Regulation on the protection of animals used for experimental purposes or for other scientific purposes (Animal Welcoming Ordinance-Animal SchVersV)

Unofficial table of contents

TierSchVersV

Date of completion: 01.08.2013

Full quote:

" Animal Protection Test Ordinance of 1 August 2013 (BGBl. 3125, 3126), as defined by Article 6 of the Regulation of 12 December 2013 (BGBl). 4145).

Status:

Amended by Art. 6 V v. 12.12.2013 I 4145

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 13.8.2013 + + +) 
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 EURL 63/2010 (CELEX Nr: 320010L0063) + + +) 

  

The V was referred to as Article 1 of V v. 1.8.2013 I 3125 from the Federal Ministry of Food, Agriculture and Consumer Protection after consultation of the Animal Protection Commission in agreement with the Federal Ministries of Education and Research, for the Environment, Nature conservation and reactor safety, for transport, construction and urban development, for economy and technology and defence, with the approval of the Bundesrat. She's gem. Art. 4 of this V entered into force on 13.8.2013. Unofficial table of contents

Content Summary

Section 1Holding
Vertebrate animals and cephalopods
use in animal experiments or
on other scientific purpose subsection 1Requirements for posture
as well as to facilities and establishments

§ 1	Requirements for the posture of vertebrate animals and cephalopods
§ 2	Requirements for the killing of vertebrate animals and cephalopods
§ 3	Requirements for the subject
§ 4	Organizational Obligations
§ 5	Animal protection officer
§ 6	Animal Protection Committee
§ 7	Keep records
§ 8	Special records of dogs, cats and primates
§ 9	Identification of dogs, cats and primates
§ 10	Other accommodation or release of vertebrate animals and cephalopods

Subsection 2Permission pursuant to § 11 paragraph 1
Sentence 1 (1) of the Animal Protection Act

§ 11	Permit requirements
§ 12	Requesting permission
§ 13	Permission notice, display of changes

Section 2Implementation, Approval
and display of animal testing

§ 14	Application for animals at an early stage of development

Subsection 1Implementation of animal tests

§ 15	Requirements for premises and facilities
§ 16	Requirements for the subject
§ 17	Pain relief and anaesthesiration
§ 18	Re-use of vertebrate animals and cephalopods
§ 19	Use of bred vertebrates and cephalopods
§ 20	Use of wild animals
Section 21	Use of herrenless or wild pets
Section 22	Using protected animal species
Section 23	Using primates
§ 24	Origin of primates to be used
Section 25	Carrying out particularly polluting animal experiments
Section 26	Authorisations in special cases
§ 27	Purpose achievement
§ 28	Procedure after completion, post-treatment
§ 29	Keeping records on animal testing
§ 30	Duties of the Head

Subsection 2Approval and display of experimental projects

Section 31	Applying for approval
Section 32	Approval procedure, deadlines for processing
§ 33	Approval certificate, freezing
Section 34	Display of changes approved trial projects
§ 35	Retrospective evaluation of experimental projects
§ 36	Display of experimental projects according to § 8a paragraph 1 of the Animal Protection Act
Section 37	Collection display, display of changes to displayed test projects
§ 38	Testing of test projects or changes thereof
§ 39	Display of experimental projects on ten-foot cancers
§ 40	Retention
Section 41	Publication of summaries
§ 42	Animal experimentation commissions
Section 43	Information to the Federal Ministry

Section 3Administrative Offences

Section 44

Irregularities

Section 4Transition and final provisions

§ 45	Tasks referred to in Article 49 of Directive 2010 /63/EU
Section 46	Advice on alternatives to animal testing
§ 47	Untouchdown clause
§ 48	Transitional provisions

Section 1
Holding vertebrate animals and cephalopods for use in animal experiments or for other scientific purposes

Subsection 1
Requirements for the posture as well as to facilities and establishments

Unofficial table of contents

§ 1 Requirements for the posture of vertebrate animals and cephalopods

(1) The head of a body or person responsible for a holding in which vertebrate animals or cephalopods are held for use in animal experiments or whose tissues or organs are intended to be used for the purpose of: be used for scientific purposes, to ensure that:

1.

the position of the animals, even during their use in animal experiments, as defined in Annex III to Directive 2010 /63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 327, 22.12.2010, p. 33), as amended, is in line with the requirements in force in each case,

2.

shall be checked at least once a day for the animals to be covered by direct inspection of the animals and the conditions for holding them, and the functioning of the holding facilities shall be checked by appropriate measures,

3.

the animals are transported in such a way that they do not cause avoidable pain, suffering or damage; and

4.

, as soon as it is established that the requirements referred to in points 1 to 3 are not complied with or that the animals are subject to avoidable pain, suffering or damage.

In so far as Article 33 (2), in conjunction with Annex III to Directive 2010 /63/EU, determines that requirements are to be applied from a date referred to therein, the first sentence of the first subparagraph shall apply from the date specified therein. Sentences 1 and 2 shall also apply to establishments and establishments in which the animals referred to therein are bred or held for the purpose of delivery to third parties. (2) The competent authority may exempt from the requirements referred to in the first sentence of paragraph 1, point 1. approve as far as

1.

it is scientifically justified that this is essential for the purpose of the animal test, or

2.

this is necessary for reasons of animal welfare or animal health.

(3) Annex A to the European Convention of 18 March 1986 on the protection of vertebrate animals used for experimental and other scientific purposes shall remain unaffected. Unofficial table of contents

§ 2 Requirements for the killing of vertebrate animals and cephalopods

Vertebrates and cephalopods referred to in Article 1 (1) may only be used:

1.

in the premises of a facility or establishment within the meaning of Article 1 (1),

2.

by a person who satisfies the requirements laid down in Annex 1, Section 2, and

3.

Under stunning or otherwise only with the greatest possible avoidance of pain and suffering

to be killed. Premises within the meaning of the first subparagraph of point 1 shall also be movable or only partially enclosed or covered locations. The first subparagraph of paragraph 1 shall not apply if an animal is killed in the course of an animal test carried out outside a facility or an establishment in accordance with Article 15 (1) sentence 3. Sentence 1 (2) shall not apply where an animal is killed in the course of an animal test for training, training or further education purposes, provided that the killing is carried out in the presence and under the supervision of a person who is the person referred to in the second sentence of the first sentence of paragraph 2 (2) vertebrate animals referred to in Article 1 (1) may also be killed only in accordance with Appendix 2, the procedure to be followed by:

1.

is the least burden on the animal, and

2.

is compatible with the experimental purpose.

Sentence 1 shall not apply to the killing of animals,

1.

who are free of sensitivity and perception, provided that they do not recover their capacity for perception and sensitivity before death and, until the death of the animal is safely ascertained, there is a control of the lack of perception and of sentimelessness, or

2.

which are used in agricultural research where the purpose of the experiment requires that the animals be held for employment under comparable conditions as in livestock farming and in accordance with the conditions laid down in the requirements of Annex I to Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 327, 30.12.2009, p. 1), as amended, are to be put to the vote in the current version.

3. The competent authority may authorise the application of a killing procedure which does not comply with the requirements of the first sentence of paragraph 2, if:

1.

according to scientific knowledge, this method is not associated with greater pain and suffering than a procedure corresponding to the requirements, or

2.

in the case of the killing of an animal in the context of its use in an animal test, it is scientifically justified that the use of this method is essential and ethically acceptable with regard to the purpose of the animal test.

Unofficial table of contents

§ 3 Requirements for the subject-matter

(1) The head of an establishment or the controller of an establishment within the meaning of Article 1 (1) shall ensure that:

1.

the persons responsible for the care of the animals, concerning the knowledge and skills referred to in Annex 1, Section 1, and

2.

the persons entrusted with the killing of the animals on the knowledge and skills referred to in Annex 1, Section 2

. The first sentence shall not apply to persons who, in the presence and under the supervision of a person with the knowledge and skills required under the first or second sentence of the first sentence of the first subparagraph, are responsible for the training, training or further training activities referred to in paragraph 1 above. (2) In addition, the person referred to in the first sentence of paragraph 1 shall ensure that persons referred to in the first sentence of paragraph 1 with regard to the knowledge and skills referred to therein and persons involved in the establishment or operation with the Carrying out animal tests on vertebrate animals or cephalopods, with regard to the tests according to § 16 (1), the knowledge and skills required shall be continued on a regular basis. Unofficial table of contents

§ 4 Organisation duties

For establishments and establishments within the meaning of the first and second sentences of Article 10 (1) of the Animal Protection Act, the institution of the establishment or the person responsible for the holding shall appoint one or more persons on the spot who shall:

1.

are responsible for the monitoring of the care of animals in the establishment or in the establishment and their welfare,

2.

ensure that persons handling the animals are given access to information on the animal species housed in the establishment or in the establishment, and

3.

ensure that

a)

the persons entrusted with tasks in the field of care or killing of the animals, the requirements of § 3 (1) and

b)

the persons carrying out animal testing, the requirements of § 7 paragraph 1 sentence 3 of the Animal Welds Act and § 16

and are continuously trained in this respect.

Unofficial table of contents

§ 5 Animal Protection Officer

(1) For establishments and establishments within the meaning of Article 10 (1) of the Animal Protection Act, the institution of the establishment or the person responsible for the holding shall appoint one or more animal protection officers prior to the commendate of the activity and shall: Order of the competent authority to be notified. In accordance with the requirements of the third sentence of paragraph 6, the indication shall also indicate the position and powers of the animal protection officer. (2) The Animal Protection Officer shall not be responsible for the breeding or holding of the animals at the same time. The person referred to in Article 11 (1), first sentence, shall be 1 point 1. The competent authority may allow exceptions to the extent that this is appropriate on the basis of the factual and staffing equipment of the establishment or operation and does not preclude the protection of animal welfare. Where an animal welfare officer carries out an experimental project himself or an establishment in which animal testing is carried out, a different animal protection officer shall be required to carry out the test. (3) Animal protection officers can only be ordered with a completed university degree in veterinary medicine. They shall have the knowledge and skills required to carry out their tasks referred to in paragraph 4 and the reliability required for that purpose. The Animal Protection Officer is obliged to keep the knowledge and skills required for his/her tasks by means of regular training on the state of science and technology. The competent authority may authorise derogations from the first sentence if the knowledge and skills required by the second sentence have been established. (4) The Animal Protection Officer shall be obliged to:

1.

to ensure compliance with the rules, conditions and obligations in the interests of animal welfare; and

2.

to advise the establishment or operation and the persons involved in the keeping of the animals, in particular as regards the welfare of the animals in the course of the acquisition, placing and care of animals and their medical treatment.

The animal welfare officer of a facility or establishment in which or in which animal testing is carried out shall also be obliged to:

1.

adopt a position on each application for the approval of an experimental project and submit this opinion to the competent authority upon request,

2.

Work within the company on the development and introduction of procedures and means for the fulfilment of the requirements of § 7 (1) sentence 2 and section 7a (2) (2), (4) and (5) of the Animal Protection Act and

3.

consult the persons involved in the conduct of animal experiments, in particular with a view to the implementation of the procedures and means referred to in paragraph 2, and shall keep them on the basis of technical and scientific developments in this field; information.

(5) The establishment or operation shall be carried out by the Animal Protection Officer

1.

to assist in the performance of its tasks in such a way as to enable it to carry out its tasks in full; and

2.

in the cases referred to in the second sentence of paragraph 4, of all the experimental projects.

You have to ensure that the Animal Protection Officer is regularly continuing. (6) The Animal Protection Officer is free of instructions in the performance of his duties. It must not be penalised because of the performance of its duties. Its position and its powers shall be governed by the statutes, in-company instructions, or in a similar manner. In doing so, it shall be ensured that the animal protection officer may present his proposals or concerns directly to the body which is crucial in the establishment or in the establishment. If several animal protection officers are appointed, their duties shall be determined. Unofficial table of contents

§ 6 Animal Protection Committee

(1) For establishments and establishments within the meaning of § 10 (1) sentence 1 and 2 of the Animal Protection Act, the institution of the establishment or the person responsible for the holding shall appoint an animal protection committee prior to the commencend of the activity. The Animal Protection Committee shall at least include:

1.

each animal welfare officer in accordance with § 5,

2.

one or more persons responsible for the care of the animals, and

3.

a scientific member, or one or more persons carrying out animal testing, to the extent that the establishment or operation has such persons.

The Animal Welfare Committee is headed by an Animal Protection Officer. (2) The Animal Protection Committee shall have the task of:

1.

to assist the animal protection officers in the performance of their duties in accordance with Article 5 (4), first sentence, point 2 and second sentence 2, points 2 and 3;

2.

participate in the definition of internal work processes relating to the implementation and evaluation of animal welfare monitoring and the follow-up to it, and to verify compliance with the work processes,

3.

to monitor the development of animal experiments and their results, taking into account the effects on the animals used, and

4.

to advise on the development and implementation of programmes pursuant to Section 10 (2).

In addition, the Committee on Animal Welfare shall be able to advise the staff of the establishment or establishment concerned with the holding, use or breeding of the animals, in particular as regards their well-being. (3) The institution of the institution or of the establishment Responsible for the holding shall ensure that recommendations made by the Committee on Animal Protection in the course of the performance of its duties as referred to in the first sentence of paragraph 2 and any decisions taken with regard to it shall be made responsible for the operation of the animal welfare committee. Recommendations are made, records are kept and they are kept for at least three years for long storage. The records shall be submitted to the competent authority upon request. Unofficial table of contents

Section 7 Management of records

(1) Anyone who is obliged to keep records in accordance with Section 11a (1), first sentence, point 1 of the Animal Protection Act shall have a control book in the operating or business premises, in accordance with the rates 2 and 3. In the control book referred to in the first sentence, any change in stock shall be entered on a permanent basis with the following information:

1.

the number and type of animals which have been bred, acquired, submitted to third parties and used in animal experiments and which have been placed or spent in accordance with Article 10;

2.

the origin of the animals, including whether or not they have been bred for use in animal experiments,

3.

the date on which the animals have been acquired, delivered or placed in accordance with § 10,

4.

the name and address of the person from which the animals were acquired;

5.

the name and address of the consignee of the animals;

6.

the number and type of animals killed or killed for other reasons in a facility or establishment and, in the latter case, the cause of death, where known,

7.

Conspicuity with regard to the state of health of the animals.

Dogs, cats and primates are to be listed individually with the following additional information:

1.

the identity of the animal,

2.

Place of birth and date of birth, as far as is known,

3.

in the case of primates, whether it is a offspring of captive bred primates.

Sections 239 and 261 of the Commercial Code shall apply mutagentily. (2) The records referred to in paragraph 1 shall be kept for a period of at least five years from the beginning of the year following the birth of the recording and shall be kept by the competent authority of the competent authority. to submit to the Authority upon request. Unofficial table of contents

§ 8 Special records of dogs, cats and primates

(1) Without prejudice to § 7, the records referred to in Article 11a (1), first sentence, point 1 of the Animal Welfare Act shall have separate records in dogs, cats and primates in accordance with the second sentence of sentence 2 and the second subparagraph of paragraph 2. , The records shall include all the essential reproduction-related, veterinary and behaviour of the animal in relation to each animal, as well as information on the experimental projects in which it has been used. (2) The person responsible for keeping the records referred to in paragraph 1

1.

begin to keep records immediately after the birth of the animal,

2.

in the case of the release of the animal to a third party in cases other than those referred to in § 10, the third party to hand over the relevant records in full and without delay,

3.

in the case of accommodation of the animal in accordance with § 10, the information contained in the records and essential for the accommodation and veterinary care of the animal, and the behaviour of the animal in accordance with the second sentence of paragraph 1, and

4.

keep the records, in so far as they have not been disclosed in accordance with point 2, after placing or placing the animal in accordance with § 10 or, failing that, after the death of the animal for three years and at the request of the competent authority .

Unofficial table of contents

§ 9 Labelling of dogs, cats and primates

Any dog, cat or primate intended for use in animal experiments or whose tissues or organs are intended to be used for scientific purposes shall, at the latest, at the time of the The use of the method which is suitable for the purpose of the experiment and which causes the least pain, suffering and damage in the respective animal to be marked permanently in such a way that its identity can be determined. (2) Non-labelled dogs, cats or primates for delivery or use to the in , the labelling referred to in paragraph 1 shall be carried out without delay and shall, at the request of the competent authority, provide proof that the animals have been bred for such purposes. (3) Any person referred to in paragraph 1 of this Article shall be entitled to: , or paragraph 2, animals must have a list of identified animals in accordance with the nature, date and labelling of animals, and shall submit this to the competent authority upon request. Unofficial table of contents

§ 10 Other accommodation or release of vertebrate animals and cephalopods

(1) vertebrate animals or cephalopods which have been used in animal experiments or which have been intended to be used in animal experiments, but whose use is no longer provided for, may be permanently outside a facility or of an establishment within the meaning of Article 1 (1), a holding system suitable for the particular species of animal or, in the case of animals taken from the natural environment, a suitable habitat if:

1.

the state of health of the animals so permits,

2.

do not pose any risk to the health of humans or other animals or to the environment; and

3.

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

(2) Those who, in accordance with paragraph 1, are subject to animals must have a programme for such accommodation, in the context of which the habituation of the animals to be accommodated shall be ensured. To the extent that this is necessary for animal welfare reasons, animals taken from the natural environment may only be transported to a suitable habitat under the aversion of an exeperation programme.

Subsection 2
Permission in accordance with § 11 paragraph 1 sentence 1 point 1 of the Animal Protection Act

Unofficial table of contents

§ 11 Conditions of approval

(1) The permission in accordance with Section 11 (1), first sentence, point 1 of the Animal Protection Act may only be granted if:

1.

the person responsible for the activity, on the basis of his or her training or previous professional or other handling of animals, has the technical knowledge and skills required for the activity,

2.

the person responsible for the activity has the reliability required,

3.

in the establishments and establishments serving the activity

a)

suitable premises and facilities are available, and

b)

is available to sufficiently competent staff,

so that the animals are kept in line with the requirements of Section 2 of the Animal Protection Act and the provisions of Section 1 (1) of the Animal Protection Act,

4.

ensure that persons under the first sentence of Article 3 (1) (1) and (2) are able to provide evidence at all times that they have the knowledge and skills referred to therein; and

5.

Compliance with § § 4 to 9 can be expected.

In the case of point 1 of the first sentence, the necessary technical knowledge and skills shall be demonstrated at the request of the competent authority on request. (2) The permit may, in so far as it is necessary for the protection of the animals, be subject to the following conditions: Temporary contracts, conditions and conditions are granted. Unofficial table of contents

§ 12 Apply for permission

The application for the grant of the licence pursuant to section 11 (1), first sentence, point 1 of the animal protection law shall be indicated.

1.

the name and address of the applicant;

2.

the facilities and establishments serving the activities, including the premises and facilities available there, and the staff there,

3.

the nature of the animals concerned and, in the case of animal species, the holding capacity,

4.

the name of the person responsible for the activity,

5.

the presence of persons in accordance with the first sentence of Article 3 (1) and (2) and (4) and

6.

the name of the animal protection officers in accordance with § 5.

The application shall be accompanied by evidence of the knowledge and skills referred to in Article 11 (1), first sentence, point 1. Unofficial table of contents

§ 13 permission notice, display of changes

(1) The person referred to in Article 12 (1) (4) and (6) shall be required to indicate in the certificate of approval. (2) if one of the persons referred to in paragraph 1 change, the holder of the permit shall immediately notify the competent authority of such change. Permission shall be revoked within one month from the date of receipt of the change notification if, due to the changes indicated, the conditions for the granting of the permission are no longer available. The first sentence shall apply mutatily to an amendment to the facts as set out in section 12, first sentence, point 2, unless it is excluded that this change has an adverse effect on the welfare of the animals.

Section 2
Implementation, approval and display of animal tests

Unofficial table of contents

§ 14 Validate for animals at an early stage of development

§ § 7 to 9 of the Animal Protection Act as well as § § 15 to 43 shall also apply to the conduct of animal experiments, including the approval and display of trial projects,

1.

in which

a)

Larvae of vertebrate animals, in so far as they are capable of self-food, or

b)

Föts of mammals from the last third of their normal development before birth

shall be used or used, or

2.

in which other vertebrate animals other than those referred to in paragraph 1 are to be used or to be used at a stage of development prior to birth or hatching, if the animals are to continue to live beyond this stage of development and after birth or the slippage due to use is likely to feel pain or suffering or to suffer damage.

Subsection 1
Animal testing

Unofficial table of contents

§ 15 Requirements for premises and facilities

(1) Animal tests on vertebrate animals and cephalopods may only be carried out on the premises of a facility or an establishment within the meaning of Article 1 (1). The second sentence of Article 2 (1) shall apply accordingly. By way of derogation from the first sentence, an animal test may be carried out outside a facility or establishment if it is scientifically justified that this is necessary with a view to the purpose of the experiment. (2) Without prejudice to § 1 Paragraph 1 (1) shall apply to premises, installations and articles intended for the carrying out of tests on vertebrate animals and cephalopods in the establishment or establishment referred to in the first sentence of paragraph 1

1.

shall be suitable for this purpose and comply with the requirements of Annex III, Part A, point 1.3 of Directive 2010 /63/EU, and

2.

ensure that animal testing is carried out in a targeted manner, using the least possible number of animals and causing the lowest possible pain, suffering, and the lowest possible number of animals, by means of their design, design and functioning; Damage to reliable results.

Unofficial table of contents

§ 16 Requirements for the subject-matter

(1) Animal tests on vertebrate animals and cephalopods may only be carried out by persons who have the knowledge and skills referred to in Annex 1, Section 3. In addition, animal testing shall only be permitted

1.

of persons with a university degree in veterinary medicine, medicine or dentistry,

2.

of persons with a university degree in natural sciences, provided that they have the necessary knowledge and skills, or

3.

of persons who have been shown to have acquired the necessary knowledge and skills in the course of completed vocational training,

are carried out. Animal experiments with surgical interventions on vertebrate animals may only be carried out without prejudice to sentence 1.

1.

of persons with a university degree in veterinary medicine, medicine or dentistry, or

2.

of persons with a university degree in natural sciences or continuing education following a university degree in natural sciences, provided that they have the necessary knowledge and skills to be able to study

are carried out. The sentences 2 and 3 do not apply to animal testing in accordance with Section 7 (2), second sentence, point 1 of the Animal Welding Act, which are carried out in accordance with procedures already tried and tested. The competent authority authorises derogations from the provisions of sentences 2 and 3 where proof of the necessary knowledge and skills is provided in other ways. (2) By way of derogation from § 2, animal tests which are intended for education, training or further training purposes may be provided for in the following cases: The third sentence of paragraph 1 of the Animal Protection Act and the first sentence of the first sentence of paragraph 1 shall also be carried out by persons who do not meet the requirements referred to in that paragraph, provided that this is carried out in the presence and under the supervision of a person who is responsible for the (3) Animal tests may only be carried out if the persons, of where the pilot project and the intended animal tests have been planned, have the necessary knowledge and skills, including the knowledge and skills referred to in Annex 1, Section 3, and the competent authorities of the competent authorities responsible for the tests and tests, Authority upon request. Unofficial table of contents

§ 17 pain relief and anaesthesiration

(1) When carrying out tests on vertebrate animals and cephalopods, the use of pain-relieving means or procedures shall ensure that pain and suffering are reduced to the least possible extent in the animal used. (2) Tests on vertebrate animals or cephalopods may only be carried out under anaesthesia or local pain disconnection (anaesthesia). Sentence 1 shall not apply if:

1.

the pain associated with the performance of the experiment for the particular animal is less than the pain and suffering associated with anesthesiration, or

2.

the purpose of the experiment precludes anesthetic and the experiment does not lead to serious injury to the animal concerned.

In vertebrate animals, stunning may only be carried out by a person who satisfies the conditions laid down in the third sentence of Article 7 (1) of the Animal Protection Act and the second sentence of Article 16 (1), or, in so far as the conduct of the anaesthesiration is carried out, training, training or training. (3) If a stunned vertebrate or cephalopod is to be expected to cause pain with decay of the stunning, the animal shall be be dealt with in good time by means of pain-relieting means or procedures. This does not apply, if ethically justifiable, if it is scientifically justified that the treatment is incompatible with pain-relieving means or procedures with the purpose of the animal test. In the case of a non-stunted vertebrate or cephalopod, no means may be used to prevent or impede the appearance of pain. Unofficial table of contents

§ 18 Re-use of vertebrate animals and cephalopods

(1) A vertebrate or cephalopod which has already been used in an experimental project may be used in a further experimental project, for which a previously unused animal could also be used, only if: if

1.

the animal has not been used in an animal test to be classified as "heavy" in accordance with Article 15 (1) in conjunction with Annex VIII to Directive 2010 /63/EU,

2.

its general state of health and well-being are fully restored,

3.

the animal is not used in an animal test in the context of the further experimental project which, in accordance with Article 15 (1) in conjunction with Annex VIII to Directive 2010 /63/EU, must be classified as "heavy";

4.

the re-use is in accordance with a veterinary recommendation, taking into account the type and extent of the pain, suffering and damage experienced by the respective animal throughout its previous life cycle.

The competent authority may, by way of derogation from paragraph 1 (1), authorise the use of a vertebrate animal or a cephalopod in a further experimental project if the animal is:

1.

has not been used more than once in an animal test to be considered as 'heavy' in accordance with Article 15 (1) in conjunction with Annex VIII to Directive 2010 /63/EU,

2.

it is not used in an animal experiment to be classified as "heavy" or "medium" in accordance with Article 15 (1) in conjunction with Annex VIII to Directive 2010 /63/EU, in the context of the further experiment, and

3.

has previously been subjected to a veterinary examination.

Unofficial table of contents

Section 19 Use of bred vertebrate animals and cephalopods

(1) Vertebrate Animals and cephalopods may only be used in animal experiments if they have been bred for such a purpose. The competent authority may, in so far as it is compatible with the protection of animals, authorise derogations therefrom if it is scientifically justified that the use of animals other than animals which have been bred in accordance with the first sentence is required. (2) Paragraph 1 The first sentence shall not apply to the use of horses, bovine animals, swine, sheep, goats, chickens, pigeons, turkeys, ducks, geese or fish, with the exception of zeba rabbit. Unofficial table of contents

§ 20 Use of wild animals

(1) Animals taken from nature shall not be used in animal experiments. The competent authority may authorise exceptions to this if the purpose of the experiment cannot be achieved by the use of other animals. (2) Vertebrate animals or cephalopods which are to be taken from nature may only be used by persons which have the knowledge and skills required for this purpose. Pain, suffering or damage may only be caused to the animals to the extent that this is essential for the catch. (3) If, during or after the capture referred to in paragraph 2, it is found that the animal is injured or is in a bad condition, the animal is not state of health, it is to be presented to a veterinarian or other competent person, and measures must be taken to ensure that the animal's pain, suffering and damage can be combined with the purpose of the animal test; to be reduced to the lowest possible level. Unofficial table of contents

§ 21 Use of herrenless or unfervated pets

Manless or wild animals of animal species which are normally kept in human care must not be used in animal experiments. The competent authority may grant derogations from such exceptions if:

1.

the animal test shall be carried out in order to meet a basic requirement for studies on the health and welfare of such animals or on major risks to the environment or human or animal health, and

2.

It is scientifically justified that the purpose of the animal experiment can only be achieved through the use of an animal in accordance with the first sentence.

Unofficial table of contents

Section 22 Use of protected animal species

In Annex A to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (OJ L 378, 27.12.1996, p. 1), in the current version, vertebrate animals which are not primates and cephalopods must not be used in animal experiments. Sentence 1 shall not apply if:

1.

the animal test

a)

the purpose of preventing, detecting or treating diseases, suffering, physical or physical harm in humans or animals or in the development and manufacture of, and testing, the quality, efficacy or safety of: substances or products with a view to the purposes referred to in Article 7a (1), first sentence, point 2 of the Animal Welfare Act, or

b)

research on the conservation of species

, and

2.

has been scientifically justified that the purpose of the animal test referred to in point 1 may not be achieved by the use of animal species other than those listed in Annex A to Regulation (EC) No 338/97.

Sentence 1 shall not apply to animals born and bred in captivity or to artificially propagated animals referred to in Article 7 (1) of Regulation (EC) No 338/97. The second sentence shall not apply to experiments on animals which serve basic research. Unofficial table of contents

§ 23 Use of primates

(1) primates shall not be used in animal experiments. (2) Paragraph 1 shall not apply, subject to paragraphs 4 and 5, if:

1.

the animal test

a)

basic research,

b)

the purpose of preventing, detecting or treating diseases, suffering, bodily harm or physical ailments in people who may be life-threatening or to a reduction in physical or mental functioning, or the development and manufacture and testing of the quality, efficacy or safety of substances or products with regard to the adverse effects of human health, or

c)

research on the conservation of species

, and

2.

has been scientifically justified that the purpose of the animal test referred to in point 1 may not be achieved by the use of other species as primates.

By way of derogation from point 1 of paragraph 2, the competent authority may authorise the use of primates in an animal test even if the animal test of research is carried out with the purpose of preventing, detecting or treating others than those referred to in paragraph 2 Point 1 (b), the use of primates for the purpose of attaining the above purpose of the animal test shall be used to treat diseases, suffering, bodily injury or physical affliction in humans. (4) In the case of primates listed in Annex A to Regulation (EC) No 338/97 and are not covered by Article 7 (1) of Regulation (EC) No 338/97, paragraph 1 shall not apply if:

1.

the animal test

a)

the purpose of preventing, detecting or treating diseases, suffering, bodily harm or physical ailments in people who may be life-threatening or to a reduction in physical or mental functioning, or the development and manufacture and testing of the quality, efficacy or safety of substances or products with regard to the adverse effects of human health, or

b)

research on the conservation of species

, and

2.

It is scientifically justified that the purpose of the animal test referred to in point 1 shall not be determined by the use of species other than those referred to in paragraph 1 and not listed in Annex A to Regulation (EC) No 338/97 and not covered by Article 7 of Regulation (EC) No 338/97. , the provisions of paragraph 1 of Regulation (EC) No 338/97 may be achieved.

The first sentence shall not apply to experiments on animals used in basic research. (5) By way of derogation from paragraph 1, the competent authority may authorise the use of great apes in an animal test if:

1.

the animal test

a)

the purpose of preventing, detecting or treating diseases, suffering, bodily harm or physical ailments in people who are life-threatening or who are responsible for reducing physical or mental functioning and which are unexpectedly, or the development and manufacture and testing of the quality, efficacy or safety of substances or products with regard to the abovementioned impairments of human health or

b)

research on the conservation of species

, and

2.

has been scientifically substantiated that

a)

Whereas there is reason to believe that the carrying out of the animal test to achieve the purpose of the animal test referred to in point 1 is essential; and

b)

that purpose cannot be achieved by the use of other species as great apes.

The first sentence shall not apply to experiments on animals which serve basic research. Unofficial table of contents

Section 24 Origin of primates to be used

Primates listed in column 1 of Annex II to Directive 2010 /63/EU may only be used in animal experiments from the date set out in column 2 of Annex II to Directive 2010 /63/EU if they are descendants of captivity farmed primates or if they come from self-sustained colonies within the meaning of the third subparagraph of Article 10 (1) of Directive 2010 /63/EU. (2) By way of derogation from paragraph 1, the competent authority may use the use of column 1 of Annex II Primates of other descent or provenance listed in Directive 2010 /63/EU , if it is scientifically substantiated that the use of these primates is necessary. Unofficial table of contents

Section 25 Implementation of particularly polluting animal tests

(1) Animal tests on vertebrate animals or cephalopods which are likely to lead to prolonged or repeated severe pain or suffering in the animals used may only be carried out if the desired results are achieved suggest that they will be of great importance to the essential needs of humans or animals, including the solution of scientific problems. (2) Animal testing in accordance with paragraph 1 may not be carried out if the significant Pain or suffering can last longer and cannot be alleviated. By way of derogation from the first sentence, the competent authority may authorise the carrying out of an animal test in accordance with the first sentence in so far as the conditions set out in paragraph 1 are met and it is scientifically justified that the carrying out of the animal test shall be due to: the importance of the knowledge sought is essential. Unofficial table of contents

Section 26 Authorisations in special cases

(1) An authorisation pursuant to § 23 (3) or (5) or § 25 (2) sentence 2 shall be granted by the competent authority, subject to the condition that the authorisation in the event of a decision by the European Commission pursuant to Article 55 (4), second subparagraph, shall be granted (2) The competent authority shall notify the Federal Ministry of Food, Agriculture and Consumer Protection (Federal Ministry) without delay of any authorisation referred to in paragraph 1. The notification referred to in the first sentence shall contain a detailed statement of reasons for the decision of the competent authority with regard to the existence of the conditions for approval. The Federal Ministry shall, on receipt of the notification referred to in the first sentence, inform the European Commission in accordance with the first subparagraph of Article 55 (4) of Directive 2010 /63/EU on the basis of the communication from the competent authority in accordance with the second sentence. Unofficial table of contents

Section 27 Purpose

(1) As soon as the purpose of an animal test has been reached, measures shall be taken to reduce the pain, suffering and damage of the animals used to the least possible extent. (2) Animal tests should be planned and carried out in such a way as to ensure that the purpose of the animal tests is to: of the experiment can be achieved without the animals being used to die directly under the action of the experiment. In particular, it shall be ensured that the death of an animal as a result of the action of the experiment is recognised as early as possible and that in this case the animal is immediately killed with the greatest possible avoidance of pain and suffering. Sentences 1 and 2 shall not apply in so far as the death of the animals used is essential, directly under the effect of the experiment, in order to achieve the purpose of the animal test; in this case, the experiment shall be carried out in such a way that:

1.

die as few of the animals used die and

2.

the duration and intensity of the pain and suffering of the animals is reduced to the least possible extent and death is ensured with the greatest possible avoidance of pain and suffering.

Unofficial table of contents

§ 28 Procedure after conclusion, after-treatment

(1) After an animal test has been completed, a veterinarian or other competent person shall decide whether a vertebrate used or a cephalopod used, the further use of which is no longer provided for in the pilot project. is to stay alive or, if there is a reasonable reason for it, to be killed. If primates, solipeds, paarhufers, dogs, hamsters, cats, rabbits or guinea pigs have been used, they shall be immediately presented to a veterinarian for examination. (2) If a vertebrate animal is used after completion of an animal test, (3) Other than those referred to in paragraph 2, the animal shall immediately be killed without delay. (3) are painless to kill, if there is a reasonable reason to do so, and according to the judgment of a competent person. (4) If an animal is to be kept alive after an animal test has been completed, it must be maintained and housed in accordance with its state of health and, in the process, by a veterinarian or by a veterinary surgeon. be observed and, if necessary, medically supplied to another competent person. Unofficial table of contents

Section 29The keeping of records on animal testing

(1) The records to be followed in accordance with Article 9 (5), first sentence, of the Animal Protection Act shall be for each experimental project in which vertebrate animals, cephalopods or ten-foot cancers are used, the purpose of and the number and type of animals used and the the nature and conduct of the animal tests and the names of the persons who carried out the animal tests. Where vertebrate animals are used, they shall also indicate their origin, including the name and address of the previous owner. In dogs, cats and primates, in addition to the sex, an animal identification according to § 9 and in dogs and cats, the breed shall be indicated. (2) The records referred to in paragraph 1 shall be those of the persons who try the animal tests. , and shall be signed by the head of the pilot project or his deputy. If the records are drawn up electronically, they shall be printed immediately after the completion of each partial trial of the test project and shall be signed by the head of the experimental project or his deputy. § § 239 and 261 of the Commercial Code apply analogously. Records relating to an experimental project shall be kept for five years, beginning with the completion of the animal test, and shall be submitted to the competent authority upon request. Unofficial table of contents

§ 30 Duties of the Head

(1) The head of the test project or, in the case of his prevention, his deputy must ensure that the provisions of § § 15 to 25 and 27 to 29 are complied with. (2) The head of the trial project or in the event of his prevention His deputy shall ensure that, as soon as avoidable pain, suffering or damage is caused to an animal during the course of the experiment, this shall be immediately prevented. It shall also ensure that the pilot project

1.

in accordance with the authorization pursuant to § 8 (1) sentence 1 of the Animal Protection Act or, in the case of a trial project pursuant to Section 8a (1) of the Animal Protection Act, in accordance with the information provided on the ad pursuant to § 36 (1) and

2.

in compliance with all the arrangements, conditions and conditions laid down by the competent authority in respect of the pilot project

is carried out. In doing so, it shall ensure that appropriate remedial measures are taken in the event of a deviation in this respect and that records are kept of the derogations and the corrective measures taken.

Subsection 2
Approval and display of experimental projects

Unofficial table of contents

Section 31 Application for authorisation

(1) The application for the approval of an experimental project pursuant to Section 8 (1) sentence 1 of the Animal Protection Act shall be submitted in writing to the competent authority. In the application

1.

be specified

a)

the name and address of the applicant;

b)

a description of the pilot project, including the purpose of the experiment;

c)

the nature, origin, stage of life and the number of animals intended for the experimental project, including the calculation thereof,

d)

the nature and implementation of the intended animal tests, including the planned use of means and methods for the purpose of stunning or alleviation of pain, as well as the situations in which an animal no longer exists in the animal testing is used,

e)

the place, the date of the commencement and the expected duration of the experiment,

f)

the name, address and subject-matter of the head of the pilot project and of his deputy, the persons from whom the pilot project or intended animal tests have been planned, and the persons carrying out the tests, and the persons responsible for carrying out the tests, the post-treatment of eligible persons and,

g)

where a killing of the animals is provided, the procedure to be used for this purpose,

2.

shall be scientifically substantiated,

a)

the conditions laid down in Article 8 (1) (2) (1) (a) and (b) of the Animal Protection Act are met,

b)

the severity of the attempt,

3.

demonstrate that the requirements of § 8 (1) sentence 2 (2) to (5) of the Animal Protection Act are met, and

4.

, it must be stated that the requirements of Section 8 (1), second sentence, points 6 to 8 of the Animal Protection Act are fulfilled.

(2) The application shall be accompanied by a summary of the trial project with the information provided for in the second sentence of Article 41 (1). Unofficial table of contents

§ 32 Approval procedure, processing deadlines

The competent authority shall, within 40 working days from the date of receipt of an application to the requirements of section 31, notify the applicant of its decision on the application. To the extent that the extent and difficulty of examining the requirements of the conditions laid down in the second sentence of Article 8 (1) of the Animal Protection Act justifies this, the competent authority may, once the period referred to in the first sentence, be up to 15 working days after (2) Upon receipt of an application in accordance with the first sentence of Article 31 (1), the competent authority shall immediately issue an acknowledgement of receipt to the applicant. The acknowledgement of receipt shall indicate that the applicant shall be notified of the decision on the application within the period referred to in the first sentence of paragraph 1. An extension referred to in the second sentence of paragraph 1 shall be notified to the applicant at the latest by the end of the period referred to in the first sentence of paragraph 1, stating the reasons. (3) The competent authority shall review a request received pursuant to Article 31 (1) sentence 1 immediately after receipt for completeness. To the extent that the latter does not meet the requirements of § 31, the competent authority shall immediately inform the applicant, under the name of the missing particulars and documents. The applicant shall be informed that the beginning of the period referred to in the first sentence of paragraph 1 shall be preceded by the receipt of an application corresponding to the requirements of section 31. (4) The competent authority shall immediately inform the Commission of: Article 15 (1), second sentence, of the Animal Welds Act on existing applications for the approval of experimental projects and gives their opportunity to express their views within a reasonable period of time. The competent authority may also submit to the Commission notification of amendments to approved experimental projects for their opinion, in so far as the extent and difficulty of the examination so require. (5) Paragraph 4 shall apply to the competent authority of the Bundeswehr accordingly, with the proviso that the Commission must be involved in accordance with the second sentence of Article 15 (3) of the Animal Welds Act. The security concerns of the Bundeswehr are to be taken into consideration. If animal experiments are to be carried out on behalf of the Bundeswehr, the Commission must also be informed of this and give it an opportunity to comment before placing the order; § 15 (1) of the Animal Protection Act shall remain unaffected. The competent authority responsible for the approval of the pilot project shall be informed. The competent authority of the Bundeswehr shall send the opinion on request. Unofficial table of contents

§ 33 Authorisation certificate, freezing

(1) The approval certificate shall contain:

1.

the indication of the head of the pilot project and of his deputy,

2.

the indication in which establishments or establishments or, in the cases referred to in the third sentence of Article 15 (1), the place where the test project is carried out,

3.

a decision as to whether and at which point the test project is to be assessed retrospectively in accordance with Section 35; and

4.

where appropriate, the secondary provisions with which the authorisation is granted.

(2) The authorisation shall be limited to a maximum of five years. If the authorisation has been granted for a period of less than five years, it shall be extended to a maximum of two times for a period of up to one year on the basis of a non-formal request, provided that the total duration of the application for the period of validity of the application is not less than five years. have not been exceeded for five years and provided that no amendments to the approved experimental project or to any such changes have occurred since the initial granting or first renewal of the authorisation, the

1.

in accordance with the first sentence of Article 34 (1) (1) (4) or (2), first sentence, and not objected to by the competent authority, or

2.

approved in accordance with Article 34 (3)

. Unofficial table of contents

Section 34 The display of amendments to approved experimental projects

(1) Changes to approved experimental projects do not require re-approval, to the extent that:

1.

the purpose of the experiment is to be maintained,

2.

the extent of the pain, suffering and damage caused by the animals used does not increase as a result of the changes,

3.

the number of animals used is not substantially increased; and

4.

those amendments have previously been indicated to the competent authority.

The amendments shall not be made before the expiry of two weeks after receipt of the notification in accordance with point 4 of the first sentence, unless the competent authority has previously indicated that there are no objections to the amendments. (2) If a pilot project or his/her deputy is a pilot, the marketing authorisation holder shall immediately notify the competent authority of this change. The authorisation shall be revoked by the competent authority within one month from the date of receipt of the change notification, if the head of the test project or his deputy meets the requirements of Section 8 (1), second sentence, point 2 of the Animal Protection Act. (3) Other amendments other than those referred to in the first sentence of paragraph 1 and the first sentence of paragraph 2 shall be subject to approval by the competent authority. § 8 (1) sentence 2 of the Animal Protection Act and § § 31 to 33 shall apply accordingly for the approval of the amendments. Unofficial table of contents

Section 35 retrospective assessment of experimental projects

If the competent authority authorisations an experimental project, it may at the same time stipulate that the test project shall be assessed by the competent authority after its conclusion and at which point the evaluation shall be carried out. An assessment as referred to in the first sentence shall be provided if the pilot project is to carry out

1.

animal experiments in which primates are used,

2.

Animal tests to be classified as "heavy" in accordance with Article 15 (1) in conjunction with Annex VIII to Directive 2010 /63/EU, or

3.

Animal tests in accordance with § 25 (2)

(2) In the context of the assessment referred to in the first sentence of paragraph 1, the competent authority shall, on the basis of documents submitted by the applicant in accordance with Article 31 (1), first sentence, to submit it on request to the extent that it is required to carry out the assessment to examine the following:

1.

whether the notified result is in accordance with the purpose of the pilot project as specified in the application in accordance with Article 31 (1), second sentence, point 1 (b),

2.

the damage caused to the animals used,

3.

the number and type of animals used,

4.

the seriousness of the animal tests carried out in accordance with Article 15 (1) in conjunction with Annex VIII to Directive 2010 /63/EU, and

5.

whether conclusions can be drawn from this in view of the requirements laid down in Article 7 (1), second sentence, and § 7a (2) (2), (4) and (5) of the Animal Protection Act.

Unofficial table of contents

§ 36 Display of experimental projects according to § 8a paragraph 1 of the Animal Protection Act

(1) In the display of an experimental project pursuant to Section 8a (1) of the Animal Protection Act, the following shall be stated:

1.

the information referred to in Article 31 (1), second sentence, point 1,

2.

in the case of experimental projects under Article 8a (1) (1) of the Animal Protection Act, the legal reason for the notification and

3.

Presentation and evidence in accordance with § 31 (1) sentence 2 number 2 to 4.

The notification must be made in writing. (2) The implementation of the test project must not start before the expiry of twenty working days from the date of receipt of a notification corresponding to the requirements of paragraph 1 with the competent authority, the competent authority has previously indicated that there are no objections to the implementation. (3) After receipt of an indication in accordance with Article 8a (1) of the Animal Welding Act, the competent authority shall immediately inform the indicating To issue the acknowledgement of receipt stating the day of the entry of the advertisement. The time limit referred to in paragraph 2 shall be pointed out in the acknowledgement of receipt. (4) A test project indicated in accordance with Article 8a (1) of the Animal Protection Act shall not be allowed after five years after the end of the period referred to in paragraph 2 or after the receipt of the Notification referred to in paragraph 2 shall be carried out. Unofficial table of contents

Section 37 Collectable display, display of changes to the test project

(1) If several similar experimental projects are to be carried out in accordance with Article 8a (1) of the Animal Welding Act, it is sufficient to display the first test project if, in addition, the estimated number of experimental projects is shown on the display. is specified. By 15 February of a year, the scoreboard of the competent authority shall indicate the number of experimental projects carried out in the previous calendar year and the nature and number of the total number of animals used. (2) In the case of the facts referred to in paragraph 1 (1) and (2) during the experiment, those changes shall be notified immediately to the competent authority. The second sentence of Article 34 (1) applies accordingly. (3) § 36 (4) shall apply mutatily. Unofficial table of contents

Section 38 Examination of test projects or their changes

In the case of the receipt of an advertisement in accordance with Article 36 (1), the competent authority shall, within the time limit laid down in Article 36 (2), examine whether, in respect of the test project indicated, the second sentence of § 8 (1), second sentence, points 1 to 8 of the Animal Protection Act , or whether the execution of the pilot project is to be understated in accordance with Article 16a (2) of the Animal Protection Act. The first sentence of the first sentence shall be deemed to apply in the event of the notification of changes pursuant to section 34 (1), first sentence, point 4 or section 37 (2) sentence 1, provided that the examination shall be carried out within two weeks. Unofficial table of contents

Section 39 Display of experimental projects on ten-foot cruises

(1) In the display of an experimental project pursuant to Section 8a (3) of the Animal Protection Act, the following shall be stated:

1.

the purpose of the pilot project,

2.

the nature of the animals intended for the experimental project,

3.

the nature and implementation of the intended animal tests, including anaesthesiration,

4.

the place, the date of the commencement and the expected duration of the experimental project; and

5.

the name, address and subject-matter of the head of the experimental project, his deputy and the person carrying out the test, and the persons who are eligible for the post-treatment.

Section 36 (1), second sentence, (3) and (4), and Articles 37 (1) and 2 (1) shall apply mutas. (2) The performance of the test project shall not be allowed before the expiry of a period of two weeks from the date of receipt of a notification corresponding to the requirements of paragraph 1. competent authority, unless the competent authority has previously indicated that there are no objections to the implementation. The time limit referred to in the first sentence may be extended by the competent authority, if necessary, for up to four weeks; the extension shall be communicated to the applicant by the end of the period referred to in the first sentence, stating the reasons. (3) In the case of Where the notification referred to in the first sentence of paragraph 1 is received, the competent authority shall examine whether, with regard to the test project indicated, compliance with the provisions of Articles 7 (1), 2 and 3 and 7a (1) and 2 (1), (2), (4) and (5) of the above-mentioned test shall be considered. § 20 (1) and § § 27 and 28 (3) and (4) is ensured or whether the implementation of the To prohibit the pilot project in accordance with Section 16a (2) of the Animal Protection Act. Unofficial table of contents

§ 40 retention obligation

The holder of a permit or, in the case of an experimental project pursuant to Article 8a (1) or (3) of the Animal Welding Act, has the indicating end

1.

a copy of the application in accordance with § 31 and the approval certificate in accordance with § 33 or, in the case of trial projects pursuant to § 8a (1) or (3) of the Animal Protection Act, a copy of the notification according to § 36 (1) or § 39 (1) sentence 1 as well as

2.

any other document which has been sent to it by the competent authority in connection with the approval or notification and the execution of the test project,

at least three years beyond the end of the period of validity of the authorisation or, in the case of trial projects pursuant to Section 8a (1) or (3) of the Animal Protection Act, on the expiry of the period referred to in Article 36 (4), including in conjunction with Article 39 (1) sentence 2 storage. In the case of experimental projects to be subject to an assessment in accordance with § 35, the documents referred to in the first sentence shall be kept until the evaluation has been completed, provided that the evaluation is completed only after the period referred to in the first sentence has expired. is done. Unofficial table of contents

Section 41 Publication of summaries

(1) The competent authority shall send a summary to the Federal Institute for Risk Assessment (Bundesinstitut) within three months of the granting of a permit pursuant to Article 8 (1), first sentence, of the Animal Protection Act to the Federal Institute for Risk Assessment (Tierschutzgesetz). Experimental projects for the purpose of publication by the Federal Institute. The summary shall, on the basis of the information in the permit application, indicate:

1.

the purposes of the pilot project,

2.

the expected benefit of the experimental project,

3.

the damage to be expected from the animals intended for use;

4.

the number and nature of the animals intended for use, and

5.

the fulfilment of the requirements of the second sentence of § 7 (1) and section 7a (2) (2), (4) and (5) of the Animal Welds Act.

The summary may not contain any device or personal data. The provisions relating to the protection of intellectual property and the protection of business and commercial secrets shall remain unaffected. (2) The summary shall be taken within 12 months of the date of transmission by the competent authority by the Bundesinstitut published on the Internet. The corresponding website is published by the Federal Institute in the Federal Gazette (Bundesanzeiger). Unofficial table of contents

§ 42 Animal Experiments

(1) The majority of the members of the Commissions to be convened in accordance with the second sentence of Article 15 (1) and the second sentence of paragraph 3 of the Animal Protection Act shall have the necessary expertise in veterinary medicine, medicine or medicine for the assessment of animal tests. of a scientific discipline. (2) In the Commissions pursuant to Section 15 (1) sentence 2 of the Animal Protection Act, members are also to be appointed who have been selected on the basis of proposals from the animal welfare organizations and on the basis of of their experience in the evaluation of animal welfare issues; the number of these Members must be at least one-third of the members of the Commission. (3) In the commissions pursuant to Section 15 (3) sentence 2 of the Animal Welding Act, members are also to be appointed who, on the basis of proposals from the animal welfare organisations, are to be appointed , and are suitable for the assessment of animal welfare issues. Unofficial table of contents

Section 43 Information of the Federal Ministry

The authorities responsible under national law shall inform the Federal Ministry of cases of fundamental importance in the approval of experimental projects, in particular on the cases in which the approval of experimental projects on the basis of the justification It has been denied that the requirements of Section 7a (2) (3) of the Animal Welds Act were not fulfilled, or in which the Commission, in accordance with Section 15 (1) of the Animal Protection Act or the Animal Protection Officer, has concerns about the situation. of these conditions. Personal data may not be transmitted.

Section 3
Irregularities

Unofficial table of contents

§ 44 Administrative Offences

(1) Contrary to the provisions of Section 18 (1) (3) (a) of the Animal Welfare Act, those who intentionally or negligently act

1.

the first sentence of Article 15 (1) or the first sentence of Article 17 (2),

2.

applying a means contrary to Article 17 (3) sentence 3,

3.

contrary to Article 30 (1), compliance with the provisions of the first sentence of Article 15 (1) shall not be ensured; or

4.

Contrary to Article 30 (1), compliance with the provisions of the first sentence of Article 17 (2) or the third sentence of paragraph 3 shall not be ensured.

(2) In the sense of Section 18 (1) (3) (b) of the Animal Welfare Act, who intentionally or negligently acts in the sense of the order of law

1.

Contrary to Article 2 (1), first sentence, point 1, a vertebrate animal or a cephalopod is killed,

2.

, contrary to the first sentence of Article 5 (1), an animal protection officer shall not be appointed or shall not

3.

Contrary to the first sentence of Article 7 (1), a control book does not lead, not correct, in full or in the prescribed manner, not in the correct manner,

4.

Contrary to Article 7 (2), a record referred to in that paragraph shall not be retained or not, or shall not be stored in time, at least five years,

5.

, contrary to the first sentence of Article 8 (1), a record is not recorded, not correct or not complete,

6.

, contrary to Article 8 (2) (2), a record is not handed over, not correct, not complete or not given in time,

7.

, contrary to Article 8 (2) (4), a record shall not be retained or not, or shall not be stored in time, at least three years,

8.

Contrary to § 9, a so-called animal does not, not correctly, not be marked in the prescribed manner or in a timely manner,

9.

contrary to Article 9 (2), does not provide the proof referred to therein,

10.

contrary to Article 30 (1), it does not ensure compliance with the provisions of Section 29 (1),

10a.

contrary to Article 30 (1), it does not ensure compliance with the provisions of Section 29 (2),

11.

it carries out an experimental project, contrary to Article 36 (2) or (4),

12.

contrary to the second sentence of Article 37 (1), even in connection with the second sentence of Article 39 (1), an indication is not made, not correct, not complete or not in good time,

13.

, contrary to Article 37 (2), second sentence, a change,

14.

contrary to Article 39 (2), first sentence, an experimental project begins, or

15.

Contrary to § 40, a document referred to there is not retained or not stored for the prescribed period.

Section 4
Transitional and final provisions

Unofficial table of contents

Section 45 Tasks referred to in Article 49 of Directive 2010 /63/EU

The Federal Institute shall advise the competent authorities and the animal protection committees in accordance with § 6 in matters related to the acquisition, breeding, placing or maintenance of vertebrate animals and cephalopods pursuant to § 1 (1) or the use of Vertebrate animals and cephalopods are related to animal testing and ensure that there is an exchange of best practices in this respect. In addition, it exchanges information with the committees established in other Member States of the European Union, in accordance with Article 49 (1) of Directive 2010 /63/EU, on:

1.

the work of the animal welfare committees according to § 6 and

2.

the assessment of experimental projects,

, including best practice in this regard. Unofficial table of contents

Section 46 Consultation on alternatives to animal testing

The Federal Institute shall advise the competent authorities on matters relating to alternatives to animal testing. Unofficial table of contents

Section 47 Untouchable clause

The provisions of nature conservation law, hunting law and fisheries law remain unaffected. Unofficial table of contents

Section 48 Transitional provisions

(1) § § 1 and 3 to 6 shall apply to establishments and establishments in which vertebrates or cephalopods,

1.

which are intended for use in animal experiments, or

2.

whose tissues or organs are intended to be used for scientific purposes,

shall be held from 1 January 2014. The provisions of the first sentence shall also apply to establishments and establishments in which the animals referred to therein are bred or kept to third parties for the purpose of delivery. For establishments and establishments in accordance with the first sentence in which animal experiments on vertebrate animals are carried out, § 8b of the Animal Protection Act shall continue to be applied until 31 December 2013 in the version in force until 13 July 2013. (2) Anyone who is in accordance with § 8b (2) of the Animal Protection Act, as amended on 12 July 2013, is authorised to act as an animal protection officer, retains that power as long as he continues to pursue the activity. (3) Anyone who is in accordance with Section 9 (1) of the Animal Welds Act in the the version in force on 12 July 2013, as part of its activity carried out on 12 July 2013, Animal testing shall retain this power as long as it continues to carry out the activity. (4) § § 14 to 41 and § 44 shall not apply to animal testing,

1.

request authorisation before the entry into force of this Regulation in accordance with the provisions of the Animal Protection Act in the version valid until 13 July 2013, subject to compliance with the requirements of Article 8 (2) of this Regulation, or

2.

the implementation of which is appropriate before the entry into force of this Regulation in accordance with the provisions of the Animal Protection Act in the version in force until 13 July 2013 and shall not be contested by the competent authority

has been made. Unofficial table of contents

Appendix 1 Knowledge and skills required for the care or killing of animals or the planning or carrying out of animal testing

(Fundstelle: BGBl. I 2013, 3140-3141)
Section 1Care of animals

1.

Existing legislation on the keeping and care of animals intended to be used in animal experiments or the tissues or organs of which are intended for scientific purposes.

2.

Fundamentals of biology and appropriate species-specific biology in relation to anatomy and physiological characteristics.

3.

Animal behaviour and husbanding requirements and methods, including enrichment of the holding devices (general and species specific).

4.

Health and hygiene of the animal stock.

5.

Detection of species-specific pain and suffering of the species most commonly used for animal testing.

6.

Requirement pursuant to Section 7 (1), second sentence, point 2 of the Animal Protection Act.

7.

Behavioural treatment of animals.

Section 2Killing of animals

1.

Legislation applicable to the killing of animals for scientific purposes or animals intended to be used in animal experiments.

2.

Ethics in relation to the relationship between man and animal, intrinsic value of life.

3.

Fundamentals of biology and appropriate species-specific biology in relation to anatomy and physiological characteristics.

4.

Basic knowledge of the behaviour of the animals.

5.

Basic knowledge of physics and chemistry, as far as these are necessary for the relevant killing procedures.

6.

Suitability and capacity of the respective killing methods.

7.

Anaesthetic, pain-relieving methods and killing, including procedures, which mean the least strain for the animals.

8.

Type-specific handling methods where appropriate.

9.

Proper execution of the killing and, where appropriate, previous stunning of the animals, accompanied by the least possible pain or suffering.

10.

Maintenance of the equipment or installations necessary for the killing and, where appropriate, preceding stunning.

11.

Identify species-specific pain and suffering of the species most commonly used for animal testing.

Section 3Planning and implementation of animal testing

1.

Existing legislation for the implementation of animal testing.

2.

Ethics in relation to the relationship between human beings and animals, intrinsic value of life and arguments for and against the use of animals for scientific purposes.

3.

Fundamentals of biology and appropriate species-specific biology in relation to anatomy, physiological traits, breeding, genetics and genetic modification.

4.

Animal behaviour and husbanding requirements and methods, including enrichment of the holding devices (general and species specific).

5.

Health and hygiene of the animal stock.

6.

Species-specific handling and testing methods.

7.

Detection of species-specific pain and suffering of the species most commonly used for animal testing.

8.

Use as painless endpoints as possible.

9.

Requirements of the principle of the indispensability of animal tests in accordance with § 7 (1) sentence 2 and § 7a (2) number 2, 4 and 5 of the Animal Protection Act.

10.

Planning of procedures and projects where appropriate.

11.

Relevant experimental techniques and surgical procedures.

12.

Research and evaluation of scientific literature, including alternatives to animal experiments.

13.

Stunning and pain-relieving methods.

14.

To the extent that the killing of the animals is also provided for in the course of the implementation, the knowledge and skills referred to in Section 2.

15.

Biometric statistics.

Unofficial table of contents

Appendix 2 (to § 2 (2))
Killings

(Fundstelle: BGBl. I 2013, 3142-3143)

1.

For the killing of animals of one of the animal categories listed in row 1 of the table, only those procedures listed in column 1, lines 2 to 9, which are listed in column 1, lines 2 to 9, shall be used only those methods listed in column 1, lines 2 to 9, in the column with a cross in the column (+), having regard to the measures contained in the observations. In this case, the least incriminating method must always be chosen, insofar as it is compatible with the test purpose.

Fish-amphibian reptile birds rodents, rabbit dogs, cats, ferrets and mummy primates

Overdose of a narcotic	+ 1	+ 1	+ 1	+ 1	+ 1	+ 1	+ 1	+ 1	+ 1
Bolzenshot			+ 2			+		+
Carbon dioxide exposure				+	+ 3
Cervical Dislocation				+ 4	+ 5	+ 6
Concussion/blunt impact on the head	+	+	+	+ 7	+ 8	+ 9	+ 10
Decapitation				+ 11	+ 12
Electrical stunning	+ 13	+ 13		+ 13		+ 13	+ 13	+ 13
Inhalation of inert gases (argon, nitrogen)				+	+			+ 14
Pistol or rifle shot with adequate weapons and adequate ammunition			+ 15				+ 16	+ 15

Notes:

1

The method must be used in conjunction with a previous sedation of the animals, unless this is inappropriate.

2

The process may only be used in large reptiles.

3

The method may only be used with the step-wise filling of the container. The procedure should not be used in foetuses and newborns.

4

The method may only be used in birds weighing less than 1 kg. Birds weighing more than 250 g have to be sedated beforehand.

5

The process may only be used in rodents weighing less than 1 kg. Rodents weighing more than 150 g have to be sedated beforehand.

6

The method may only be used in rabbits weighing less than 1 kg. Rabbits weighing more than 150 g have to be sedated beforehand.

7

The method may only be used in birds weighing less than 5 kg.

8

The process may only be used in rodents weighing less than 1 kg.

9

The method may only be used in rabbits weighing less than 5 kg.

10

The procedure may only be used in newborns.

11

The method may only be used in birds with a weight of less than 250 g.

12

The procedure may only be used if the application of other procedures is not possible.

13

Suitable equipment and equipment are required for the application of the method.

14

The procedure may only be used in pigs.

15

The procedure may only be used in the cases of § 2 paragraph 1 sentence 3 and only by an experienced shooter.

16

The procedure may only be used in the cases of § 2 paragraph 1 sentence 3 and only by an experienced shooter. In addition, it may only be used if the application of other procedures is not possible.

2.

The killing of the animals using the procedures referred to in point 1 shall be completed by one of the following procedures:

a)

Confirm the final closed-loop shutdown,

b)

Destroy the Brain,

c)

Severing of the spinal cord in the neck,

d)

Bleeding or

e)

Confirm the entry of the dead rigid.