German Animal Welfare Act (2021) PDF

German Animal Welfare Act (parts relevant for lab animal science only) supplemented by relevant ordinances (TierSchVersV (Laboratory Animal Welfare Ordinance), TierSchTrV (Animal Protection Transport Ordinance)) in italic letters. Own comments are in handwriting font. This translation is for educati...

German Animal Welfare Act (parts relevant for lab animal science only) supplemented by relevant ordinances (TierSchVersV (Laboratory Animal Welfare Ordinance), TierSchTrV (Animal Protection Transport Ordinance)) in italic letters. Own comments are in handwriting font. This translation is for educational purposes. Latest amendments (2021) are inserted in red letters. Animal Welfare Act TierSchG Principle §1... No one shall inflict pain, suffering or harm on an animal without reasonable cause. Animal husbandry §2 Anyone who keeps, looks after or has to look after an animal, 1. must feed, care for and accommodate the animal in a manner appropriate to its species and needs, 2. shall not restrict the animal's ability to move in a way that causes it pain or avoidable suffering or injury, 3. must have the knowledge and skills necessary for adequate feeding, care and behavioural housing of the animal § 2a (1) The Federal Ministry of Food, Agriculture and Consumer Protection (Federal Ministry) shall be authorised to adopt insofar as it is necessary to protect animals, the requirements for the keeping of animals pursuant to § 2 must be defined in more detail... TierSchVersV (Laboratory Animal Welfare Ordinance, serves to implement the 2010/63 EU Regulation into national law): §1 The head of an institution... must ensure that 1. the keeping of animals, including during their use in animal experiments, is in accordance with Annex III to Directive 2010/63/EU , 2. the welfare of the animals is checked at least once a day by direct observation and the conditions in which they are kept and the functioning of the installations used for keeping them are checked by appropriate means, 3. the animals are transported in such a way as to avoid causing them any avoidable pain, suffering or injury, and 4. immediate remedial action is taken as soon as it is established that the requirements referred to in points 1 to 3 are not being complied with or that avoidable pain, suffering or injury is being inflicted on the animals and 5. animal husbandry is continuously reviewed to find possible improvements to the welfare of the animals, including during experimental use. TierSchVersV: §3 The head of an institution... must ensure that 1. the persons entrusted with the care of the animals have the knowledge and skills referred to in Annex 1, Section 1... (2)... persons pursuant to subsection (1) first sentence above shall regularly undergo further training with regard to the knowledge and skills mentioned therein and persons who are entrusted with the performance of animal experiments on vertebrates or cephalopods in the establishment or plant with regard to the knowledge and skills required pursuant to § 16 subsection (1) first sentence above. TierSchVersV: Annex 1 Knowledge and skills required for the care or killing of animals or the planning or performance of animal experiments Section 1 Care of animals 1. Existing legislation on the keeping and care of animals intended to be used in animal experiments or whose tissues or organs are intended to be used for scientific purposes 2. Basic biology and appropriate species-specific biology in terms of anatomy and physiological characteristics. 3. Animal behaviour and husbandry requirements and methods, including enrichment of husbandry facilities 4. Health and hygiene of livestock. 5. Identification of species-specific pain and suffering of the species most commonly used in animal experiments. 6. Requirement pursuant to § 7 (1) sentence 2 number 2 of the German Animal Welfare Act. 7. Behaviourally appropriate handling of animals... 1  Section 3 Design and performance of animal experiments 1. Existing legislation on the performance of animal experiments. 2. Ethics in relation to the relationship between humans and animals, intrinsic value of life and arguments for and against the use of animals for scientific purposes 3. Basic biology and appropriate species-specific biology in relation to anatomy, physiological characteristics, breeding, genetics and genetic modification. 4. Animal behaviour and husbandry requirements and methods, including enrichment of husbandry facilities 5. Health and hygiene of the livestock. 6. Species-specific handling and testing methods. 7. Identification of species-specific pain and suffering of the species most commonly used in animal experiments. 8. Application of endpoints that are as painless as possible. 9. Requirements of the principle of the indispensability of animal experiments in accordance with § 7 (1) sentence 2 and § 7a (2) numbers 2, 4 and 5 of the German Animal Welfare Act 10. Where appropriate, planning of procedures and projects. 11. Relevant experimental techniques and surgical interventions. 12. Research and evaluation of scientific literature including literature on alternatives to animal testing. 13. Anaesthesia and pain relief methods. 14. Where the implementation of the scheme includes the killing of the animals, the knowledge and skills referred to in § 2. 15. Biometric statistics. (2) The Federal Ministry shall be authorized to regulate their transport insofar as this is necessary for the protection of animals. … TierSchTrV (Animal Protection Transport Ordinance):  Regulation on the protection of animals during transport and implementing Council Regulation (EC) No 1/2005  Regulates not only commercial transport of animals but also the dispatch of non-pet animals Section Three Killing of animals §4 (1) A vertebrate animal shall be killed only under effective analgesia (stunning) in a state of unconsciousness and insensibility or otherwise, as far as is reasonably practicable under the circumstances, only with avoidance of pain. …. A vertebrate animal may only be killed by a person with the necessary knowledge and skills.... (3) For the killing of vertebrate animals solely for the purpose of using their organs or tissues for scientific purposes, § 7a(2)(1) shall apply mutatis mutandis. … § 4b The Federal Ministry is authorised, for the purposes of §§ 4 and 4a, 1. … b) to regulate, prescribe, authorise or prohibit certain methods of killing and stunning TierSchVersV: §2...vertebrates and cephalopods may only 1. on the premises of an institution or business within the meaning of § 1 (1) 2. by a person meeting the requirements of Section 2 of Appendix 1, and 3. under anaesthesia or otherwise only with the greatest possible avoidance of pain and suffering be killed. …...may only be killed in accordance with Appendix 2, using the method which 1. is the least stressful for the animal, and 2. is compatible with the experimental purpose. Sentence 1 shall not apply to the killing of animals, 1. who are insensitive and insentient, provided that they do not regain their perceptive and sentient faculties before death and until the death of the animal has been established with certainty, a check of the insensitivity and insensibility is carried out 2  3. The competent authority may authorise the use of a killing method not complying with the requirements of the first sentence of paragraph 2 if 1. this procedure has been scientifically proven not to cause more pain and suffering than a procedure that complies with the requirements; or 2. in the case of the killing of an animal in the course of its use in an animal experiment, it is scientifically justified that the use of this procedure is indispensable and ethically justifiable with regard to the purpose of the animal experiment. TierSchVersV: Appendix 2 (to § 2 paragraph 2) Killing method Fish Amphibians Reptiles Birds Rodents Rabbits dogs, large Primates cats, mammals ferrets, foxes Overdose of an anaesthetic 1 + + + + + + + + + Bolt shot + 2 + + CARBON DIOXIDE + + 3 cervical dislocation +4 + 5 + 6 blunt impact on the head + + + +7 + 8 + 9 + 10 Decapitation + + 12 11 Electrical stunning 13 + + + + + + Inhalation of inert gases + + + 14 (nitrogen, argon) Firearms + 15 + 15 + 15 ,16 Legend: 1 Sedation, if not inappropriate, 2 only for large reptiles, 3 gradual filling of the box, not in fetuses and newborns, 4 BW < 1kg, BW > 250g sedation required, 5 BW < 1kg, BW > 150g sedation required, 6 BW < 1kg, BW > 150g sedation required, 7 BW < 5kg, 8 BW < 1kg, 9 BW < 5kg, 10 neonates only, 11 BW < 250g, 12 if other methods not applicable, 13 appropriate equipment required, 14 only in pigs, 15 experienced gunner, 16 if other methods not applicable. 2. The killing of animals using the methods referred to in point 1 must be completed by one of the following procedures: (a) Confirmation of the final circuit shutdown, b) Destruction of the brain, (c) severing of the spinal cord in the neck, (d) bleeding; or (e) confirm the onset of rigor mortis. TierSchVersV: Annex 1 Knowledge and skills required for the care or killing of animals or the planning or performance of animal experiments Section 2 Killing of animals 1. existing legislation on the killing of animals for scientific purposes or animals intended to be used in animal experiments 2. ethics in relation to the relationship between humans and animals, intrinsic value of life 3. basic biology and appropriate species-specific biology in terms of anatomy and physiological characteristics 4. basic knowledge of animal behaviour. 3  5. basic knowledge of physics and chemistry, in so far as these are necessary for the killing methods concerned 6. the suitability and capacity of the respective killing methods. 7. stunning, pain-relieving methods and killing, including those methods which cause the least distress to the animals 8. where appropriate, species-specific handling methods. (9) the killing of the animals has been carried out correctly and, where appropriate, the animals have been stunned beforehand, causing the least possible pain or suffering 10. maintenance of the equipment or installations necessary for the killing and, where appropriate, prior stunning 11. identification of species-specific pain and suffering of the species most commonly used in animal experiments Fourth Section Interventions on animals §5 (1) A vertebrate animal shall not be subjected to a procedure involving pain without anaesthesia. A veterinarian shall administer anaesthesia to warm-blooded vertebrates, amphibians and reptiles.... Where anaesthesia is not required in accordance with paragraphs 2, 3 and 4(1), all means of reducing the pain or suffering of the animals must be used. (2) Stunning is not necessary, 1. where, in comparable operations on humans, anaesthesia is generally not used or the pain associated with the operation is less severe than the impairment of the animal's welfare which would be associated with anaesthesia, 2. if, in the opinion of a veterinarian, stunning does not appear to be feasible in a particular case. (3) Anaesthesia is also not necessary... 7. for labelling a) through implanted electronic transponders, b) mammals other than pigs, sheep, goats and rabbits by ear or thigh tattooing within the first two weeks of life,... f) rodents to be used in animal experiments by ear tattoo, ear tag, or ear punching (4) The Federal Ministry is authorised, 1 1. to exempt further measures from the stunning obligation beyond those laid down in paragraph 3, provided that this is compatible with § 1, 2. To prescribe, authorise or prohibit procedures and methods for the implementation of measures in accordance with paragraph 3 and certain measures on the basis of a statutory instrument in accordance with point 1, insofar as this is necessary for the protection of the animals. Fifth Section Animal Experimentation §7 (1) The provisions of this Section are intended to protect animals intended for use in animal experiments or whose tissues or organs are intended to be used for scientific purposes. This includes 1. Animal testing with regard to a) the pain, suffering and harm inflicted on the animals, b) the number of animals used, c) to limit the species-specific ability of the animals used to suffer from the effects of the test to the 4  minimum necessary; and 2. to improve the keeping, breeding and care of animals intended for use in animal experiments or whose tissues or organs are intended to be used for scientific purposes, in such a way that they are subjected to no more than the minimum degree of distress necessary for their use for scientific purposes. The obligation to limit animal experiments to the indispensable extent (pursuant to sentence 2 number 1 letter a and c) also includes the obligation to improve the methods used in animal experiments. Animal experiments may only be planned and performed by persons who have the necessary knowledge and skills. § 1 remains unaffected. (2) For the purposes of this Act, animal experiments are interventions or treatments for experimental purposes 1. on animals when they may cause pain, suffering or harm to those animals 2. on animals that may cause them to be born or hatch, causing pain, suffering or injury; or 3. to the genetic material of animals, if they may cause pain, suffering or harm to the mutant animals or their carriers Interventions or treatments are also considered as animal experiments that are not for experimental purposes, but 1. which are carried out for the production, extraction, storage or propagation of substances, products or organisms 2. by which organs or tissues are removed, in whole or in part, for scientific purposes a) to transplant the organs or tissues, b) to grow crops, or c) to examine isolated organs, tissues or cells, or 3. which are carried out for the purposes of education, further education or training, insofar as one of the prerequisites mentioned in sentence 1 numbers 1 to 3 exists. The following shall not be regarded as animal experiments 1. the killing of an animal, provided that the killing is carried out solely for the purpose of using the animal's organs or tissues for scientific purposes, 2. an intervention or treatment on a farm animal which (a) is carried out on a farm in the course of farming activities; and (b) is not carried out for scientific purposes; or 3. a veterinary clinical trial required for the authorisation of a veterinary medicinal product. (2a) In order to avoid duplication or repetition of tests, data from animal tests obtained in procedures recognised under Union law in other Member States of the European Union shall be recognised. This shall not apply if further animal testing must be carried out in order to protect public health, safety or the environment in relation to the data referred to in the first sentence. (3) The Federal Ministry is authorised, in agreement with the Federal Ministry of Education and research by statutory instrument with the consent of the Federal Council to regulate the further details of the requirements pursuant to para. 1 sentence 2 number 2. § 7a (1) Animal experiments may only be performed if they are indispensable for one of the following purposes: 1. Basic research, 2. other research with one of the following objectives: a) Prevention, detection or treatment of disease, suffering, bodily harm or physical discomfort in humans or animals, b) Recognition or manipulation of physiological states or functions in humans or animals, c) Promoting animal welfare or improving the welfare of farm animals, 3. Protection of the environment in the interests of human or animal health or welfare, 5 4. the development, manufacture and testing of the quality, efficacy or safety of medicinal products, food, feed or other substances or products with any of the objectives referred to in points 2(a) to (c) or 3, 5. Testing of substances or products for their effectiveness against animal pests, 6. Research with a view to the conservation of species, 7. Education, training or further training, 8. Forensic examinations. Animal experiments for basic, further or advanced training in accordance with sentence 1 number 7 may only be carried out 1. at a university, other scientific institution or hospital, or 2. within the framework of initial, further or continuing training for healing or therapeutic auxiliary professions or scientific auxiliary professions (2) The following principles should be observed when deciding whether animal experiments are indispensable and when conducting animal experiments: 1. The current state of scientific knowledge shall be taken as a basis. 2. It must be examined whether the intended purpose cannot be achieved by other methods or procedures. In particular, it shall be examined whether another method or experimental strategy, which does not involve the use of a live animal and which is recognised under Union law, is available to achieve the result sought by the animal experiment. 3. Tests on vertebrate animals or cephalopods may only be carried out if the pain, suffering or harm to the animals is ethically acceptable in relation to the purpose of the test. 4. Pain, suffering or injury shall be inflicted on the animals only to the extent that it is indispensable for the purpose pursued; in particular, it shall not be inflicted for reasons of saving labour, time or money. 5. Tests on animals whose species-specific ability to suffer from the effects of the test may only be carried out on animals whose species-specific ability to suffer from the effects of the test is more highly developed if such animals are not sufficiently developed for the purpose intended. (3) Animal testing for the development or testing of weapons, ammunition and related equipment is prohibited. (4) Animal testing for the development of tobacco products, detergents and cosmetics is generally prohibited. The Federal Ministry is authorized to determine exceptions insofar as this is necessary to 1. to ward off concrete health risks and the necessary new findings cannot be obtained in any other way, or 2. to implement acts of the European Community or the European Union. (5) An animal experiment is considered to be completed when 1. no further observations are to be made for the animal experiment; or, 2. where genetically modified new lines of livestock are used, a) no further observations are to be made on the progeny, and b) it is no longer expected that the offspring will feel pain or suffering or suffer permanent damage as a result of the biotechnological or genetic modifications TierSchVersV: § 14 Application for animals in an early stage of development Sections 7 to 9 of the Animal Welfare Act and sections 15 to 43 shall also apply to the performance of animal experiments, including the approval and notification of experimental projects, 1. in which a) larvae of vertebrates, provided that they are capable of independent feeding, or b) foetuses of mammals are used or intended to be used from the last third of their normal development before birth, or 2. in which vertebrate animals other than those referred to in point 1 are used or intended to be used at a stage of development before birth or hatching, where the animals are intended to continue beyond that stage of development and are likely to experience pain, suffering or injury after birth or hatching as a result of such use § 8 Approval of animal testing projects 6 (1) Any person wishing to carry out experiments on vertebrate animals or cephalopods shall obtain authorisation. The approval of an experimental project shall be granted after review by the competent authority if 1. it is justified from a scientific or pedagogical point of view that a) the requirements of § 7a paragraph 1 and 2 numbers 1 to 3 are met, b) the desired result is not sufficiently known despite the use of all available information, or verification of a sufficiently known result by means of a duplicate or repeat attempt is indispensable, 2. the person in charge of the experimental project and his deputy have the necessary professional competence, in particular with regard to the supervision of the animal experiments, and there are no facts giving rise to doubts as to their reliability 3. the necessary premises, installations and other material means meet the requirements laid down in a statutory instrument issued on the basis of § 9 para. 4 sentence 1 number 1, 4. the personnel and organisational conditions for the performance of animal experiments, including the activities of the animal welfare officer, are in place, 5. the keeping of the animals complies with the requirements of § 2 and the requirements laid down in a statutory instrument issued on the basis of § 2a (1) Nos. 1 to 4, also in conjunction with § 11 (3), or § 2a (2) Sentence 1, and their medical care is ensured, 6. compliance with the provisions of § 7 para. 1 sentence 2 number 1 and sentence 3 § 7a para. 2 numbers 4 and 5 can be expected, 7. the observance of a) Competence requirements, b) rules on pain relief and stunning of animals, c) rules on the re-use of animals, d) Prohibitions and restrictions on use, e) Rules to prevent pain, suffering and harm after the purpose of the animal experiment has been achieved, f) provisions to prevent the death of an animal under the influence of the experiment or to avoid pain and suffering on the death of an animal, and g) provisions on the procedure to be followed after completion of the animal experiment, which can be expected to be laid down in a statutory instrument issued on the basis of § 2a(1)(5) or § 4b first sentence number 1(b), in each case also in conjunction with § 11(3), or § 9(1) to (3) and (4) first sentence number 2 or 3 or second sentence, 7a. the animal experiment can be expected to be conducted in the most environmentally sound manner possible, and 8. the keeping of records pursuant to § 9 para. 5 sentence 1 in conjunction with the requirements laid down in a statutory instrument issued on the basis of § 9 para. 5 sentence 2 can be expected. The competent authority's assessment shall be carried out with the level of detail appropriate to the nature of the trial project. (2) Where authorisation is granted by a university or other institution, the persons carrying out the animal experiments must be employed by the institution or authorised to use the institution with the agreement of the responsible head. (3) The Federal Ministry is authorised, in agreement with the Federal Ministry of Education and Research, to issue regulations on 1. the form and content of the application for a permit pursuant to subsection (1) first sentence and the persons entitled to apply 2. the authorisation procedure including its duration, 3. the content of the permit notice, 4. the procedure to be followed in the event of subsequent changes to the essential facts underlying the approval, including the obligation to notify or approve such changes, 5. the limitation of the duration of authorisations or the extension of their validity, and 6. the reservation of the withdrawal of authorisations. 7 TierSchVersV: § 31 Application for approval (1) The application for approval of an experimental project pursuant to § 8(1), first sentence, of the Animal Welfare Act shall be submitted in writing or electronically to the competent authority. In the application 1. shall be indicated a) Name and address of the applicant, b) a description and scientific justification of the experimental project, including the purpose of the experiment, (c) a scientific justification of the species, origin, life stage and estimated number of animals intended for the proposed experiment, (d) the nature and conduct of the proposed animal experimentation, including the proposed use of means and methods of anaesthesia or pain relief, and the circumstances in which an animal will no longer be used in the experimentation (e) the location, the date of commencement and the expected duration of the experimental project (f) the name, address and qualifications of the person in charge of the proposed experiment and their deputy, of the persons by whom the proposed experiment or experiments have been planned, of the persons carrying out the experiment(s), and of the persons who may be responsible for its aftercare (g) where it is planned to kill the animals, the procedure to be followed for this purpose (h) a summary of the measures taken to reduce, prevent and alleviate any form of suffering to animals from birth to death, (i) information on experimental and monitoring strategies, and statistical design to minimise animal numbers, pain, suffering, harm and, where appropriate, environmental impact, j) methods to ensure compliance with the requirements of § 7(1), sentences 2 and 3, and § 7a(2), numbers 2, 4 and 5 of the Animal Welfare Act for the use of animals in procedures; and k) planned acclimatisation and training programmes which are suitable for the animals, the procedures, and the duration of the experimental project, 2. it shall be demonstrated on a scientifically justified basis a) that the requirements of § 8(1), second sentence, number 1 letters a and b of the Animal Welfare Act are met b) the degree of severity to which the experiment is classified, and c) in the case of § 17(4), stating the means referred to therein aa) the necessity of any intervention that prevents or impairs the animal’s ability to express pain, (bb) the appropriate use of anaesthesia or local analgesia; and cc) in the case of § 17 paragraph 4 sentence 1 number 3, the appropriate use of pain-relieving means, 3. it shall be demonstrated that the requirements of § 8(1), second sentence, numbers 2 to 5 of the Animal Welfare Act are met, and 4. it shall be demonstrated a) that the requirements of § 8 paragraph 1 sentence 2 numbers 6 to 8 of the Animal Welfare Act are fulfilled and b) how environmental concerns are to be taken into account. (2) The application shall be accompanied by a summary of the experimental project with the information pursuant to § 41(1) second sentence. (3) The application for approval of an experimental project may be accompanied by scientific assessments by independent third parties. TierSchVersV: § 32 Approval procedure, processing deadlines (1) The competent authority shall, within 40 working days of receipt of a request for a certificate that meets the requirements of § 31, the applicant shall be informed of the decision on the application. Insofar as the scope and difficulty of the examination of the existence of the conditions pursuant to § 8 para. 1 sentence 2 of the Animal Protection Act justify this, the competent authority may extend the period of time mentioned in sentence 1 once by up to 15 working days in accordance with para. 2 sentence 3. (4) The competent authority shall inform the Commission without delay in accordance with the second sentence of § 15(1) of the Animal Welfare Act of any applications for authorisation of experimental projects and shall give the Commission the opportunity to comment within a reasonable time. The competent authority may also submit notifications of changes to approved experimental projects to the Commission for its opinion, where the scope and difficulty of the examination so require. (4a) The competent authority shall take into account the scientifically substantiated statements of the applicant pursuant to § 31(1), second sentence, number 2 and the scientific assessments pursuant to § 31(3) when deciding whether the requirements pursuant to § 8(1), second sentence, number 1(a) and (b) of the Animal Welfare Act are met. TierSchVersV: § 33 Letter of approval, time limit (1) The notice of approval is submitted in writing or electronically and shall contain 1. The name of the head of the experimental project and his deputy, 2. an indication of the facilities or establishments or, in the cases of § 15 subsection (1), third sentence, the location where the experimental project is to be carried out 3. a decision on whether and at what point in time the experimental project is to be evaluated retrospectively in accordance with § 35, and 4. where appropriate, the ancillary provisions with which the authorisation is accompanied and 5. if the competent authority decides to deviate from the scientifically substantiated statements pursuant to § 31(1), 8  second sentence, number 2 and the scientific assessments pursuant to § 31(3), an explanation of the reasons, without prejudice to the requirements under administrative procedure law for the substantiation of an administrative act. (2) The authorisation shall be limited to a maximum period of five years. Where the authorisation has been granted for a period of less than five years, it shall be extended on application, even on an informal and reasoned basis, for a maximum of two further periods of up to one year each time, provided that the total duration of the authorised experimental project does not exceed five years and provided that, since the initial granting or initial extension of the authorisation, no changes have been made to the authorised experimental project or only such changes have occurred which 1. notified pursuant to § 34 paragraph 2 sentence 1 or paragraph 3 sentence 1 and not objected to by the competent authority, or 2. have been approved in accordance with § 34 paragraph 3. § 34 Approval and notification of changes to approved experimental projects (1) Modifications of approved experimental projects which may have a detrimental effect on animal welfare shall require approval. A change within the meaning of sentence 1 shall be deemed to have occurred in particular if 1. the purpose of the experimental project is not maintained 2. the degree of pain, suffering and damage caused to the animals used may increase as a result of the modification, or 3. the number of animals used is substantially increased. (2) In the event of a change of the leader of the experimental project or his representative, the authorisation holder shall immediately notify the competent authority of the change. The permit shall be revoked by the competent authority within one month of receipt of the notification of change if the head of the experimental project or his deputy does not comply with the requirements of § 8 (1) sentence 2 number 2 of the German Animal Welfare Act. (3) Changes other than those specified in paragraph 1 sentence 1 shall require notification to the competent authority. The changes may be made no earlier than two weeks after receipt of the notification pursuant to sentence 1, unless the competent authority has previously notified that there are no objections to the changes. TierSchVersV: § 35 Retrospective assessment of experimental projects (1) Where the competent authority approves an experimental project, it may at the same time stipulate that the experimental project shall be evaluated by the competent authority upon its completion and the date of such evaluation. An evaluation in accordance with the first sentence shall be provided for where the experimental project involves the implementation of 1. Animal experiments in which primates are used, 2. Tests on animals which are to be regarded as "non-animal tests" in accordance with Article 15(1) in conjunction with Annex VIII to Directive 2010/63/EU. "difficult" to classify, or 3. includes animal experiments in accordance with § 25 paragraph 2. (2) Within the framework of the assessment pursuant to Paragraph 1 Sentence 1, the competent authority shall examine the following on the basis of documents which the applicant must submit to it on request pursuant to § 31 Paragraph 1 Sentence 1, insofar as they are necessary for carrying out the assessment 1. whether the notified result is consistent with the purpose of the experimental project stated in the application under Paragraph 31(1), second sentence, point 1(b) 2. the damage caused to the animals used, 3. the number and species of animals used, 4. the severity 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 any conclusions can be drawn from this with regard to the requirements under § 7(1) sentences 2 and 3 and § 7a(2) numbers 2, 4 and 5 of the Animal Welfare Act. Directive 2010/63/EU Article 15 Classification of the severity of procedures 1. Member States shall ensure that all procedures are classified on a case-by-case basis as 'no restoration of viability', 'low', 'moderate' or 'severe' using the classification criteria set out in Annex VIII. 2. Subject to the application of the safeguard clause provided for in Article 55(3), Member States shall ensure that a procedure is not carried out if it causes severe pain, suffering or distress which is likely to be prolonged and cannot be alleviated. Directive 2010/63/EU ANNEX VIII CLASSIFICATION OF THE Severity of Proceedings The severity of a procedure shall be determined by the degree of pain, suffering, distress or lasting harm that the individual animal is likely to experience or suffer during the procedure. 9  Section I: Severity categories No life-function restoration: Procedures performed entirely under general anaesthesia from which the animal does not recover are classified as "no restoration of vital function". Little: Procedures that are expected to cause little pain, suffering or distress to the animals for a short period of time and procedures without significant impairment of the welfare or general condition of the animals are classified as 'minor'. Medium: Procedures that are expected to cause moderate pain, moderate suffering or distress for a short period of time, or long lasting minor pain, and procedures that are expected to cause a moderate impairment of the welfare or general condition of the animals are classified as 'moderate'. Heavy: Procedures which are likely to cause severe pain, suffering or distress to the animals, or prolonged moderate pain, suffering or distress of moderate severity, and procedures which are likely to cause serious harm to the welfare or general condition of the animals shall be classified as 'severe'. Section II: Assignment criteria In assigning the category of severity, account shall be taken of any intervention or manipulation of the animal in the course of a specific procedure. It shall be based on the most serious effects to which an individual animal is likely to be exposed after application of all appropriate enhancement techniques. When assigning a procedure to a specific category, the type of procedure and a number of other factors are taken into account. All these factors must be considered on a case-by-case basis. Factors related to the procedure include - Type of manipulation, handling, - Type of pain, suffering, anxiety or permanent damage caused by the procedure (taking into account all elements) and its intensity, duration and frequency and the use of several techniques, - cumulative suffering during a trial, - prevention of natural behaviour, including restrictions on housing, husbandry and standards of care (6) The Federal Ministry is authorised, in agreement with the Federal Ministry of Education and Research, to provide that the competent authorities shall transmit for publication summaries of approved experimental projects containing information on 1. the objectives of the experimental project, including the expected benefits, 2. the number, species and expected pain, suffering and injury of the animals to be used, and 3. compliance with the requirements of § 7 para. 1 sentence 2 number 1 and § 7a para. 2 numbers 2, 4 and 5 and to regulate the form of the summaries and the procedure for their publication to the extent necessary to improve the protection of animals used in experiments and to implement European Union acts. The ordinance may also provide that 1. the publication of the summaries shall be carried out by the Federal Institute for Risk Assessment, and 2. the Federal Institute for Risk Assessment forwards the summaries to the European Commission for publication. TierSchVersV: § 41 Publication of summaries (1) The competent authority shall send the Federal Institute for Risk Assessment (Federal Institute) a summary of the approved experimental project within three months of the granting of a license pursuant to § 8 (1) first sentence of the Animal Welfare Act for publication by the Federal Institute (so-called non-technical project summary, in short NTP; www.animaltestinfo.de). The summary shall contain the following information on the basis of the information provided in the application for approval: 1. the purposes of the experimental project, 2. the expected benefit of the experimental project, 3. the damage to be expected in the animals intended for use, 4. the number and species of animals intended for use, and 5. the fulfilment of the requirements of § 7 (1) sentence 2 and § 7a (2) numbers 2, 4 and 5 of the Animal Protection Act The summary shall not contain any institution or personal data. The provisions on the protection of intellectual property and the protection of industrial and business secrets shall remain unaffected. 10  (2) The summary shall be published on the internet within twelve months of the competent authority's transmission by the Federal Institute... (3) The submission of the summary pursuant to paragraph 1 sentence 1 shall also be made for the purpose of forwarding it to the European Commission. The Federal Institute shall forward the summary, including any necessary updates, electronically to the European Commission within three months of its transmission by the competent authorities. § 8a Notification and approval of animal testing projects in a simplified authorisation procedure (1) The authorisation shall be granted in a simplified authorisation procedure if the experimental project is a project pursuant to § 8(1), first sentence, 1. which is exclusively concerned with animal experiments, the performance of which is expressly a) is required by law or regulation, by the pharmacopoeia or by a directly applicable legal act of the European Community or the European Union, b) is provided for in a general administrative provision issued by the Federal Government or a Federal Ministry, or c) on the basis of a law or a legal regulation or a directly applicable legal act of the European Community or the European Union, is ordered by an administrative or judicial authority or is required in individual cases as a precondition for an administrative decision 2. which is exclusively concerned with animal experiments which are carried out on animals as vaccinations, blood samples or other diagnostic measures using methods which have already been tried and tested, and a) the detection of disease, suffering, bodily injury or physical discomfort in humans or animals, or b) the testing of sera, blood preparations, vaccines, antigens or test allergens as part of approval procedures or batch testing serve, or 3. which exclusively involves animal experiments pursuant to § 7 (2) sentence 2 number 1 or 2, which are carried out in accordance with procedures already tested a) for the production, extraction, storage or reproduction of substances, products or organisms, or b) for diagnostic purposes, or 4. which is exclusively concerned with animal experiments carried out for the purposes of education, training or further training using methods which have already been tested, shall notify the competent authority of the experimental project. Approval in the cases of sentence 1 shall be deemed granted if 1. the inspection carried out by the competent authority has shown that the requirements of § 8 subsection 1 sentence 2 numbers 1, 3, 5, 6 and 7 letters b to g and number 7a are met 2. the competent authority has made a determination on the conduct of the retrospective assessment in accordance with a statutory instrument issued on the basis of § 8(5), 3. the competent authority has not taken a final decision on the application for a permit within the period specified in a statutory instrument issued on the basis of § 8 subsection (3), and 4. the competent authority has notified the applicant of the existence of the requirements under No. 1 and of the determination under No. 2. If the applicant carries out an experimental project on the basis of the authorisation pursuant to sentence 2, he shall ensure compliance with the further requirements of § 8(1) sentence 2 going beyond sentence 2 number 1. (2) Section 1 shall not apply to experimental projects, 1. in which primates are used, or 2. which involve animal testing which is to be classified as 'severe' in accordance with Article 15(1) in conjunction with Annex VIII to Directive 2010/63/EU. (3) Any person wishing to carry out an experimental project using decapods shall notify the experimental project to the competent authority. 11 (4) The Federal Ministry is authorised to define by ordinance that experiments on invertebrates other than cephalopods and decapods must be notified to the competent authority if these animals have a species- specific capacity to suffer from the effects of the experiment equivalent to that of vertebrates and if it is necessary for their protection. (Legislation provides here for the possibility of a later tightening of the rules). (5) The Federal Ministry is authorised, to issue regulations on 1. the form and content of the advertisement pursuant to paragraph 1 or 3, 2. the procedure for notification under paragraph 1 or 3, including the time limits applicable to notification, 3. the date from or up to which the implementation of notified experimental projects is permitted under paragraphs 1 or 3, and 4. the procedure to be followed in the event of subsequent changes to the facts notified in the notification pursuant to paragraph 1 or 3. TierSchVersV: § 36 Simplified approval procedure for experimental projects under § 8a(1) of the Animal Welfare Act (1) The application for approval of an experimental project under the simplified approval procedure pursuant to § 8a(1) of the Animal Welfare Act shall be submitted in writing or electronically to the competent authority. The application shall state: 1. the fact that the application is for authorisation of an experimental project under the simplified authorisation procedure, 2. the information, explanations and evidence required in accordance with the second sentence of § 31 subsection (1), and 3. in the case of an experimental project pursuant to § 8a(1), first sentence, number 1 of the Animal Protection Act, additionally the legal basis for carrying out the experimental project. (2) The competent authority shall notify the applicant within 1. 15 working days from receipt of an application meeting the requirements of subsection 1 a) the result of its examination as to whether the requirements of § 8 subsection 1, second sentence, numbers 1, 3, 5, 6 and 7 letters b to g and number 7a of the Animal Protection Act are met, and b) the determination on the performance of a retrospective assessment pursuant to § 35, 2. 20 working days from receipt of an application complying with the requirements of subsection (1), of their final decision on the application. The competent authority may extend the period referred to in sentence 1 numbers 1 and 2 once in each case by up to ten working days in accordance with subsection (3) sentence 3, insofar as the scope and difficulty of the examination of the existence of the requirements pursuant to 1. § 8 subsection (1) sentence 2 numbers 1, 3, 5, 6 and 7 letters b to g and number 7a of the Animal Protection Act in the case of sentence 1 number 1 or 2. § 8a subsection 1 of the Animal Welfare Act in the case of sentence 1 number 2 justify this. (3) Upon receipt of an application pursuant to subsection 1, the competent authority shall issue an acknowledgement of receipt to the applicant without delay. The acknowledgement of receipt shall state that the applicant will be notified of the final decision on the application within the period referred to in paragraph 2, sentence 1, point 2. An extension pursuant to paragraph 2, sentence 2, point 2, shall be notified to the applicant at the latest by the expiry of the period referred to in paragraph 2, sentence 1, point 2, stating the reasons. (4) The competent authority shall check an application received in accordance with paragraph 1 sentence 1 for completeness immediately after receipt. If the application does not meet the requirements pursuant to paragraph 1, the competent authority shall notify the applicant without delay, indicating the missing information, explanations and evidence pursuant to paragraph 1, sentence 2. The applicant shall be informed that the commencement of the periods specified in paragraph 2, first sentence, requires the receipt of an application that meets the requirements of paragraph 1. (5) The competent authority may inform the Commission pursuant to § 15(1), second sentence, of the Animal Welfare Act of applications for approval of experimental projects in the simplified approval procedure pursuant to §8a(1) of the Animal Welfare Act and give it the opportunity to comment within a reasonable period of time. (6) Paragraph 5 shall apply, with necessary changes, to the competent authority of the Federal Armed Forces, with the proviso that the Commission may be involved in accordance with § 15(3), second sentence, of the Animal Welfare Act. The security concerns of the Federal Armed Forces shall be taken into account. If animal experiments are to be carried out on behalf of the Federal Armed Forces, the Commission may also be informed of this and may be given the opportunity to comment before the contract is awarded; § 15, paragraph 1 of the Animal Protection Act shall remain unaffected. The federal state authority responsible for approving the experimental project shall be informed thereof. The competent authority of the Federal Armed Forces shall send the statement upon request. (7) § 33 shall apply subject to the proviso that the permit pursuant to § 33(2), second sentence, shall be renewed if the other requirements specified therein are met, provided that since the initial granting or first renewal of the permit in the simplified permit procedure 1. no changes have occurred, or 2. only such changes have occurred which a) have been approved in accordance with § 37(2), first sentence, in conjunction with § 34(1), or 12  b) have been notified in accordance with § 37 subsection (2) sentence 2 and have not been objected to by the competent authority. (8) An experimental project for which approval is deemed to have been granted under § 8a(1)(2) of the Animal Welfare Act may not be carried out after five years have elapsed from the expiry of the period specified in subsection (2)(1)(2). TierSchVersV: § 37 Collective approval and approval of modifications to approved experimental projects in the simplified approval procedure (1) If several similar experimental projects are to be carried out in accordance with § 8a(1), first sentence, of the Animal Welfare Act, approval of the first experimental project under the simplified approval procedure shall suffice if the application for approval also states the expected number of experimental projects. By 15 February of each year, the applicant shall inform the competent authority of the number of experimental projects carried out in the previous calendar year and the type and total number of animals used. (2) § 34(1) shall apply with the proviso that the changes shall require renewed approval under the simplified approval procedure. TierSchVersV: § 38 Examination of Notification of Changes to Experimental Projects 1. in the case of notification of amendments pursuant to § 34 subsection (3), the competent authority shall examine within two weeks whether the requirements specified in § 8 subsection (1), second sentence, numbers 1 to 8 of the Animal Welfare Act have been met, or 2. the performance of the experimental project is to be prohibited in accordance with § 16a subsection (2) of the Animal Welfare Act. TierSchVersV: § 40 compulsory period of record keeping The holder of a permit or, in the case of experimental projects pursuant to § 8a subsection (3) of the Animal Welfare Act, the person notifying the permit shall keep 1. a copy of the application under § 31 and the notice of approval under § 33 or, in the case of experimental projects under § 8a(1), first sentence, of the Animal Welfare Act, a copy of the application under § 36(1) and the notice of approval under § 33 in conjunction with § 36(6) or, in the case of experimental projects under § 8a(3) of the Animal Welfare Act, a copy of the notification under § 39(1), first sentence, as well as 2. all other documents submitted to him by the competent authority in connection with the authorisation or notification and the conduct of the experimental project. These documents shall be kept for at least three years beyond the end of the period of validity of the authorisation or, in the case of experimental projects pursuant to § 8a subsection (3) of the Animal Protection Act, beyond the expiry of the period specified in § 39 subsection (2b). Special exception is given to sentence 1, in the case of electronic transmission of the documents referred to therein, if these documents are retained by storage on a durable medium. In the case of experimental projects which are to be subjected to an assessment pursuant to § 35, the documents referred to in sentence 1 shall be retained until the assessment has been completed, insofar as the assessment is not completed until after expiry of the period referred to in sentence 1. §9 (1) The Federal Ministry is authorised to define more detailed provisions by ordinance on the nature and extent of the knowledge and skills required pursuant to § 7 para. 1 sentence 4 of the persons who plan or perform animal experiments, in particular biological, veterinary, legal and ethical knowledge and skills relating to the performance of animal experiments, and lay down requirements for demonstrating and maintaining the necessary knowledge and skills; the legislative instrument may also require that records of the measures taken to maintain knowledge and skills be made, kept and presented to the competent authority on request TierSchVersV: § 16 Requirements for expertise (1) Experiments on vertebrate animals and cephalopods may only be carried out by persons possessing the knowledge and skills listed in Section 3 of Appendix 1. In addition, animal experiments may only be carried out 1. by persons with a university degree in veterinary medicine, medicine or dentistry 2. by persons with a degree in natural sciences, provided that they can prove that they have the necessary knowledge and skills, or 3. by persons who have demonstrably acquired the necessary knowledge and skills in the course of completed vocational training, can be carried out. Without prejudice to the first sentence, animal experiments involving surgical procedures on vertebrate animals may only 1. by persons with a university degree in veterinary medicine, medicine or dentistry, or 2. are carried out by persons who have completed a university degree in natural sciences or further training following a university degree in natural sciences, provided that they can prove that they have the necessary knowledge and skills. Sentences 2 and 3 shall not apply to animal experiments pursuant to § 7 (2) sentence 2 number 1 of the Animal Protection Act which are carried out using methods which have already been tested. The competent 13  authority shall approve exceptions to sentences 2 and 3 if proof of the required knowledge and skills is provided in some other way. (2) Notwithstanding § 7 (1) sentence 3 of the German Animal Welfare Act and (1) sentences 1 to 3, animal experiments which serve education, training or further training purposes may also be carried out by persons who do not meet the requirements specified therein, provided that this is done in the presence and under the supervision of a person who meets the respective requirements. (3) Animal experiments may only be carried out if the persons who planned the experimental project and the intended animal experiments have the necessary knowledge and skills, including the knowledge and skills referred to in Section 3 of Appendix 1, and provide evidence of these to the competent authority on request. TierSchVersV: Annex 1 Knowledge and skills required for the care or killing of animals or the planning or performance of animal experiments Section 3 Design and performance of animal experiments 1. Existing legislation on the performance of animal experiments. 2. Ethics in relation to the relationship between humans and animals, intrinsic value of life and arguments for and against the use of animals for scientific purposes 3. Basic biology and appropriate species-specific biology in relation to anatomy, physiological characteristics, breeding, genetics and genetic modification. 4. Animal behaviour and husbandry requirements and methods, including enrichment of husbandry facilities (general and species-specific). 5. Health and hygiene of the livestock. 6. Species-specific handling and testing methods. 7. Identification of species-specific pain and suffering of the species most commonly used in animal experiments. 8. Application of endpoints that are as painless as possible. 9. Requirements of the principle of the indispensability of animal experiments in accordance with § 7 (1) sentence 2 and § 7a (2) numbers 2, 4 and 5 of the German Animal Welfare Act 10. Where appropriate, planning of procedures and projects. 11. Relevant experimental techniques and surgical interventions. 12. Research and evaluation of scientific literature including literature on alternatives to animal testing. 13. Anaesthesia and pain relief methods. 14. Where the implementation of the scheme includes the killing of the animals, the knowledge and skills referred to in Section 2. 15. Biometric statistics. TierSchVersV: § 17 Pain relief and anaesthesia (1) When tests are carried out on vertebrate animals and cephalopods, painkillers or procedures shall be used to ensure that pain and suffering is minimised in the animal used. (2) Experiments on vertebrates or cephalopods may only be carried out under anaesthesia or local anaesthetic. Sentence 1 shall not apply if 1. the pain and suffering associated with the performance of the test for the animal concerned is less than that associated with stunning; or 2. the purpose of the experiment precludes stunning and the experiment does not cause serious injury to the animal concerned Stunning of vertebrate animals may only be carried out by a person who fulfils the requirements of § 7 (1) sentence 3 of the Animal Protection Act and § 16 (1) sentence 2, or, where the performance of stunning serves educational, training or further training purposes, in the presence and under the supervision of such a person. § 16 paragraph 1 sentence 5 shall apply accordingly. (3) Where pain is likely to occur in a stunned vertebrate or cephalopod as the anaesthetic wears off, the animal shall be treated with analgesics or procedures in a timely manner. This shall not apply, where ethically justifiable, if it is scientifically demonstrated that treatment with analgesics or procedures is incompatible with the purpose of the animal experiment. No means of preventing or minimising the expression of pain shall be used on a non-anesturised vertebrate or cephalopod. (4) In the case of an anaesthetised vertebrate or cephalopod, agents which prevent or impair the expression of pain may only be used if there is scientific justification for: 1. the necessity of the use of the means to prevent or impair the expression of pain, 2. the appropriate use of anaesthetic or local analgesic agents; and 3. in the cases of paragraph 3, sentence 1, the appropriate use of analgesics. In the justification according to sentence 1, the means to be used shall be indicated and it shall be explained that the use of the means does not serve to prevent or limit the expression of pain because the animal is sufficiently protected from actually 14  perceiving pain due to the simultaneous administration of the anaesthetic or analgesics. (5) In the case of an unanaesthetised vertebrate or cephalopod, no means shall be used which prevents or restricts the expression of pain. (3) The Federal Ministry is authorised to define more detailed provisions by ordinance with respect to animal experiments… 1. on primates, TierSchVersV: § 23 Use of primates (1) Primates must not be used in animal experiments. (2) Subject to paragraphs 4 and 5, paragraph 1 shall not apply where 1. the animal experiment a) of basic research, b) the purpose of preventing, diagnosing or treating diseases, illnesses, physical injuries or physical complaints in human beings which may be life-threatening or result in a reduction in physical or mental functioning, or of developing, manufacturing and testing the quality, efficacy or safety of substances or products with regard to the abovementioned impairments of human health, or c) serves research with a view to the conservation of species, and 2. it is scientifically justified that the purpose of the animal experiment referred to in point 1 cannot be achieved by the use of animal species other than primates (3) By way of derogation from paragraph 2(1), the competent authority may also authorise the use of primates in an animal experiment where the animal experiment is intended to conduct research for the purpose of preventing, diagnosing or treating diseases, suffering, physical injury or physical disorders in humans other than those referred to in paragraph 2(1)(b), provided that it is scientifically established that the use of primates is essential to achieve the stated purpose of the animal experiment. (4) In the case of primates listed in Annex A to Regulation (EC) No 338/97 and not covered by Article 7(1) of Regulation (EC) No 338/97, paragraph 1 shall not apply if 1. the animal experiment a) the purpose of preventing, diagnosing or treating diseases, illnesses, physical injuries or physical complaints in human beings which may be life-threatening or result in a reduction in physical or mental functioning, or of developing, manufacturing and testing the quality, efficacy or safety of substances or products with regard to the abovementioned impairments of human health, or b) serves research with a view to the conservation of species, and 2. it is scientifically justified that the purpose of the animal experiment referred to in point 1 cannot be achieved by the use of animal species other than those referred to in paragraph 1 and listed in Annex A to Regulation (EC) No 338/97 and not covered by Article 7(1) of Regulation (EC) No 338/97. Sentence 1 shall not apply to animal experiments that serve basic research. (5) By way of derogation from paragraph 1, the competent authority may authorise the use of great apes in an animal experiment if 1. the animal experiment a) the purpose of preventing, diagnosing or treating life-threatening diseases, illnesses, physical injury or physical complaints in human beings or a reduction in physical or mental functioning which have occurred unexpectedly, or of developing, manufacturing and testing the quality, efficacy or safety of substances or products with regard to the abovementioned adverse effects on human health, or b) serves research with a view to the conservation of species, and 2. it is scientifically established that a) there are reasons to believe that the performance of the animal experiment is indispensable to achieve the purpose of the animal experiment as stated in point 1, and b) this purpose cannot be achieved by the use of species other than great apes. Sentence 1 shall not apply to animal experiments that serve basic research. 15  TierSchVersV: § 24 Origin of primates to be used (1) Primates listed in column 1 of Annex 11 to Directive 2010/63/EU may be used in animal experiments from the respective dates set out in column 2 of Annex 11 to Directive 2010/63/EU only if they are the offspring of primates bred in captivity or if they come from self-sustaining colonies within the meaning of the third subparagraph of Article 10(1) of Directive 2010/63/EU. 2. on animals of a certain origin, TierSchVersV: § 19 Use of bred vertebrates and cephalopods (1) Vertebrates and cephalopods may be used in animal experiments only if they have been bred for such a purpose. The competent authority may, in so far as is compatible with the protection of the animals, grant exemptions from this requirement if it is scientifically justified that the use of animals other than those bred in accordance with the first sentence is necessary. (2) The first sentence of paragraph 1 shall not apply to the use of horses, bovine animals, pigs, sheep, goats, chickens, pigeons, turkeys, ducks, geese or fish, except zebrafish. TierSchVersV: § 20 Use of wild animals (1) Animals taken from the wild must not be used in animal experiments. The competent authority may grant derogations from this requirement if the purpose of the experiment cannot be achieved by the use of other animals. (2) Vertebrates or cephalopods to be taken from the wild shall only be captured by persons having the necessary knowledge and skills. Pain, suffering or injury may be inflicted on the animals only to the extent necessary for the capture. (3) If, at or after the capture referred to in paragraph 2, the animal is found to be injured or in poor health, it shall be presented to a veterinarian or other competent person and measures shall be taken to reduce pain, suffering and injury to the animal to the minimum extent compatible with the purpose of the experiment. TierSchVersV: § 21 Use of stray or wild pets Unattended or feral animals of species normally kept in human custody shall not be used in animal experiments. The competent authority may grant derogations from this requirement if 1. animal experiments are carried out to meet a basic need for studies on the health and welfare of these animals or on serious risks to the environment or to human or animal health, and 2. it is scientifically justified that the purpose of the animal experiment can only be achieved by using an animal in accordance with the first sentence. TierSchVersV: § 22 Use of protected animal species Vertebrates other than primates and cephalopods listed 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 61, 3.3.1997, p. 1), as amended, shall not be used in animal experiments. The first sentence shall not apply if 1. the animal experiment a) the purpose of preventing, recognising or treating diseases, suffering, bodily injury or physical complaints in humans or animals or the development and production and testing of the quality, effectiveness or safety of substances or products with regard to the purposes mentioned in § 7a (1) sentence 1 number 2 of the Animal Protection Act or b) serves research with a view to the conservation of species, and 2. it is scientifically justified that the purpose of the animal experiment referred to in point 1 cannot 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 artificially propagated animals pursuant to Article 7(1) of Regulation (EC) No 338/97; sentence 2 shall not apply to animal experiments which serve basic research. 3. which are particularly stressful, TierSchVersV: § 25 Performance of particularly distressing animal experiments (1) Experiments on vertebrate animals or cephalopods which cause significant pain or suffering which is likely to be prolonged or repetitive in the animals used shall only be carried out if the intended results suggest that they will be of outstanding importance for essential human or animal needs, including the resolution of scientific problems. (2) Animal experiments referred to in paragraph 1 shall not be carried out if the significant pain or suffering is 16  prolonged and cannot be alleviated. By way of derogation from the first sentence, the competent authority may authorise the performance of an animal experiment in accordance with the first sentence if the conditions of paragraph 1 are met and it is scientifically justified that the performance of the animal experiment is indispensable because of the importance of the knowledge sought. to prohibit or restrict, in particular to make such prohibition or restriction dependent on approval or the fulfilment of further requirements going beyond § 8 (1) sentence 2 numbers 2 to 8. (Legislator provides here for the possibility of a later tightening). (4) The Federal Ministry is authorised, to lay down requirements for 1. premises, installations and objects intended for the performance of animal experiments, TierSchVersV: § 15 Requirements for premises and facilities (1) Experiments on vertebrate animals and cephalopods may only be carried out on the premises of an institution. …. By way of derogation from the first sentence, an animal experiment may be carried out outside a facility or establishment if it is scientifically justified that this is necessary in view of the purpose of the experiment. (2)...the premises, equipment and objects at the facility... intended for the performance of animal experiments on vertebrate animals and cephalopods must 1. be suitable for that purpose and meet the requirements set out in point 1.3 of Part A of Annex III to Directive 2010/63/EU, and 2. ensure by their design, construction and functioning that animal experiments are targeted to obtain reliable results using the minimum number of animals and causing the least pain, suffering and harm. 2. the capture of wild animals for use in animal experiments, including the subsequent treatment of the animals, and the knowledge and skills required for this purpose, and 3. the re-use of animals in animal experiments TierSchVersV: § 18 Reuse of vertebrates and cephalopods (1) A vertebrate animal or cephalopod which has already been used in a research project may be used in a further research project for which a previously unused animal could also be used, only if 1. the animal has not been used in an animal experiment which is to be classified as 'severe' in accordance with Article 15(1) in conjunction with Annex VIII to Directive 2010/63/EU, 2. his general state of health and well-being have been fully restored 3. the animal is not used in any animal test which is to be classified as "severe" in accordance with Article 15(1) in conjunction with Annex VIII to Directive 2010/63/EU, and 4. the re-use is in accordance with a veterinary recommendation which takes into account the nature and extent of the pain, suffering and distress experienced by the animal throughout its life history. (2) By way of derogation from paragraph 1(1), the competent authority may authorise the use of a vertebrate animal or a cephalopod in a further experimental project if the animal 1. has not been used more than once in an animal experiment which is to be classified as 'severe' in accordance with Article 15(1) in conjunction with Annex VIII to Directive 2010/63/EU, 2. is not used in the further course of the experimental project in an animal experiment which is to be classified as 'severe' or 'moderate' in accordance with Article 15(1) in conjunction with Annex VIII to Directive 2010/63/EU, and 3. has previously undergone a veterinary examination. The Federal Ministry is also authorised, to regulate the treatment of an animal used in an animal experiment after the animal experiment has been completed, and in doing so 1. to provide that the animal must be presented to a veterinarian 2. to provide that the animal is to be killed under certain conditions, and TierSchVersV: § 27 Achievement of purpose (1) Once the purpose of an animal experiment has been achieved, measures shall be taken to minimise the pain, suffering and harm to the animals used. (2) Animal experiments shall be designed and conducted in such a way that the purpose of the experiment can be achieved without causing the immediate death of the animals used. In particular, it must be ensured that the impending death of an animal as a result of the test is detected as early as possible and that in such a case the animal is killed without delay, avoiding pain and suffering as far as possible. The first and second sentences shall not apply where the death of the animals used immediately under the test is essential to achieve the purpose of the experiment; in this case the experiment shall be conducted in such a way that 17  1. as few of the animals used as possible die, and 2. the duration and intensity of the pain and suffering of the animals is reduced to the lowest possible level and death is ensured while avoiding pain and suffering as far as possible. TierSchVersV: § 28 Procedure after completion, post-treatment (1) On completion of an animal experiment, a veterinarian or other competent person shall decide whether a vertebrate animal or a cephalopod used, the further use of which is no longer provided for in the particular experimental project, shall be kept alive or, if there is a reasonable reason for doing so, killed. If primates, solipeds, cloven-hoofed animals, dogs, hamsters, cats, rabbits or guinea pigs have been used, they must be presented without delay to a veterinarian for examination. (2) Where, after completion of an animal experiment, a vertebrate animal or cephalopod used can, in the opinion of the veterinarian or qualified person, survive only with more than minimal pain, suffering or injury, the animal shall be killed immediately and painlessly. (3) Animals other than those referred to in paragraph 2 shall be killed painlessly where there are reasonable grounds for doing so and where, in the judgment of a competent person, this is necessary. (4) If an animal is to be kept alive after the completion of an animal experiment, it must be cared for and housed in a manner appropriate to its state of health, under the supervision of a veterinarian or other competent person and, if necessary, receive medical care. 3. to lay down requirements for the further keeping and medical care of the animal. TierSchVersV: § 10 Other housing or release of vertebrates and cephalopods (1) Vertebrate animals or cephalopods which have been used or which were intended to be used in animal experiments but are no longer intended to be used may be permanently removed from a facility... or placed in a husbandry system appropriate to the species or, in the case of animals taken from the wild, a suitable habitat, provided that 1. the state of health of the animals allows it, 2. the animals do not pose a risk to the health of humans or other animals or to the environment, and 3. appropriate measures have been taken to ensure the welfare of the animals (2) Any person accommodating animals in accordance with paragraph 1 shall have a programme for such accommodation which ensures the habituation of the animals to be accommodated. Where necessary for animal welfare reasons, animals taken from the wild may only be moved to a suitable habitat as part of a release programme. (5) Records must be kept of the animal experiments (the so-called §9 records). The Federal Ministry shall be authorized to regulate the details in accordance with sentence 1; it may stipulate that the records must be retained and presented to the competent authority on request. TierSchVersV: § 29 Keeping records of animal experiments (1) The records to be kept in accordance with § 9 (5) sentence 1 of the Animal Protection Act shall state for each experimental project in which vertebrates, cephalopods or decapods are used, the purpose as well as the number and type of animals used and the type and performance of the animal experiments as well as the names of the persons who performed the animal experiments. Where vertebrate animals are used, their origin must also be indicated, including the name and address of the previous owner. In the case of dogs, cats and primates, the sex, a mark on the animal in accordance with § 9 and, in the case of dogs and cats, the breed must also be stated. (2) The records referred to in paragraph 1 shall be signed by the persons who have carried out the animal experiments and by the person responsible for the experimental project or his representative. If the records are generated electronically, they shall be printed out immediately after the completion of each part of the experiment and signed by the experimentation manager or his representative. …. Records of an experimental project must be kept for five years from the date of completion of the animal experiment and must be made available to the competent authority on request. If the records are made electronically, they shall immediately after the completion of each sub-trial of the project… 1. be printed out and signed by the head of the experiment or his/her deputy; or 2. time-stamped by the head of the experiment or his deputy using an advanced electronic signature, stored on a durable medium and printed out at the request of the competent authority. Subject to other legal provisions, personal data contained in these records shall be deleted immediately after expiry of the retention period pursuant to sentence 4 or, in the case of electronic storage, automatically if technically possible. (6) The head of the experimental project or, if he is prevented from doing so, his deputy, shall ensure that 18 1. of the regulations a) the second sentence of § 7(1), point 1 and sentence 3, § 7a(2), points 1, 4 and 5 and the first sentence of § 9(5), and b) the fourth sentence of § 7(1), and 2. the provisions of the regulations adopted on the basis of paragraphs 1 to 5. The Federal Ministry shall be authorised, to regulate the details of the obligation pursuant to sentence 1 TierSchVersV: § 30 Duties of the head (1) The head of the experimental project or, if he is prevented from doing so, his deputy shall ensure that the provisions of §§ 15 to 25 and 27 to 29 are complied with. (2) The head of the experimental project or, if he or she is prevented from doing so, his or her representative, shall ensure that any avoidable pain, suffering or injury caused to an animal during the conduct of the experimental project is stopped immediately. He shall also ensure that the experimental project 1. in accordance with the approval pursuant to § 8 (1) sentence 1 of the Animal Welfare Act or, in the case of an experimental project pursuant to § 8a (1) of the Animal Welfare Act, in accordance with the information in the notification pursuant to § 36 (1), and 2. taking into account all orders, requirements and conditions of the competent authority in relation to the experimental project is performed. In doing so, he shall ensure that appropriate corrective action is taken in the event of any such deviation and that records are kept of the deviations and the corrective action taken. (3) The head of the experimental project or his deputy shall ensure that the possibilities for improving the welfare of the animals are taken into account in the planning and implementation of the experimental project. Sixth Section - Animal Welfare Officers § 10 (1) Establishments and plants where vertebrates or cephalopods, 1. which are intended to be used in animal experiments, or 2. whose organs or tissues are intended to be used for scientific purposes are kept or used, must have animal welfare officers and, where this is stipulated, other persons (Animal Welfare Committee) who are obliged to pay particular attention to the protection of animals Sentence 1 shall also apply to facilities and establishments where the animals referred to therein are bred or kept for the purpose of supplying third parties. Facilities and holdings, 1. in which vertebrate animals are killed for scientific purposes in accordance with § 4 paragraph 3, or 2. in which interventions pursuant to § 6 (1) sentence 2 number 4 are carried out must also have animal welfare officers pursuant to sentence 1. (2) The animal welfare officers and other persons shall carry out their duties in particular by advising the institution or holding for which they work and the persons employed there, and by issuing opinions. The Federal Ministry is authorized to regulate the details of the Animal Welfare Officers and other persons by statutory instrument and to lay down provisions on 1. the procedure for their appointment, 2. their expertise, 3. their duties and obligations, in particular with regard to ensuring that animals are kept, killed and used competently and in a manner compatible with their welfare, and 4. internal measures and arrangements to ensure the effective discharge of the tasks and obligations referred to in point 3 to be enacted. In doing so, the Federal Ministry may 1. provide that the animal welfare officers and other persons are to work together in advisory committees, 2. specify the tasks and composition, including the management, of the advisory committee referred to in point 1, and 3. require that records of the activities of the advisory committee referred to in point 1 be made, kept and presented to the competent authority on request. TierSchVersV §4 Organisational duties 19 For institutions and establishments... the institution or body responsible... shall appoint one or more persons locally who 1. be responsible for supervising the care and welfare of animals in the establishment or on the holding, 2. ensure that persons handling the animals have access to information on the species housed in the establishment or on the holding, and 3. make sure that a) the persons entrusted with tasks relating to the care or killing of the animals meet the requirements of § 3 (1) and b) persons who carry out animal experiments meet the requirements of § 7 (1) sentence 3 of the Animal Protection Act and § 16 and are continuously trained in this respect and supervised until the required skills have been demonstrated in practice. § 5 Animal welfare officer (1)... has... to appoint one or more animal welfare officers... (2) The animal welfare officer may not at the same time be the person responsible for breeding or keeping the animals within the meaning of § 11 (1), first sentence, number 1. The competent authority may allow exceptions... If an animal welfare officer... carries out an experimental project himself, another animal welfare officer must be employed for this experimental project. (3) Only persons with a university degree in veterinary medicine may be appointed as animal welfare officers. They must have the knowledge, skills and reliability required to carry out the tasks referred to in paragraph 4. The animal welfare officer shall maintain the knowledge and skills necessary for his or her tasks by means of regular further training in line with the state of the art in science and technology. The competent authority may approve exceptions to the first sentence if 1. the appointment of another specialised person is more suitable than the appointment of a person with a university degree in veterinary medicine, and 2. the person has demonstrated the knowledge and skills required in accordance with sentence 2. (4) The Animal Welfare Officer is obliged 1. to ensure compliance with rules, conditions and requirements in the interest of animal welfare; and 2. to advise the establishment or holding and the persons responsible for keeping the animals, in particular on the welfare of the animals and ways to improve their wellbeing when they are acquired, their keeping and care, and on their medical treatment. The Animal Welfare Officer...is also obliged 1. to give its opinion on any application for authorisation of an experimental project and to submit this opinion to the competent authority on request, 2. to work internally towards the development and introduction of procedures and means to meet the requirements of § 7 (1) sentence 2 and § 7a (2) numbers 2, 4 and 5 of the Animal Protection Act, and 3. to advise persons involved in the performance of animal experiments, in particular with regard to the application of the methods and means referred to in point 2, and to keep them informed of technical and scientific developments in this respect. (5) The establishment or holding shall appoint the animal welfare officer 1. to assist him in the performance of his duties in such a way as to enable him to carry out his functions fully; and 2. in the cases of paragraph 4 sentence 2, to be informed of all experimental projects. They shall ensure that the animal welfare officer receives regular further training. (6) The Animal Welfare Officer shall be free from instructions in the performance of his or her duties. He shall not be disadvantaged in the performance of his duties. His position and his powers are to be regulated by statutes, internal instructions or in a similar form. It shall be ensured that the animal welfare officer is able to make his or her suggestions or concerns directly to the competent body in the establishment or on the holding. Where several animal welfare officers are appointed, their terms of reference shall be defined. § 6 Animal Welfare Committee (1)...has... to appoint an animal welfare committee. The animal welfare committee shall include at least any animal welfare officer referred to in § 5, 1. the persons responsible for supervising the care and welfare of the animals in the establishment or on the holding; and 2. a scientific member, if animal experiments are carried out in the facility or establishment. The animal welfare committee is chaired by an animal welfare officer. 20  (2) The Animal Welfare Committee has the task 1. to support the animal welfare officers in the fulfilment of their tasks in accordance with § 5 (4) sentence 1 number 2 and sentence 2 numbers 2 and 3 2. Participate in the establishment of internal operating procedures relating to the performance, evaluation and follow-up of animal welfare monitoring and to the verification of compliance with those procedures, 3. to follow the development of animal experiments and their results, taking into account the effects on the animals used, and 4. to act in an advisory capacity with regard to the development and implementation of programmes in accordance with § 10 paragraph 2 5. in regards to all personnel of the institution or establishment involved in animal experiments and in the breeding, keeping, care and killing of animals a) to advise on compliance with the requirements of § 7(1), sentences 2 and 3, and § 7a(2)(2), (4) and (5) of the Animal Welfare Act and on measures to improve the breeding, housing and care of animals and the procedures used in the killing of animals (b) to keep informed of technical and scientific developments to meet the requirements of the second and third sentences of § 7(1) and of § 7a(2)(2), (4) and (5) of the Animal Welfare Act and to improve breeding, housing and care and the procedures used to kill animals, in particular developments on ways to improve animal welfare, 6. to monitor developments and the results of animal experiments, taking into account the impact on the animals used; and 7. to identify factors, also on the basis of findings from in-house experiments, that contribute to further compliance with the requirements of § 7(1), sentences 2 and 3, and § 7a(2), numbers 2, 4 and 5, of the Animal Welfare Act and to improving breeding, housing and care and the procedures used in the killing of animals, and to make appropriate recommendations, in particular to improve animal welfare. The Animal Welfare Committee may also advise the staff of the establishment or holding involved in the keeping, use or breeding of animals, in particular on their welfare. (3) The Animal Welfare Officer may make submissions to the Animal Welfare Committee. (4) The sponsor... must ensure that records are kept of recommendations made by the Animal Welfare Committee... and that these are retained for at least three years. The records shall be made available to the competent authority on request. Seventh section - Breeding, keeping of animals, trade in animals § 11 (1) Who wants to breed or keep 1. Vertebrates or cephalopods for scientific purposes including for the purpose of supplying these animals to third parties, a) which are intended to be used in animal experiments, or b) whose organs or tissues are intended for used for scientific purposes, requires permission (The so-called $11 permission.) the competent authority. … (2) The Federal Ministry shall be authorised, in the cases of subsection (1), first sentence 1. the details of the form and content of the application for a permit pursuant to the first sentence of paragraph 1, 2. the conditions and procedure for granting the licence, 3. the content of the permit, in the case of paragraph 1, first sentence, point 1, only to the extent necessary for the implementation of acts of the European Union, and 4. the procedure to be followed in the event of subsequent changes to the facts essential to the granting of the licence, including the obligation to notify such changes, to settle. Ordinances pursuant to sentence 1 require the consent of the Federal Ministry of Education and Research if they concern the breeding or keeping of animals pursuant to paragraph 1 sentence 1 number 1 or 2. TierSchVersV: § 11 Conditions for permission 21  (1) Permission pursuant to § 11 paragraph... may only be granted if 1. the person responsible for the activity has, by virtue of his training or previous professional or other dealings with animals, the technical knowledge and skills required for the activity 2. the person responsible for the activity has the necessary reliability, 3. in the institutions and establishments serving the activity a) suitable premises and facilities are available, and b) there are sufficient competent personnel available, so that the keeping of the animals in accordance with the requirements of § 2 of the Animal We