Animal Experimentation Law Amendment Act - Tvräg

Original Language Title: Tierversuchsrechtsänderungsgesetz – TVRÄG

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114. Federal Law, which enacted a 2012 Animal Experiments Act, as well as the Medicines Act, the Biocides Products Act, the Feed Act 1999, the Genetic Engineering Act and the Animal Protection Act (Animal Experiments Law Amendment Act- TVRÄG)

The National Council has decided:

Article 1

Federal Law on Experiments On Live Animals (Animal Experiments Act 2012-TVG 2012)

table of contents

§

Object/Label

Article 1
Federal Law on Experiments On Live Animals (Animal Experiments Act 2012-TVG 2012)

Section 1
General provisions

§ 1

Subject matter

§ 2

Definitions

§ 3

Severities

§ 4

Illegal animal testing

§ 5

Permitted purposes of animal testing

§ 6

Guiding principles

§ 7

Killing methods

§ 8

Stunning methods

§ 9

Re-use of animals

§ 10

Release of animals and private accommodation

§ 11

Completion of animal testing

Section 2
Specific rules applicable to certain species

§ 12

Endangered species

§ 13

Non-human primates

§ 14

Wild animals

§ 15

Specially designed for use in animal experiments

Section 3
Requirements for breeders, suppliers and users

§ 16

Approval of breeders, suppliers and users

§ 17

Preliminary or final revocation

§ 18

Requirements for equipment and equipment

§ 19

Staff requirements

§ 20

Veterinary care

Section 21

Animal protection body

Section 22

Records of the animals

Section 23

Information about dogs, cats and non-human primates

§ 24

Identification and identification of dogs, cats and non-human primates

Section 25

Care and accommodation

Section 4
Requirements for projects

Section 26

Approval of projects

§ 27

Approval of project managers and project managers

§ 28

Change, renewal or revocation of a project approval

§ 29

Project Assessment

§ 30

Retrospective Assessment

Section 31

Information to the public and documentation

Section 5
Monitoring

Section 32

Control by the competent authorities

§ 33

Verification of controls

Section 34

Safeguards and coercive measures

6.
Organisation and cooperation in the field of animal experimentation

§ 35

Federal Animal Experiments Commission

§ 36

Commissions

Section 37

Cooperation with the European Commission

§ 38

Cooperation with the European Commission on the development of alternative approaches

Section 7
Final provisions

§ 39

Criminal provisions

§ 40

Protection of workers in the event of a refusal of animal testing

Section 41

Implementation Notice

§ 42

Transitional provisions

Section 43

Regulation

Section 44

entry into force

§ 45

Enforcement

Section 1

General provisions

Subject matter

§ 1. (1) The subject matter of this Federal Act is the protection of the following animals, to the extent that they are to be used for scientific purposes or educational purposes or are to be used:

1.

live vertebrates, including

a)

self-food receiving larvae and

b)

Föts of mammals from the last third of their normal development,

2.

Animals which are at an earlier stage of development than that in Z 1 lit. (a) or (b) if they are to continue to live beyond this and, as a result of the animal experiments carried out, are likely to experience pain, suffering or distress, or to suffer permanent damage after that stage of development as well as

3.

live cephalopods.

(2) This federal law shall not apply to:

1.

non-periment agricultural practices,

2.

non-periment veterinary clinical practices,

3.

practices used for recognised purposes of animal husbandry,

4.

practices that are mainly used for the identification of animals,

5.

practices in which it is not to be expected that they cause pain, suffering, distress or permanent damage, which are equivalent to or exceed those of a canoe instipation in accordance with good veterinary practice, and

6.

Animals referred to in paragraph 1, which have been released in accordance with the provisions of § 10 or have been privately housed.

(3) The objectives of this Federal Act are:

1.

the prevention and reduction of the use of animals in animal experiments,

2.

the improvement of conditions for the breeding, placing, care and use of animals in animal experiments,

3.

the promotion of replacement methods for animal testing, and

4.

the elimination or, as far as possible, reduction of the burden on the animals used in animal experiments.

Definitions

§ 2. In the sense of this federal law:

1.

"animal test" means any use of animals for experimental, training or other scientific purposes with a known or unknown outcome, which shall:

a)

in the case of animals, it may cause pain, suffering, distress or lasting damage to an extent which is equivalent to or exceeds that of a canoe, in accordance with good veterinary practice, or

b)

should or may result in an animal in a state according to lit. a was born or outburdened, or

c)

should or may result in a genetically modified animal line in a state according to lit. a is created and preserved,

not, however, the killing of animals solely for the purpose of using their tissues or organs.

2.

"Project": a work programme with a defined scientific objective ("Project objective") , which includes one or more animal experiments, whereby, for the purposes of this Federal Act, project objectives shall be described in sufficient detail by specifying a purpose in accordance with § 5.

3.

"facilities" means facilities, buildings, building complexes or other premises, whether or not they are fully fenced, covered, or movable.

4.

"breeder" means any natural or legal person who bans animals with the aim of:

a)

these in animal experiments or

b)

their tissues or organs for scientific purposes

shall be used, whether or not they are made for profit or not.

5.

"supplier" means any natural or legal person who is not a breeder and who supplies animals with the aim of:

a)

these in animal experiments or

b)

their tissues or organs for scientific purposes

shall be used, whether or not they are made for profit or not.

6.

"user" means any natural or legal person who uses animals in animal experiments, whether or not they are made for profit or not.

7.

"endangered species" means animal species listed in Annex A to Regulation (EC) No 338/97 on the protection of species of wild fauna and flora by regulating trade therein, OJ L 327, 31.12.1997, p. No. OJ L 61, 3.3.1997, p. 1, as last amended by Regulation (EU) No 101/2012, OJ L 136, 31.5.2012, p. No. OJ L 39, 11.2.2012 p. 133, which does not fall under Article 7 (1) of Regulation (EC) No 338/97.

8.

"competent authority": in the case of animal experiments within the framework of the higher education system or the scientific institutions of the federal government, the Federal Minister or The Federal Minister for Science and Research is otherwise the competent national primary wife or the competent provincial governor.

9.

"LD-50" means the dose of a chemical (substance, preparation, product) or a micro-organism (including a virus), after which it is administered once, 50 per cent of the animals treated in this way are within a defined period of time for such an experiment. Time period (usually two weeks) die. This dose is statistically determined as a median lethal dose and is usually expressed as a function of the body weight of the animals.

Severities

§ 3. (1) The following severities are to be distinguished in animal experiments:

1.

"no restoration of life function": animal experiments carried out entirely under general anaesthesia, from which the animal no longer wakes up;

2.

"low" means animal testing which is expected to cause short-term minor pain, suffering or distress in the animals, as well as animal testing without any substantial impairment of the animal's welfare or general condition;

3.

"medium" means animal testing which is expected to cause short-term moderate pain, moderate suffering or distress or long-lasting low pain in the animals, as well as animal testing which is expected to be -causing serious adverse effects on the welfare or general condition of the animals;

4.

'severe': animal testing to be expected to cause severe pain, severe suffering or distress or long-lasting moderate pain, moderate suffering or distress in the animals, as well as animal tests to be expected from is that they cause serious damage to the welfare state or to the general condition of the animals.

(2) In the allocation of degrees of severity to animal experiments, any intervention or manipulation of the animals in the context of animal testing shall be taken into account. The allocation shall be based on the most serious effects which the animals may be exposed to after all appropriate improvement techniques have been applied. The factors referred to in paragraph 3 shall be considered in individual cases.

(3) The classification of degrees of severity shall take account in particular of the following factors:

1.

Type of manipulation and handling,

2.

the type of pain, suffering, distress or permanent damage caused by the animal test, taking into account all the elements and its intensity, duration and frequency, and the use of several techniques,

3.

cumulative suffering during an animal test,

4.

prevention of natural behaviour, including restrictions on accommodation, posture and care standards,

5.

animal species and genotype,

6.

the degree of development, age and sex of the animals,

7.

the experience of animals with regard to animal testing,

8.

the actual severity of the previous animal tests, provided that animals are to be used again,

9.

Methods of reducing or eliminating pain, suffering and distress, including improvement of accommodation, posture and care conditions, and

10.

endpoints as painless as possible.

Illegal animal testing

§ 4. In any case, an animal test shall be inadmissible if

1.

there is a scientifically satisfactory and legally permissible method or test strategy in which no live animals are used, or

2.

the results of an identical animal test are actually and legally accessible and where there is no reasonable doubt as to the accuracy and validity of the results, or

3.

from this animal test

a)

are not expected to be additional or new, and

b)

it is also not necessary for control purposes,

or

4.

the animal test is based on methods which have been found to be inadmissible pursuant to Article 43 (2) (1) of the Regulation, or

5.

the animal test

a)

all species and subspecies of chimpanzees ( Pan troglodytes ), Bonobos ( Pan paniscus ) and gorillas ( Gorilla gorilla spp ), as well as in all species and subspecies of the Orang Utans family ( Pongidae ) and gibbons ( Hylobatidae ) or

b)

stray or wild animals

shall be carried out, or

6.

the animal test for white-ear silk Callithrix jacchus ), which neither

a)

Descendants of animals that have been bred in captivity, nor

b)

have been obtained from self-sustained colonies,

shall be carried out, or

7.

the animal test

a)

in other non-human primates (Section 13 (1)), which neither

aa)

Descendants of animals that have been bred in captivity, nor

bb)

have been obtained from self-sustained colonies,

and

b)

five years after the publication of the feasibility study pursuant to the fourth subparagraph of Article 10 (1) of Directive 2010 /63/EU on the protection of animals used for scientific purposes, OJ L 327, 30.4.2010, p. No. OJ L 276, 20.10.2010 p. 33 (as a result of the Animal Experiments Directive), unless an extended period is recommended in the study,

shall be carried out, or

8.

the animal test causes severe pain, severe suffering or severe distress, which is likely to persist and cannot be alleviated unless otherwise specified, unless

a)

this is necessary for scientifically justified reasons, and

b)

ensure that no non-human primates are used in accordance with § 13,

or

9.

the animal test is to be carried out without stunning (§ 8); and

a)

the animal test results in serious injuries which may cause severe pain, or

b)

substances which prevent or restrict the appearance of pain,

or

9a.

the animal test of the development or testing of cosmetics, unless it is expressly stated in the Regulation as permitted under Section 43 (4), or

10.

the animal test carried out in accordance with Article 18 of Regulation (EC) No 1223/2009 on cosmetic products, OJ L 327, 31.12.2009, p. No. 59 OJ L 342, 22.12.2009 p. 59, or

11.

the sole aim of the animal test is to identify the "LD-50" (§ 2 Z 9), where animal observation and animal testing are confined solely to the determination of the mortality rate, unless the animal test is carried out

a)

includes, in addition to the identification of the "LD-50", further animal observations or animal studies, or

b)

is required by applicable laws, or

c)

Serves biological standardization or the development, production and batch testing of medicinal products within the meaning of § 26 of the Medicines Act, BGBl. No. 185/1983 in the version of the Federal Law BGBl. No 748/1988, and no equivalent alternative methods are available in accordance with the recognised state of the sciences.

Permitted purposes of animal testing

§ 5. Animal tests may only be carried out if they are essential for one of the following purposes:

1.

basic research or

2.

translational or applied research

a)

Prevention, prevention, diagnosis or treatment of diseases or other anomalies or their consequences in humans, animals or plants, or

b)

Assessment, detection, regulation or alteration of physiological conditions in humans, animals or plants, or

c)

improvement of the welfare of animals and production conditions for animals reared for agricultural purposes, or

3.

development and production, as well as the quality, efficacy and safety of medicinal products, food, feed and other substances or products, where this is necessary to achieve the objectives set out in Z 2, or

4.

protection of the natural environment in the interest of human or animal health or well-being, or

5.

research relating to the conservation of species or

6.

Training in higher education or training for the purpose of acquiring, maintaining or improving professional skills or

7.

forensic investigations.

Guiding principles

§ 6. (1) The following principles shall apply to animal testing:

1.

Animal experiments have to comply with the principles of scientific research.

2.

The adoption and the procedure to be adopted must be reasonable, taking into account the recognised state of the sciences.

3.

Animal experiments must be carried out in order to obtain the greatest possible knowledge of the knowledge.

4.

Animal tests may only be carried out within the framework of projects.

5.

Animal testing shall only be carried out in establishments of users, unless this is scientifically justified and approved by the competent authority.

6.

Only animals whose state of health has been identified as being suitable for trial by project managers (§ 27) may only be used for carrying out animal experiments.

7.

Animal tests may only be carried out with the least possible number of animals.

8.

Animal testing shall be designed to cause the least pain, suffering, distress or lasting damage.

9.

Animal testing may only be carried out on animals which have the slightest ability to feel pain, suffering or distress, or suffer the least lasting damage.

10.

Death is to be avoided as the end point of an animal test as far as possible and replaced by early and as painless end points as possible. If death as an end point is unavoidable, the animal test must be such that:

a)

die as few animals as possible,

b)

the duration and intensity of pain, suffering and distress are reduced to the lowest possible level; and

c)

the killing as far as possible is painless.

(2) The validity and applicability of animal test models must be critically reviewed with a view to reducing the number of animal experiments and the use of alternative methods and to the recognized state of the sciences . Knowledge of behavioural research and laboratory tests, as well as the development of measurement and laboratory technology, must be taken into account in order to reduce the burden on the test animals to a minimum.

(3) All persons involved in the implementation of animal experiments shall be responsible for ethical and scientific responsibility within the framework of the tasks assigned to them. They shall therefore, in particular, examine the need and appropriateness of the animal experiments which they have planned, conducted or to be carried out, and to weigh them up against the burden on the animals.

Killing methods

§ 7. (1) Animals may only be killed with the least possible pain, suffering and distress.

(2) Animals may only be

1.

in establishments of breeders, suppliers or users, or in the context of a field study, outside such facilities, and

2.

of knowledgeable staff

to be killed.

(3) Only the appropriate killing methods specified therein may be used for the animals listed in the Regulation pursuant to § 43 (1) (1) (1).

(4) The competent authorities may grant further exemptions from the appropriate killing methods referred to in the Regulation in accordance with Article 43 (1) (1) (1);

1.

in order to allow the use of a different method, provided that the method is considered to be at least as painless as the method is scientific, or

2.

if there is a scientific justification for the fact that the purpose of the animal test cannot be achieved by the application of a killing method referred to in the regulation in accordance with § 43 (1) (1) (1).

(5) The provisions of paragraphs 2 and 3 shall not apply if an animal is to be killed in an emergency situation on grounds of animal welfare, public health, public safety, animal health or environmental protection.

Stunning methods

§ 8. (1) Animal testing shall in principle be carried out under general anaesthesia or local anaesthesia of the animals, unless the anesthetic

1.

shall be considered to be more traumatic for the animal than the animal test itself, or

2.

is incompatible with the purpose of the animal test.

Pain, suffering and distress shall be reduced to a minimum at any stage of the animal test, in particular preventively and after the purpose of the animal test has been reached, by analgesia or other appropriate methods.

(3) Where substances are to be administered which prevent or restrict the appearance of pain (§ 4 Z 9 lit. (b) where the application is submitted, a scientific justification shall be provided with information on the narcotic drugs or analgesics prescribed by the competent authority.

Re-use of animals

§ 9. Animals which have already been used in one or more animal experiments may be used only in a new animal test, for which other animals which have not previously been used may be used, provided that:

1.

the actual severity of the previous animal test was "low" or "medium";

2.

the general state of health and the welfare of the animals has been proven to be fully restored,

3.

the further animal experiment is classified as "low", "medium" or "no restoration of life function"; and

4.

a veterinary recommendation, taking into account the experience of the whole life cycle of the animals.

(2) In exceptional circumstances, by way of derogation from paragraph 1 (1) and after a veterinary examination of the animal, the competent authority may authorise the re-use of an animal if the animal has not been used more than once in an animal test which has caused severe pain, severe anxiety or similar suffering.

Release of animals and private accommodation

§ 10. (1) Animals which have been or are to be used in animal experiments may be privately housed or returned to a suitable habitat or a suitable holding system if:

1.

the state of health of the animals so permits,

2.

there is no danger to human, animal health or the environment, and

3.

appropriate measures have been taken in order to ensure the welfare of animals.

(2) breeders, suppliers and users whose animals are to be accommodated privately must have a programme for private accommodation, in the context of which the socialisation of the animals which are to be privately accommodated is guaranteed. In the case of wild animals, there must be, where appropriate, a spout programme before they are returned to their habitat.

Completion of animal testing

§ 11. (1) An animal test shall be deemed to have been terminated if:

1.

no further observations more

a)

on the animals used, or

b)

in the case of genetically modified, new animal lines in progeny

or

2.

is no longer expected to be found in Z 1 lit. (b) suffer pain, suffering or distress or suffer permanent damage which is equivalent to or exceeds that of a canoe instipation in accordance with good veterinary practice.

(2) At the end of the animal test, a veterinarian or a veterinarian or other knowledgeable person must decide whether an animal should remain alive. Animals suffering from pain after an animal experiment shall be treated as veterinary medicinal products. An animal shall be killed if it is assumed that:

1.

Continue

a)

Moderate or severe pain, or

b)

moderate or severe suffering or distress

is or may not be

2.

moderate or severe lasting damage.

(3) If an animal is to remain alive, it shall be given adequate care and accommodation to its state of health.

Section 2

Specific rules applicable to certain species

Endangered species

§ 12. (1) Endangered animal species (§ 2 Z 7) may not be used in an animal experiment unless:

1.

the animal test shall be used for research with a view to the conservation of the species or essential biomedical purposes in question; and

2.

there is a scientific justification for the fact that the purpose of this animal test cannot be achieved through the use of other species as endangered species (§ 2 Z 7).

(2) Non-human primates may only be used for animal testing under the conditions laid down in § 13.

Non-human primates

§ 13. (1) Other non-human primates other than those in § 4 Z 5 lit. (a) may only be used for animal testing if:

1.

the animal test for a purpose in accordance with

a)

§ 5 Z 2 lit. (a) or Z 3 is used for the prevention, prevention, diagnosis or treatment of clinical conditions in humans leading to the detoxification or potentially life-threatening, or

b)

§ 5 Z 1 or Z 5

, and

2.

a scientific justification for the fact that the purpose of the animal test cannot be achieved through the use of other species.

(2) Other non-human primates (para. 1), which belong to a endangered species, may only be used for animal testing under the conditions set out in paragraph 1, with the proviso that the purposes of basic research (§ 5 Z 1) cannot justify such use.

(3) breeders of non-human primates must have a strategy which allows them to increase the proportion of animals that are the offspring of animals bred in captivity.

Wild animals

§ 14. (1) Wildlife animals must not be used in animal experiments unless:

1.

the purpose of the animal test cannot be achieved through the use of an animal specially bred for use in animal experiments (§ 15),

2.

this is scientifically justified and

3.

this shall be approved by the competent authority.

(2) The catch of wild animals shall be carried out exclusively by knowledgeable persons using methods which do not cause avoidable pain, suffering, distress or permanent damage to the animals.

(3) Animals in which an injury or injury is detected or which are in poor health are to be examined by a veterinarian or by a veterinarian or by another competent person. The suffering of the animal shall be reduced to a minimum, unless it is scientifically justified and approved by the competent authority.

Specially designed for use in animal experiments

§ 15. (1) Animals, the species listed in the Regulation in accordance with Article 43 (1) (2) may only be used for animal testing if they have been specially bred for use in animal experiments.

(2) The competent authorities may authorise exemptions from paragraph 1 only on the condition that there is a scientific justification for this.

Section 3

Requirements for breeders, suppliers and users

Approval of breeders, suppliers and users

§ 16. (1) The activities of breeders, suppliers and users shall be subject to the authorisation of the competent authority. Licences shall be issued on request by means of a communication if the requirements of this Federal Act as well as of the regulations in force under this Federal Act are fulfilled. For this purpose, authorisations may also be granted for a limited period, conditionally or subject to conditions. Breeders, suppliers and users shall be registered by the competent authority.

(2) Applications for authorisations and authorisations referred to in paragraph 1 shall be included:

1.

The name, service address and date of birth of the person responsible for complying with the provisions of this Federal Law,

2.

the name, the service address and the date of birth of the persons responsible for the animal welfare (section 19 (1)),

3.

the name, service address and date of birth of the designated veterinarian or designated veterinarian (§ 20);

4.

Structure and functioning of the facilities of the breeder, supplier or user.

(3) authorisations for the activities of users may be granted only if it is ensured that unforeseen loads on the animals used or to be used in animal experiments can be alleviated as soon as possible, or should be removed.

(4) Changes in relation to the information referred to in paragraph 2 shall be notified to the competent authority in writing.

(5) A significant change in the structure or functioning referred to in paragraph 2 (2) (4), which could have a negative effect on the welfare of the animals, shall be subject to the authorisation of the competent authority.

Preliminary or final revocation

§ 17. (1) If the requirements of this Federal Act as well as of the regulations in force under this Federal Act are no longer fulfilled, the competent authority shall:

1.

take appropriate remedial action, or

2.

require appropriate remedial action, or

3.

Authorisations pursuant to § 16 shall be revoked provisionally or definitively.

(2) The competent authority shall ensure that the provisional or final revocation does not adversely affect the welfare of the animals housed in the facilities concerned.

Requirements for equipment and equipment

§ 18. (1) The facilities of breeders, suppliers and users must have facilities and equipment which:

1.

for the animal species housed there, and where animal testing is carried out, suitable for the carrying out of animal testing; and

2.

in particular, comply with the Regulation in accordance with Section 43 (1) (3) of the Regulation on the requirements for facilities and the care and accommodation of animals.

(2) The installations and equipment referred to in paragraph 1 shall be designed in such a way as to be such as to: shall work to ensure that the guiding principles in accordance with Section 6 are not violated.

Staff requirements

§ 19. (1) Breeder, supplier and user must have sufficient local staff, with at least one person

1.

is responsible for the supervision of the welfare and care of the animals,

2.

ensure that the personnel involved in the animals are given access to information on the animal species housed, and

3.

is responsible for ensuring that the staff are trained, knowledgeable and continuously trained, and that it is supervised until such time as it has demonstrated the necessary expertise.

(2) The staff must be trained and trained before carrying out any of the following activities:

1.

the carrying out of animal experiments or

2.

Design of animal experiments and projects, or

3.

Care of animals or

4.

Killing of animals.

(3) Persons who:

1.

Exercising activities as defined in paragraph 2 (1), these activities may only be carried out under the responsibility or supervision of project managers (§ 27), or

2.

The activities referred to in paragraph 2 (2) (3) and (4) shall only carry out these activities under the responsibility or supervision of project managers (§ 27) or of persons referred to in paragraph 1 above,

until they prove the necessary expertise.

Veterinary care

§ 20. (1) Breeder, supplier and user

1.

a veterinarian or a veterinarian with specialist knowledge in the field of experimental medicine or

2.

an appropriately qualified specialist or an appropriately qualified specialist

, which shall carry out an advisory role in relation to the welfare and treatment of animals.

(2) The persons designated pursuant to paragraph 1 (1) (1) and (2) shall report to the latter on a regular basis in the event that an animal protection body is to be established within the meaning of Article 21 (1).

Animal protection body

§ 21. (1) Breeder, supplier and user have, if they are permanently at least five employees entitled to vote (§ 49 para. 1 of the Labour Constitution Act, BGBl. No 22/1974), to set up an animal protection body. In any case, an animal welfare body must be set up:

1.

Breeders, who breed more than 500 animals a year,

2.

Suppliers supplying more than 2 000 animals per year, and

3.

Users who use more than 50 animals per year for animal testing.

(2) In the case of breeders, suppliers and users who do not fall under Section 1, at least one person responsible for the animal welfare in accordance with Section 19 (1) shall take over the performance of the tasks set out in paragraph 4.

(3) In any case, the animal protection body shall have to include:

1.

all persons responsible for the animal welfare pursuant to section 19 (1) and

2.

in the case of users, a scientific member.

(4) The tasks of the Animal Protection Body include:

1.

advice to the personnel involved in the animal welfare with regard to the welfare of the animals, as regards their acquisition, accommodation, care and use,

2.

advice to staff with regard to the application of the requirements of prevention, reduction and improvement, and the provision of information on technical and scientific developments concerning the application of those requirements,

3.

the establishment and verification of internal work processes with regard to the monitoring, reporting and follow-up of the welfare of the animals housed or used in the facility,

4.

the consequences of the development and results of projects, taking into account the effects on the animals used,

5.

the identification and recommendation of factors contributing to further prevention, reduction and improvement; and

6.

advice on programmes for private accommodation, including the appropriate socialisation of the animals to be accommodated in private.

(5) The records of all recommendations of the Animal Protection Body and any decisions taken with regard to these recommendations shall be kept for at least three years and shall be kept by the competent authority on request at that time. .

Records of the animals

§ 22. (1) Breeders, suppliers and users shall keep records of at least the following information:

1.

the number and type of animals which have been bred, acquired, supplied and used in animal experiments, or animals which have been released or are privately housed,

2.

the origin of the animals, including whether they have been specially bred for use in animal experiments,

3.

the date on which the animals were acquired, delivered, released or accommodated privately,

4.

The person from which the animals were acquired,

5.

the name and address of the consignee of the animals;

6.

the number and nature of the animals that have died or have been killed in any establishment, including the cause of death, as far as they are known,

7.

in the case of users,

a)

the projects in which animals are used, and

b)

the actual seriousness of the animal tests carried out, and

8.

further data referred to in the Regulation in accordance with Section 43 (1) (8).

(2) The records referred to in paragraph 1 shall be kept for a period of at least five years and shall be transmitted to the competent authority upon request.

Users shall have a statistical record of the animals used in animal experiments:

1.

the data referred to in points (1) (1) and (7) (b)

2.

data in accordance with paragraph 1 Z 8, provided that this is provided for in the Regulation in accordance with Section 43 (1) Z 8, and

3.

in the case of non-human primates, the data referred to in paragraph 1 (2),

by 1 March of the following year, to the competent authority electronically.

(4) The competent authorities have submitted the data referred to in paragraph 3 above the previous calendar year to the Federal Minister for Science and Research for publication in the form of a common statistics on the Internet without Personal reference to be transmitted. This publication has to be made by 30 June.

Information about dogs, cats and non-human primates

§ 23. (1) In addition to the records referred to in § 22, breeders, suppliers and users shall have the following information on dogs, cats and non-human primates in addition to the records referred to in § 22:

1.

the identity of the animals,

2.

Place of birth and date of birth, if available,

3.

Indication of whether the animals have been specially bred for use in animal experiments, and

4.

in the case of non-human primates, whether or not they are offspring of animals bred in captivity.

(2) For the animals referred to in paragraph 1, an individual file shall be carried out on the date of their development, which shall remain with the animal for as long as it is held for the purposes of this Federal Law. The file shall be established at birth or as soon as possible and shall contain all relevant reproduction-related, veterinary and social information relating to the animal concerned and to the projects in which it was used.

(3) The information referred to in paragraphs 1 and 2 shall be kept for at least three years after the death or private placement of the animal and shall be made available to the competent authority on request. In the case of private accommodation, information relevant to the animal concerning veterinary care and social behaviour shall be included in the file referred to in paragraph 2 above the date of its demise.

Identification and identification of dogs, cats and non-human primates

§ 24. (1) Dogs, cats and non-human primates shall be identified at the latest at the time of deposition using the least painful method that is possible to identify permanently and individually.

(2) Where animals referred to in paragraph 1 are moved from a breeder, supplier or user to another, and if, for practical reasons, it is not possible to identify the animals in advance, the recipient shall keep records in which the animals are: in particular, the parent animals shall be designated for as long as the animals are labelled.

(3) Where unlabelled animals are included in a breeder, supplier or user in accordance with paragraph 1 following discontinuation, they shall be deemed to be permanently available as soon as possible using the least painful method which is possible. flag.

(4) breeders, suppliers and users shall, on request, submit an explanatory statement to the competent authority for the reason why an animal is not labelled.

Care and accommodation

§ 25. (1) Breeders, suppliers and users shall ensure that:

1.

all animals are given adequate accommodation for their health and well-being, the environment, the necessary food, water and care,

2.

all factors which limit an animal in the satisfaction of its physiological and ethological needs are kept as low as possible,

3.

the environmental conditions for the breeding, keeping or use of the animals are controlled on a daily basis,

4.

measures are taken to ensure that, as soon as there is a shortage or avoidable pain, suffering, distress or lasting damage, a remedy is provided as quickly as possible,

5.

the animals are transported under appropriate conditions; and

6.

the detailed requirements for facilities as well as the care and accommodation of animals are complied with in accordance with Section 43 (1) (3) of the Regulation.

(2) For scientific reasons, as well as for animal welfare or animal health reasons, the requirements of paragraph 1 (1) or (6) shall be allowed to deviate from the requirements of paragraph 1. These deviations are to be kept as short as possible and to the lowest possible extent, and must also be documented.

Section 4

Requirements for projects

Approval of projects

§ 26. (1) Projects shall not be carried out without the prior approval of the competent authority.

(2) Applications for approval of a project shall be submitted by the user or the project manager or the project manager, where the applications shall at least

1.

the user who carries out the project,

2.

the responsible project manager or the responsible project manager (§ 27),

3.

the facilities in which the project may be carried out,

4.

the project proposal,

5.

a non-technical project summary (Section 31 (2)),

6.

the documents in accordance with § 43 (1) Z 5,

7.

a declaration that the objective pursued cannot be achieved by scientifically meaningful alternative methods which are recognised by the authorities; and

8.

the completed criteria catalogue in accordance with § 31 (4)

to be included.

(3) The scope of applications shall be reduced to the extent provided for in the Regulation in accordance with Section 43 (1) (6) of the Regulation, if:

1.

the project is provided for by law, regulation or directly applicable legal acts of the European Communities or by the European Union, or by the animals for production or diagnostic purposes, according to good practice. methods are used,

2.

shall only be carried out in animal experiments which shall be considered as

a)

"no restoration of the function of life" (§ 3 (1) (1) (1)) or

b)

"slight" (§ 3 (1) (2)) or

c)

"medium" (§ 3 (1) (3))

, and

3.

do not use non-human primates.

(4) Decisions concerning authorisations referred to in paragraph 6 shall be taken within six weeks after the date of receipt of the complete and correctly completed application. In the cases referred to in paragraph 3, the decision-making period shall be three weeks, excluding an extension of the decision-making period in accordance with paragraph 5.

(5) The competent authority shall confirm the receipt of applications as soon as possible and shall announce the expiry of the decision-making period. The competent authority may extend the decision-making period for a maximum of 15 working days, provided that:

1.

is justified by the complex or interdisciplinary nature of the project,

2.

the applicant or the applicant is duly substantiated, and

3.

within the original decision-making period.

(6) Authorisations have to be included:

1.

the user who carries out the project,

2.

the responsible project manager or the responsible project manager (§ 27),

3.

the facilities in which the project may be carried out, and

4.

all specific conditions resulting from the appraisal of the project (section 29), in particular the decision as to whether and when a retrospective assessment (§ 30) of the project is taking place.

(7) Authorisations shall be granted on request by means of a communication for a period not exceeding five years, if:

1.

there is a positive appraisal of the project and

2.

the requirements of this Federal Act as well as the regulations in force under this Federal Act are complied with.

For this purpose, authorisations may also be granted for a limited period, conditionally or subject to conditions.

(8) Authorisations which grant exemptions from the prohibition of § 4 Z 8 are:

1.

on the condition that the projects concerned are not submitted until after a decision has been taken in accordance with Article 55 (4), second subparagraph, lit. a of the animal testing directive may be started, and

2.

, together with a detailed justification for the decision of the competent authorities with regard to the existence of the conditions of approval, immediately by the Federal Minister for Science and Research for the purpose of in accordance with Section 37 (3).

(9) The competent authorities may authorise several similar projects carried out by the same user, if:

1.

such projects are being carried out in order to meet regulatory requirements, or

2.

in such projects animals are used for manufacturing purposes or for diagnostic purposes according to best practice.

Approval of project managers and project managers

§ 27. (1) Persons performing activities in accordance with Section 19 (2) (2) Z 2 ("Project leaders") must:

1.

for animal testing with surgical interventions in vertebrate animals, sufficient specialist knowledge and completed university education in the field of veterinary, human medicine, pharmacy or biology, or a completed training on one of the areas referred to in the Regulation referred to in Article 43 (1) (4), or equivalent, or

2.

for other animal experiments on

a)

the requirements of Z 1 or

b)

Sufficient special knowledge as well as a completed university education in the field of another natural science study direction or a study direction of the soil culture or on one of those in the regulation according to § 43 (1) Z 4 or an equivalent area of another natural science study or a study direction of soil culture

.

(2) The activities of project managers shall require the approval of the competent authority. Such authorisations shall be granted if the requirements of Section 1 and of the Regulations are met pursuant to Section 43 (1) (4) and (2) (2) (2) (2) of the Regulations. In the case of authorisation, the competent authorities may, at the request of animal testing without operational intervention, grant exemptions from the conditions laid down in paragraph 1 with regard to the completed training provided that the persons concerned are informed of: have a sufficient level of specialist knowledge without having completed the required studies.

(3) Project managers and project managers shall have:

1.

to carry out projects only in accordance with the decisions taken by the competent authority, in particular the authorisation, and to ensure that appropriate remedial action is taken and recorded in the event of non-compliance and,

2.

To stop animal testing when causing unnecessary pain, suffering, distress or permanent damage to an animal in the course of an animal test.

Change, renewal or revocation of a project approval

§ 28. (1) A new application shall be submitted to the competent authority in accordance with Article 26 (2) in the case of changes in projects which may have a detrimental effect on the welfare of the animals.

(2) The competent authority may revoke the authorisation if the project is not carried out in accordance with the authorisation and if the defect is not remedied within a time limit set by the authority.

(3) In so doing, the revocation of the authorisation shall not have an adverse effect on the welfare of the animals used or intended to be used in the project.

Project Assessment

§ 29. (1) In the appraisal of the project, an appropriate level of detail is to be examined in a manner appropriate to the nature of the project.

1.

the project is justified from a scientific or pedagogical point of view or is required by law,

2.

the purposes of the project justify the use of animals and

3.

the project is designed in such a way as to ensure that animal testing is carried out in the most painless and environmentally sound manner possible.

(2) The appraisal of the project shall include in particular:

1.

an assessment of the objectives of the project, the expected scientific benefits or the educational value,

2.

an evaluation of the project with a view to meeting the requirements of prevention, reduction and improvement;

3.

an assessment and a classification of the classification of the severity of animal tests,

4.

a damage-benefit analysis of the project, which evaluates whether the damage to the animals in the form of suffering, pain and distress is justified by the expected outcome, taking ethical considerations into account, and ultimately people, animals or the environment, taking into account the filled-out criteria catalogue in accordance with section 26 (2) (8) (8) (8) (8),

5.

an assessment of each of the justifications mentioned in § § 6 (1) Z 5, 7 (4), (2), (8) (3), (9) (1) (4), (1) (1) (2), (1) (2), (2), (1), (2), (2), (2), (1), (2),

6.

a decision as to whether and when the project is to be assessed retrospectively (§ 30).

(3) In carrying out the appraisal of the project, the competent authority shall, in particular with regard to the following areas, draw on expertise:

1.

scientific areas of use in which the animals are used, including prevention, reduction and improvement in the relevant areas;

2.

Experimental design, including, where appropriate, statistics,

3.

veterinary practice of experimental animals or, where appropriate, veterinary practice in respect of wild animals; and

4.

Animal husbandry and care with regard to the species to be used.

(4) Scientific assessments may be settled in accordance with § 26 and shall be taken into account by the competent authorities in the assessment pursuant to Section 1 (1) (1) and (2) (1) (1).

(5) The procedure for appraisal of the project is transparent. Subject to the maintenance of intellectual property rights and confidential information, the appraisal of the project shall be carried out in an impartial manner and, where appropriate, with the inclusion of the opinions of third parties.

Retrospective Assessment

§ 30. (1) In any case, a retrospective assessment shall be carried out if:

1.

the competent authority shall, in its appraisal of the project referred to in Article 29 (2) (6) of the Z 6,

2.

Projects involving the use of non-human primates, or

3.

Projects classified as "difficult" (Article 3 (1) (4)) include animal experiments classified as "heavy".

(2) No retrospective assessment is required for projects which include animal experiments classified as "low" (§ 3 para. 1 Z 2) or "no restoration of life function" (§ 3 paragraph 1 Z 1).

(3) In the context of the retrospective assessment, the competent authority shall, on the basis of the necessary documentation provided by the user, including the updates of the non-technical project summaries to be published, the following: to be assessed:

1.

whether the project objectives have been achieved,

2.

the damage inflicted on the animals, including the number and type of animals used and the severity of the animal tests; and

3.

the elements that can contribute to the further implementation of the requirements of prevention, reduction and improvement.

Information to the public and documentation

§ 31. (1) The competent authorities shall publish non-technical project summaries of approved projects and their updates under the Internet address defined in accordance with Section 43 (1) (7) of the Directive. The protection of intellectual property rights, as well as confidential information, must be observed. Non-technical project summaries shall not be subject to personal data according to § 4 Z 1 of the Data Protection Act 2000, BGBl. I No 165/1999.

(2) Non-technical project summaries have to be included:

1.

information on the objectives of the project, including the expected damage and benefits, as well as the number and type of animals to be used,

2.

proof of compliance with the requirements of prevention, reduction and improvement, and

3.

an indication as to whether a project is subject to a retrospective assessment (§ 30) and within which period the evaluation will be carried out.

(3) The users whose projects have been approved under this Section shall have all the essential documents, in particular the approval and the outcome of the appraisal of the project (§ 29), at least three years after the expiry of the approval period. and to make available to the competent authority on request. In any case, the documents of projects subject to a retrospective assessment (§ 30) must be kept until the conclusion of the retrospective assessment.

(4) The Federal Minister for Science and Research (Federal Minister for Science and Research) has, by 31 December 2015, after consultation of the Federal Animal Experiments Commission, a catalogue based on scientific criteria for objectification of the Damage-benefit analysis in accordance with § 29 para. 2 Z 4 to be published.

Section 5

Monitoring

Control by the competent authorities

§ 32. (1) The competent authorities shall carry out checks on all breeders, suppliers and users, including their facilities. These checks shall be carried out on a regular basis by the competent authorities of the animal welfare ombudswomen and animal welfare ombudsmen.

(2) Each user shall be unregistered at least once a year.

(3) The frequency of checks on the facilities of breeders and suppliers is based on a risk analysis, taking into account:

1.

of the number and type of animals which have been housed,

2.

the prior history of the breeders or suppliers in respect of compliance with the provisions of this Federal Law and

3.

any evidence that could indicate non-compliance,

where an appropriate part of the controls is to be carried out without prior notice.

(4) In the case of breeders and suppliers of non-human primates, checks shall be carried out at least once a year.

(5) The breeders, suppliers and users shall have access to their facilities to the competent authorities, as well as access to all information necessary for compliance with the provisions of this Federal Act and of the provisions of this Federal Law. regulations could be relevant.

(6) The competent authorities shall keep records of controls for at least five years.

Verification of controls

§ 33. The competent authorities shall assist the experts of the European Commission in their activities in accordance with Article 35 of the animal testing directive and shall, in particular, make available all the necessary information.

2. The competent authorities shall take due account of the results of the review referred to in paragraph 1.

Safeguards and coercive measures

§ 34. (1) The competent authorities may, in the event of danger in default or by means of communication, have the complete or partial closure of establishments of breeders, suppliers or users.

(2) In this connection, the total or partial closure must not have any adverse effects on the welfare of the animals concerned.

6.

Organisation and cooperation in the field of animal experimentation

Federal Animal Experiments Commission

§ 35. (1) The Federal Ministry of Science and Research is to establish a federal animal testing commission. Their tasks are:

1.

advising the competent authorities and animal welfare bodies in matters relating to the acquisition, breeding, accommodation, care and use of animals in animal experiments;

2.

the exchange of best practices and

3.

the exchange of information on

a)

the functioning of the animal welfare bodies;

b)

the carrying out of project assessments and

c)

best practices

within the European Union with other national committees in accordance with Article 49 of the Animal Experiments Directive.

(2) The Federal Animal Experiments Commission shall be members of the following members:

1.

two representatives of the Federal Ministry of Science and Research,

2.

two representatives of the Federal Ministry of Health,

3.

a representative of the Federal Ministry of Agriculture, Forestry, the Environment and Water Management,

4.

A representative of the Federal Ministry for Economic Affairs, Family and Youth,

5.

two representatives of the University Conference,

6.

a representative or a representative of the Austrian Academy of Sciences,

7.

five representatives of the Austrian Economic Chamber,

8.

five representatives of the association Österreichischer TierschutzOrganizations-pro-tier.at,

9.

two representatives of the Federal Chamber of Labour,

10.

a representative or a representative of the Chamber of Agriculture,

11.

a representative or a representative of the animal welfare ombudswomen and animal welfare ombudsmen.

(3) The activity for the Federal Animal Experiments Commission is honorary. Any travel expenses are according to the provisions of the travel fee rule 1955, BGBl. No 133/1955, to replace the travel allowance. The provisions of the travel fee rule are in 1955, BGBl. No 133/1955, on accounting.

(4) The Federal Animal Testing Committee of the Federal Republic of Germany shall have its own rules of procedure.

Commissions

§ 36. (1) In so far as the competent authorities establish commissions for their support, or in accordance with § 29 (3) and (5) persons, the provisions of paragraphs 2 and 3 shall apply.

(2) The members of the Commissions and persons referred to in paragraph 1 shall be subject to the secrecy of the office.

(3) Members of the Commissions as well as persons according to paragraph 1, which are caught within the meaning of Section 7 of the General Administrative Procedure Act 1991, BGBl. No 51/1991, they have to be included in these cases.

Cooperation with the European Commission

§ 37. (1) The Federal Minister for Science and Research, the Federal Minister for Science and Research, has until 10 November 2018 and thereafter every five years information on the implementation of the animal testing directive and, in particular, its Article 10 (1), (26), (28), (34), (38), (39) and (46).

(2) The Federal Minister for Science and Research shall forward the data to the European Commission in accordance with section 22 (3) to 10 November 2015 and thereafter each year.

(3) The Federal Minister for Science and Research (Federal Minister for Science and Research) shall immediately inform the European Commission and the other Member States of the exceptions granted in accordance with § 4 (8) (8).

(4) The Federal Minister for Science and Research (Federal Minister for Science and Research) has provided the European Commission with detailed information on the exceptions granted in accordance with § 7 (4) (1) of the Regulation in accordance with § 43 (1) (1) (1) (1) (1) (1) the killing methods mentioned above.

Cooperation with the European Commission on the development of alternative approaches

§ 38. (1) The Federal Ministers appointed for the enforcement of this Federal Law have, in accordance with the respective Federal Finance Act, the elaboration of other methods and procedures on the basis of the state of the art. (replacement methods) within the meaning of Section 1 (3) (3) (3) and the information on it. The aim is to develop scientifically meaningful alternative methods, which make it possible to reduce the number or burden of experimental animals or to make animal experiments at all deprivation.

(2) The Federal Minister for Science and Research has the following:

1.

to assist the European Commission in the identification and designation of appropriate specialised and qualified laboratories for the implementation of such validation studies; and

2.

to appoint a contact point to advise on the regulatory relevance and suitability of alternative approaches proposed for validation.

Section 7

Final provisions

Criminal provisions

§ 39. (1) Who

1.

, contrary to § 4, an inadmissible animal test or

2.

is used other than the killing methods authorized in accordance with Article 7; or

3.

, contrary to § 8, the anesthetic is carried out or is completely omitted, or

4.

animals contrary to § 9 used again in an animal experiment, or

5.

at the end of the animal test, the decision in accordance with section 11 (2), whether an animal shall remain alive after the end of the animal test, shall not be taken, or

6.

in accordance with § 12 endangered animal species used in animal experiments, or

7.

Contrary to § 13, non-human primates are used in animal experiments, or

8.

Against § 14 of wild animals used in animal experiments, or

9.

Contrary to § 15, animals not specifically farmed for use in animal experiments are used or

10.

shall carry out the activities of a breeder, supplier or user without authorisation in accordance with Article 16; or

11.

does not meet the requirements for equipment and equipment in accordance with Section 18; or

12.

as the managing body of a breeder, supplier or user shall refrain from the staff measures provided for in paragraph 19, or

13.

as the managing body of a breeder, supplier or user, the appointment of a veterinary care pursuant to § 20 is not allowed, or

14.

as the managing body of a breeder, supplier or user, the appointment of an animal protection body in accordance with section 21 (1) or of a person responsible for the animal welfare under Article 19 (1) is not required or

15.

carry out an animal test without authorisation, or

16.

as the managing body of a breeder, supplier or user, § 25 shall not be responsible for such care and accommodation, or

17.

as project manager or project manager conducting an animal test without authorisation in accordance with section 27 (2), or

18.

as project manager or project manager, animal testing, contrary to § 27 (3) (1) (1) or contrary to § 27 (3) (2) (2) does not terminate, or

19.

as the managing body of a user, the display of changes in accordance with section 28 (1) is not allowed,

In the case of deliberate commission of a fine of up to EUR 10 000, in the event of a recurrence of up to EUR 20 000, shall be punished by the district administrative authority. The negligent commission must be punished with a fine of up to EUR 5 000, in the event of a repetition of up to EUR 10 000.

(2) Who

1.

as a breeder, supplier or user, does not have a private accommodation programme in accordance with § 10 para. 2, or

2.

the display of changes in accordance with section 16 (4) is not allowed, or

3.

as the managing body of a breeder, supplier or user, the management of records of the recommendations of an animal protection body shall be left in accordance with section 21 (5), or

4.

the keeping of records in accordance with § § 22 or 23 does not result in incomplete or incorrect recordings or does not transmit these records in accordance with § § 22 or 23; or

5.

does not comply with the labelling requirement in accordance with Section 24; or

6.

as the managing body of a user, the storage obligation is infringed in accordance with § 31 (3), or

7.

refuse access to facilities or access to information, contrary to Article 32 (5),

In the event of a deliberate commission of a fine of up to EUR 5 000, in the event of a repetition of up to EUR 10 000, shall be punished. The negligent commission is punishable by a fine of up to EUR 2 500, in the event of a repetition of up to 5 000 euros.

(3) An administrative surrender in accordance with paragraphs 1 and 2 does not exist if the act constitutes the offence of a criminal offence which falls within the jurisdiction of the courts.

Protection of workers in the event of a refusal of animal testing

§ 40. The refusal of a worker to carry out an animal test within the meaning of this Federal Law shall not constitute a breach of duty if the person concerned does not expressly commit himself to such work. it has, or is connected with animal testing, a risk to the health of the person concerned.

Implementation Notice

§ 41. With this federal law, Directive 2010 /63/EU on the protection of animals used for scientific purposes, OJ L 327, 22.3.2010, p. No. OJ L 276, 20.10.2010 p. 33 transposed into Austrian law.

Transitional provisions

§ 42. (1) Approvals which are based on § § 6 and 15a (2) of the Animal Experiments Act, BGBl. No 501/1989, shall remain valid until the competent authority has taken a decision, if the relevant applications have been duly and fully completed by 30 June 2013 with the competent authorities.

(2) authorisations of project managers based on § 7 of the Animal Experiments Act, BGBl. No 501/1989, have been retained.

(3) Authorisations of animal experiments based on § 8 of the Animal Experiments Act, BGBl. No 501/1989, continue to apply until 31 December 2017, with the following:

1.

on these projects, instead of § § 26 and 28 to 31 on the requirements for projects, the relevant provisions of the Animal Experiments Act, BGBl. No. 501/1989, in the version of the Federal Law BGBl. I n ° 162/2005, and

2.

for projects whose duration is greater than 1. Jänner 2018 is to go out, until the 1. January 2018 is to be approved in accordance with § 26.

(4) Projects that are in accordance with § 9 of the Animal Experiments Act, BGBl. No 501/1989, may not be authorised under the conditions of Z 1 and 2 of paragraph 3 until the end of 31 December 2017 without authorisation.

(5) In the cases of paragraphs 1 to 4, criminal liability shall only be considered in accordance with § 39 (1) Z 1, 3 to 6, 8, 10, 11, 15 to 17 as well as subsections 2 Z 2, 4 and 7.

(6) Activities and projects for which a permit is required under this federal law, but which is subject to the provisions of the Animal Experiments Act, BGBl. No 501/1989, may not be authorised until the decision of the competent authorities without authorisation, if the respective applications are completed in full and correctly by 30 June 2013 with the competent authorities .

(7) Fulfilled criteria catalogues are six months from the date of publication in accordance with § 31 (4) Application requirement pursuant to § 26 paragraph 2 Z 8.

(8) By the end of 31 December 2013, the decision on

1.

Appeals against the authorities of the Governor of the country or of the Governor of the State; and

2.

Requests for devolution in matters to which the Governor or the Governor of the State would be called,

appoint the independent administrative senates in the countries. With 1. In January 2014, these decisions are the responsibility of the administrative courts.

(9) The following Regulations also retain BGBl, after the expiry of the Animal Experiments Act. No 501/1989, their validity:

1.

the Federal Minister of Education, Science and Culture Regulation on the position, accommodation and care, breeding and delivery facilities, and labeling of laboratory animals (Animal Experiments Regulation), BGBl. II No 198/2000, and

2.

the Animal Experiments Statistics Regulation, BGBl. II No 199/2000, until the entry into force of the Regulation in accordance with Article 43 (1) (8).

(10) § 4 Z 10 shall not apply until the end of 10 July 2013.

Regulation

§ 43. (1) The Federal Minister for Science and Research (Federal Minister for Science and Research) has in implementation of the Animal Experiments Directive and after consultation of the Federal Animal Experiments Commission with Regulation

1.

the killing methods of animals allowed in accordance with Article 7 (3);

2.

a list of those species which, in accordance with Article 15 (1), may only be used for animal testing if they have been specifically bred for use in animal experiments,

3.

the requirements for facilities and the care and accommodation of animals in accordance with section 18 (1),

4.

the minimum requirements for initial and further training, as well as the requirements for the acquisition, maintenance and proof of the necessary expertise in respect of the activities referred to in Article 19 (2),

5.

the scope and content of the documents relating to applications for the approval of a project, in particular the detailed project description,

6.

the scope and content of the simplified applications for the approval of a project;

7.

the Internet address at which the non-technical project summaries are to be published in accordance with Article 31 (1), and

8.

Scope and content of the data to be transmitted in accordance with § § 22 (3) and (37)

to the Commission. With regard to Z 1 to 4, the agreement with the Federal Minister of Health or the Federal Minister for Health is to be established.

(2) The Federal Minister The Federal Minister for Science and Research can, in agreement with the Federal Minister, the Federal Minister of Health and after consultation of the Federal Animal Experiments Commission by means of a regulation, which

1.

Methods of carrying out animal experiments in accordance with the recognised state of the art are considered to be outdated and should therefore be considered inadmissible; and

2.

the further requirements for staff to be placed on the guidelines in accordance with Article 23 (4) of the Animal Experiment-Directive.

(3) Regulations on the basis of this Federal Act, as amended, may already be adopted from the day following the presentation of the legislation to be carried out. However, they must not enter into force before the legislative provisions to be implemented.

(4) The Federal Minister or Federal Minister responsible in accordance with § 45 for the enforcement of this Federal Act may, after hearing the Federal Animal Experiments Commission by Regulation, determine exceptions to the prohibition in accordance with § 4 Z 9a, to the extent that: this is necessary for the prevention of health hazards or for the detection of health safety, and provided that, in accordance with the recognised state of the sciences, no equivalent, meaningful and officially recognised replacement methods are available.

entry into force

§ 44. (1) This federal law shall enter into force 1. Jänner 2013 in force.

(2) With the entry into force of this Federal Act, the Animal Experiments Act, BGBl. No. 501/1989, except for force.

(3) § § 4 (Z) 9a, 42 (9) and (43) (4) shall expire on the expiry of the 10th July 2013.

Enforcement

§ 45. With the enforcement of this federal law are entrusted:

1.

the Federal Minister for Science and Research, and the Federal Minister for Science and Research, in matters of higher education, the Federal Government's scientific institutions, and in respect of § § 35, 37 and 38 (2), and

2.

as regards Section 43 (1) and (2), the Federal Minister for Science and Research, in agreement with the Federal Minister for Health, and the Federal Minister for Health, and

3.

In addition, the relevant Federal Minister, or the relevant Federal Minister, respectively.

Article 2

Amendment of the Medicines Act

The Drug Law, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I n ° 146/2009, shall be amended as follows:

1. In Section 48 (2), the word order shall be " 1988, BGBl. No. 501/1989 " through the phrase " 2012, BGBl. I No 114/2012 " replaced.

2. In § 48 (2) the word order is deleted "and consumer protection" .

Section 86 (4) Z 9 reads as follows:

" 9.

the Animal Experiments Act 2012, BGBl. I No 114/2012, "

(4) The following paragraph 12 is added to § 95:

" (12) § § 48 (2) and 86 (4) (9) (9) in the version of the Animal Experiments Law Amendment Act, BGBl. I n ° 114/2012, enter 1. Jänner 2013 in force. "

Article 3

Amendment of the Biocidal Products Act

The Biocide Products Act, BGBl. No 105/2000, as last amended by the Federal Law of the Federal Republic of Germany (BGBl). I No 50/2012, shall be amended as follows:

1. In § 10, paragraph 10, last sentence, the word order shall be " (TVG), BGBl. No. 501/1989 " through the phrase " 2012, BGBl. I No 114/2012 " replaced.

(2) The following paragraph 10 is added to § 46:

" (10) § 10 para. 10 in the version of the Animal Experiments Law Amendment Act, BGBl. I n ° 114/2012, occurs with 1. Jänner 2013 in force. "

Article 4

Amendment of the Animal Feed Act 1999

The Animal Feed Act 1999, BGBl. I n ° 139/1999, as last amended by the Federal Law Gazette (BGBl). I No 87/2005, shall be amended as follows:

1. In Section 10 (3), the word "1988" through the phrase " 2012, BGBl. I No 114/2012, " replaced.

(2) The following paragraph 4 is added to § 24:

" (4) § 10 para. 3 in the version of the Animal Experiments Law Amendment Act, BGBl. I n ° 114/2012, occurs with 1. Jänner 2013 in force. "

Article 5

Amendment of the Gentechnikgesetz

The Genetic Engineering Act, BGBl. N ° 510/1994, as last amended by the Federal Law BGBl. I n ° 13/2006, shall be amended as follows:

1. In § 26, first sentence, the word shall be: "1988" through the phrase " 2012, BGBl. I No 114/2012, " replaced.

2. In § 26, second sentence, the word "1988" by the word "2012" replaced.

3. In § 26, second sentence, the word order shall be "the Federal Minister for Health and Women" through the phrase "the Federal Minister of Health" replaced.

4. In Section 27 (1), the phrase "Animal Experiments Act-TVG" through the phrase "Animal Experiments Act 2012" replaced.

5. In § 27 (2) the word order shall be "Animal Experiments Act-TVG" through the phrase "Animal Experiments Act 2012" replaced.

6. The Art. III the following paragraph 3 is added:

" (3) § § 26 and 27 in the version of the Animal Experiments Law Amendment Act, BGBl. I n ° 114/2012, enter 1. Jänner 2013 in force. "

Article 6

Amendment of the Animal Protection Act

The Animal Protection Act, BGBl. I n ° 118/2004, as last amended by the Federal Law BGBl. I No 80/2010, shall be amended as follows:

1. § 3 (3) Z 1 reads as follows:

" 1.

the Animal Experiments Act 2012, BGBl. I No 114/2012, "

1a. In § 5 paragraph 2 Z 1 lit. m is the word "continue" through the phrase "mediates, passes on" replaced.

1b. In § 7 (5), first sentence, the words "The Ausstellen" through the phrase "The issue, the import, the acquisition, the transfer and the transfer" replaced.

2. In § 10, the word order shall be " § 2 of the Animal Experiments Act, BGBl. No. 501/1989 " through the phrase " § 2 paragraph 1 Z 1 of the Animal Experiments Act 2012, BGBl. No. 114/2012 " replaced.

3. In § 10, the word "Animal Experiments Act" through the phrase "Animal Experiments Act 2012" replaced.

4. In § 10, the phrase " BGBl. No. 501/1989 " through the phrase " BGBl. I No 114/2012 " replaced.

5. In Section 25 (2), the phrase " Animal Experiments Act, BGBl. No. 501/1989 " through the phrase " Animal Experiments Act 2012, BGBl. I No 114/2012 " replaced.

5a. In § 38, the following paragraph 8 is added:

"(8) By way of derogation from § 31 (2), first sentence of the Administrative Criminal Law 1991-VStG, the limitation period for administrative transgressions under this Federal Act amounts to one year."

5b. § 42 para. 2 Z 10 reads:

" 10.

a representative of the Association of Austrian Animal Protection Organisations-pro-tier.at, "

(6) The following paragraph 20 is added to § 44:

" (20) § § 3 (3) Z 1, 10 and 25 (2) in the version of the Animal Experiments Law Amendment Act, BGBl. I n ° 114/2012 will be 1. Jänner 2013 in force. "

7. In § 44, the following paragraph 21 is added:

" (21) § § 5 paragraph 2 Z 1 lit. m, § 7 para. 5 first sentence, § 38 paragraph 8 and § 42 paragraph 2 Z10 in the version BGBl. I n ° 114/2012 will enter into force with the end of the day of the presentation of this Federal Law. "

Fischer

Faymann