Animal Welfare Act

Source: https://www.gesetze-im-internet.de/tierschg/BJNR012770972.html

first part
principle
1

The purpose of this law is to protect the life and welfare of humans from their responsibility to animals as fellow creatures. No one shall inflict pain, suffering or harm on an animal without just cause.

Second part
animal husbandry
2

Anyone who keeps, looks after or has to look after an animal

1.
must feed the animal properly according to its species and needs, care for it and house it in a way that is appropriate to its behaviour,
2.
shall not restrict the animal’s ability to take part in exercise appropriate to its species in such a way as to cause it pain or avoidable suffering or injury,
3.
shall possess the knowledge and skills necessary for the proper feeding, care and housing of the animal.
§ 2a

(1) The Federal Ministry of Food and Agriculture (Federal Ministry) is authorised, with the consent of the Bundesrat, to issue statutory regulations, to the extent necessary for the protection of animals, to specify the requirements for the keeping of animals in accordance with Paragraph 2 and in particular to issue regulations on requirements

1.
Relating to the possibility of movement or the community needs of the animals,
2.
on rooms, cages, other containers and other facilities for housing animals and on the condition of fastening, feeding and watering devices,
3.
on lighting conditions and room climate in which animals are housed,
4.
to the care including supervision of the animals; the Federal Ministry may also prescribe that the results of the monitoring be recorded, kept and submitted to the competent authority on request,
5.
the knowledge and skills of people who keep, care for or have to care for animals and evidence of this knowledge and skills,
6.
of safety measures in the event of technical failure or fire.

(1a) The Federal Ministry is authorised, with the consent of the Federal Council, to enact statutory regulations for aims, means and methods in the education, training or instruction of animals, insofar as this is necessary for the protection of animals. (1b) The Federal Ministry is empowered by Ordinance with the consent of the Federal Council, insofar as this is necessary for the protection of animals and there is no obligation to identify them from § 11a (3), to lay down regulations for the identification of animals, in particular dogs and cats, as well as the type and implementation of marking.

(2) The Federal Ministry is authorised, in agreement with the Federal Ministry of Transport and Digital Infrastructure, to regulate the transport of animals by Ordinance with the consent of the Bundesrat, as far as this is necessary for the protection of animals. In particular, it may

1.

conditions

a)
on the transportability of animals,
b)
of means of transport for animals

to be established,

1a.
prohibit or restrict certain means of transport and types of dispatch for the transport of certain animals, in particular cash on delivery,
2.
to prescribe certain means of transport and types of dispatch for the transport of certain animals,
3.
require that certain animals be accompanied by an attendant when being transported,
3a.
Require that persons transporting animals or involved in such transports have certain knowledge and skills and are able to demonstrate this,
4.
lay down rules on the loading, unloading, housing, feeding and care of animals,
5.
prescribe certain certificates, statements or reports as a condition for carrying out animal transports and regulate their issue and storage,
6.
prescribe that any person transporting animals on a commercial basis must be authorised by the competent authority or registered with the competent authority and regulate the requirements and the procedure for authorisation and registration,
7.
require any person who wishes to feed, care for or house animals during transport in an establishment or facility to obtain an authorisation from the competent authority and lay down the requirements and the procedure for obtaining such authorisation where this is necessary for the implementation of legal acts of the European Community or the European Union.

(3) Regulations require the consent of the Federal Ministry of Education and Research

1.
in accordance with paragraph 1, insofar as they specify requirements for the keeping of animals intended for use in animal experiments or whose tissues or organs are intended to be used for scientific purposes,
2.
pursuant to paragraph 2 sentence 1, in so far as they regulate the transport of animals intended for experimental purposes

or whose tissue or organs are intended to be used for scientific purposes.
3

It is prohibited,

1.
Except in emergencies, to demand services from an animal that it is clearly incapable of providing because of its condition or that are clearly beyond its strength,
1a.
to demand performance from an animal that has undergone operations and treatments that mask a performance-related physical condition that it is unable to cope with because of its physical condition,
1b.
taking any action against an animal in training or at sporting events or similar events that involves significant pain, suffering or harm and which is likely to affect its performance, and the use of doping substances on an animal at sporting events or similar events,
2.
the sale or purchase of a weak, sick, aborted or elderly animal which is kept in the home, on the farm or otherwise in the care of humans and for which survival is associated with insoluble pain or suffering, for any purpose other than immediate painless killing; this shall not apply to the immediate delivery of a sick animal to a person or establishment requiring a permit under Article 8 paragraph 1 sentence 1 and, in the case of a vertebrate animal, where necessary a permit under regulations based on Article 9 paragraph 3 Numbers 1 and 2 have been issued for experiments on such animals,
3.
to release or abandon an animal which is kept in the home, business or otherwise in the care of humans, in order to get rid of it or to evade the obligation to keep or care for it,
4.
releasing or introducing into the wild an animal of a wild species which has not been prepared for the food intake appropriate to the species and necessary for survival in the intended habitat, and which is not adapted to the climate; the provisions of hunting law and nature conservation law remain unaffected
5.
to educate or train an animal if this involves considerable pain, suffering or damage to the animal,
6.
to use an animal for the purposes of filming, showing, advertising or similar events, insofar as such use causes pain, suffering or harm to the animal,
7.
to train or test an animal on another living animal for keenness,
8e.
to hunt an animal to another animal, unless this is required by the principles of fair game,
8a.

To train or exercise an animal to behave aggressively in such a way that such behaviour

a)
causes him or her pain, suffering or loss; or
b)
causes pain or avoidable suffering or harm to itself or to a fellow species in the context of any species-appropriate contact; or
c)
allows it to be kept only in conditions which cause it pain or avoidable suffering or harm,
9.
force-feed an animal unless this is necessary for health reasons,
10
feeding an animal in a way which causes it substantial pain, suffering or harm,
11.
Use any device that uses direct current to substantially limit, or force, the animal’s behaviour, including movement, causing it substantial pain, suffering or harm, except as permitted by federal or state law,
12.
Offering an animal as a prize or reward in a contest, sweepstakes, or similar event;
13.
to use an animal for one’s own sexual acts or to train or make it available for the sexual acts of others, thereby coercing conspecifics.

Sentence 1 number 12 does not apply if the animal is advertised at an event mentioned in sentence 1 number 12, where it can be expected that the participants in the event as future owners of animals can ensure that the requirements of paragraph 2 are met if they win.

part three
killing animals

4

(1) A vertebrate may only be killed with effective pain relief (anaesthesia) in a state of insensibility or otherwise, where reasonable under the circumstances, only with avoidance of pain. If the killing of a vertebrate animal without anaesthesia is permitted within the framework of environmentally sound hunting or under other legal provisions, or if it takes place within the framework of permissible pest control measures, the killing may only be carried out if it does not cause more than unavoidable pain. Only those with the necessary knowledge and skills may kill vertebrate animals.(1a) Persons who professionally or commercially regularly kill vertebrate animals for the purposes of killing

stunning or killing must submit a certificate of competence to the competent authority. If poultry are stunned or killed in the framework of an activity pursuant to sentence 1 in the presence of a supervisor for the purpose of killing, the supervisor must submit a certificate of competence in addition to the person who stuns or kills the animals. If fish are stunned or killed for the purpose of killing in the presence of a supervisor as part of an activity pursuant to sentence 1, the presentation of a certificate of competence shall be sufficient. Sentences 1 to 3 shall not apply to the stunning for the purpose of killing and the killing of vertebrate animals intended for use in animal experiments or whose organs or tissues are intended to be used for scientific purposes. (2) For the slaughter of a warm-blooded animal, § 4a shall apply.

(3) For the killing of vertebrate animals solely for the purpose of using their organs or tissues for scientific purposes, § 7a, paragraph 2, number 1 applies accordingly. Dogs, cats and primates may only be killed for scientific purposes if they have been bred for that purpose or for use in animal experiments. In derogation from sentence 2, the competent authority may, where it is compatible with the protection of the animals, authorise the killing of animals which have not been bred in accordance with sentence 2, provided that

1.
animals bred in accordance with sentence 2 and having the required characteristics for the purpose are not available, or
2.
the respective scientific purposes require the use of animals not bred in accordance with sentence 2.
§ 4a

(1) A warm-blooded animal may only be slaughtered if it has been stunned before the onset of bleeding for the purpose of slaughter.

(2) By way of derogation from paragraph 1, anaesthesia is not necessary if:

1.
in the case of emergency slaughter it is not possible under the given circumstances,
2.
the competent authority has granted an exemption for unanaesthetised slaughter (butchering); it may grant exceptional approval only to the extent necessary to meet the needs of members of certain religious communities within the scope of this Act, for whom mandatory provisions of their religious community prescribe slaughter or prohibit the consumption of unslaughtered meat animals or
3.
this is determined by ordinance as an exception in accordance with § 4b no. 3.
4b

The Federal Ministry is competent for the application of §§ 4 and 4a by statutory order with the consent of the Bundesrat

1.
a)
to regulate the slaughter of fish and other cold-blooded animals,
b)
to regulate, prescribe, authorise or prohibit certain types of killing and stunning procedures,
c)
regulate further the conditions under which slaughter within the meaning of Article 4a(2) may take place,
d)
laying down more detailed rules concerning the type and scope of knowledge and skills necessary to stun or kill vertebrate animals and concerning the procedure for their verification,
e)
to lay down non-commercial activities for which the acquisition of a certificate of competence to kill vertebrates is required,

ensuring that no more than unavoidable pain is inflicted on the animals,

2.
To further regulate the slaughter of animals within the framework of the provisions of the European Convention of 10 May 1979 on the Protection of Animals for the Purposes of Slaughter (Federal Law Gazette 1983 II p. 770),
3.
establish derogations from the stunning requirement for the slaughter of poultry.

Statutory regulations under sentence 1 number 1 letters b and d require

1.
insofar as it involves stunning or killing using dangerous substances or mixtures within the meaning of the Chemicals Act or related requirements for obtaining a certificate of competence, the agreement of the Federal Ministries for Economic Affairs and Energy and for the Environment, Nature Conservation, Construction and Nuclear Safety,
2.
in so far as it concerns the stunning or killing of animals intended for use in animal experiments or of which the tissues or organs are intended to be used for scientific purposes, or in so far as it concerns related requirements for obtaining a certificate of competence, the agreement of the Federal Ministry of Education and Research.
PART IV
interventions on animals
5

(1) An operation involving pain shall not be performed on a vertebrate animal without anaesthesia. A veterinarian must anaesthetise warm-blooded vertebrates, amphibians and reptiles. This does not apply if the anaesthesia is used exclusively by external application of a veterinary medicinal product that is approved according to pharmaceutical regulations to achieve local pain relief and is suitable for performing the relevant procedure according to the state of the art of science and technology. This also does not apply to an intervention i

m within the meaning of article 6, paragraph 1, sentence 2, number 2a, insofar as the anaesthesia is carried out without influencing the state of perception and sensibility, with the exception of the sensation of pain, using a veterinary medicinal product that is approved according to pharmaceutical regulations for the elimination of pain in this procedure. The competent authority may grant exemptions from sentence 2 for stunning with stun batons provided that a valid reason can be demonstrated. Where anaesthesia is not necessary in accordance with paragraphs 2, 3 and 4 no. 1, all possibilities to reduce pain or suffering of the animals shall be exhausted.

(2) Anaesthesia is not necessary,

1.
if in similar procedures in humans anaesthesia is not generally used or the pain associated with the procedure is less than the worsening of the animal’s condition associated with the anaesthesia,
2.
if, in the opinion of the veterinarian, anaesthesia is not feasible in individual cases.

(3) Stunning is also not required

1.
for the castration of male bovine animals, sheep and goats under the age of four weeks, provided that there are no findings that deviate from the normal anatomical condition,
1a.
(offspring)
2.
for dehorning or prevention of the growth of horns in bovine animals of less than six weeks old,
3.
for tail trimming of piglets under four days old and lambs under eight days old,
4.
for trimming the tails of lambs less than eight days old with elastic rings,
5.
for the cutting of corner teeth of piglets less than eight days old, provided that this is essential for the protection of the dam or littermates,
6.
for the weaning of the scratched last phalanx of broilers to be used as breeding cocks during the first day of life,
7.

for marking

a)
by an implanted electronic transponder,
b)
of mammals other than pigs, sheep, goats and rabbits, by tattooing of the ears or thighs within the first two weeks of life
c)
of pigs, sheep, goats and rabbits, by an ear tattoo,
d)
of pigs by impact and
e)
of farm animals by ear tag or wing tag.

(4) The Federal Ministry is authorised by statutory instrument with the approval of the Federal Council

1.
Exempt further measures outside paragraph 3 from the obligation to stun, in so far as this is compatible with paragraph 1,
2.
to prescribe, authorise or prohibit procedures and methods for taking measures pursuant to Paragraph 3 and pursuant to a statutory regulation pursuant to Paragraph 1, insofar as this is necessary for the protection of animals.
6

(1) The complete or partial amputation of body parts or the complete or partial removal or destruction of organs or tissues of a vertebrate animal is prohibited. The prohibition shall not apply if:

1.

the intervention on a case-by-case basis

a)
is required on veterinary indication or
b)
in the case of dogs to be led for hunting purposes, is essential for the intended use of the animal and there is no veterinary justification to the contrary,
1a.
labelling in accordance with species protection rules is carried out,
1b.
horses are marked by thigh branding,
2.
a case of § 5(3) no. 1 or 7 exists,
2a.
male pigs less than eight days old are castrated,
3.
a case of § 5(3) nos. 2 to 6 exists and the intervention in the individual case is indispensable for the intended use of the animal for its protection or for the protection of other animals,

4.
The removal, in whole or in part, of organs or tissues is necessary for transplantation, the creation of cultures, or the examination of isolated organs, tissues or cells for purposes other than scientific ones,
5.
Sterilisation is carried out to prevent uncontrolled reproduction or – if there are no veterinary objections – for further use or keeping of the animal.

Interventions according to sentence 2 number 1 and 5 shall be carried out by a veterinarian; in the case of an intervention according to sentence 2 number 2a this also applies if there are findings that deviate from the normal anatomical condition. interventions after

1.
sentence 2 numbers 1a, 1b, 2 and 3,
2.
Number 2a, which may not be performed by a veterinary surgeon, as well as
3.
paragraph 3

may also be performed by another person having the necessary knowledge and skills. After castration of a pig which is more than seven days old, analgesics including anaesthetics must be administered to the animal.

(1a) For the interventions according to paragraph 1 sentence 2 number 4 applies

1.
§ 7 paragraph 1 sentence 2 number 1 and sentence 3, § 7a paragraph 2 number 1, 4 and 5 and § 9 paragraph 5 sentence 1, each also in connection with § 9 paragraph 6 sentence 1, as well as
2.

Provisions in regulations based on Gru

and des

a)
§ 7(3) or
b)
§ 9 paragraphs 1, 2 and 3 number 2, paragraph 4 sentence 1 number 3 and sentence 2 and paragraph 5 sentence 2, each also in connection with paragraph 6 sentence 2,

are laid down, insofar as this is provided for in a regulation issued by the Federal Ministry with the consent of the Bundesrat,

correspondingly. Anyone wishing to carry out an intervention in accordance with Paragraph 1 Sentence 2 No. 4 shall report the intervention to the competent authority at least two weeks before its commencement. The deadline need not be adhered to if an emergency requires immediate performance of the intervention; the notification must be made immediately. The deadline specified in sentence 2 may, if necessary, be extended by the competent authority to a maximum of four weeks. The advertisement must state:

1.
The purpose of the intervention,
2.
the type and number of animals intended for intervention,
3.
the type and carrying out of the intervention, including anaesthesia,
4.
Location, start and expected duration of the operation,
5.
Name, address and specialist knowledge of the person responsible for the project and his/her deputy, as well as the person who will carry out the work and the person who will be in charge of the follow-up treatment
6.
The justification for the intervention.

(2) The use of elastic rings in amputation or castration is prohibited; this does not apply in the case of paragraph 3 no. 3 or paragraph 5 paragraph 3 no. 4.

(3) Notwithstanding paragraph 1 sentence 1, the competent authority

1.
trimming the beak tips of laying hens in chicks less than ten days old,
2.
the trimming of beak tips in productive poultry not included in paragraph 1
3.
trimming the connective tissue end of the tail of male calves under three months of age by means of elastic rings

permit. Authorisation may only be granted if it can be justified that the intervention is essential for the protection of the animals in relation to the intended use. The authorisation must be limited and, in the case of number 1, contain provisions on the type, extent and timing of the intervention and the person carrying it out.

(4) The Federal Ministry is authorised, with the consent of the Federal Council, to prescribe the permanent marking of animals on which no clearly identifiable interventions have been carried out, if this is necessary for the protection of the animals. (5) The competent authority shall, in the case of paragraph 1 sentence 2 no. 3, be obliged to prove that the intervention is necessary for the intended use.

(6) The Federal Ministry is authorised, with the consent of the Federal Council, to issue a regulation for interventions within the meaning of Paragraph 1 Sentence 2 No 2a, in deviation from Article 5 Paragraph 1 Sentence 2, that stunning may be carried out by certain other persons, insofar as this is compatible with the protection of animals. The National Ordinance pursuant to paragraph 1 lays down the requirements under which these persons may perform stunning; in particular

1.
Procedures and methods, including drugs and equipment for carrying out anaesthesia and intervention in accordance with sentence 1 are prescribed or prohibited,
2.
provide that the person performing stunning has the necessary reliability, knowledge and skills for this activity and must prove it, and
3.
details of the nature and extent of the knowledge and skills required under sentence 2 shall be provided, and requirements for proving and maintaining the required knowledge and skills shall be specified and the procedure for proving shall be regulated.
§ 6a

The provisions of this Article do not apply to animal testing in accordance with Article 7(2)(1), also in conjunction with Article 2.

Fifth Section
animal experiments
§ 7

(1) The provisions of this section shall serve to protect animals intended for use in experiments on animals or whose tissue or organs are intended to be used for scientific purposes. are for this purpose

1.

Animal experiments relating to

a)
pain, suffering and harm inflicted on animals
b)
the number of animals used
c)
the species-specific capacity of animals to suffer the effects of the experiment,

limited to what is necessary; and

2.
The keeping, breeding and care of animals intended for use in experiments or of tissues or organs intended to be used for scientific purposes shall be undertaken in such a way that they are only used to the extent necessary for scientific purposes.

Animal experiments may only be planned and carried out by people who possess the necessary knowledge and skills. § 1 remains unaffected.

(2) Animal experiments within the meaning of this Act are interventions or treatments carried out for experimental purposes

1.
on animals,

if they are likely to cause those animals pain, suffering or harm,
2.
on animals, if they are likely to cause them pain, suffering or harm, or
3.
to the genetic material of animals if they can be associated with pain, suffering or harm to the genetically modified animals or their carriers.

Interventions or treatments which are not used for experimental purposes are also considered to be animal experiments

1.
that are performed for the production, extraction, storage or propagation of substances, products or organisms,
2.

that remove, in whole or in part, organs or tissues for scientific purposes

a)
for the purpose of transplantation of the organs or tissues
b)
to create cultures or
c)
examine isolated organs, tissues or cells

or

3.
carried out for training, further training or retraining purposes,

if one of the conditions set out in sentence 1 numbers 1 to 3 is met. The killing of an animal shall not be considered an animal experiment if it is performed solely for the purpose of using its organs or tissues for scientific purposes.

(3) The Federal Ministry is authorised, in agreement with the Federal Ministry of Education and Research, to regulate by law, with the consent of the Bundesrat, the details of the requirements under § 1 sentence 2 number 2.

§ 7a

(1) Animal experiments may only be carried out if they are essential for one of the following purposes:

1.
Basic research,
2.

other research with one of the following aims:

a)
prevention, detection or treatment of disease, injury or bodily injury in human beings or animals
b)
detection of or interference with physiological states or functions in human beings or animals
c)
the promotion of animal welfare or the improvement of the husbandry conditions of farm animals,
3.
protecting the environment in the interests of human or animal health or welfare,
4.
The development and manufacture as well as the testing of the quality, efficacy or safety of medicines, foodstuffs, animal feedingstuffs or other substances or products with one of the aims referred to in number 2 (a) to (c) or number 3,
5.
Testing of substances or products for their effectiveness against animal pests,
6.
Research for the preservation of species,
7.
education, training or further training,
8e.
forensic investigations.

Animal testing for education, training or further training according to sentence 1 number 7 may only be performed

1.
at a university, another scientific institution or a hospital or
2.
in the context of training, further training or retraining for healing or supporting medical professions or scientific support professions.

(2) In deciding whether an animal experiment is necessary and when conducting animal experiments, the following principles shall be observed:

1.
The current state of scientific knowledge should be taken as a basis.
2.
A check should be carried out to establish whether the aim pursued cannot be achieved by other methods or procedures.
3.
Experiments on vertebrates or cephalopods shall only be carried out if the anticipated pain, suffering or harm to the animals is ethically justified in relation to the aims of the experiment.
4.
Pain, suffering or harm may be inflicted on animals only to the extent necessary to achieve the aims of the experiment; in particular, it may not be inflicted for reasons of labour, time or cost saving.
5.
Experiments on animals which have a species-specific capacity to suffer from the effects of the experiment shall not be carried out unless the species-specific capacity to suffer from the effects of the experiment has been exceeded.

(3) Animal testing for the development or testing of weapons, ammunition and related equipment shall be prohibited.

(4) Animal testing for the development of tobacco products, detergents and cosmetics is strictly prohibited. The Federal Ministry is authorised to lay down exemptions by regulation with the consent of the Bundesrat if this is necessary in order to

1.
to avert specific health risks and the necessary new knowledge cannot be acquired in any other way, or
2.
implement legal acts of the European Community or the European Union.

(5) An animal experiment shall be considered to be completed when:

1.
no further observations are made for the purposes of the animal experiment or,
2.

if genetically modified, new animal lines are used,

a)
no further observations are to be made on the progeny, and
b)
offspring are no longer expected to experience pain, suffering or permanent damage as a result of the biotechnical or genetic modifications.

(6) The Federal Ministry shall be empowered in agreement with the Federal Minister

erium for education and research by Ordinance with the consent of the Federal Council

1.
provisions of this Act or
2.
Statutory regulations under this Act for the performance, approval and reporting of animal experiments

on animal experimentation at a developmental stage before birth or hatching, if this is necessary to protect those animals because of their capacity to feel pain, suffering or harm, and to carry out acts of the European Union.

Unofficial table of contents

§ 8e

(1) Anyone wishing to carry out experiments involving vertebrate animals or cephalopods shall require the approval of the experimental project by the competent authority. An experimental project shall be approved if:

1.

it is scientifically proven that

a)
the requirements of § 7a(1) and (2) numbers 1 to 3 are met
b)
the desired result is not sufficiently known despite the exhaustion of available information possibilities or the verification of a sufficiently known result by means of a duplicate or repeat attempt is essential,
2.
the person responsible for the trial project and his deputy have the necessary professional qualifications, in particular with respect to the supervision of animal experiments, and there are no facts which cast doubt on their reliability,
3.
the necessary premises, facilities and other material resources meet the requirements of a regulation issued pursuant to Article 9, paragraph 4, sentence 1 number 1,
4.
the personnel and organisational requirements for performing the animal experiments, including the activity of the animal welfare officer, are in place,
5.
the keeping of the animals complies with the requirements of Article 2 and the requirements laid down in a legal regulation adopted pursuant to Article 2a, paragraph 1, numbers 1 to 4, also in conjunction with Article 11, paragraph 3, or Article 2a, paragraph 2, sentence 1, and their medical care is ensured,
6.
compliance with the provisions of article 7 paragraph 1 sentence 2 number 1 and article 7a paragraph 2 numbers 4 and 5 may be expected,
7.

Compliance with

a)
competence requirements,
b)
rules on the pain management and stunning of animals,
c)
rules on the re-use of animals,
d)
prohibitions and restrictions on use,
e)
provisions for the prevention of pain, suffering and harm occurring after the completion of the object of the animal experiment
f)
provisions to prevent the death of an animal during the experiment or to prevent pain and suffering should an animal die, and
G)
rules on the procedure after termination of the animal experiment,

which are based on Article 2a paragraph 1 number 5 or Article 4b sentence 1 number 1 letter b, in each case also adopted in conjunction with Article 11 paragraph 3, or Article 9 paragraphs 1 to 3 and 4 sentence 1 number 2 or 3 or sentence 2 of the enacted regulation, can be expected and

8e.
the keeping of records in accordance with § 9 paragraph 5 sentence 1 in connection with the requirements stated in a regulation issued on the basis of 9 paragraph 5 sentence 2 can be expected.

(2) If approval is granted by a university or other institution, the persons carrying out the animal experiments must be employed by the institution or must be authorised to use the institution with the consent of the responsible manager.

(3) The Federal Ministry is authorised, in agreement with the Federal Ministry of Education and Research, to issue regulations by law with the approval of the Bundesrat

1.
The form and content of the application for a licence pursuant to subsection (1) and the applicants,
2.
the approval process, including its duration,
3.
the content of the approval message,
4.
The procedure to be followed in the case of subsequent changes to the essential facts on which the approval is based, including the obligation to notify or approve such changes.

5.
the limitation of authorisations or the extension of their validity; and
6.
the right to revoke licences.

(4) The Federal Ministry is authorised, in agreement with the Federal Ministry of Education and Research, to provide by ordinance with the consent of the Bundesrat that animal experiments shall be classified according to their degree of severity in accordance with Article 15(1) of 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 276, 20. 10.2010, p. 33) and regulating the procedure and content of the classification and the relevant cooperation obligations of the applicant in so far as required for the implementation of legal acts of the European Union (5) The Federal Ministry

m is authorised, in agreement with the Federal Ministry of Education and Research, to issue a decree, with the consent of the Bundesrat, stipulating that experimental projects shall be subject to retrospective assessment by the competent authority and regulating the procedure and content of the assessment as well as the applicant’s obligation to cooperate, insofar as this is necessary to improve the protection of animals in experiments and to implement legal acts of the European Union.

(6) The Federal Ministry is authorised, in agreement with the Federal Ministry of Education and Research, to stipulate by Ordinance with the consent of the Bundesrat that the competent authorities shall provide summaries of approved experimental projects for publication, the information on

1.
The objectives of the experimental project, including the expected benefit,
2.
the number, type and expected pain, suffering and harm of the animals to be used, and
3.
the compliance with the requirements of Article 7(1)(2) number 1 and Article 7a(2) numbers 2, 4 and 5

and to regulate the format of the summaries and the procedure for their publication to the extent necessary to improve the protection of animals in experiments and to implement legal acts of the European Union. It may provide for the publication of the summaries by the Federal Institute for Risk Assessment.

§ 8a

(1) Any person intending to carry out an experimental project involving vertebrate animals or cephalopods

1.

which relates exclusively to animal experiments, the performance of which is expressly mentioned

a)
is required by law, regulation, pharmacopoeia or any directly applicable legal act of the European Community or the European Union
b)
is provided for in a general administrative regulation issued by the Federal Government or a Federal Ministry, or
c)
is ordered by the authorities or a court on the basis of a law or a regulation or a directly applicable legal act of the European Community or the European Union or is required in individual cases as a condition for an official decision,
2.

which is conducted solely for the purpose of animal testing, as vaccinations, blood testing or other diagnostic measures on animals in accordance with methods already tested and

a)
the detection of disease, ill-health or physical defects in human beings or animals; or
b)
the testing of sera, blood preparations, vaccines, antigens or test allergens as part of approval procedures or batch tests

serving,

3.

which concern exclusively animal testing according to § 7(2) sentence 2 number 1 or 2, carried out in accordance with methods already tried and tested

a)
for the production, extraction, storage or propagation of substances, products or organisms or
b)
for diagnostic purposes

are made, or

4.
which is conducted solely for the purpose of animal training or further training in accordance with well-established methods,

must notify the competent authority of the experiment.

(2) Paragraph 1 does not apply to experimental projects,