfare body” means a group of persons set up by a breeder, supplier or user pursuant to Regulation 50;

“animal welfare notice” means a notice served by the IMB pursuant to Regulation 76;

“breeder” means any natural or legal person breeding animals referred to in Annex I to the Directive with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, or breeding other animals primarily for those purposes, whether for profit or not;

“breeder authorisation” means an authorisation granted to a breeder under Part 6;

“closure order” means an order served by the IMB pursuant to Regulation 77;

“Commission” means the Commission of the European Union;

“compliance notice” means a notice served by the IMB pursuant to Regulation 74;

“compliance officer” means a person designated by a breeder, supplier or user pursuant to Regulation 44;

“debilitating clinical condition” means a reduction in a person’s normal physical or psychological ability to function;

“designated veterinarian or expert” means a person designated by a breeder, supplier or user pursuant to Regulation 48;

“Directive” means Directive 2010/63/EU of the European Parliament and of the Council of 22 September 20101;

“EEA State” means a member state of the European Economic Area, created by the Agreement on the European Economic Area signed in Oporto on 2 May 1992;

“establishment” means any installation, building, group of buildings or other premises and may include a place that is not wholly enclosed or covered and mobile facilities;

“IMB” means the Irish Medicines Board established under section 3 of Irish Medicines Board Act 1995 (No. 29 of 1995);

“killing authorisation” means an authorisation granted to an individual under Part 8 to kill animals used, or intended to be used, in procedures, or bred specifically so that their organs or tissues may be used for scientific purposes;

“Minister” means the Minister for Health;

“premises” means any place (physical or virtual), ship or other vessel, aircraft, railway wagon or other vehicle or other mobile facility, and includes a container used to transport animals or relevant thing;

“procedure” means any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. This includes any course of action intended, or liable, to result in the birth or hatching of an animal or the creation and maintenance of a genetically modified animal line in any such condition, but excludes the killing of animals solely for the use of their organs or tissues;

“procedures authorisation” means an authorisation granted to an individual under Part 8 to carry out procedures;

“project” means a programme of work having a defined scientific objective and involving one or more procedures;

“project authorisation” means an authorisation granted under Part 5;

“project evaluation” means evaluation carried out by the IMB in accordance with Regulation 31;

“project manager” means a person designated by a user pursuant to Regulation 47;

“project manager authorisation” means an authorisation granted to an individual under Part 8 to carry out the role of project manager;

“revocation order” means an order for the revocation of an authorisation served by the IMB pursuant to Regulation 75;

“supplier” means any natural or legal person, other than a breeder, supplying animals with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, whether for profit or not;

“supplier authorisation” means an authorisation granted to a supplier under Part 6;

“suspension order” means an order for the suspension of an authorisation served by the IMB pursuant to Regulation 75;

“training officer” means a person designated by a breeder, supplier or user pursuant to Regulation 46;

“user” means any natural or legal person using animals in procedures, whether for profit or not;

“user authorisation” means an authorisation granted to a user under Part 6;

“veterinarian” means a veterinary practitioner registered with the Veterinary Council of Ireland;

“Wildlife Trade Regulation” means Council Regulation (EC) No. 338/97 of 9 December 1996³ , as amended by Commission Regulation (EC) No. 938/97 of 26 May 1997⁴ , Commission Regulation (EC) No. 2307/97 of 18 November 1997⁵ , Commission Regulation (EC) No. 2214/98 of 15 October 1998⁶ , Commission Regulation (EC) No. 1476/1999 of 6 July 1999⁷ , Commission Regulation (EC) No. 2724/2000 of 30 November 2000⁸ , Commission Regulation (EC) No. 1579/2001 of 1 August 2001⁹ , Commission Regulation (EC) No. 2476/2001 of 17 December 2001¹⁰ , Commission Regulation (EC) No. 1497/2003 of 18 August 2003¹¹ , Regulation (EC) No. 1882/2003 of the European Parliament and of the Council of 29 September 2003¹² , Commission Regulation (EC) No. 834/2004 of 28 April 2004¹³ , Commission Regulation (EC) No. 1332/2005 of 9 August 2005¹⁴ , Commission Regulation (EC) No. 318/2008 of 31 March 2008¹⁵ , Regulation (EC) No. 398/2009 of the European Parliament and of the Council of 23 April 2009¹⁶ , Commission Regulation (EC) No. 407/2009 of 14 May 2009¹⁷ , Commission Regulation (EU) No. 709/2010 of 22 July 2010¹⁸ and Commission Regulation (EU) No. 101/2012 of 6 February 2012¹⁹ .

• (2) A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.

• (3) A reference in these Regulations to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other Regulations is intended.

• (4) A reference in these Regulations to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.

• (5) A reference in these Regulations to a Schedule is to the Schedule to these Regulations, unless it is indicated that reference to some other Regulations is intended.

Scope

• (2) These Regulations apply until the animal referred to in paragraph (1) has been killed, rehomed, or returned to a suitable habitat or husbandry system.

• (3) The elimination of pain, suffering, distress or lasting harm by the successful use of anaesthesia, analgesia or other methods shall not exclude the use of an animal in a procedure from the scope of these Regulations.

• (4) These Regulations shall not apply to:

• (a) non-experimental agricultural practices;

• (b) non-experimental clinical veterinary practices;

• (c) veterinary clinical trials required for the marketing authorisation of a veterinary medicinal product;

• (d) practices undertaken for the purposes of recognised animal husbandry;

• (e) practices undertaken for the primary purpose of identification of an animal; and

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

• (5) These Regulations shall apply without prejudice to the European Communities (Cosmetic Products) Regulations 2004 ( S.I. No. 870 of 2004 ) and—

• (a) Council Directive 76/768/EEC of 27 July 1976²⁰ , or

• (b) when applicable, Regulation (EC) No. 1223/2009 of the European Parliament and the Council of 30 November 2009²¹ .

Responsibility for functions under Directive

• (2) Paragraph (1) shall not apply to those functions of a Member State referred to in Articles 2, 47(2) and (5), 55, 59 and 61 of the Directive.

• (3) The IMB may charge fees for its functions under the Directive and these Regulations in accordance with regulations made under s. 13(1) of the Act, read in conjunction with s. 4(1)(v) of the Act.

• (4) The IMB may, for the purposes of Regulation 8, 14 or 22, publish guidelines in relation to the qualifications and experience required of a “competent person”.

PART 2 GENERAL PROVISIONS

Replacement, reduction and refinement

• (2) A user carrying out a project shall use the minimum number of animals possible without compromising the objectives of the project.

• (3) Breeders, suppliers and users shall ensure that the breeding, accommodation and care of animals, and the methods used in procedures, are refined to eliminate or reduce to the minimum any possible pain, suffering, distress or lasting harm to animals.

• (4) This Regulation shall, in the choice of methods, be implemented in accordance with Regulation 18.

Purposes of procedures

• (a) basic research;

• (b) translational or applied research with any of the following aims—

• (i) the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality or their effects in human beings, animals or plants,

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

• (iii) the welfare of animals and the improvement of the production conditions for animals reared for agricultural purposes;

• (c) for any of the aims in subparagraph (b) in the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs and other substances or products;

• (d) protection of the natural environment in the interests of the health or welfare of human beings or animals;

• (e) research aimed at preservation of the species;

• (f) higher education, or training for the acquisition, maintenance or improvement of vocational skills;

• (g) forensic inquiries.

Methods of killing

• (a) the method of killing with the minimum pain, suffering and distress is used, and

• (b) subject to paragraphs (2) and (5), the animal is killed by a competent person in the establishment of the breeder, supplier or user, as appropriate.

• (2) In the case of a field study, an animal may be killed by a competent person outside of an establishment.

• (3) Subject to paragraphs (4) and (5), in the case of the killing of an animal covered by Annex IV to the Directive, the breeder, supplier or user, or other person responsible, shall ensure that the appropriate method of killing as set out in that Annex is used.

• (4) The IMB may grant exemptions from the requirement in paragraph (3)—

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

• (b) when, on the basis of scientific justification, the purpose of the procedure cannot be achieved by the use of a method of killing set out in Annex IV to the Directive.

• (5) Paragraphs (1)(b) and (3) shall not apply where an animal has to be killed in emergency circumstances for animal welfare, public health, public security, animal health or environmental reasons.

Setting free of animals and rehoming

• (a) authorised by the IMB to do so in the applicable project authorisation,

• (b) the state of health of the animal allows it,

• (c) there is no danger to public health, animal health or the environment,

• (d) appropriate measures have been taken to safeguard the well-being of the animal,

• (e) a rehoming scheme is in place that ensures socialisation of the animal, and

• (f) in the case of a wild animal, where appropriate, a programme of rehabilitation is in place before it is returned to its habitat.

Care and accommodation

• (a) all animals are provided with accommodation, an environment, food, water and care which are appropriate to their health and well-being;

• (b) any restrictions on the extent to which an animal can satisfy its physiological and ethological needs are kept to a minimum;

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

• (d) arrangements are made to ensure that any defect or avoidable pain, suffering, distress or lasting harm discovered is eliminated as quickly as possible;

• (e) animals are transported under appropriate conditions;

• (f) they apply the standards set out in Section A of Annex III to the Directive; and

• (g) from the dates provided for therein or, if no date is provided, from 1 January 2013, they apply the standards set out in Section B of Annex III to the Directive.

• (2) The IMB may exempt a breeder, supplier or user from the requirements of paragraph (1)(a),(f) or (g) for scientific, animal welfare or animal health reasons.

Installations and equipment

• (2) Breeders, suppliers and users shall ensure that the design, construction and method of functioning of the installations and equipment in their establishments—

• (a) are such as to ensure that procedures are carried out as effectively as possible, and

• (b) aim at obtaining reliable results using the minimum number of animals and causing the minimum degree of pain, suffering, distress or lasting harm.

• (3) For the purposes of implementation of paragraphs (1) and (2), breeders, suppliers and users shall ensure that the relevant requirements as set out in Annex III of the Directive are complied with.

PART 3 RESTRICTIONS IN RELATION TO CERTAIN ANIMALS

Endangered species

• (a) the procedure has one of the purposes referred to in Regulation 7(b)(i), (c) or (e); and

• (b) there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of a species not listed in that Annex.

• (2) Paragraph (1) shall not apply to any species of non-human primate.

Non-human primates

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

• (i) Regulation 7(b)(i) or (c) and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings, or

• (ii) Regulation 7(a) or (e); and

• (b) there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates.

• (2) In the case of a specimen of non-human primate listed in Annex A to the Wildlife Trade Regulation, which does not fall within the scope of Article 7(1) of that Regulation, a user shall not use such specimen in a procedure, unless—

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

• (i) Regulation 7(b)(i) or (c) and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings, or

• (ii) Regulation 7(e); and

• (b) there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates and by the use of species not listed in that Annex.

• (3) Notwithstanding paragraphs (1) and (2), but subject to Regulation 88(2), a user shall not use a great ape in a procedure.

• (4) A breeder shall not breed non-human primates unless he, she or it has in place, maintains and implements, a strategy for increasing the proportion of animals that are the offspring of non-human primates that have been bred in captivity.

Animals taken from the wild

• (2) The IMB may grant an exemption from paragraph (1) on the basis of scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of an animal which has been bred for use in procedures.

• (3) A user using an animal taken from the wild in a procedure shall ensure that—

• (a) the animal is captured by one or more competent persons using methods which do not cause the animal avoidable pain, suffering, distress or lasting harm, and

• (b) where the animal is found, at or after capture, to be injured or in poor health—

• (i) it is examined by a veterinarian or another competent person, and

• (ii) subject to paragraph (4), action is taken to minimise the suffering of the animal.

• (4) The IMB may grant an exemption from the requirement in paragraph (3)(b)(ii) to take action to minimise the suffering of the animal if there is scientific justification.

Animals bred for use in procedures

• (2) Subject to paragraph (3), from the dates set out in Annex II to the Directive, a user shall not use a non-human primate listed therein in a procedure unless the animal is the offspring of non-human primates which have been bred in captivity or where it is sourced from a self-sustaining colony.

• (3) The IMB may grant exemptions from the requirements of paragraphs (1) and (2) on the basis of scientific justification.

• (4) In this Regulation, “self-sustaining colony” means a colony in which animals are bred only within the colony or sourced from other colonies but not taken from the wild, and where the animals are kept in a way that ensures that they are accustomed to humans.

Stray and feral animals of domestic species

• (2) The IMB may grant an exemption from paragraph (1) where—

• (a) there is an essential need for studies concerning the health and welfare of the animal or serious threats to the environment or to human or animal health, and

• (b) there is scientific justification to the effect that the purpose of the procedure can be achieved only by the use of a stray or feral animal.

PART 4 PROCEDURES

Restrictions on carrying out of procedures

• (a) in the user’s establishment, and

• (b) within the framework of a project.

• (2) The IMB may grant an exemption from the requirement in paragraph (1)(a) on the basis of scientific justification.

Choice of methods

• (2) A user shall, when choosing between alternative procedures, select the procedure which to the greatest extent meets the following requirements:

• (a) uses the minimum number of animals;

• (b) involves animals with the lowest capacity to experience pain, suffering, distress or lasting harm; and

• (c) causes the least pain, suffering, distress or lasting harm,

and is most likely to provide satisfactory results.

• (3) Subject to paragraph (4), a user shall ensure that, as far as possible, the end-point of any procedure carried out by the user is not the death of the animal or animals concerned, but rather an alternative early and humane end-point.

• (4) Where the death of the animal or animals concerned is the unavoidable end-point of a procedure carried out by a user, the user shall design the procedure so as to—

• (a) result in the deaths of as few animals as possible, and

• (b) reduce the duration and intensity of suffering to the animal or animals to the minimum possible and, as far as possible, ensure painless death.

Anaesthesia

• (a) in the case of any procedure involving serious injuries to the animal or animals concerned that may cause severe pain, and

• (b) unless it is inappropriate, in the case of any other procedure,

carry out the procedure under general or local anaesthesia.

• (2) When deciding, under paragraph (1)(b), on the appropriateness of using anaesthesia in a procedure coming within that subparagraph, a user shall take into account—

• (a) whether anaesthesia is judged to be more traumatic to the animal than the procedure itself, and

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

• (3) Subject to paragraph (1), unless it is inappropriate, a user shall use analgesia or another appropriate method in a procedure to ensure that pain, suffering and distress are kept to a minimum.

• (4) A user shall not give an animal used in a procedure any drug to stop or restrict the animal from showing pain unless—

• (a) an adequate level of anaesthesia or analgesia is used,

• (b) a scientific justification for the use of the drug in such a procedure is established, and

• (c) a record is kept, and made available to the IMB on request, of the justification referred to in subparagraph (b) and the details of the anaesthetic or analgesic regimen.

• (5) Where an animal used in a procedure may suffer pain once anaesthesia has worn off, the user carrying out the procedure shall treat the animal with pre-emptive and post-operative analgesics or other appropriate pain-relieving methods, provided that it is compatible with the purpose of the procedure.

• (6) As soon as the purpose of a procedure has been achieved, the user carrying out the procedure shall take appropriate action to minimise the suffering of the animal or animals concerned.

Classification of severity of procedures

• (2) A user shall keep a record of all classifications made under paragraph (1) and shall make such record available to the IMB on request.

• (3) Subject to Regulation 88(4), a user shall not perform a procedure if it involves severe pain, suffering or distress which is likely to be long-lasting and cannot be ameliorated.

Reuse

• (a) the actual severity of the previous procedure or procedures was classified as “mild” or “moderate” under Regulation 20(1),

• (b) it is demonstrated that the animal’s general state of health and well-being has been fully restored,

• (c) the further procedure is classified as “mild”, “moderate” or “non-recovery” under Regulation 20(1), and

• (d) it is in accordance with veterinary advice, taking into account the lifetime experience of the animal.

• (2) In exceptional circumstances, after a veterinary examination of the animal concerned, the IMB may grant a derogation from the requirement in paragraph (1)(a) allowing the reuse of an animal, provided the animal has not been used more than once in a procedure entailing severe pain, distress or equivalent suffering.

End of procedure

• (a) engage a veterinarian or another competent person to decide whether or not to keep the animal or animals used in the procedure alive, and

• (b) arrange for the killing of any animal used in the procedure which is likely to remain in moderate or severe pain, suffering, distress or lasting harm.

• (2) Where an animal is to be kept alive at the end of a procedure, the user shall ensure that the animal receives care and accommodation appropriate to its state of health.

• (3) For the purposes of this Regulation, a procedure shall be deemed to end when no further observations are to be made for that procedure or, as regards new genetically modified animal lines, when the progeny are no longer observed or expected to experience pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle.

Avoidance of duplication of procedures

• (2) Paragraph (1) shall not apply where, in the interests of the protection of public health, safety or the environment, a further procedure needs to be carried out regarding the data produced by the previous procedure.

PART 5 AUTHORISATION OF PROJECTS

Requirement for project authorisation

• (2) The IMB shall maintain registers of projects granted authorisations under this Part.

Application for project authorisation

• (a) made in writing to the IMB by the user or the project manager on behalf of the user,

• (b) signed by or on behalf of the applicant, whether in ink or by means of electronic signature,

• (c) accompanied by a written undertaking that, in the event of the project authorisation being granted, the applicant shall ensure fulfilment of the obligations arising by virtue of the terms and conditions of the project authorisation, and

• (d) accompanied by the appropriate fee.

• (2) An application for a project authorisation shall include the following information:

• (a) the project proposal,

• (b) the name and qualifications of at least one project manager designated under Regulation 47,

• (c) a non-technical project summary in accordance with Regulation 33,

• (d) information on the elements set out in Annex VI of the Directive, and

• (e) such other relevant information as determined by the IMB.

• (3) The IMB shall acknowledge the receipt of an application for a project authorisation as quickly as possible and shall indicate to the applicant the period referred to in Regulation 26(2) within which the decision is to be taken.

• (4) In the case of an incomplete or incorrect application for a project authorisation, the IMB shall, as quickly as possible, inform the applicant of the need to supply any additional documentation and of any possible effects on the running of the applicable time period.

Project authorisation decision

• (a) refuse to grant the project authorisation,

• (b) grant the project authorisation, or

• (c) grant the project authorisation in respect of particular establishments or procedures only,

and in the case of decision pursuant to subparagraph (b) or (c), the IMB may attach conditions to the authorisation.

• (2) Subject to paragraph (4) and Regulation 25(4), the IMB shall make a decision regarding an application for a project authorisation, and communicate same to the applicant, no later than 40 working days after receiving from the applicant a complete and correct application.

• (3) The period referred to in paragraph (2) shall include the project evaluation.

• (4) The IMB may extend the period referred to in paragraph (2) once, by an additional period not exceeding 15 working days when justified by the complexity or the multi-disciplinary nature of the project concerned.

• (5) Where, pursuant to paragraph (4), the IMB extends the period referred to in paragraph (2), it shall notify the applicant of—

• (a) the decision, and

• (b) the duration of the extension,

before the expiry of the period referred to in paragraph (2).

Grant of project authorisation

• (a) a favourable project evaluation, and

• (b) the severity classifications assigned to those procedures.

• (2) Where the IMB grants a project authorisation, it shall give notice in writing to the applicant specifying—

• (a) the user who will undertake the project,

• (b) the project manager(s),

• (c) the establishment(s) in which the project will be undertaken, where applicable,

• (d) whether, and in what manner, the user is authorised to rehome, or return to a suitable habitat or husbandry system, the animals used, and

• (e) any specific conditions arising from the project evaluation, including whether and when the project shall be assessed retrospectively and limitations as to the severity of procedures.

• (3) Project authorisations shall be granted for a period not exceeding 5 years.

• (4) The IMB may grant a project authorisation in respect of multiple generic projects to be carried out by the same user if such projects are to satisfy regulatory requirements or if such projects use animals for production or diagnostic purposes with established methods.

Refusal to grant project authorisation

• (2) If any representations are made by or on behalf of the applicant in response to a notice under paragraph (1) within 15 working days after the date of such notice, the IMB shall consider such representations.

• (3) Where the IMB, having considered representations pursuant to paragraph (2), decides to refuse to grant a project authorisation, it shall notify that person within the extended time period under Regulation 26(4), stating the reasons on which its decision is based.

Removal, variation and addition of conditions to project authorisation

• (2) Where the IMB proposes to remove or vary a condition, or impose an additional condition, in respect of a project authorisation, pursuant to paragraph (1), it shall serve a notice on the user or project manager which shall—

• (a) give details of the condition which it proposes to remove, or of the variation which it proposes to make to an existing condition, or of the additional condition which it proposes to impose,

• (b) give the reasons for its decision, and

• (c) specify the date, which shall be not less than 14 working days from the date on which the notice is served, from which the removal, variation or imposition shall apply.

Amendment or renewal of project authorisation

• (2) Any amendment or renewal of a project authorisation shall be subject to a favourable outcome of a further project evaluation.

• (3) An application for an amendment or renewal of a project authorisation shall be—

• (a) made in writing to the IMB by the user or the project manager, on behalf of the user,

• (b) signed by or on behalf of the applicant, whether in ink or by means of an electronic signature,

• (c) accompanied by a written undertaking that, in the event of the project authorisation being amended or renewed, the applicant shall ensure fulfilment of the obligations arising by virtue of the terms and conditions of the project authorisation, and

• (d) accompanied by the appropriate fee.

• (4) The IMB shall acknowledge the receipt of an application under paragraph (3) as quickly as possible and shall indicate to the applicant the period within which the decision is to be taken.

• (5) In the case of an incomplete or incorrect application under paragraph (3), the IMB shall, as quickly as possible, inform the applicant of the need to supply any additional documentation and of any possible effects on the running of the applicable time period.

• (6) For the purpose of this Regulation, “a substantial change in a project” means any change to the project which would result in one or more of the following:

• (a) a failure to comply with the requirements of these Regulations;

• (b) a negative impact on animal welfare.

• (7) The IMB shall establish and publish conditions for amendment and renewal of project authorisations.

Project evaluation

• (2) The IMB shall perform the project evaluation with a degree of detail appropriate for the type of project and shall verify that the project meets the following criteria:

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

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

• (c) the project is designed so as to enable procedures to be carried out in the most humane and environmentally sensitive manner possible.

• (3) The project evaluation shall consist in particular of the following:

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

• (b) an assessment of the compliance of the project with the requirement of replacement, reduction and refinement;

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

• (d) a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical considerations, and may ultimately benefit human beings, animals or the environment;

• (e) an assessment of any justification referred to in Regulations 8, 10, 12 to 17, 19 and 21; and

• (f) a determination as to whether and when the project should be assessed retrospectively in accordance with Regulation 32.

• (4) In carrying out the project evaluation, the IMB shall consider expertise in particular in the following areas:

• (a) the areas of scientific use for which animals will be used including replacement, reduction and refinement in the respective areas;

• (b) experimental design, including statistics where appropriate;

• (c) veterinary practice in laboratory animal science or wildlife veterinary practice where appropriate; and

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

• (5) The project evaluation process shall be transparent.

• (6) Subject to safeguarding intellectual property and confidential information, the project evaluation shall be performed in an impartial manner and may integrate the opinion of independent parties.

Retrospective assessment

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

• (b) the harm inflicted on animals, including the numbers and species of animals used, and the severity of the procedures;

• (c) any elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.

• (2) Where a retrospective assessment is to be carried out by the IMB, the user or project manager concerned shall, on request, provide such documentation to the IMB as the IMB considers necessary for the purposes of the retrospective assessment.

• (3) Notwithstanding paragraph (1), all projects using non-human primates and projects involving procedures classified as “severe”, including those referred to in Regulation 20(3), shall undergo a retrospective assessment.

Non-technical project summaries

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

• (b) a demonstration of compliance with the requirement of replacement, reduction and refinement.

• (2) The non-technical project summary referred to in Regulation 25(2)(c) shall be anonymous and shall not contain the names and addresses of the user and his, her or its personnel.

• (3) The IMB may require the non-technical project summary to specify whether the project is to undergo a retrospective assessment in accordance with Regulation 32, and by what deadline, and, in such a case, the IMB shall ensure that the non-technical project summary is updated with the results of any retrospective assessment.

• (4) The IMB shall publish the non-technical project summaries of authorised projects and any updates thereto.

Documentation

• (a) where the project authorisation is granted, the expiry date of the project authorisation, or

• (b) where the project authorisation is refused, the expiry of the period referred to in Regulation 26(2),

and shall make such documentation available to the IMB on request.

• (2) The user or project manager shall keep the documentation for projects which have to undergo retrospective assessment in accordance with Regulation 32 until the retrospective assessment has been completed.

PART 6 AUTHORISATION OF BREEDERS, SUPPLIERS AND USERS

Requirement for authorisation

• (2) No person may carry out the activities of a supplier otherwise than in accordance with an appropriate authorisation granted by the IMB under this Part (“a supplier authorisation”), including any conditions to which the supplier authorisation is subject.

• (3) No person may carry out the activities of a user otherwise than in accordance with an appropriate authorisation granted by the IMB under this Part (“a user authorisation”), including any conditions to which the user authorisation is subject.

• (4) The IMB shall maintain registers of persons granted authorisations under this Part.

Application for authorisation

• (a) made in writing to the IMB by the breeder, supplier or user, as appropriate,

• (b) signed by or on behalf of the applicant, whether in ink or by means of electronic signature,

• (c) accompanied by a written undertaking that, in the event of the authorisation being granted, the applicant shall ensure fulfilment of the obligations arising by virtue of the terms and conditions of the authorisation, and

• (d) accompanied by the appropriate fee.

• (2) An application for an authorisation under this Part shall include the following information:

• (a) the name and contact details of the breeder, supplier or user,

• (b) the activities for which the breeder, supplier or user seeks authorisation,

• (c) the establishment(s) at which the said activities will be carried out,

• (d) the name and qualifications of the compliance officer(s),

• (e) the name and qualifications of the animal care and welfare officer(s),

• (f) the name and qualifications of the training officer(s),

• (g) the name and qualifications of the designated veterinarian or expert,

• (h) a “Site Master File” providing clear information on the breeder, supplier or user’s establishment(s) including the quality management systems in place in the said establishment(s),

• (i) such other relevant information as determined by the IMB.

• (3) The IMB shall acknowledge the receipt of an application for an authorisation under this Part as quickly as possible and shall indicate to the applicant the period within which the decision is to be taken.

• (4) In the case of an incomplete or incorrect application for an authorisation under this Part, the IMB shall, as quickly as possible, inform the applicant of the need to supply any additional documentation and of any possible effects on the running of the applicable time period.

Authorisation decision

• (a) refuse to grant the authorisation,

• (b) grant the authorisation, or

• (c) grant the authorisation in respect of particular establishment(s), activities or species only,

and in the case of decision pursuant to subparagraph (b) or (c), the IMB may attach conditions to the authorisation.

• (2) The IMB shall make a decision regarding an application for an authorisation under this Part, and communicate same to the applicant, within a reasonable time period after receiving from the applicant a complete and correct application.

Restrictions on grant of authorisation

• (2) The IMB shall not grant a breeder authorisation covering the breeding of non-human primates unless the breeder has in place, maintains and implements a strategy for increasing the proportion of animals that are the offspring of non-human primates that have been bred in captivity.

Grant of authorisation

• (a) the establishment(s) to which the authorisation applies,

• (b) the compliance officer(s),

• (c) the animal care and welfare officer(s),

• (d) the training officer(s)

• (e) the designated veterinarian or expert, and

• (f) any specific conditions relevant to the authorisation as determined by the IMB.

• (2) Authorisations under this Part shall be granted for a period not exceeding 3 years.

Refusal to grant authorisation

• (2) Where the IMB, having considered the representations (if any) made by or on behalf of the breeder, supplier or user in response to a notice under paragraph (1), decides to refuse to grant an authorisation under this Part, it shall notify that person stating the reasons on which its decision is based.

Removal, variation and addition of conditions

• (2) Where the IMB proposes to remove or vary a condition, or impose an additional condition, in respect of an authorisation under this Part, pursuant to paragraph (1), it shall serve a notice on the breeder, supplier or user which shall—

• (a) give details of the condition which it proposes to remove, or of the variation which it proposes to make to an existing condition, or of the additional condition which it proposes to impose,

• (b) give the reasons for its decision, and

• (c) specify the date, which shall be not less than 14 working days from the date on which the notice is served, from which the removal, variation or imposition shall apply.

Amendment or renewal of authorisation

• (2) Where the IMB is notified of a change under paragraph (1), it shall issue an amended authorisation to the breeder, supplier or user, incorporating the said change.

• (3) A breeder, supplier or user shall not make any significant change unless granted a renewal of the relevant authorisation by the IMB.

• (4) Any application by a breeder, supplier or user for an amendment or renewal of an authorisation under this Part, whether because of the expiry of the authorisation or pursuant to paragraph (3), shall be—

• (a) made in writing to the IMB by the breeder, supplier or user,

• (b) signed on behalf of the breeder, supplier or user, whether in ink or by means of an electronic signature, and

• (c) accompanied by a written undertaking that, in the event of the authorisation being amended or renewed, the applicant shall ensure fulfilment of the obligations arising by virtue of the terms and conditions of the authorisation, and

• (d) accompanied by the appropriate fee.

• (5) The IMB shall acknowledge the receipt of an application under paragraph (4) as quickly as possible and shall indicate to the applicant the period within which the decision is to be taken.

• (6) In the case of an incomplete or incorrect application under paragraph (4), the IMB shall, as quickly as possible, inform the applicant of the need to supply any additional documentation and of any possible effects on the running of the applicable time period.

• (7) The IMB shall establish and publish conditions for amendment and renewal of authorisations under this Part.

• (8) In this Regulation, “significant change” means any significant change to the structure or function of an establishment that could negatively affect animal welfare, including—

• (a) the addition of a new building, premises, mobile facility or establishment site,

• (b) the addition of a new species of animal that can be kept at the establishment, or

• (c) a change in the main type of operations conducted at the establishment.

PART 7 PERSONNEL

Competence of personnel

• (2) A breeder, supplier or user shall not carry out any of the following functions unless each member of staff involved in that function complies with the education and training requirements published in accordance with paragraph (5):

• (a) carrying out procedures on animals,

• (b) designing procedures and projects,

• (c) taking care of animals, or

• (d) killing animals.

• (3) Without prejudice to paragraph (2), a breeder, supplier or user shall not carry out the designing of procedures and projects unless each member of staff involved in the function has received instruction in a scientific discipline relevant to the work being undertaken and has species-specific knowledge.

• (4) A breeder, supplier or user may permit a member of staff who has not yet demonstrated the requisite competence to carry out functions referred to in paragraph (2)(a), (c) or (d), if that member of staff is appropriately supervised in the performance of his or her tasks.

• (5) The IMB shall publish, on the basis of the elements set out in Annex V to the Directive, minimum requirements with regard to education and training and the requirements for obtaining, maintaining and demonstrating requisite competence for the functions set out in paragraphs (2), (3) and (4).

Compliance officer

Animal care and welfare officer

• (a) be responsible for overseeing the welfare and care of the animals in the establishment, and

• (b) ensure that the staff dealing with animals have access to information specific to the species housed in the establishment.

Training officer

Project manager

• (a) any unnecessary pain, suffering, distress or lasting harm that is being inflicted on an animal in the course of a procedure is stopped,

• (b) the project is carried out in accordance with the relevant project authorisation, and

• (c) in the event of non-compliance, the appropriate measures to rectify it are taken and recorded.

Designated veterinarian or expert

• (2) The designated veterinarian or expert shall assist the animal welfare body in its tasks.

Delegation

• (2) Breeders, suppliers and users shall notify the IMB of the name of any persons to whom functions have been delegated under paragraph (1), and the specific functions which have been delegated to such persons.

• (3) Where a person delegates functions pursuant to paragraph (1), he or she shall remain accountable for the performance of those functions.

Animal welfare body

• (a) consist of at least the animal care and welfare officer(s) and, in the case of a user, a scientific member, and

• (b) receive input from the designated veterinarian or expert.

• (2) Animal welfare bodies shall, as a minimum, carry out the following tasks:

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

• (b) advise the staff on the application of the requirement of replacement, reduction and refinement, and keep it informed of technical and scientific developments concerning the application of that requirement;

• (c) establish and review internal operational processes as regards monitoring, reporting and follow-up in relation to the welfare of animals housed or used in the establishment;

• (d) follow the development and outcome of projects, taking into account the effect on the animals used, and identify and advise as regards elements that further contribute to replacement, reduction and refinement,

• (e) advise on rehoming schemes, including the appropriate socialisation of the animals to be rehomed, and

• (f) facilitate, where appropriate, the establishment of programmes for the sharing of organs and tissues of animals killed.

• (3) Breeders, suppliers and users shall keep, for at least 3 years, and make available to the IMB upon request, the records of any advice given by the animal welfare body and decisions taken regarding that advice.

PART 8 AUTHORISATION OF INDIVIDUALS

Requirement for authorisation

• (2) No person may carry out the role of project manager otherwise than in accordance with an appropriate authorisation granted by the IMB under this Part (“a project manager authorisation”), including any conditions to which the project manager authorisation is subject.

• (3) Subject to paragraph (4) and Regulation 8, no person may kill an animal used, or intended to be used, in a procedure, or where an animal bred specifically so that its organs or tissues may be used for scientific purposes, otherwise than in accordance with an appropriate authorisation granted by the IMB under this Part (“a killing authorisation”), including any conditions to which the killing authorisation is subject.

• (4) Paragraph (3) shall not apply in the case of—

• (a) killing an animal in emergency circumstances for animal welfare, public health, public security, animal health or environmental reasons,

• (b) euthanasia by veterinarians of animals under their care, and

• (c) killing by an authorised officer.

• (5) The IMB shall maintain registers of persons granted authorisations under this Part.

Annual maintenance fee

Application for authorisation

• (a) made in writing to the IMB,

• (b) signed by the applicant, whether in ink or by means of electronic signature,

• (c) accompanied by written confirmation of endorsement by the breeder, supplier or user of the establishment in which the applicant shall perform the activities for which he or she requires authorisation,

• (d) accompanied by a written undertaking that, in the event of the authorisation being granted, the applicant shall ensure fulfilment of the obligations arising by virtue of the terms and conditions of the authorisation, and

• (e) accompanied by the appropriate fee.

• (2) An application for an authorisation under this Part shall include the following information:

• (a) the name and contact details of the applicant,

• (b) details of the activities (including the techniques and species of animals involved) for which the applicant seeks authorisation,

• (c) details of the establishment(s) at which the said activities will be carried out,

• (d) details of the applicant’s education, training and experience relevant to the activities for which the applicant seeks authorisation, and

• (e) such other relevant information as determined by the IMB.

• (3) The IMB shall acknowledge the receipt of an application for an authorisation under this Part as quickly as possible and shall indicate to the applicant the period within which the decision is to be taken.

• (4) In the case of an incomplete or incorrect application for an authorisation under this Part, the IMB shall, as quickly as possible, inform the applicant of the need to supply any additional documentation and of any possible effects on the running of the applicable time period.

Authorisation decision

• (a) refuse to grant the authorisation,

• (b) grant the authorisation, or

• (c) grant the authorisation in respect of particular establishment(s), project(s), procedures, species or methods of killing only,

and in the case of decision pursuant to subparagraph (b) or (c), the IMB may attach conditions to the authorisation.

• (2) The IMB shall make a decision regarding an application for an authorisation under this Part, and communicate same to the applicant, within a reasonable time period after receiving from the applicant a complete and correct application.

Grant of authorisation

• (a) the activities which the individual may carry out under the authorisation in accordance with these Regulations and the Directive,

• (b) the establishment(s) at which such activities may be carried out,

• (c) any specific conditions relevant to the authorisation as determined by the IMB.

• (2) Authorisations under this Part shall be granted for a period not exceeding 5 years.

Refusal to grant authorisation

• (2) Where the IMB, having considered the representations (if any) made by the applicant in response to a notice under paragraph (1), decides to refuse to grant an authorisation under this Part, it shall notify the applicant stating the reasons on which its decision is based.

Removal, variation and addition of conditions

• (2) Where the IMB proposes to remove or vary a condition, or impose an additional condition, in respect of an authorisation under this Part, pursuant to paragraph (1), it shall serve a notice on the applicant which shall—

• (a) give details of the condition which it proposes to remove, or of the variation which it proposes to make to an existing condition, or of the additional condition which it proposes to impose,

• (b) give the reasons for its decision, and

• (c) specify the date, which shall be not less than 14 working days from the date on which the notice is served, from which the removal, variation or imposition shall apply.

Amendment of authorisation

• (a) authorisation to carry out a new type of procedure,

• (b) authorisation to carry out activities on a new project in the establishment(s) at which he or she is authorised to carry out activities, and

• (c) authorisation to carry out activities in relation to a new species in such establishment(s).

• (2) An application under paragraph (1) shall—

• (a) be made in writing to the IMB,

• (b) be signed by the applicant, whether in ink or by means of electronic signature,

• (c) be accompanied by written confirmation of endorsement by the breeder, supplier or user of the establishment in which the applicant shall perform the activities for which he or she requires authorisation,

• (d) accompanied by a written undertaking that, in the event of the authorisation being amended, the applicant shall ensure fulfilment of the obligations arising by virtue of the terms and conditions of the authorisation and

• (e) be accompanied by the appropriate fee.

• (3) An application under paragraph (1) shall include the following information:

• (a) the name and contact details of the applicant,

• (b) details of the amendment sought, and

• (c) such other relevant information as determined by the IMB.

• (4) The IMB shall acknowledge the receipt of an application under paragraph (1) as quickly as possible and shall indicate to the applicant the period within which the decision is to be taken.

• (5) In the case of an incomplete or incorrect application under paragraph (1), the IMB shall, as quickly as possible, inform the applicant of the need to supply any additional documentation and of any possible effects on the running of the applicable time period.

PART 9 NATIONAL COMMITTEE

Establishment of National Committee

• (2) The National Committee shall stand established on such day as the Minister by order appoints.

Membership of National Committee

• (2) The persons appointed to the National Committee shall possess specialist expertise and competence relevant to the functions of the National Committee.