Decree No. 419 / 2012 Coll.

Ordinance on the protection of experimental animals

Valid Order Effective from 01.01.2013
419
DECLARATION
of 22 November 2012
on the protection of experimental animals
The Ministry of Agriculture provides, pursuant to Article 29 (1) of Act No. 246 / 1992 Coll., for the protection of animals against torture, as amended by Act No. 162 / 1993 Coll., Act No. 77 / 2004 Coll., Act No. 312 / 2008 Coll., Act No. 291 / 2009 Coll. and Act No. 359 / 2012 Coll., ("the Act ') for the implementation of Sections 15b (1), 15c (7), § 15g (7), § 16a (1), § 17 (3), § 17a (5) (b), (c) and (d), § 18c (5) and § 18g (8):
§ 1
Subject matter
This decree implements the relevant provisions of the European Union1) and provides for
(a) a list of the data which the keeper of the experimental animals, the supplier of the experimental animals or the user of the experimental animals is obliged to submit to the assessors and the content of the written opinion of the assessors;
(b) requirements for premises and equipment for their function and general arrangement, breeding premises, premises for conducting general and specific experiments, operating premises, environmental requirements and its control as regards ventilation and temperature, lighting, noise, alarm systems, and other requirements for equipment, spaces and equipment;
(c) requirements relating to the care and location of experimental animals in the case of health status, animals caught in the wild for experiments, the location of experimental animals, the modification of the environment, the construction of enclosed premises, feeding, feeding and construction and equipment for rest and sleep and handling of experimental animals;
(d) care and placement requirements in relation to individual species of experimental animals;
(e) the criteria of association, the factors relating to the experiment and the examples of different trials classified in each category of severity on the basis of factors relating to the type of experiment;
(f) methods of killing individual species of experimental animals;
(g) the number of experimental animals transported in the container.
§ 3
List of data submitted to assessors and content of the written opinion
(1) The keeper of experimental animals, the supplier of experimental animals or the user of experimental animals who applies for authorisation to breed experimental animals, to supply experimental animals or to authorise the use of experimental animals (the applicant) shall submit to the assessors:
(a) a document authorising the use of a building for breeding or supplying experimental animals or for conducting experiments on experimental animals under a building law or a binding opinion of the relevant regional veterinary administration in the territorial, building and approval proceedings, if required by other legislation2); This does not apply if:
1. conduct experiments in the wild,
2. the agricultural research referred to in Annex 7 to this Decree, point 7, in which the objective of the experiment project requires experimental animals to be kept under similar conditions as commercial livestock;
(b) a written statement by the competent regional veterinary authority on the operation of the establishment which:
1. on the date on which the application for authorisation for the use of experimental animals, for breeding of experimental animals or for the supply of experimental animals shall not exceed two months;
2. shall apply to the establishments referred to in the application for authorisation to use experimental animals, to breed experimental animals or to supply experimental animals;
(c) the operating rules of the establishments, including the emergency arrangements of the premises of the experimental animal breeder, the supplier of the experimental animals or the user of the experimental animals;
(d) technological procedures; the breeder of experimental animals, the supplier of experimental animals or the user of experimental animals, who is obliged to process standard operational procedures under other legislation3), submit standard operational procedures;
(e) documentation of the nature of the objects, including:
1. addresses, exact location, name and, where appropriate, any other indication of the individual premises used for breeding or supplying experimental animals or where experiments are carried out on experimental animals, in particular the identification of individual rooms, stables and similar parts of establishments;
2. species of experimental animals intended for breeding, delivery or use, their maximum daily status in total and in individual rooms, stables or similar parts of the establishment and the weight categories of animals to which the maximum daily status applies;
3. an indication of whether individual rooms, stables or similar parts of equipment are intended for the alternating location of different species of animals which are not or may not be present at the same time; an indication of which animal species and the maximum daily condition they may be placed alternately in the premises if such use of the premises takes place;
4. the indication of the farming system used in the establishment, in particular whether it is an open, barrier or insulator system, or the use of animals in the wild;
5. a description of the technical equipment suitable for the species of experimental animals present therein and, if experiments are carried out in the establishment, also for conducting experiments, in particular their number, type and size;
6. a plan of plan of equipment in which individual rooms, stables and similar parts of equipment are marked,
(f) records of the professional competence to design experiments and experimental projects and of the competence to conduct experiments on experimental animals, the care of experimental animals and the killing of experimental animals pursuant to Article 15d (8) of the Act;
(g) proof of the provision of the person responsible for the care of experimental animals and his certificate of competence for the design of experiments and experimental projects;
(h) evidence of the establishment of a expert panel on the welfare of experimental animals;
(i) the list of members of the expert panel on the welfare of experimental animals, the proof of the provision of a member of that expert committee, the certificate of competence of the members of that expert panel for the design of experiments and experimental projects;
(j) proof of the provision
1. a designated veterinarian and a document proving that he has obtained appropriate veterinary higher education under the Higher Education Act or his certificate of professional competence to design experiments and experimental projects; or
2. a suitably qualified expert responsible for providing advice on the welfare and handling of experimental animals and his certificate of competence for the design of experiments and experimental projects;
(k) the strategy for maintaining the health status of experimental animals as set out in Annex 8 to this Decree, point (a) (1).
(2) Where an applicant applies for authorisation to breed experimental animals, to supply experimental animals or to use experimental animals for a further period, he shall submit to the assessors for the previous period of authorisation, in addition to the data and documents referred to in paragraph 1,
(a) documentation on:
1. breeding of experimental animals, if they are breeders of experimental animals or suppliers of experimental animals; and
2. the keeping and use of experimental animals, if they are users of experimental animals,
(b) records kept pursuant to Article 17g (1) of the Act,
(c) the information and documentation referred to in Article 17h (1) of the Act as regards the applicant who maintains, supplies or uses dogs, cats or non-human primates;
(d) records of checks on the health status of experimental animals, including results of laboratory control tests;
(e) records of the supervisory authorities;
(f) experimental projects, including documents which have not been approved by the expert panel on the welfare of experimental animals or by the state authority responsible for approving experimental projects, in the case of users of experimental animals;
(g) experimental protocols, including inspection records, carried out by the person responsible for the care of experimental animals and by the expert committee for the protection of the welfare of experimental animals in the case of users of experimental animals;
(h) documentation of the experimental animals used in relation to the relevant experimental projects which have taken place since the previous assessment to the assessor, unless such documentation is part of the experimental protocol referred to in point (h), when the users of the experimental animals are involved;
(i) the documents provided to the State authority responsible for approving experimental projects pursuant to Article 15g (5) of the Act in the case of users of experimental animals;
(j) changes in the data of the establishment or keeper of experimental animals, supplier of experimental animals or user of experimental animals.
(3) In addition to the requirements laid down in the administrative rules and the requirements laid down in Section 15b (4) of the Act, the written opinion shall contain, in particular:
(a) the name, names and surnames of the assessors, the number of the certificate of competence for the design of the trials and projects of the assessor's experiments;
(b) an indication of whether the applicant has submitted all the particulars and documents referred to in paragraphs 1 and 2, as appropriate;
(c) an assessment of the documentation submitted, in particular the defects and deficiencies identified;
(d) assessment of the spatial capacity of the facilities and technical equipment of the premises in which experimental animals are kept, delivered and used, in particular:
1. the types of experimental animals intended for breeding, delivery or use, their maximum daily status in total and in individual rooms, stables or similar parts of establishments, and the weight category of animals to which the maximum daily status applies;
2. defects and deficiencies detected,
(e) the farming system used in the establishment, in particular whether it is an open, barrier or isolation system, or the use of animals in the wild;
(f) an indication of whether the size of the premises has been assessed under this Regulation or under the Ordinance governing minimum standards for the protection of livestock (4), in the case of agricultural research under Annex 7 to this Regulation, point 7, in which the objective of the experiment project requires experimental animals to be kept under similar conditions as commercial animals;
(g) the opinion of the assessors on the application for exemption from the obligation to conduct experiments only in approved establishments of the experimental animal user pursuant to Article 15a (2) of the Act, if the applicant has submitted such an application;
(h) the opinion of the assessors on the application for exemption from the obligation to use experimental animals referred to in Article 17f (1) of the Act only if they have been kept for use in experiments, if the applicant has made such a request;
(i) the recommended measures for immediate implementation prior to the decision to authorise the breeding of experimental animals, the supply of experimental animals or the use of experimental animals and the recommended measures of a long-term nature, together with the deadline for their implementation;
(j) the opinion of the assessors as to whether or not the applicant meets the requirements for breeding experimental animals, the supply of experimental animals or the use of experimental animals laid down by law and by this decree; If the applicant does not meet these requirements, also an indication of the deficiencies which are contrary to the law or this decree,
(k) the name of the public authority responsible for approving experimental projects pursuant to Article 23 of the Act, in the case of users of experimental animals;
(l) a statement by the keeper of the experimental animals, the supplier of the experimental animals or the user of the experimental animals that the content of the assessment is known, the date and signatures of the assessors and the applicant.
§ 6
Requirements for premises and equipment, environmental and control requirements and other requirements for equipment, premises and equipment
(1) The requirements for premises and equipment for their function and general arrangement, breeding premises, premises for conducting general and specific experiments, operating premises, environmental and temperature requirements, lighting, noise, alarm systems are set out in Annex 6 to this Regulation.
(2) The requirements for premises, their size and equipment in relation to each species of experimental animals and the requirements for care and placement in relation to each species of experimental animals are set out in Annex 7 to this Decree.
§ 7
Requirements concerning care and location of experimental animals
The requirements relating to the care and location of experimental animals as regards health status, animals caught in the wild for experiments, the location of experimental animals, the modification of the environment, the construction of enclosed areas, feeding, feeding and construction and equipment for rest and sleep and handling experimental animals are set out in Annex 8 to this Decree.
§ 8
Criteria for the assignment of experiments to individual severity categories, factors and examples of different trials to different severity categories based on factors
The assessment criteria, the factors relating to the experiment and the examples of the various trials classified in each severity category on the basis of the factors relating to the type of experiment in question are set out in Annex 9 to this Decree.
§ 9
Methods of killing individual species of experimental animals
(1) The methods of certification of mortality (5) must be appropriate for the species to be killed.
(2) The methods of killing individual species of experimental animals are set out in Annex 10 to this Regulation.
§ 10
Number of test animals transported in container
The number of experimental animals carried in the container is given in Annex 11 to this Decree.
§ 11
Transitional provision
Until 31 December 2016, the keeper of experimental animals, the supplier of experimental animals and the user of experimental animals may, in premises within the premises of the establishment which are permanently intended for the breeding or use of experimental animals, the size of breeding vessels or cages, the spatial layout of the boxes or the standing for selected species of experimental animals according to existing legislation.
§ 12
Repeal
The following shall be deleted:
1. Decree No. 207 / 2004 Coll., on the protection, breeding and use of experimental animals.
2. Decree No. 39 / 2009 Coll., amending Decree No. 207 / 2004 Coll., on the protection, breeding and use of experimental animals.
3. Decree No. 128 / 2010 Coll., on the competence to label dogs with tattoos.
§ 13
Efficacy
This Decree shall take effect on 1 January 2013.
Minister:
Ing. Bendl v. r.

Příloha č. 6

Annex No 6 to Decree No 419 / 2012 Coll.
Requirements for premises and equipment for their function and general arrangement, breeding premises, premises for conducting general and specific experiments, operating spaces, environmental requirements and its control as regards ventilation and temperature, lighting, noise, alarm systems
(1) Breeders of experimental animals, suppliers of experimental animals and users of experimental animals shall ensure that the premises of the establishment meet the following requirements and that the following activities are carried out in respect of:
(a) the function and general arrangement where:
1. all equipment and equipment shall be so designed as to provide species of experimental animals present in them with an environment that takes into account their physiological and ethological needs. In addition, it must be addressed and managed in such a way as to ensure that unauthorised persons, persons with obvious signs of disease communicable to experimental animals, and other animals or the escape of experimental animals present, are prevented,
2. an active maintenance programme shall be in place to prevent and correct any damage to buildings or equipment;
3. facilities and equipment shall be available to place newly obtained experimental animals in isolation until their health status has been established and the potential risk to experimental animals in the establishment is assessed and minimised;
4. separate premises must be provided for the location of sick or injured experimental animals;
(b) breeding premises where:
1. a regular and effective space cleaning programme shall be established in the facilities and satisfactory hygiene standards shall be maintained;
2. the walls and floors of the premises shall have a particularly durable surface which is not subject to heavy wear by experimental animals or wear by cleaning operations. The material shall be harmless to test animals and not injure them. The tools and equipment shall be particularly protected so that test animals cannot damage them or injure themselves;
3. intolerant species of experimental animals, such as the predator and its potential prey, or experimental animals requiring different living conditions, shall not be placed in the same room and, in the case of predator and prey, shall be at such a distance that they cannot see, feel or hear each other,
(c) premises for conducting general and specific experiments where:
1. a laboratory shall be provided with equipment for carrying out simple diagnostic tests, post-mortem examinations or for sampling which will be subjected elsewhere to a more thorough laboratory examination. Where such activities are carried out, premises for conducting general and specific experiments shall be available,
2. one or more suitably equipped rooms and post-operative recovery facilities shall be available if surgery is necessary under sterile conditions;
(d) premises where:
1. storage facilities must be designed, used and maintained to ensure the quality of feed and litter. These premises shall be protected, as far as possible, against insects and other pests. Other materials which could be contaminated or pose a danger to experimental animals or workers must be stored separately,
2. the cleaning and washing facilities shall be large enough to accommodate equipment for cleaning and disinfection of the equipment used. The cleaning process must be carried out in such a way that clean equipment does not come into contact with contaminated and freshly cleaned equipment is thus protected from contamination,
3. the equipment must ensure the hygienic storage and safe disposal of dead experimental animals and waste of animal origin.
(2) The environment and its control must meet the following requirements as regards:
(a) ventilation and temperature where:
1. the thermal insulation, heating and ventilation of the breeding premises must ensure that the flow of air, dust and gas concentration is maintained within a range which is not harmful to the test animals present;
2. the temperature and relative humidity in the breeding premises shall be adapted to the species of test animals and age groups present. Temperature must be measured and recorded daily,
3. Experimental animals shall not be kept in their enclosures under climatic conditions which would give rise to fear;
(b) lighting where:
1. where natural daylight does not provide the proper rhythm of day and night, this rhythm shall be provided by artificial lighting in order to satisfy the biological needs of experimental animals while ensuring satisfactory working conditions;
2. lighting must meet the requirements for carrying out breeding practices and inspection of experimental animals;
3. the periodic photopernicity and intensity of lighting suitable for the species of test animals shall be ensured;
4. in the case of breeding albino test animals, the lighting shall be adapted to the sensitivity of these test animals to light;
(c) noise and vibration where:
1. noise levels, including ultrasound, shall not adversely affect the welfare of experimental animals;
2. the device shall have alarm systems set to frequencies outside the zone to which the test animals are sensitive; but they must be audible with the human ear,
3. breeding premises shall be equipped with noise isolation and sound absorbing materials where necessary for the welfare of experimental animals;
4. in aquatic animals, equipment causing noise or vibration such as electricity generators or filtration systems shall not adversely affect the welfare of experimental animals;
(d) alarm systems and emergency plans where:
1. equipment with electrical or mechanical equipment for the control and protection of the environment shall have a replacement system to provide essential services and emergency lighting and the operation of the alarm systems themselves;
2. heating and ventilation systems shall be equipped with monitoring and alarm devices;
3. clear instructions for emergency situations shall be visibly located;
4. effective emergency plans to ensure the health and welfare of experimental animals must be available in the event of failure of essential breeding elements.

Příloha č. 7

Annex No 7 to Decree No 419 / 2012 Coll.
Requirements for premises, their size and equipment in relation to individual species of experimental animals, care and location requirements for individual species of experimental animals
1. Mice, rats, gerbils, hamsters and guinea pigs
In the following tables for mice, rats, gerbils, hamsters and guinea pigs, the "height of the enclosed space 'means the vertical distance between the floor and the ceiling of the space, the space should have a minimum floor area of more than 50% of its height before adding an environmental adjustment device.
When planning experiments, the potential growth of experimental animals must be taken into account in order to provide sufficient space for them (as detailed in Tables 1.1 to 1.5) throughout the study.
Table 1.1
Mice
Tělesná hmotnost (g)Minimální plocha uzavřeného prostoru
(cm2)
Podlahová plocha najedno zvíře (cm2)Minimální výška uzavřeného prostoru (cm)
K dispozici v zařízení a během pokusůaž do 203306012
od 20 do 253307012
od 25 do 303308012
nad 3033010012
Rozmnožování330

Pro monogamní pár (outbrední/inbrední) nebo trojici (inbrední). Pro každou další samici a vrh se přidá 180 cm2.
12
Chovná zvířata1)
Plocha uzavřeného prostoru
950 cm2
méně než 209504012
Plocha uzavřeného prostoru
1500 cm2
méně než 2015003012
Note:
1) After weaning, mice may be kept at these higher stocking densities in the short period after weaning for experiments, provided that the animals are placed in larger enclosed areas with a reasonably modified environment and these conditions of placement do not adversely affect the welfare of the animals, for example do not cause increased aggression, morbidity and mortality, stereotyping and other behavioural disorders, weight loss or other disruption of physiological functions or behaviour due to stress.
Table 1.2
Rats
Tělesná hmotnost (g)Minimální plocha uzavřeného prostoru
(cm2)
Podlahová plocha na jedno zvíře (cm2)Minimální výška uzavřeného prostoru
(cm)
K dispozici v zařízení a během pokusů1)až do 20080020018
od 200 do 30080025018
od 300 do 40080035018
od 400 do 60080045018
nad 600150060018
Rozmnožování800
Matka a vrh. Pro každé další dospělé zvíře umístěné nastálo do uzavřeného prostoru se přidá 400 cm2.
18
Chovná zvířata2)
Plocha uzavřeného prostoru 1500 cm2
až do 50150010018
od 50 do 100150012518
od 100 do 150150015018
od 150 do 200150017518
Chovná zvířata3)
Plocha uzavřeného prostoru 2500 cm2
až do 100250010018
od 100 do 150250012518
od 150 do 200250015018
Notes:
(1) In the conduct of long-term studies where, at the end of those studies, the space allocated to each individual test animal is smaller than that referred to above, the priority is to maintain socially stable structures.
2) After weaning, rats may be kept at these higher stocking densities in the short period after weaning for experiments, provided that the test animals are placed in larger enclosed areas with an appropriately modified environment and these conditions of placement do not adversely affect the living conditions of experimental animals, for example do not cause increased aggression, morbidity and mortality, stereotypes and other behavioural disturbances, weight loss or other disturbances of physiological functions or behaviour due to stress.
3) After weaning, rats may be kept at these higher stocking densities in the short period after weaning for experiments, provided that the test animals are placed in larger enclosed areas with an appropriately modified environment and these conditions of placement do not adversely affect the living conditions of experimental animals, for example do not cause increased aggression, morbidity and mortality, stereotypes and other behavioural disturbances, weight loss or other disturbances of physiological functions or behaviour due to stress.
Table 1.3
Fenugreek
Tělesná hmotnost (g)Minimální plocha uzavřeného prostoru
(cm2)
Podlahová plocha najedno zvíře
(cm2)
Minimální výška uzavřeného prostoru
(cm)
K dispozici v zařízení a během pokusůaž do 40120015018
nad 40120025018
Rozmnožování1200

Monogamní pár nebo tříčlenná skupina s potomkem.
18
Table 1.4
Barley
Tělesná hmotnost (g)Minimální plocha uzavřeného prostoru
(cm2)
Podlahová plocha najedno zvíře
(cm2)
Minimální výška uzavřeného prostoru
(cm)
K dispozici v zařízení a během pokusůaž do 6080015014
od 60 do 10080020014
nad 10080025014
Rozmnožování800

Matka nebo monogamní pár s vrhem mláďat.
14
Chovná zvířata1)méně než 60150010014
Note:
1) Post-weaning hamsters may be kept at these higher stocking densities in the short period after weaning for experiments, provided that the test animals are placed in larger enclosed areas with a reasonably modified environment and these conditions of placement do not adversely affect the living conditions of the test animals, for example do not cause increased aggression, morbidity and mortality, stereotypes and other behavioural disturbances, weight loss or other disruption of physiological functions or behaviour due to stress.
Table 1.5
guinea fowls
Tělesná hmotnost (g)Minimální plocha uzavřeného prostoru
(cm2)
Podlahová plocha najedno zvíře
(cm2)
Minimální výška uzavřeného prostoru
(cm)
K dispozici v zařízení a během pokusůaž do 200180020023
od 200 do 300180035023
od 300 do 450180050023
od 450 do 700250070023
nad 700250090023
Rozmnožování2500

Pár s vrhem mláďat. Pro každou další chovnou samici se přidá 1000 cm2.
23
2. Rabbits
During agricultural research, where the objective of the experiment project requires experimental animals to be kept under similar conditions as commercial animals, their breeding must at least comply with the standards laid down in Act No. 246 / 1992 Coll., for the protection of animals against abuse, as amended, and Act No. 166 / 1999 Coll., on Veterinary Care and on the amendment of certain related laws (Veterinary Act), as amended.
A raised platform shall be provided in the enclosed space. This raised platform must allow experimental animals to lie down and sit and easily hide under it and do not cover more than 40% of the floor area. If for scientific or veterinary reasons the raised platform cannot be used, the enclosed area for rabbits shall be 33% larger for one rabbit and 60% larger for two rabbits. If the raised platform is used for rabbits under 10 weeks of age, the size of the platform shall be at least 55 cm per 25 cm and shall be so high as to allow test animals to use it.
Table 2.1
Rabbits over 10 weeks
Table 2.1 shall be used for cages and pens. An additional area of not less than 3000 cm2 shall be added for each third, fourth, fifth and sixth rabbit and an area of not less than 2500 cm2 for each additional rabbit.
Konečná tělesná hmotnost
(kg)
Minimální podlahová plocha pro jedno nebo dvě sociálně slučitelná zvířata
(cm2)
Minimální výška
(cm)
méně než 3350045
od 3 do 5420045
nad 5540060
Table 2.2
Rabbit and litter
Hmotnost králice
(kg)
Minimální plocha uzavřeného prostoru
(cm2)
Dodatečný prostor pro hnízdící boxy
(cm2)
Minimální výška
(cm)
méně než 33500100045
od 3 do 54200120045
nad 55400140060
Table 2.3
Rabbits under 10 weeks
Table 2.3 shall be used for cages and pens.
StáříMinimální plocha uzavřeného prostoru
(cm2)
Minimální podlahová plocha na
jedno zvíře
(cm2)
Minimální výška
(cm)
do 7 týdnů po odstavení400080040
od 7 do 10 týdnů4000120040
Table 2.4
Rabbits: optimal dimensions of raised platform in enclosed spaces with dimensions listed in Table 2.1
Stáří (týdny)Konečná tělesná hmotnost
(kg)
Optimální velikost
(cm × cm)
Optimální výška od podlahy uzavřeného prostoru
(cm)
nad 10méně než 355 × 2525
od 3 do 555 × 3025
nad 560 × 3530
3. Cats
Cats shall not be placed individually for more than 24 hours without a break. Cats which are repeatedly aggressive against other cats shall only be placed separately if it is not possible to find the individual with whom they can be tolerated. Social stress is monitored at least once a week in all individuals in pairs or groups. Women with kittens under four weeks or during the last two weeks of pregnancy may be placed separately.
Table 3
Cats

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Regulation Information

CitationDecree No. 419 / 2012 Coll., on the protection of experimental animals
Regulation TypeOrder
Author-
CollectionCode of Laws
Date of Promulgation04.12.2012
Effective from01.01.2013
Effective until-
Status Valid
The regulation text is for informational purposes only.
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