An animal experiment can only be approved and carried out if proof is shown that
- the result cannot be found in already existing literature,
- the result cannot be achieved by other means,
- the number of animals is limited to the absolute minimum,
- the living conditions are appropriate to the species and competent supervision is guaranteed, and
- the relevant requirements for the experiment and the involved persons are met.
Every staff member has to prove that he or she has completed the necessary additional training. This includes training on the living conditions, care, and correct handling of the animals. A core element is also the 3-R-principle:
- Replace: If possible, animal experiments shall be replaced by other methods
- Refine: The suffering of the animals shall be limited to the absolute minimum
- Reduce: The number of animals shall be kept to the absolute minimum
This means that every experiment has to be approved by the Regional Council. In the process of approval, according to Sec. 15 TierSchG, the Regional Council is supported by an advisory commission. At least one third of the commission members are appointed following the suggestions of animal protection organizations.
Not only experiments but also animal husbandry at the University of Hohenheim is authorized by the government. Experiments, animal husbandry, and animal protection are supervised by the Veterinary Offices.
All approved experiments in Germany are published by the Federal Institute for Risk Assessment (bfR) in the database AnimalTestInfo. Furthermore, the use of vertebrates or cephalopods in animal experiments or for certain scientific purposes statistically is recorded each year and published by the Federal Ministry of Food and Agriculture (BMEL).
Requirements and documents for applications and notifications
Interventions or treatments for experimental purposes require agency approval if
- they are done on animals and could be linked to pain, suffering, or harm for these animals,
- they are done on animals and could lead to animals be born or hatched who have pain, suffering, or harm, or
- they are done on the genetic material of animals and could be linked to pain, suffering, or harm for these animals with the genetic modifications or the animals carrying them to term,
Experiments requiring notification to authorities:
- by law, legal ordinance, or administrative regulation (Sec. 8a(1) No. 1 TierSchG).
- Vaccinations, drawing blood, or other diagnostic measures according to proven procedures (Sec. 8a(1) no. 2 TierSchG) to determine or check illnesses
- Removing organs/tissue according to proven procedures for diagnostic purposes (not for experimental purposes) (Sec. 8a(1) no. 3 TierSchG)
- Interventions and treatments for purposes of training, education, or continuing education according to proven procedures (Sec. 8a(1) no. 4 TierSchG); procedures not proven on-site are considered by the authorities to require approval
- Experiment on decapods (Sec. 8a(3) TierschG)
The notification procedure is not possible, however, for experiments with primates and “seriously” stressful experiments.
How the procedure works
Please plan on at least 3 months for the decision on your application.
1. Complete and submit form
The form must be submitted to the Animal Protection Representative. Experiment applications must be forwarded to the Regional Council by the Animal Welfare Officer, as with all correspondence with the agency. Please note that only complete applications can be forwarded to the Regional Council. Only applications that have been signed or taken note of by the Animal Welfare Officer will be processed by the Regional Councils. When completing the request, the Animal Welfare Officer is happy to assist you.
Applications requiring approval
The following documents must be submitted:
- 3x complete application including two originals and one copy
- 6x application (RP Tübingen: starting with Point 2, RP Stuttgart: starting with Point 7)
- 3x personnel forms
- 9x publications, biometric planning / reviews, score sheet
- NTP (non-technical project summary: Create the NTP in the password-protected area of the database “AnimalTestInfo-Antragsteller,” print it as a pdf including the assigned ten-digit identification number (NTP-ID), and include it with the application to the Regional Council and Animal Welfare Officer. For the Regional Council Tübingen, you should also note this ID on the first page of the application form. If the project is approved, the NTP is authorized directly by the government.
Applications requiring notification
The following documents must be submitted:
- 3x complete application (1 original, 2 copies)
- 3x annexes (1 original, 2 copies)
2. Evaluation by the Regional Council (Regierungspräsidium)
The Animal Welfare Officer submits a position on the experiment and forwards the request to the veterinary office that is responsible for monitoring animal living conditions and also forwards the request to the Regional Council.
The Regional Council reviews the application in regard to completeness and sends the person submitting the application and the Animal Welfare Officer a notification of receipt. Experiments for which the authorities need to be notified are usually processed directly by the government. For experiments that require approval and any notifications of changes for approved experiences, an Animal Experiment Committee advises the government. It is made up of 4 scientific representatives and 2 representatives from animal welfare organizations. The sessions take place regularly every 6-8 weeks, and the applications should be sent at least 2-3 weeks before the session. Not until the Animal Experiment Committee has met can the government grant or reject approval or forward the Committee’s questions to the person submitting the application. The person submitting the application should only respond to these questions in a response letter without re-writing the application and submitting it again. In contrast, a notification is reviewed directly by the Regional Council. You will receive an acknowledgement that your application was received with the time limit of the project or questions from the agency.
The forms are only available for logged-in university employees.
All experiments on animals that have a purpose and are not linked to pain, suffering, or damage (e.g. feed experiments, behavioral studies), as well as the killing of animals for scientific purposes without previous treatment do not need to be approved and registered with the authorities.
How the procedure works
Animal Welfare Officer must be informed 2 weeks in advance.
To kill animals according to Sec. 4(3) TierSchG, you will receive a T number, for all other notifications an S number. Only after receiving this internal experiment number and the signature of the operations manager (for other notifications) can you start the experiment. The length of experiments requiring internal notification is limited to 3 years. Also for these experiments you have to explain the indispensability based on the current state of scientific knowledge and the 3-R-principle. Furthermore you have to prove that all persons involved have the necessary expertise and give reasons for the number of animals. Please note that for killing according to Sec. 4(3) TierSchG is subject to registration with the authorities.
The forms are only available for logged-in university employees.
Additional information
There is an obligation to record and label when keeping and breeding vertebrates and cephalopods. Records on the origin and what happens to the animals must be kept. A record book with continual entries on every change to the number of animals must be kept. Information must be recorded on the number and type as well as origin of the animals, including the name and address of the person from whom the animals were purchased. The number and type of animals that were killed or died due to other reasons in an institution or operation including the cause of death (if known) and any particularities related to their health must be recorded. The records must be retained for at least five years.
In the context of an animal experiment, the head of the project has a legal obligation to record information on the experiment. In these records, for each experiment in which vertebrates, cephalopods, or decapods are used, the purpose, number, and species of the animals used and the type and implementation of the animal experiments as well as the names of the people who carried out the experiments must be listed. If vertebrates are used, their original including the name and address of the previous owner must be entered. The records are to be signed by the people who carried out the experiment and from the head of the project or his assistant. If the records are created electronically, they must be printed out immediately after the conclusion of each experiment in the project and signed by the head or his assistant. The records are to be retained for five years as of the conclusion of the experiment and submitted to the responsible authorities upon request. If this requirement is violated, this represents an administrative offense.
In both cases, Sections 239 and 261 of the German Commercial Code shall apply mutatis mutandis.
Assistants in animal experiment projects must be included in the application or registered by the head of the experiment before starting work. For each person and each application, please include copies of a personnel information sheet and the necessary proof of qualification (transcripts, course certificates, etc.). Animal experiments may only be carried out by the following people.
Non-operative interventions
- completed university degree in veterinary medicine, medicine, or dentistry
- completed natural science university degree (with proven knowledge and abilities in the required areas)
- completed vocational training (if the required knowledge and abilities are included in the curriculum of this vocational education program)
The responsible authorities may approve exceptions if proof of the required knowledge and abilities can be shown in another way. To obtain the required knowledge and abilities, participation in animal experiment courses is recommended. For people who carry out or participate in experiments, a course should make up 40 hours in order to obtain the knowledge required according to Annex 1(2 and 3) of the TierSchVersV. Such a course (rodent-specific) is offered once a year at the University of Hohenheim. For the position of the head/assistant head, a course should be 80 hours. Proof of the number of hours and content of the course must be given, and the knowledge must be confirmed by a successfully completed examination.
Operative interventions
An operative intervention (definition: more than a punctiform separation of the skin or mucous membranes) may only be carried out by one of the following people:
- completed university degree in veterinary medicine, medicine, or dentistry
- completed natural science university degree (with proven knowledge and abilities in the required areas)
The responsible authorities may approve exceptions if proof of the required knowledge and abilities can be shown in another way.
Anesthesia
Only people who fulfill the requirements may administer anesthesia in animal experiments. Insofar as administering the anesthesia serves the purpose of education or continuing education, this must be done in the presence and under the supervision of a qualified person.
- completed university degree in veterinary medicine, medicine, or dentistry
- completed natural science university degree (with proven knowledge and abilities in the required areas)
- completed vocational training (if the required knowledge and abilities are included in the curriculum of this vocational education program)
Here the authorities cannot grant exceptions. If anesthesia was not already learned in the context of vocational training, this cannot be done at a later point in time.
- Extension requests should be submitted around 8 weeks before the approval expires! It is not possible to retroactively request an extension after the approval period has expired.
- In an informal letter, please give reasons for why the experiment is not yet completed, why the timeline could not be kept as in the initial application, and whether the goal of the experiment is still scientifically relevant.
- An experimental project is approved for a maximum of 5 years. For animal experiments that were initially approved for a shorter period of time, an informal, reasoned request for an extension of a maximum of one year may be submitted up to two times insofar as the total time of 5 years is not surpassed. Please enter the time period for which the approval should be extended and whether the experiment is to be continued as per the original plan and as approved.
- Enter the number of animals used up to the present and the number of animals remaining from the approval. If the number of animals approved is to be increased, reasons must be given.
Please note that any change in the project head and assistant, other people in the experimental plan who carry out interventions or anesthesia, and any change to what was approved, e.g. number or species of animals, experimental design/methods, purpose of experiment, total stress, must be immediately reported to the Animal Welfare Officer and she then reports this to the Regional Council.
Changes that retain the purpose of the experiment, in which no increased stress to the animals ensues, and in which the number of animals used is not significantly increased (usually <10%), can usually be reported in advance with an informal request to the Regional Council.
If the changes go beyond this, however, then they require approval! In the end, the final decision as to whether the change must only be reported or whether it requires approval lies with the Regional Council.
Ending an experiment must be reported to the Animal Protection Representative and the government at the latest after 4 weeks and must include the number of animals actually used.
As of 2014, there are no regulations for registration of the use of experimental animals. The use of vertebrates or cephalopods in animal experiments or for certain scientific purposes is statistically recorded each year by the BMEL on the basis of the Experimental Animal Registration Ordinance (Versuchstiermeldeverordnung). All heads of experiments, who are responsible for animal experiments requiring approval and notification according to Sec. 7(2) TierSchG and for killing according to Sec. 4(3) TierSchG during the reporting year (Meldejahr), are obliged to registration. Two uses are differentiated in the annual report. For this, the species, origin, and number of vertebrates or cephalopods used, the purposes and type of animal experiments, and the actual degree of severity in the animal experiment must be reported to the responsible Regional Council for each calendar year by 31 March of the following year.
To report, please use the Excel file created by the BMEL. Please use one Excel list for each Regional Council. If you have not used any animals for a project in the reporting year, please indicate animal number 0 in the form. Please send your experimental animal report from the previous year electronically to the Animal Welfare Officer by 31 January. She will generate the experimental animal reports for the University of Hohenheim for the Regional Councils of Stuttgart and Tübingen and forward them to the correct Regional Councils.
To make the annual report easier, it makes sense to maintain a list in ongoing experiments, as multiple lines per experiment can be necessary due to the various genetic status, treatments with different stress levels, and a possible re-use or multiple use of the animals.
The breeding of genetically modified lines of animals is subject to approval if the animals may experience pain, suffering, or damage. This also applies to the import of such lines. In case of the abovementioned stress (pain, suffering, or damage), the breeding is subject to approval before the import. Please ask in the course of the import if the animal line has already been evaluated. This way, the stress evaluation can be given to the Regional Council as proof. Only if the evaluation indicates that the animals are not subject to stress due to their genotype is approval no longer necessary. The Federal Institute for Risk Assessment (BfR) has set down criteria for the evaluation of stress of lines possibly subject to stress. The Animal Welfare Officer has the right to consult the Animal Protection Committee in case of an unclear evaluation.
Importing experimental animals from third countries may require approval.
Discuss details with the Animal Welfare Officer.
