Source: https://www.riigiteataja.ee/en/eli/ee/517012019002/consolide/current
Timestamp: 2020-04-05 18:00:13
Document Index: 191743778

Matched Legal Cases: ['§ 341', '§ 381', '§ 403', '§ 421', '§ 451', '§ 48', '§ 10', '§ 12', '§ 18', '§ 43', '§ 47', '§ 131', '§ 414', '§ 11', '§ 201', '§ 206', '§ 9', '§ 28', '§ 341', '§ 35', '§ 35', '§ 35', '§ 35', '§ 381', '§ 3', '§ 11', '§ 403', '§ 30', '§ 421', '§ 39', '§ 421', '§ 451', '§ 5', '§ 48', '§ 44', '§ 10', '§ 26', '§ 45', '§ 38', '§ 64', '§ 15', '§ 662', '§ 3', '§ 36', '§ 22', '§ 11', '§ 3']

§ 341 Requirement for replacement, reduction and refinement of procedure
§ 381 Keeping experimental animals
§ 403 Obligation to notify of change of factors relating to business activity
§ 421 Employees of establishment engaged in breeding, supplying and using experimental animals and experimental animal welfare records
§ 451 Assessment of project
§ 48 Granting of authorisation, term of validity of authorisation and disclosure of information
(4) For the purposes of this Act, ‘experimental animal’ means a vertebrate animal, an independently feeding larval form, the foetal form of a mammal as from the last third of its normal development or a live cephalopod used in a procedure or bred for animal experimentation or for the purpose of use of tissue and organs for scientific or educational purposes. ‘Experimental animal’ also means a larval form at an earlier stage of development and the foetal form of a mammal where it is to be allowed to live beyond that stage of development and, as a result of the procedures performed, is likely to experience pain, suffering, distress or lasting harm after it has reached that stage of development.
(34) In intensive farming, the number of animals kept in a room or construction works for certain animal keeping purposes or for keeping animals of a certain species or belonging to a certain group must not exceed the maximum stocking density. The maximum stocking density may be exceeded only to the permitted extent where the room or construction works used for keeping animals complies with additional requirements regulating animal welfare and health or where, according to the results of state supervision, the animal keeper’s level of compliance with animal keeping requirements has been high or where the animal keeper takes measures to ensure animal welfare and health. The Veterinary and Food Board must be informed of the exceeding of the maximum stocking density in advance. The animal keeper must keep record of its activities.
(41) The requirements specified in clause 1 of subsection 1 of this section may also set out the maximum stocking density, the permitted extent of exceeding it and requirements applicable to rooms and construction works used for keeping animals and to animal keepers in the event of exceeding the maximum stocking density and to accounting the activities of animal keepers.
(5) The Government of the Republic or a minister authorised by the Government of the Republic may establish requirements for keeping animals on the basis of the purpose of keeping animals or the characteristics of particular species or groups of animals, which particularise the requirements provided for in subsections 2 and 3 of this section, including requirements provided for rooms or construction works for keeping animals.
(3) The person must hold a certificate regarding the completion of the training specified in subsection 2 of this Act, which certifies that the person may directly engage in keeping animals kept for the purpose specified therein or in keeping animals of the specifies or group specified therein.
(4) The requirements for the purpose of animal keeping, the animal species or groups whereby the person directly engaged in keeping animals must have completed the training specified in subsection 2 of this section and the requirements for the training, that arise from the purpose of animal keeping or from the animal belonging to a certain species or group, may be established by the minister responsible for the field.
(1) A prohibited act with respect to an animal is an act causing the death or injury of an animal, or an act causing pain or avoidable physical or mental suffering to an animal, such as forcing an animal to undertake efforts beyond its capabilities, organising animal fights, abandoning or leaving an animal in a helpless state, breeding activities that cause suffering to an animal, and other acts with similar consequences that are not caused by the medical treatment of an animal, another veterinary procedure or an emergency, except the events specified in subsection 1 of § 10 of this Act and procedures in compliance with the requirements established by this Act.
(1) Animals without an owner and loose (hereinafter stray) domestic animals within the meaning of subsections 1 and 2 of § 12 of the Infectious Animal Disease Control Act must be captured and returned to the owner or a new owner must be found for such animals.
(2) Where the owner of a stray animal cannot be identified and a new owner cannot be found for the animal, animal euthanasia must be performed in accordance with the procedure provided for in § 18 of this Act. A period of at least two weeks must be left between the beginning of the procedure of identifying the owner of an animal and the euthanasia of the animal, during which the keeping of the animal in compliance with the requirements and, where necessary, the medical treatment of the animal must be ensured.
(4) The Government of the Republic establishes the procedure for the capture and keeping of stray animals, for the identification of their owners, and for the killing of stray animals.
(1) The health and welfare of a pet animal must be examined regularly. Greater attention must be paid to the health and welfare of an animal during the period when the animal is giving birth, is reproducing or ill and where significant changes occur in the environment where the pet animal is kept. Where, upon examination of the health and welfare of a pet animal, a deviation from usual behaviour is found, the reasons for such deviation must be immediately identified and measures for improvement of the health and welfare of the pet animal must be taken. A pet animal who has fallen ill or is injured must receive proper treatment.
(4) Rooms and construction works for keeping pet animals must be equipped suitably for the animal species. Where the behavioural habits of the species, such as scratching, digging, chewing, hiding, bathing, diving and nest building, cannot be practised by a pet animal outside of the room or construction works, the room or construction works must be equipped with suitable material for the specified activities.
(3) An injured animal or an animal in poor health captured in the wild for the purpose of animal experimentation must be examined by a veterinarian or another competent person and the veterinarian or another competent person takes measures to minimise the suffering of the animal, where necessary, unless according to scientific knowledge such measures are not suitable for the purpose of the animal experimentation.
[RT I, 04.01.2019, 13 – entry into force 15.01.2019]
(4) An animal used in experimentation procedure, which has been captured in the wild and does not belong to an introduced specifies may, on the conditions specified in subsection 7 of § 43 of this Act and taking into account the opinion of the Environmental Board given in accordance with subsection 6 of § 47, be returned to a suitable living environment in a location specified in the project authorisation. The described returning of the animal to its natural habitat is not governed by the Nature Conservation Act.
(2) A precept for the suspension of the activities specified in subsection 1 of this section or for the application of protective measures enters into force as of the time of its delivery or communication. The costs of compliance with the precept must be borne by the person who commissioned the work.
(2) Veterinary procedures such as the castration, sterilisation, clipping of hooves of animals, tattooing of animals and implantation of animals with a micro-chip identification system, docking of tails of bird dogs and badger dogs used in hunting, clipping the teeth of piglets, fitting bulls with nose-rings, trimming the beaks of chicks and fitting of boars kept in outdoor pens with nose rings are permitted. The tails of piglets may be cut only in the event where this is essential for the safeguarding of their health and welfare in accordance with the decision of a veterinarian. Castration of animals in a manner that causes long-lasting pain and tissue necrosis is prohibited.
(4) The Government of the Republic or a minister authorised by the Government of the Republic establishes a list of permitted veterinary procedures, and of persons authorised to perform the procedures, and requirements for the performance of the procedures and the training of the persons performing such procedures.
(3) An animal may be killed in self-defence where an attack by the animal endangers human life or health and the attack cannot be prevented or repelled in any other manner.
(1) Poultry, rabbits and hares kept as farm animals and slaughtered outside a slaughterhouse for private domestic consumption must be stunned and, where necessary, restrained before slaughter.
(3) The animals specified in subsection 1 of this section must be stunned and slaughtered by a person having relevant knowledge and practical skills.
(4) Before the further handling of the animals specified in subsection 1 of this section, one must verify that the animal is dead.
(5) The requirements provided for in Council Regulation (EC) No 1099/2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, pp 1–30) must be followed upon slaughtering farm animals, except animals specified in subsection 1 of this section.
(6) The Veterinary and Food Board is the competent authority for the purposes of Article 2(q) of Council Regulation (EC) No 1099/2009.
(7) The Veterinary and Food Board publishes on its website the guides to good practice of slaughter and killing drafted in accordance with Article 13 of Council Regulation (EC) No 1099/2009 and approved by the Veterinary and Food Board, and submits them to the European Commission.
(8) For the purposes of implementation of Article 14(3) of Council Regulation (EC) No 1099/2009, the minister responsible for the field may, based on animal species, establish requirements for mobile slaughterhouses and equipment used therein for stunning and slaughtering farm animals.
(2) A training establishment specified in subsection 1 of this section may provide training in slaughtering animals where the Veterinary and Food Board has approved the training establishment’s programme of training in slaughtering animals. The Veterinary and Food Board decides to approve the programme of training in slaughtering animals or refuse to approve it within 20 working days after the receipt of the programme. The Veterinary and Food Board does not approve a programme of training in slaughtering animals where it does not comply with the requirements established for the programme.
(3) A training establishment specified in subsection 1 of this section may provide training in slaughtering animals where the Veterinary and Food Board has approved the examination structure and procedure prepared by the training establishment. The Veterinary and Food Board decides to approve the structure and procedure for examination in slaughtering animals or refuse to approve it within 20 working days after the receipt thereof.
(4) The training establishment must inform the Veterinary and Food Board in writing of a change in the details specified in subsections 2 and 3 of this section and in the staff organising training and examinations within seven working days after the change.
(5) The training establishment submits to the Veterinary and Food Board the full name and personal identification code or, upon absence thereof, the date of birth of the person who passed the examination within three working days after the examination.
Regarding the passing of the examination specified in subsection 3 of § 131 of this Act, the Veterinary and Food Board, in accordance with Council Regulation (EC) No 1099/2009, issues a certificate to a person who has passed the examination.
(3) The emergency slaughter of sick, weak or injured farm animals must be carried out immediately. Farm animals that are unable to walk must be slaughtered on site or must be transported to the place of slaughter where it does not cause any suffering to the animals.
An animal that is in a helpless state as a result of an accident or emergency may be killed where survival would cause long-time suffering to the animal or where the animal cannot be granted species-specific life or where the re-introduction of the animal to its natural habitat proves to be impossible.
(1) A religious association registered in Estonia may, for a religious purpose, slaughter a farm animal using a special method in accordance with the requirements set out in Council Regulation (EC) No 1099/2009 and this section, provided that the animal is slaughtered in a slaughterhouse and it is necessary for the members of the religious association and the law enforcement authority attends the slaughter.
(3) Where a farm animal is slaughtered without prior stunning, the animal must be stunned immediately after cutting both jugular veins and carotid arteries, taking into account the tradition of the religious association.
(5) In order to obtain a permit to slaughter farm animals for a religious purpose, a religious association submits to the Veterinary and Food Board a written application containing the following information:
(6) The Veterinary and Food Board decides to grant or refuse to grant a permit for slaughter of farm animals for a religious purpose within 20 working days after the receipt of an application specified in subsection 5 of this section.
(7) The Veterinary and Food Board may refuse to grant a permit for slaughter of farm animals for a religious purpose where:
2) the circumstances described in the application do not correspond to the relevant requirements established in this section or on the basis thereof or in Council Regulation (EC) No 1099/2009;
(8) The special methods of slaughtering farm animals for religious purposes, more detailed substantive and formal requirements for slaughtering for religious purposes and requirements and procedure for slaughtering for religious purposes are established by a regulation of the minister responsible for the field.
(1) ‘Euthanasia’ means the killing of an animal on the initiative of the animal owner or for mercy where survival would cause long-time suffering to the animal or where the animal cannot be granted species-specific life.
(5) It is prohibited to use suffocation, drowning, administration of toxic substances or medicinal products the dosage and administered amount of which might not bring on the effect referred to in subsection 4 of this section, and killing by electrocution, unless this brings on an instantaneous loss of consciousness.
(1) An experimental animal may be killed in an establishment engaged in breeding, supplying or using experimental animals or, in the event of a field study, outside such an establishment by a person who has undergone relevant training specified in § 414 of this Act, in accordance with the requirements established on the basis of subsection 2 of this section.
(2) The requirements for killing experimental animals and the methods of killing are established by a regulation of the minister responsible for the field.
(3) An experimental animal may be killed using another method where it has been scientifically proven that it is at least as humane as a method established on the basis of subsection 2 of this section and where according to scientific knowledge the purpose of the procedure cannot be achieved using the latter method.
(4) The requirements of this section do not apply where an experimental animal is killed in an emergency for reasons relating to the welfare or health of a person or animal, public safety or the environment.
(1) The requirements provided for in Council Regulation (EC) No 1/2005 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 05.01.2005, pp 1–44) must be adhered to upon transporting animals.
(2) Control posts must comply with the requirements provided for in Council Regulation (EC) No 1255/97 concerning Community criteria for control posts and amending the route plan referred to in the Annex to Directive 91/628/EEC (OJ L 174, 2.7.1997, pp 1‑6).
(3) For the purposes of Article 2(f) of Council Regulation (EC) No 1/2005 and Council Regulation (EC) No 1255/97, the competent authority is the Veterinary and Food Board.
(4) The authorisation specified in subsection 1 of this section is not required in the events specified in Articles 1(2) and (5) and Article 6(7) of Council Regulation (EC) No 1/2005.
(3) In addition to the data and documents specified in subsection 2 of this section, an application for a long journeys transporter authorisation must contain the documents specified in Article 11(1)(b) of Council Regulation (EC) No 1/2005 and, in the event specified in Article 11(2) thereof, the application must contain data on the navigation systems used.
(4) The information specified in this section is entered in the register of farm animals established on the basis of subsection 3 of § 11 of the Infectious Animal Disease Control Act.
(5) The operator does not have to pay a state fee for a review of an application for the activity licence specified in subsection 1 of § 201 of this Act.
An undertaking is granted a transporter authorisation where the undertaking meets the requirements established in Article 10 of Council Regulation (EC) No 1/2005.
An undertaking is granted a long journeys transporter authorisation where the undertaking meets the requirements established in Article 11 of Council Regulation (EC) No 1/2005.
(2) The supplementary training establishment specified in subsection (1) of this Act may organise driver and attendant training where the Veterinary and Food Board has approved the driver and attendant training curriculum drawn up by the supplementary training establishment. The Veterinary and Food Board decides to approve or reject a driver and attendant training curriculum within 20 working days as of its receipt. The Veterinary and Food Board does not approve a driver and attendant training curriculum where it does not meet the requirements established for the training curriculum.
(3) The supplementary training establishment specified in subsection 1 of this section may provide driver and attendant training where the Veterinary and Food Board has approved the examination structure and procedure prepared by the supplementary training establishment. The Veterinary and Food Board decides to approve the structure and procedure for driver and attendant examination or refuse to approve it within 20 working days after the receipt thereof.
(4) Before amendment of the curriculum and the structure and procedure for driver and attendant examination specified in subsections 2 and 3 of this section, the Veterinary and Food Board must approve the amendments planned by the supplementary training establishment. The Veterinary and Food Board decides to approve or refuse to approve the amendments within 20 working days after the receipt of the planned amendments.
Regarding the passing of the examination specified in subsection 1 of § 206 of this Act, the Veterinary and Food Board, in accordance with Council Regulation (EC) No 1/2005, issues a certificate of competence to a person who has passed the examination.
4) provide animals with first aid and, where necessary, prescribe further treatment;
[RT I, 11.10.2017, 1 – entry into force 01.06.2018]
(4) It is prohibited to use an animal in an animal exhibition, animal competition, animal fair, animal auction or at another public event involving the gathering of animals where the participation of the animal in such event may cause the animal pain, suffering or injury; it is also prohibited to train an animal in a manner that causes the animal pain, suffering or injury.
(5) It is prohibited to publicly exhibit a dog born in Estonia who belongs to a person domiciled in Estonia or to a legal person located in Estonia where the dog’s ears have been cropped and the tail has been docked without medical indication. A dog with a docked tail whose tail is permitted to be docked on the basis of subsection 2 of § 9 of this Act may be exhibited to the public at an exhibition.
(1) The Environmental Board reviews an application for an activity licence and grants or refuses to grant the activity licence within 60 days as of the receipt of the application.
1) where the zoo has a name, the name of the zoo;
An activity licence is granted to a person where the following requirements have been fulfilled:
2) the person has staff properly qualified to work in a zoo and sufficient funds for building the zoo and performing the duties specified in subsection 4 of § 28 of this Act.
(2) The law enforcement authority must ascertain that, upon winding up a zoo, the provisions of subsection 1 of this section are duly complied with. Where necessary, compliance with the requirements provided for in subsection 1 of this section must be organised by the law enforcement authority. In such event, the law enforcement authority has the right to demand that the holder of the suspended activity licence cover reasonable expenses relating to the steps taken.
(2) For the purposes of this Act, ‘procedure’ also means the use of an experimental animal for the purposes specified in subsection 1 of this section along with analgesia.
§ 341. Requirement for replacement, reduction and refinement of procedure
Upon planning and carrying out a procedure, the requirement for the replacement, reduction and refinement is followed, according to which:
1) another scientifically acceptable method or procedural strategy whereby live experimental animals are not used is opted for, where possible;
2) the number of experimental animals used in the project is minimised without harming the purpose of the project;
3) the breeding and keeping of and caring for experimental animals and the methods used in the procedure are refined, eliminating or minimising the possible pain, suffering, stress or lasting harm caused to the animals.
2) translational research or applied research aimed at preventing, diagnosing or treating a human, animal or plant disease, health disorder or their impact;
3) translational research or applied research aimed at identifying, assessing, regulating or changing the physiological condition of a human, animal or plant;
4) translational research or applied research aimed at improving animal welfare or the conditions of keeping farm animals;
5) development and production of medicinal products, food and other substances and products for the purposes specified in clauses 2 to 4 of this section and their quality, efficacy and safety control;
(1) It is prohibited to carry out a procedure for a purpose listed in § 35 of this Act where the purpose of the procedure may be achieved by another method recognised under a legal act of the European Union or under a procedural strategy that does not prescribe the use of experimental animals.
(2) It is prohibited to carry out a procedure without anaesthesia where the procedure results in a serious injury that may cause severe pain to the animal.
(21) It is prohibited to carry out a procedure where it results in severe pain, suffering or stress of the animal, which is likely to last long and cannot be alleviated.
(7) It is prohibited to carry out a procedure for the purposes of conformity assessment of the safety of the ingredients of cosmetic products or their combinations as of the date when the procedure must be replaced with at least one of the validated method listed in Commission Regulation (EC) No 440/2008 laying down test methods in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.05.2008, pp 1–739) or Annex IX to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.09.1976, pp 169–200).
(8) A procedure may be conducted either on the basis of a decision of the European Chemicals Agency or with the consent of the Health Board in order to obtain information required in the dossiers provided for in Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC and 2000/21/EC (OJ L 396, 30.12.2006, pp 1–850), or in the Biocides Act.
(9) The repeating of a procedure without reason is avoided and to that end people keep themselves up to date with the relevant data of the Member States of the European Union sent to the European Commission on procedures carried out on the basis of the legislation of the European Union. A procedure may be repeated where in connection with the aforementioned data further animal experimentation is required for public health, safety or environmental protection purposes.
(1) It is prohibited to use an animal specified in Article 7(1) of Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes (OJ L 267, 20.10.2010, pp 33–79) in a procedure, unless the procedure is in accordance with the Nature Conservation Act and the purpose of the procedure is specified in clause 2, 5 or 7 of § 35 of this Act and there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of another experimental animal.
(2) Subsection 1 of this section does not apply to any species of non-human primates.
(1) It is prohibited to use non-human primates in a procedure, unless there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of another experimental animal and where the purpose of the procedure is:
1) the purpose specified in clause 2 of § 35 of this Act and the procedure is undertaken with a view to the avoidance, prevention, diagnosis or treatment of a debilitating or potentially life-threatening clinical condition in human beings;
2) the purpose specified in clause 7 of § 35 of this Act.
(2) It is prohibited to carry out a procedure where the procedure carried out for the purpose specified in subsection 1 of this section results in severe long-lasting pain or stress that cannot be ameliorated.
(41) Non-human primates not complying with the origin requirement provided for in subsection 3 of this section may be used in a procedure where it according to scientific knowledge the use of such non-human primates that are the offspring of animals bred in artificial conditions or sourced from a self-sustaining colony are insufficient for the attainment of the purpose of the procedure.
(2) An experimental animal specified in subsection 1 of this section, which has not been bred in the establishment of an operator that received an activity licence for breeding experimental animals may be used in a procedure where it has been scientifically proven that the use of an animal bred in the establishment is not sufficient for attaining the goal of the procedure.
§ 381. Keeping experimental animals
Upon keeping experimental animals, the following requirements must be complied with in addition to those provided for in subsection 2 of § 3 of this Act:
1) the satisfaction of the physiological and ethological needs of the experimental animals are restricted as little as possible;
2) the microclimate in which the experimental animals are bred, kept or used is checked on a daily basis;
3) a plan is drawn up and implemented to ensure that a deficiency identified in the keeping of the experimental animals or preventable pain, suffering, stress or harm is eliminated as soon as possible;
4) the experimental animals are transported in suitable conditions.
(3) The requirements applicable to establishments engaged in breeding, supplying and using experimental animals are established by a regulation of the minister responsible for the field.
(4) A procedure is carried out in an established engaged in using experimental animals, unless according to scientific knowledge the procedure needs to be carried out outside the establishment, for instance in a natural environment, livestock building, construction works, area enclosed for keeping animals or zoo to which an activity licence for using experimental animals has not been granted.
(3) The information specified in this section is entered in the register of farm animals established on the basis of subsection 3 of § 11 of the Infectious Animal Disease Control Act.
An activity licence is granted to an operator where its establishment engaged in breeding, supplying or using experimental animals complies with the requirements of this Act and legislation established on the basis thereof.
1) the name and contact details of the person in charge of the compliance of the establishment’s operations with the requirements;
2) the name and contact details of the person in charge of the welfare and care of experimental animals;
3) the name and contact details of the person whose grants an employee attending to experimental animals access to the animal species kept in the establishment;
4) the name and contact details of the person in charge of the education and competence of the employees of the establishment;
5) the name and contact details of the veterinarian or a person with relevant qualifications whose duty is to give advice regarding the welfare and treatment of experimental animals;
6) the term of validity of the activity licence.
§ 403. Obligation to notify of change of factors relating to business activity
(1) In a notice on the intention to change the economic activities and in a notice on a change of the economic activities, the operator submits the description or the data specified in subsection 3 of § 30 of the General Part of the Economic Activities Code Act.
(2) Where the economic activities of the operator no longer comply with the requirements of the object of inspection of the activity licence following a change of the circumstances and this may adversely impact the welfare of experimental animals, the operator must, for the purpose of ensuring the welfare of the experimental animals:
1) omit the changes;
2) bring its activities or planned changes into compliance with the requirements of the object of inspection of the activity licence, or
3) apply for the amendment of the activity licence or a new activity licence.
(3) A further training establishment specified in subsection 2 of this section draws up a programme for training in the care and killing of experimental animals, training in procedures and training in designing projects, taking into account the characteristics of the functions and liability of persons engaged in caring and killing experimental animals, carrying out procedures and designing projects, and submits it to the Ministry of Rural Affairs for approval.
(4) The Ministry of Rural Affairs approves or rejects a training programme specified in subsection 3 of this section within 20 working days after the receipt thereof.
(5) The Ministry of Rural Affairs rejects a training programme specified in subsection 3 of this section where it does not comply with the requirements established for the programme.
(6) A training establishment issues a relevant certificate to a person who has passed an examination in the care and killing of experimental animals, in carrying out procedures and in designing projects.
(7) More detailed requirements for programmes of training in the care and killing of experimental animals, carrying out procedures and designing projects and for topics covered by training are established by a regulation of the minister responsible for the field.
§ 421. Employees of establishment engaged in breeding, supplying and using experimental animals and experimental animal welfare records
(1) There must be a sufficient number of employees on site in an establishment engaged in breeding, supplying and using experimental animals.
(2) For the purpose of ensuring the welfare of experimental animals, a supervisor is appointed for a natural person directly engaged in taking care of and killing experimental animals and in carrying out a procedure who commences work with such a species of experimental animals with which it has not any prior work experience. The supervisor supervises and evaluates the employee for as long as the employee has acquired competence in working with the experimental animals on their own without causing them unnecessary pain, suffering, stress or lasting harm.
(3) Where a natural person directly engaged in taking care of and killing experimental animals and in carrying out a procedure has not participated in any project or worked in an establishment engaged in breeding, supplying or using experimental animals in the last five years, their competence for working with experimental animals on their own is deemed lost and a supervisor is appointed for them in accordance with subsection 2 of this section upon commencement of work in the establishment.
(4) A person engaged in breeding, supplying or using experimental animals appoints in their establishment a person with relevant training who is on site in the establishment during working hours and who:
1) is in charge of the welfare and caretaking of animals kept in the establishment;
2) grants an employee attending to experimental animals access to information on the animal species kept in the establishment;
3) is in charge of ensuring that the employees of the establishment have relevant education and are competent, participate in continuous training and, where necessary, work under the supervision of a relevant person until they have acquired the competence for working on their own.
(5) A person engaged in breeding, supplying or using experimental animals appoints a veterinarian competent in the field of the medicine of the experimental animals or another person holding relevant qualifications to give advice on the welfare and treatment of experimental animals.
(6) A person engaged in breeding, supplying or using experimental animals draws up relevant records in their establishment for the purpose of ensuring experimental animal welfare and health in their establishment, following the requirements established on the basis of subsection 3 of § 39 of this Act.
(1) A person engaged in breeding, supplying or using experimental animals establishes an animal welfare unit comprising of at least the persons specified in clause 1 of subsection 4 and subsection 5 of § 421 of this Act whose duty is to give advice on the welfare, treatment and care of experimental animals. In a user establishment, the animal welfare unit must comprise at least one person with a research degree in medicine, biology or another relevant field and experience in carrying out procedures.
(2) More detailed requirements for animal welfare bodies are established by a regulation of the minister responsible for the field.
(2) Where a dog, cat or non-human primate is transferred from establishment to another before it is weaned, a record specifying the animal’s mother must be maintained until the animal is marked. Where an unmarked dog, cat or non-human primate, which has been weaned, is received by an establishment, it is marked as soon as possible.
(4) After birth, each dog, cat and non-human primate gets an individual history file that contains information about the animal.
(5) More detailed requirements for keeping records of experimental animals, including the list of data to be recognised in such records, are established by a regulation of the minister responsible for the field.
(2) Upon choosing a procedure, preference is given to one that is likely to produce a satisfactory result and:
1) uses the minimum number of experimental animals;
2) involves animals of a species with the lowest capacity to experience pain, suffering and stress and causes the least pain, suffering, stress or possible lasting harm;
3) causes as little pain, suffering, stress or lasting harm as possible to the experimental animals.
(3) A procedure is carried out under general or local anaesthesia, using analgesia or another appropriate method to ensure that the pain, suffering and stress of the experimental animal is as little as possible.
(4) The requirement for using anaesthesia provided for in subsection 3 of this section does not apply where:
1) the pain, suffering or stress caused by the procedure itself is smaller than the harming of the welfare of the animal upon using anaesthesia, or
2) anaesthesia is incompatible with the purpose of the procedure.
(41) Where the experimental animal may fee pain once anaesthesia ends, preventive and post-surgical analgesia or another pain-reducing method is used with regard to it, unless according to scientific knowledge this is incompatible with the purpose of the procedure.
(42) It is prohibited to administer to an experimental animal a medicinal product to stop or restrict the showing of their pain without an adequate level of anaesthesia or analgesia. Where it is intended to administer such a medicinal product to an experimental animal, scientific reasons along with a detailed description of the anaesthetic or analgesic regime are submitted upon applying for a project authorisation.
(5) Where possible, death as the end-point of a procedure is avoided, replacing it with an earlier and humane end-point. Where the death of experimental animals as the end-point of a procedure is unavoidable, the procedure is designed so as to result in the deaths of as few animals as possible, the duration and intensity of the animal’s suffering is minimised, and it is ensured that the animal dies as painless a death as possible.
(51) Upon attainment of the purpose of a procedure, measures for reducing the suffering of the experimental animal are taken immediately.
(52) A procedure is deemed completed where no observations are carried out for that purpose or, in the case of a genetically modified animal line, where pain, suffering, stress or lasting harm equal to or exceeding that caused by a needle sting is no longer observed or presumed in the offspring.
(6) Upon completion of a procedure, the veterinarian or another competent person decides whether the experimental animal is kept alive or killed. The animal is killed where it would otherwise be likely forced to permanently experience moderate or severe pain, suffering or stress or where lasting harm would be caused to it.
(61) Where an experimental animal is kept alive after the completion of a procedure, the animal is provided with care and keeping corresponding to its health status.
(7) Where the health status of an experimental animal allows it, where there is no threat to human or animal health or to the environment and where animal welfare is ensured, the animal that has been kept alive may be rehomed or taken back to a suitable environment, livestock building or facility or to an area enclosed for keeping animals.
(1) The categories of severity of a procedure based on the pain, suffering, stress and lasting harm are as follows: non-recovery, mild, moderate and severe.
(2) An experimental animal may be used in a severe procedure only once. An experimental animal used in a moderate or mild procedure may be reused where, according to the estimate of a veterinarian, taking into account what the animal has experienced during its life, the health status and welfare of the animal has restored, and the next procedure is a mild, moderate or non-recovery procedure.
(3) The definitions of severity categories of procedures and more detailed requirements for classification of procedures are established by a regulation of the minister responsible for the field.
(3) The procedure protocol form is established by a regulation of the minister responsible for the field.
(1) In order to carry out a project one must hold a project authorisation (hereinafter project authorisation). The authorisation sets out the name and address of the holder of the project authorisation and of the person responsible for the project, the place of implementation of the project, the special conditions arising from the assessment of the project, including the need for a retrospective assessment of the project and, where necessary, other conditions of implementing the project.
(3) The procedure for establishment and the rules of procedure of the project authorisation committee are established by a regulation of the minister responsible for the field.
§ 451. Assessment of project
(1) An authorisation is granted only for the implementation of a project that has been assessed, to the procedures of which severity categories have been attributed and to which the project authorisation committee has given a positive assessment.
(2) A project is assessed with the thoroughness suitable for the given project type, checking whether:
1) the project is reasoned from the scientific or educational point of view or prescribed by a legal act;
2) the purpose of the project justifies the using of experimental animals;
3) the project is planned in such a way that it allows for carrying out procedures in an as humane and environmentally friendly manner as possible.
(3) In the course of the assessment of a project:
1) the purposes of the project and the estimated scientific benefits or educational value are assessed;
2) the compliance of the project with the replacement, reduction and refinement requirement is assessed;
3) the severity categories of the procedures are assessed and determined;
4) the gains and losses of the project are analysed in order to assess whether the harm caused to the animals in the form of suffering, pain and stress is, given the ethical considerations, justified for the sake of the expected result and may ultimately be beneficial for humans, animals or the environment;
5) the reasons given for making the exceptions permitted under this Act upon carrying out a procedure are assessed;
6) it is determined whether and when a retrospective assessment of the project needs to be carried out.
(4) A project is assessed in a transparent and impartial manner.
(3) Where a person responsible for a project is a legal person, the requirements provided for in subsection 2 of this section are met where a natural person working for the legal person under a contract meets the requirements.
(31) The person responsible for a project ensures that:
1) the causing of unnecessary pain, suffering, stress or lasting harm caused to an experimental animal in the course of a procedure is terminated;
2) the project is carried out on the conditions established in its authorisation and where the project does not comply with the conditions of the authorisation, appropriate measures are taken to remedy it and these are indicated in the protocol of the procedure.
(2) An application sets out information about the designer of the project, the person responsible for the project, the involved person, the experimental animals and genetically modified animals to be used, and the time and place of the project, justifies the need for the project, the choice of the animal species and the number of animals to be used, and lists and describes various proceedings that the animals are subjected to. In addition to the aforementioned, the following is annexed to an application for a procedure involving genetically modified animals: information concerning the donor, recipient and parental organism, and also concerning the genetic modification, monitoring, control and waste handling involved in the procedure; an emergency plan indicating extraordinary measures to be applied in the event of an accident.
(3) Standard application forms for project authorisations are established by a regulation of the minister responsible for the field.
(4) The authorisation committee communicates to the applicant as soon as possible in writing the time limit during which a decision to grant or refuse to grant the authorisation is made.
(5) In the event of a procedure involving a genetically modified animal, the authorisation committee forwards a copy of the application and of the documents annexed thereto the gene technology committee specified in § 5 of the Release into Environment of Genetically Modified Organisms Act. The authorisation committee takes into account the opinion of the gene technology committee upon deciding whether to grant the authorisation. In the event of applying for an authorisation for implementing a follow-up project of an implemented project, the authorisation committee does not need to forward copies of the application and its accompanying documents to the gene technology committee.
(6) In the event of a procedure involving an animal living freely in the wild, the authorisation committee forwards a copy of the application and of the documents annexed thereto to the Environmental Board for the purpose of obtaining its opinion. The authorisation committee takes into account the opinion of the Environmental Board upon deciding whether to grant or refuse to grant the authorisation.
(7) The authorisation committee makes a decision to grant or refuse to grant an authorisation within 40 working days after the receipt of a due application.
(8) The authorisation committee may extend the time limit specified in subsection 7 of this section once by up to 15 working days where an authorisation for a project calling for additional expert assessment is applied for or where the project involves several fields. The applicant is informed of the extension of the time limit in writing before the expiry of the time limit specified in subsection 7 of this section, stating the reasons for the extension of the time limit.
(9) The application and the documents annexed thereto, a copy of the application and other documents and records relating to the project are retained for at least three years after the completion of the project.
(10) The documents related to a project that needs to be assessed retrospectively are retained at least until the retrospective assessment has been completed.
§ 48. Granting of authorisation, term of validity of authorisation and disclosure of information
(1) An authorisation is granted on the conditions set forth in the application and it is valid until the expiry of the term of validity or until the authorisation becomes invalid or is revoked.
(11) Non-technical summaries of authorised projects are published on the website of the Ministry of Rural Affairs. Statistical information on the use of experimental animals in procedures, including information on the actual categories of severity of procedures and on the origin and species of non-human primates used in procedures is also annually published on the website of the Ministry of Rural Affairs based on protocols submitted in accordance with subsection 6 of § 44 of this Act.
(3) An authorisation may be revoked by a decision of the authorisation committee.
(4) In the event of the expiry, invalidity or revocation of an authorisation, the person responsible for the project ensures that the welfare of the animals used or intended to be used in the project does not deteriorate.
(1) The authorisation committee has the right to refuse to grant an authorisation where:
(1) Where a project is amended in such a manner that it no longer meets the conditions established in its authorisation and may adversely affect the welfare of the animals used in the project, the authorisation holder applies for a new authorisation.
(2) A new authorisation is issued only where the authorisation committee has made a positive assessment of the revision of the project.
(1) The authorisation committee must carry out a retrospective assessment of a project in the event of a severe procedure and where non-human primates have been used in a procedure carried out in the framework of a project.
(2) Upon retrospective assessment of a project, the attainment of the purpose of the project and the harm caused to animals must be assessed on the basis of the procedure protocol, taking into account the number and species of the experimental animals used, the severity categories of the procedure and other circumstances that contribute to the application of the requirement to replace, reduce and refine the procedure.
(3) Upon performance of the functions provided for in subsection 1 of this section, the Ministry of Rural Affairs may, for the purpose of obtaining an opinion, address the experimental animal protection commission that has been established by the minister responsible for the field for advisory purposes and involves experts of the following fields:
(2) The provisions of this Chapter do not apply to genetically modified animals that are marketed or deliberately released into the environment in compliance with the Act referred to in subsection 1 of this section or to genetically modified micro-organisms.
(3) The requirements for preparation of risk analyses of procedures and mandatory information to be presented in a risk analysis are established by a regulation of the Government of the Republic or of a minister authorised by the Government of the Republic.
(2) Where any of the circumstances listed in subsection 1 of this section become evident, the person who carries out the procedure must immediately submit a new application for an authorisation and bring the conditions of the procedure into compliance with new requirements.
(3) Where any of the circumstances listed in clauses 2 or 3 of subsection 1 of this section become evident, the processing of the application must be suspended until the submission of a new application and the procedure is suspended until a new authorisation has been granted.
(1) The authorisation authority publishes a notice in the official publication Ametlikud Teadaanded concerning the granting of each authorisation to carry out a procedure involving a genetically modified animal .
(2) Where necessary, the authorisation authority may grant the authorisation to carry out a procedure involving a genetically modified animal by way of open proceedings in accordance with § 10 of the Release into Environment of Genetically Modified Organisms Act, while adhering to the requirement of maintaining the confidentiality of information.
Before carrying out a procedure involving a genetically modified animal and the use of the premises prescribed for such purposes, the person carrying out the procedure must:
2) inform, in an appropriate manner, potentially endangered persons of safety measures to be applied and correct action to be taken in the event of an accident. The person carrying out a procedure must update this information at appropriate intervals and make the information available to the public.
(2) In the event of an accident, the person carrying out the procedure must immediately inform the authorisation authority thereof and submit the following information:
(3) Upon receipt of the information specified in subsection 2 of this section, the authorisation authority is required to:
(4) The person carrying out the procedure must remove the genetically modified animals from the environment and remedy the environmental damage caused by the release of such animals into the environment.
(5) The law enforcement authority removes the genetically modified animals from the environment and remedy the environmental damage caused by the release of such animals into the environment where the person carrying out the procedure fails to do so. Under § 26 of the Environmental Liability Act, the person who remedied the environmental damage has the right to demand that the person who carried out the procedure compensate reasonable expenses incurred upon remedying the environmental damage.
(6) The authorisation authority organises an evaluation of the effectiveness of remedying the environmental damage at the cost of the person who caused the damage.
(7) The authorisation authority must record all accidents. Information concerning an accident must be preserved together with the materials relating to the corresponding application for carrying out a procedure in accordance with subsection 6 of § 45 of this Act.
(1) The authorisation authority has the right to temporarily restrict or suspend procedures involving genetically modified animals where concrete evidence exists that such procedures endanger human health or the environment.
(2) Where, after granting an authorisation, the authorisation authority learns that the conditions established in the authorisation have been violated or are not complied with as required, the authority may demand that the person carrying out the procedure amend the conditions of the procedure or suspend or terminate the procedure.
In the event of failure to comply with a precept the maximum penalty payment imposed in accordance with the procedure provided for in the Substitutive Enforcement and Penalty Payment Act is 13 000 euros.
(1) Upon repeated failure to comply with a precept issued by the law enforcement authority or repeated failure to comply therewith according to the requirements, or upon a material violation of the requirements of this Act, the law enforcement authority has the right to take the animal away from the owner where leaving the animal with the owner threatens the health or life of the animal.
(2) The law enforcement authority gives an animal that has been taken away from its owner to the local authority that imposes substitutive enforcement for the keeping of the animal in accordance with the procedure provided for in the Substitutive Enforcement and Penalty Payment Act.
(3) An animal owner from whom the animal has been taken away in accordance with subsection 1 of this section either transfers the animal or organises the slaughter or killing of the animal by the date, in the manner and under the conditions prescribed by the precept issued by the law enforcement authority.
(4) In the event of failure to transfer, slaughter or kill an animal by the due date, the law enforcement authority organises the transfer, slaughter or killing of the animal in accordance with the procedure provided for in the Substitutive Enforcement and Penalty Payment Act.
(5) The income received from the transfer, slaughter or killing of an animal in the event specified in subsection 4 of this section is used for covering the costs of substitutive enforcement incurred by the local authority and the remaining income belongs to the owner of the animal from whom the animal has been taken away.
(6) A local authority may take a loan for organising the keeping of an animal that has been taken away from the owner. Subsection 3 of § 38 of the Local Authority Financial Management Act regulates the taking of such a loan.
Where the law enforcement authority has, on the basis of subsection 1 of § 64 of this Act, taken an animal away from an animal owner who is a legal person and where bankruptcy proceedings are initiated with regard to the animal owner on the basis of subsection 1 of § 15 of the Bankruptcy Act before the transfer, slaughter or killing of the animal, the reasons for taking the animal away are deemed to have ceased to exist, and the law enforcement authority returns the animal to the animal owner.
The court sends a copy of the judgment on the prohibition to keep a farm animal subject to registration to the register of farm animals within five working days after the date on which the court judgment enters into force.
(3) The court hears misdemeanours provided for in § 662 of this Act where revocation of the right to keep animals is to be decided upon hearing the misdemeanour case.
(1) Animal keepers who are operating on 1 July 2002 must comply with the requirements for keeping of animals established on the basis of subsection 4 of § 3 of this Act as of 1 January 2003, unless the requirements prescribe a later date for compliance with specific requirements.
(5) The requirements of this Act, which entered into force on 1 January 2013, do not apply to procedures that, before the given date, have been granted an authorisation that remains in force no later than until 1 January 2018.
(6) Decisions authorising breeding establishments, supply establishments and user establishments under this Act before 1 January 2013 remains in force until 31 December 2016.
(7) Where a person has gained at least three years of experience in slaughtering animals and related acts before 1 January 2013, it is until 8 December 2015 considered equal to undergoing training and passing an examination in slaughtering animals and a certificate specified in Article 21 of Council Regulation (EC) No 1099/2009 is issued to the person.
(8) A person specified in subsection 7 of this section, not later than by 8 November 2015, submits to the Veterinary and Food Board information on at least three-year experience in slaughtering animals and performing related acts along with copies of documents certifying the experience.
(9) Where, on the basis of the documents specified in subsection 8 of this section, the at least three-year experience of a person in slaughtering animals and performing related acts, which has been acquired before 1 January 2013, is considered certified, the Veterinary and Food Board issues a certificate specified in Article 21 of Council Regulation (EC) No 1099/2009 within 20 working days after the submission of the documents.
(10) Subsections 6 and 7 of § 36 of this Act remain in force until 11 July 2013.
(11) Authorisations for the breeding, supplying and using of experimental animals granted on the basis of this Act before 1 January 2019 remain in force until expiry of the period specified therein.
(1) This Act enters into force on 1 July 2001, except subsections 1-3 and 7 of § 22 that enter into force on 1 January 2002, Chapters 8 and 9 enter into force on 1 July 2002 and subsection 1 of § 11 enter into force on 1 January 2003.
(2) The requirements for keeping animals established on the basis of subsection 4 of § 3 of this Act enter into force on 1 July 2002.
1 Council Directive 98/58/EC concerning the protection of animals kept for farming purposes (OJ L 221, 08.08.1998, pp 23–27), amended by Regulation (EC) No 806/2003/EC (OJ L 122, 16.05.2003, pp 1–35); Council Directive 1999/74/EC laying down minimum standards for the protection of laying hens (OJ L 203, 3.8.1999, pp 53–57), amended by Regulation (EC) No 806/2003/EC (OJ L 122, 16.05.2003, pp 1–35); Council Directive 2007/43/EC laying down minimum rules for the protection of chickens kept for meat production (OJ L 182, 12.07.2007, pp 19–28); Council Directive 2008/119/EC laying down minimum standards for the protection of calves (OJ L 10, 15.01.2009, pp 19–28); Council Directive 2008/120/EC laying down minimum standards for the protection of pigs (OJ L 47, 18.02.2009, pp 5–13); Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes (OJ L 267, 20.10.2010, pp 33–79).