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Regulation on the reporting of vertebrate animals or cephalopods used for experimental purposes or vertebrates used for certain other purposes

Original Language Title: Verordnung über die Meldung zu Versuchszwecken verwendeter Wirbeltiere oder Kopffüßer oder zu bestimmten anderen Zwecken verwendeter Wirbeltiere

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Regulation on the reporting of vertebrate animals or cephalopods used for experimental purposes or vertebrate animals used for certain other purposes (Regulation on the subject of experimental animals)

Unofficial table of contents

VersTierMeldV 2013

Date of completion: 12.12.2013

Full quote:

" Ordinance of 12 December 2013 (BGBl. I p. 4145) "

Replacing V 7833-3-13 v. 4.11.1999 I 2156

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof: 18.12.2013 + + +) 
(+ + + For application cf. § 4 + + +)

The V was referred to as Article 1 of the V v. 12.12.2013 I 4145 from the Federal Ministry of Food, Agriculture and Consumer Protection after consultation of the Animal Protection Commission, in agreement with the Federal Ministry of Education and Research and the Federal Ministry of Transport, Building and Urban Development, with the approval of the Federal Council. She's gem. Art. 8 (1) of this V entered into force on 18.12.2013. Unofficial table of contents

§ 1 Reporting procedure

(1) If animal testing is carried out in accordance with Article 7 (2) of the Animal Protection Act on vertebrate animals or cephalopods, the competent authority shall provide information on:
1.
the nature, origin and number of vertebrates or cephalopods used,
2.
Purpose and type of animal testing and
3.
the severity of the animal tests referred to in Article 15 (1), in conjunction with Annex VIII to Directive 2010 /63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 327, 22.12.2010, p. (OJ L 276, 20.10.2010, p. 33)
shall be notified in accordance with paragraph 2. The first and second sentence of the first sentence of paragraph 1 shall apply in the case of the use of vertebrate animals in accordance with the first sentence of Article 4 (3) of the Animal Protection Act Sentences 1 and 2 shall not apply to the use of animals as defined in Section 14 (1) (b) of the Animal Welfare Ordinance of 1 August 2013 (BGBl). 2) The reports shall be submitted in electronic form for each calendar year up to 31 March of the following year, with the content according to the model of the Appendix. Unofficial table of contents

§ 2 Delivery procedures

By 30 June of the following year, the competent authority shall forward to the Federal Ministry for Food, Agriculture and Consumer Protection all notifications made in a country for a calendar year in anonymized form. Unofficial table of contents

§ 3 Administrative Offences

Contrary to § 18 (1) (3) (b) of the Animal Welfare Act, who intentionally or negligently contrasts with § 1, paragraph 1, sentence 1, also in connection with sentence 2, a notification not, not correct, not complete or not in time. Unofficial table of contents

§ 4 Transitional provision

For the notifications for the calendar year 2013, the experimental registration regulation of 4 November 1999 (BGBl. 2156), as last amended by Article 3 of the Regulation of 1 August 2013 (BGBl). 3125), with the proviso that references to the Animal Protection Act are to be considered as references to the Animal Protection Act in the version valid up to 13 July 2013. Unofficial table of contents

Appendix (to § 1 paragraph 2) Notification of vertebrate animals used in animal experiments or cephalopods or vertebrates used in accordance with Section 4 (3) of the Animal Welds Act for the year: ______

(Fundstelle: BGBl. I 2013, 4147-4152)

A EU transmission
B ID 1
C ID 2
D Usage
E Animal species
F Other species
G Number of animals used
H Reused
I Birthplace
Y Primate birthplace
C Primate Generation
L Genetic status
M Creation of a new genetic line
N Purpose
O Other use
P Legally required review after ...
Q Other legal basis
R Legal Source
S Severity
T Experimental projects
U Note



Information on how to fill out the survey sheet


1.
A l l g e m e i n e r l ä u t e r u n g e n The data refer in principle to all vertebrate animals and cephalopods, which in the period under review in animal experiments according to § 7 (2) of the Animal Protection Act as well as to all vertebrate animals, according to § 4 (3) of the Animal Protection Act Genetically modified animals are used in accordance with the Explanatory Notes to Annex II (A) of Commission Implementing Decision 2012/707/EU of 14 November 2012 establishing a common set of animals for the protection of animals. Format for presentation of the information in accordance with Directive 2010 /63/EU of the European Parliament and on the protection of animals used for scientific purposes (OJ L 136, 31.7.2006, p 33). Do not report:
-
Cephalopods, which have been used in accordance with Article 4 (3) of the Animal Protection Act,
-
Föten of mammals,
-
animals in the larval stage which are not yet able to receive food independently; and
-
Sentineltiere.
Animals born and living, including caesarean section, as well as larval animals which are able to receive food independently, are to be counted. Any use of an animal must be reported at the end of the trial. For experimental projects over two calendar years, the data on the animals shall be reported for the year in which they are killed or die or are no longer used in the trial project. electronic form on the basis of an electronic recording sheet. In addition to the columns F, G, O, Q and U, it is possible to choose between predetermined options. If the "Other ..." option is specified in columns E, N, and P, the columns F, O, Q and, if applicable, the following columns will be used. in column U, particulars of animals of an animal species shall, in principle, be entered on a line, provided that they have been used in a project which has been similar in relation to the aspects covered by the Directive. Within a row, only one option can be specified per column. Therefore, in the case of complex projects in which several options in one column are satisfied, the data can be broken down in several lines. Constant options, such as B. the purpose of use, should be entered in each line.
2.
E r u t e r u n t h e n t h e n t h e n t h e n t o n t h e n t h e n t h e

Columns A, B, and C:These columns are not to be completed. They are used for administrative processing.

Column D:Es is to be specified whether a use in animal testing is carried out in accordance with Section 7 (2) of the Animal Protection Act (T1) or in accordance with Section 4 (3) of the Animal Protection Act (T2).

Column E:It is one of the following animal species to be specified:

(A1) Mice (Mus musculus)
(A2) rats (Rattus norvegicus)
(A3) Meerschweinchen (Cavia porcellus)
(A4) Goldhamster (Mesocricetus auratus)
(A5) Chinese Grey Hamster (Cricetulus griseus)
(A6) Mongolian racing meds (Meriones unguiculatus)
(A7) Other Nager (other Rodentia)
(A8) Rabbit (Oryctolagus cuniculus)
(A9) Cats (Felis catus)
(A10) Dogs (Canis familiaris)
(A11) ferrets (Mustela putorius furo)
(A12) Other carnivores (other carnivora)
(A13) Horses, donkeys and intersections (Equidae)
(A14) Pigs (Sus scrofa domesticus)
(A15) Goats (Capra aegagrus hircus)
(A16) Sheep (Ovis aries)
(A17) Cattle (Bos primigenius)
(A18) Halbaffen (Prosimia)
(A19) Marmosettes and Tamarine (e.g. B. Callithrix jacchus)
(A20) Javanerapes (Macaca fascicularis)
(A21) Rhesus monkeys (Macaca mulatta)
(A22) Green Meerkatzen (Cholorocebus spp. (as a rule pygerythrus or sabaeus))
(A23) Paviane (Papio spp.)
(A24) Totenkopfaffen (e. g. B. Saimiri sciureus)
(A25) Other types of non-human primates (other types of Ceboidea and Cercopithecoidea)
(A26) Great Apes (Hominoidea)
(A27) Other mammals (other Mammalia)
(A28) domestic chickens (Gallus gallus domesticus)
(A29) Other birds (other Aves)
(A30) Reptiles (Reptilia)
(A31) Frösche (Rana temporaria and Rana pipiens)
(A32) Krallenfrösche (Xenopus laevis and Xenopus tropicalis)
(A33) Other amphibians (other Amphibia)
(A34) Zebrabärblinge (Danio rerio)
(A35) Other fish (other Pisces)
(A36) Cephalopoda (cephalopoda)


Cephalopods and fish shall be indicated from the time at which the animal is able to receive food independently.

Column F:If the option "Other ..." is specified in column E (A7, A12, A25, A27, A29, A33, A35), the animal species used should be entered in the same line.

Column G:The number of animals used shall be indicated. With regard to the fish and cephalopods used, the indication, unless otherwise possible, can be made on the basis of estimated values.

Column H:It is necessary to indicate whether the animals were once again used in a trial project (Ja/No). If both animals were used for the first time as well as for the first time in the test project, the data should be broken down in several lines.

Column I:The place of birth of the animals used, except for primates, shall be indicated. The place of birth of animals re-used shall not be disclosed.

(O1) Animals born in the EU in a registered breeding farm
(O2) In the EU, however, animals not born in a registered farm
(O3) Animals born in the rest of Europe
(O4) Animals born in the rest of the world


Column J:The column is to be completed only when primates are used.

(NHPO1) In the EU, animals born in a registered breeding farm
(NHPO2) In the rest of Europe, born animals
(NHPO3) Animals born in Asia
(NHPO4) Animals born in America
(NHPO5) Animals born in Africa
(NHPO6) Animals born in other parts of the world


Column K:The generation of primates used shall be indicated. As long as the colony does not receive itself, animals born into this colony are to be recorded under F0, F1, F2 or higher, according to their generation led by maternal side.

(NHPG1) F0
(NHPG2) F1
(NHPG3) F2 or higher
(NHPG4) Self-sustaining colony


Column L:The genetic status of the animals used (GS1, GS2, GS3) shall be indicated in accordance with the Explanatory Notes to Annex II (B) (6) of the Implementing Decision 2012 /707/EU.

(GS1) Genetically not changed
(GS2) Genetically modified without pathological phenotype
(GS3) Genetically modified with pathologist phenotype


Column M:It is necessary to indicate whether the use of the creation of new genetically modified lines/tribes has been used (Ja/No). Animals used for the creation of new genetically modified lines/strains are those which are used to create a new genetically modified line or strain and from other animals that have been used for "basic research" or other animals. Research is subject to a distinction.

Column N:

The purpose of the use shall be indicated:

(PB1) Basic Research/Oncology
(PB2) Basic research/Cardiovascular System (blood and lymphatic vessels)
(PB3) Basic research/nervous system
(PB4) Basic Research/Atmation System
(PB5) Basic research/Gastrointestinal system, including liver
(PB6) Basic Research/Musculoskeletal System
(PB7) Basic research/Immune system
(PB8) Basic Research/Urogenitales System/reproductive system
(PB9) Basic research/sensory organs (skin, eyes, ears)
(PB10) Basic research/Endocrines System/metabolism
(PB11) Basic Research/Multisystemic
(PB12) Basic Research/Ethology, Animal Behavior, Animal Biology
(PB13) Basic Research/Other
(PT21) Translational and applied research/cancer of humans
(PT22) Translational and applied research/infectious diseases of humans
(PT23) Translational and applied research/Cardiovascular Diseases of the People
(PT24) Translational and applied research/nerves and mental disorders of the human
(PT25) Translational and applied research/respiratory diseases of humans
(PT26) Translational and applied research/Gastrointestinal disorders of the human, including the liver
(PT27) Translational and applied research/Musculoskeletal disorders of the human
(PT28) Translational and applied research/immune diseases of humans
(PT29) Translational and applied research/Diseases of the urogenital/reproductive system of humans
(PT30) Translational and applied research/Diseases of the sensory organs (skin, eyes and ears) of humans
(PT31) Translational and applied research/Diseases of the endocrine system/metabolic system of humans
(PT32) Translational and applied research/Other human diseases
(PT33) Translational and applied research/animal diseases
(PT34) Translational and applied research/animal welfare
(PT35) Translational and applied research/disease diagnosis
(PT36) Translational and applied research/plant diseases
(PT37) Translational and Applied Research/Non-regulatory Toxicology and Ecotoxicology
(PE40) Protection of the natural environment in the interest of the health or well-being of humans and animals
(PS41) Preservation of the species
(PE42) Higher education and Training for the acquisition, maintenance or improvement of professional skills
(PF43) Forensic investigations
(PG43) Conservation of colonies of established genetically modified animals which are not used in other processes
(PR51) Regulatory purpose, routine production/blood-based product
(PR52) Regulatory purpose, routine production/monoclonal antibodies
(PR53) Regulatory purpose, routine production/Other
(PR61) Regulatory purpose, Quality Control/Charge Safety Assessment
(PR62) Regulatory purpose, Quality Control/Pyrogenicity Check
(PR63) Regulatory purpose, Quality Control/Chargen potenzaudit
(PR64) Regulatory purpose, Quality Control/Other Quality Control
(PR71) Regulatory purpose/Other efficacy and tolerance testing
(PR81) Regulatory purpose, toxicity and safety tests, by type of test, acute and subacute toxicities/LD50, LC50
(PR82) Regulatory purpose, toxicity and safety tests, by type of test/acute and subacute toxicity/Other lethal methods
(PR83) Regulatory purpose, toxicity and safety tests, by type of test/acute and subacute toxicity/non-lethal methods
(PR84) Regulatory purpose, toxicity and safety tests, by type of examination/skin irritor/corrosion
(PR85) Regulatory purpose, toxicity and safety tests, according to test methods/skin sensitisation
(PR86) Regulatory purpose, toxicity and safety tests, after examination methods/eye irritation/corrosion
(PR87) Regulatory purpose, toxicity and safety tests, by type of examination/toxicity-with repeated administration/up to 28 days
(PR88) Regulatory purpose, toxicity and safety tests, by type of examination/toxicity-in the case of repeated administration/29-90 days
(PR89) Regulatory purpose, toxicity and safety tests, by type of examination/toxicity-in the case of repeated administration/> 90 days
(PR90) Regulatory purpose, toxicity and safety tests, by type of test/carcinogenicity
(PR91) Regulatory purpose, toxicity and safety tests, by type of test/genotoxicity
(PR92) Regulatory purpose, toxicity and safety tests, according to test methods/reproductive toxicity
(PR93) Regulatory purpose, toxicity and safety tests, by type of examination/developmental toxicity
(PR94) Regulatory purpose, toxicity and safety tests, according to test type/neurotoxicity
(PR95) Regulatory purpose, toxicity and safety tests, by type of examination/kinetics (pharmacokinetics, toxicokinetics, decativeness)
(PR96) Regulatory purpose, toxicity and safety tests, by type of examination/pharmacodynamics (including safety pharmacology)
(PR97) Regulatory purpose, toxicity and safety tests, by type of test/phototoxicity
(PR98) Regulatory purpose, toxicity and safety tests, by type of test/ecotoxicity/acute toxicity
(PR99) Regulatory purpose, toxicity and safety tests, by type of test/ecotoxicity/chronic toxicity
(PR100) Regulatory purpose, toxicity and safety tests, by type of examination/ecotoxicity/reproductive toxicity
(PR101) Regulatory purpose, toxicity and safety tests, by type of examination/ecotoxicity/endocrine action
(PR102) Regulatory purpose, toxicity and safety tests, by type of examination/ecotoxicity/bioaccumulation
(PR103) Regulatory purpose, toxicity and safety tests, by type of test/ecotoxicity/Other
(PR104) Regulatory purpose, toxicity and safety tests, according to test methods/safety assessment of food and feed
(PR105) Regulatory purpose, toxicity and safety tests, for test types/safety for target animals
(PR106) Regulatory purpose, toxicity and safety tests, by type of test/Other


Column O:If the option "Other ..." has been specified (PB13, PT32, PR53, PR64, PR82, PR103, PR106), the specific use is to be named.

Column P:This column is to be completed only if column N indicates "Use purpose", one of the options PR51 to PR106 (Regulatory purpose, ...). The legislation must be given in accordance with the main purpose of use envisaged.

(LT1) provisions relating to medicinal products for human use
(LT2) Rules relating to veterinary medicinal products and their residues
(LT3) Regulations on medical devices
(LT4) Rules for industrial chemicals
(LT5) Rules for plant protection products
(LT6) Regulations for biocidal products
(LT7) Rules for food, including materials in contact with food
(LT8) Regulations on feedingstuffs, including rules on the safety of target animals, workers and the environment
(LT9) Rules for cosmetic products
(LT10) Other


Column Q:If specified in column P "Other", the specific piece of legislation on which the use is based should be named.

Column R:This column is to be completed only if a rule is given by column P or another is specified in column Q. The decisive factor is not who is responsible for the test, but which rules are complied with, with the following: is to give priority to more far-reaching rules. Are the national provisions of the implementation of EU law (e.g. Implementation of EU directives, implementation of EU regulations, etc. ), "rules that meet EU requirements" must be chosen.

(LO1) Rules that meet EU requirements
(LO2) Rules that only meet national requirements
(LO3) Rules that meet EU external requirements


Column S: The actual severity of the pain, suffering and damage to which the animals were exposed by use is to be specified, not the severity indicated in the permit application or in the display. In the case of use in accordance with Section 4 (3) of the Animal Protection Act, this column is not to be filled out. In the case of Article 25 (2) of the Animal Welfare Ordinance on Animal Welfare, the subject-matter of the particularly incriminating animal experiments with severe pain or suffering that may continue and cannot be alleviated for longer shall be given in column U of information on a Exceptional authorisation, details of the use and the reasons for the achievement of these particular burdens.

(SV1) No restoration of life function
(SV2) Gering (maximum)
(SV3) Medium
(SV4) Schwer


Column T:In this column, the information given by the competent authority in the context of the approval or notification procedure is the clear identification of the test project, e.g. For example, identification numbers or business signs.

Column U:In this column, annotations can be entered.