Key Benefits:
Act of 12 January 1977, laying down detailed rules for the conduct of tests on animals
We JULIANA, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc., etc., etc.
All of them, who will see or hear these, saluut! do know:
In this regard, we have taken the view that it is desirable to regulate the protection of the animal with regard to the carrying out of tests on animals;
In this way, we, the Council of State, and with the mean consultations of the States-General, have been well-regarded and understood to be right and to be understood by the following:
1 For the purpose of applying to or pursuant to this Act, the following definitions shall apply:
a. Animal test: any or non-invasive use of an animal for experimental or other purposes, the result of which is known or unknown, or educational purposes, which may cause as many or more pain, suffering, distress or lasting harm to the animal If, then, then insertion of a needle according to good animal health craftsmanship. This includes any use whose purpose or effect is the birth or the breaking of an animal, or putting it in such a situation and holding a genetically modified animal line, including killing of animals. animals for the use of their organs, tissues or body fluids for a purpose mentioned in Article 1c ;
b. project: a work programme with a well-defined purpose comprising one or more animal experiments;
c. establishment: an installation, building, group of buildings or other premises, including, where applicable, spaces which are not completely severed or covered, as well as movable facilities;
ed. Breeder: a natural person or a legal person who breeds the animals designated in the Directive in order to use them in animal experiments or use their tissues or organs for scientific purposes, or which is essentially for these purposes other animals bred, whether for profit or not;
e. vendor: a natural person or a legal person who is not breeder and provides animals for use in animal experiments or for the use of their tissues or organs for scientific purposes, whether for profit or not;
f. user: a natural person or a legal person, whether for profit or not, used in animal experiments;
g. Debilitating disease: a restriction on a person's normal physical or mental capacity to function;
h. Self-maintained breeding colony: a colony in which the animals are bred only in the colony or come from other colonies but not caught in the wild and in which the animals are kept in such a way that they are used to humans;
i. Directive: the directive to be adopted by our Minister.
2 For the purposes of applying to or pursuant to this Act, the following definitions shall apply:
Our Minister: Our Minister for Economic Affairs;
Inspector: the designation under a designation Article 20 Inspector of the State Public Health Authority responsible on the spot.
3 An amendment to the Directive shall apply to the implementation of the provisions of the Act on animal testing as from the day on which the relevant amending Directive has to be implemented.
The recognition of the intrinsic value of the animal shall be used as a general basis for the exercise of powers by, or under this law, as a general basis.
1 This Law shall apply to animals which:
a. shall be used for scientific or educational purposes; or
b. Are used or intended to be used in animal experiments or specially bred so that their organs or tissues can be used for scientific purposes.
This Law shall apply to the animals referred to in paragraph 1 until they are killed or adopted or placed in their habitat or in a suitable animal husbandage system.
3 This law applies to all animals present to breeders, suppliers and users, except to the extent that it is likely that the animals present are present for purposes other than those mentioned in the first paragraph.
4 The elimination of pain, suffering, distress or lasting harm through the efficient application of anaesthesia, analgesia or any other method does not result in the use of an animal in a animal test outside the scope of this Act.
5 This Act shall apply to:
a. Living non-human vertebrates, including:
-self-sustaining larval-larval forms, and
-foetal forms of mammals from the last third part of their normal development,
b. Live cephalopods and other aquatic invertebrates designated by general measure of which it is reasonable to assume that they are unaffected by a animal test.
6 By way of derogation from paragraph 5, this Law shall apply to animals used in experiments on animals which are at an earlier stage of development than those referred to in paragraph 5, if these animals are intended to be kept near that stage of development; the development stage to be maintained and, as a result of the animal test carried out, is at risk of suffering from pain, suffering, distress or lasting harm after reaching that stage of development.
7 This Act does not apply to:
a. Non-experimental agricultural practices;
b. Non-experimental practices in clinical veterinary medicine;
c. experiments in clinical veterinary medicine required for marketing authorization for an animal medicinal product;
Practices for regular animal husbandry;
e. practices whose main objective is to identify the animal;
f. practices that are unlikely to cause as much, or more, pain, suffering, distress or lasting harm to them, or to the insertion of a needle according to good veterinary craftsmanship.
Without prejudice Article 2, second and third paragraphs , animal tests shall be carried out only for the purpose of the following purposes:
a. Basic research;
b. translational or applied research with one of the following objectives:
-the avoidance, prevention, diagnosis or treatment of diseases, health disorders or other abnormalities, or their effects, in humans, animals or plants,
-the assessment, detection, regulation or modification of physiological conditions in humans, animals or plants, or
-the welfare of animals and the improvement of production conditions for animals reared for farming purposes;
c. any objective set out in subparagraph (b), during the development, production or testing of the quality, efficacy and safety of medicinal products, food and feed and other substances or products;
d. Environmental protection in the interest of the health or well-being of humans or animals;
e. research aimed at the preservation of the species;
f. higher education or training for the acquisition, maintenance or improvement of professional skills;
Forensics.
1 A animal test shall be carried out only if the intended result cannot be achieved by means of a scientifically sound method or a research strategy which does not involve the use of live animals.
2 The number of animals used in projects is kept to the minimum without the objectives of the project being compromised.
3 The breeding, housing and care of animals and methods used in animal experiments are being refined so that any form of pain, suffering, distress and lasting damage that the animals may encounter is prevented or kept to the minimum Limited.
4 If there is a choice between methods as referred to in paragraph 1, the choice shall be made in accordance with Article 10, second paragraph .
1 In the case of an animal test, where an animal has not previously been tested before, a animal test shall be carried out only with an animal which has previously been used in a animal test, if the following conditions are fulfilled:
a. The actual severity of pain, suffering, distress or lasting harm with which the previous animal experiments were associated with "light" or "moderate";
(b) it has been established that the general health and welfare state of the animal has been fully restored;
c. the next animal test based on Article 10b is classified in the category: "light," moderate "or" terminal "; and
(d) the act to be performed is in accordance with veterinary advice, when taking into account the full course of life of the animal.
2 In exceptional circumstances and by way of derogation from the first paragraph, a project permit may be granted for a project involving the re-use of an animal, if:
a. A veterinarian has examined the animal prior to the animal test; and
(b) the animal has not been used more than once in a animal test involving severe pain, distress or similar suffering.
1 It is forbidden without the permission of our Minister to carry out animal testing.
2 The institution permit shall apply as regards the conduct of animal testing as in Article 1c (b) to (f) Intended solely to the extent that the tests, whether directly or indirectly, are directed to the interest of human or animal health or food.
3 If our Minister considers that a significant other importance so requires, it may, in the institution's authorization, provide that it shall be co-valid with regard to the conduct of tests on animals such as that in which it is not Article 1c (b) to (f) The purpose of which, whether directly or indirectly, is to indicate that-in the institution permit-other importance.
4 With application of Article 28, first paragraph, final phrase, of the Services Act is Section 4.1.3.3 of the General Law on administrative law does not apply to an application for an institution permit as referred to in the first paragraph.
1 Our Minister may arrange for the information to be provided on an application for an institution's authorization and after the institution's authorization is given.
2 An amount to be fixed by ministerial order must be lodged when applying for an application. The amount referred to in the preceding sentence shall be fixed in such a way as to cover the costs of processing the application.
1 An application for the institution's authorisation shall be subject to a decision within eight weeks. Our Minister may by decision extend this period by not more than eight weeks.
2 Our Minister shall decide, in agreement with Our Ministers, who shall take part.
3 Of the grant of an institution permit shall be granted in the Official Gazette Communication. It shall specify the main cases of the institution permit relating to the purpose of the trials and the limits and requirements laid down in the institution's authorisation. Application of the preceding sentence may be omitted, in so far as there are objections to the communication on grounds relating to the communication.
An institution permit may be refused only if:
(a) there are grounds for fear that the holder of the authorisation would not comply with the rules applicable to him under this law;
b. An institution licence previously granted to the applicant has been withdrawn other than on the Article 7, second paragraph, point (b) The above ground and not yet two years have elapsed since the decision to revoke has become final.
1 An institution permit may be granted under restrictions and for a limited period of time.
2 Requirements may be attached to an institution permit. The rules may be amended, supplemented or cancelled.
3 In the institution's licence, the following shall be stated:
a. The person responsible within the institution for the supervision of compliance with the law;
b. The persons referred to in Article 13f, third paragraph ; and
c. the person intended in Article 14 .
1 An institution authorisation shall be revoked if:
(a) the information given in order to obtain it is found to be incomplete or incomplete, that another decision would have been taken on the application as if the appropriate conditions had been fully disclosed;
b. a significant change has occurred of the structure or operation of a device of a user, which may adversely affect animal welfare.
2 An institution permit may, moreover, be withdrawn if:
(a) it appears that the holder of the authorisation has not complied with the rules applicable to him under this Act;
(b) during an uninterrupted period of one year no operations have been carried out using the institution permit.
3 In cases where the institution permit may be revoked, a restriction may be added to the institution permit, instead.
4 Article 4, second paragraph , shall apply mutatis mutandis.
5 From a decision adopted under the first or second paragraph, notification shall be made in the Official Gazette .
1 An institution permit under this Law shall be granted to a natural person or to a legal person; it shall be bound by the natural or legal person to whom it is granted.
2 Where the holder of the authorisation is a natural person, the institution's authorisation shall remain in force for the purposes of the rectified persons after his death during a period of six months. Where an application for a new institution's authorisation has been filed within this period, the first set of institution licence shall remain in force until that application is irrevocably decided. Article 7 continue to be subject to this institution's authorisation for the period of validity.
It shall be prohibited to carry out an animal test if the person who design the project and the animal test fails to comply with or pursuant to general management measures for the purposes of the competence and competence to be established.
1 It is prohibited to carry out an animal test for a purpose
a. that, according to the general view of experts, can also be achieved by means of an animal test, or by means of an animal test in which fewer animals can be used or are being reduced to less than that of the animals is the case in the case of the test at issue;
b. that can be achieved by means of a different method or test strategy in which no live animals are used and recognised in European Union law;
c. The importance of which does not outweighs the amount of inconvenience caused to the test animal.
2 Where there are several possibilities for carrying out an animal test, the animal test meeting the following conditions and expected to produce satisfactory results shall be selected:
a. The minimum number of animals is to be used;
b. the animals concerned are animals that are least susceptible to pain, suffering, distress or lasting harm;
The animal test in question shall cause the animals to suffer at least the pain, suffering, distress or lasting damage.
3 It is prohibited to conduct a animal test by means of LD50/LC50 test methods.
4 The prohibition on the prohibition referred to in paragraph 3 may be granted by our Minister for a maximum period of five years if it is shown that no alternative is available for the methods mentioned in that paragraph.
1 It is prohibited to carry out a project if the Central Committee on Animal Testing has not granted a project authorisation for this purpose.
2 An application for a project authorisation shall be accompanied by a project proposal that is appropriate to the animal welfare authority.
3 The central committee on animal testing is of the opinion of a project proposal following the opinion of one of the following opinions: Article 18a approved animal experimenter committee and on the basis of the Article 2, second and third paragraphs , 9 , 10 , 10a2 , 10a4 , 10b , 10d up to and including 10h , 11 , 13 and 13f .
4 The costs relating to the opinion of a recognised animal experimenter committee referred to in paragraph 3 shall be borne by the applicant for a project authorisation.
5 In the case of a ministerial arrangement, the documents and data shall be submitted in the event of an application for a project authorisation. A ministerial arrangement shall lay down rules on the amount to be paid upon submission of the application. The amount referred to in the preceding sentence shall be fixed in such a way as to cover the costs of processing the application.
6 The receipt of the application for a project authorisation shall be confirmed as soon as possible by the Central Committee on Animal Testing. The period within which a decision on the application is to be made shall be indicated.
7 The assessment of a project takes place to a degree of practicality that fits the type of project and is necessary to assess whether the project meets the in Article 10a2 Those criteria.
8 The Central Committee on Animal testing shall give its opinion and publish it to the applicant within 40 working days of the receipt of the application. If this is justified by the complexity or the multidisciplinary nature of the project, this time limit may be extended by up to 15 working days. The extension and duration of such extension shall be reasoned and shall be notified to the applicant for the expiry of the time limit.
9 With application of Article 28, first paragraph, final phrase, of the Services Act is Section 4.1.3.3 of the General Law on administrative law does not apply to a project authorisation application as referred to in the first paragraph.
10 The project permit is limited to the animal tests included in the project proposal on the basis of which the project assessment has taken place and without prejudice Article 10a5 to the categories in which these animal experiments are classified in severity.
1 In the project permit, intended in Article 10a, first paragraph The following shall be indicated:
a. the user who is performing the project;
b. the persons responsible for the overall implementation of the project and for the conformity of the project with the project authorisation granted;
c. where appropriate, the establishments in which the project will be implemented; and
d. Special conditions arising from the project evaluation, including the provision or and when the project is to be assessed in retrospect.
2 To the project permit, referred to in 10a, 1st Member , rules can be connected.
3 Projects using non-human primates and projects included as severely classified animal experiments or a animal test as intended in Article 10b, second paragraph , be assessed in retrospect.
4 The in Article 10a, first paragraph , the project authorisation is granted for a maximum period of five years.
5 A project permit may cover different generic projects to be carried out by the same user, if such projects are required to comply with legal requirements or if in those projects are generally acceptable Methods of animal use shall be used for production or diagnostic purposes.
6 The Central Committee on Animal Testing accepts data resulting from the animal test carried out in another Member State, which has been approved on the basis of European Union legislation, unless further animal testing is carried out in connection with that data necessary for the protection of public health, safety or the environment.
7 The non-technical summary of a project for which the Central Committee on Animal Testing has issued a project permit and any additions thereto shall be known to a manner determined by or under general management Made. A ministerial arrangement shall lay down rules on the submission of the non-technical summary and any additions to it by the applicant or of the holder of the authorisation.
8 If the proposed project requires the release of the animal concerned, only a project permit is granted for this, if the Central Committee on Animal Testing has obtained the assurance that everything possible will be done to ensure the welfare of the animal to ensure that the animal is released only if the state of health of the animal so permits and there is no risk to public health and the environment.
1 The Central Committee on Animal Testing shall grant a project authorisation only if:
a. The project is justified or legally required from a scientific or educational point of view;
(b) the aims of the project justify the use of animals;
(c) the project is designed to allow animal testing to be carried out in the most humane and environmentally friendly way possible; and
d. the project is set up in accordance with Article 9 .
2 The project assessment shall include in particular:
a. an assessment of the objectives of the project and the predicted scientific returns or educational value;
b. an assessment of whether the project is in compliance with Article 10 ;
c. an assessment of the classification of the project according to the seriousness of the animal experiments;
d. an analysis of the damage and benefits resulting from the project, assessing whether the damage in the form of pain, suffering, distress or lasting harm in the animals is justified by the expected result respecting the conditions. ethical considerations, and may, in the long term, provide benefits for humans, animals or the environment;
An assessment of the reasons for diverting a derogation from the aid to or from the Articles 1st, 1st paragraph , 10th, second to fourth Member States , 10f, 1st and 4th Member , 10g, 1st Member , 10h, 1st Member , 11, 1st Member , 13, third member , 13c, second paragraph , certain, or of the reasons, intended for Article 13f, second paragraph, part f ;
f. a decision on whether, and if so when, the project will have to be evaluated in retrospect.
3 When on the basis of Article 10a1, first and third paragraphs , it was decided that the project will be assessed in retrospect, the central committee assesses animal testing after advice from the Animal Experiments Committee that previously gave advice on the project proposal, based on user submission. documentation which the Central Committee on Animal testing has indicated, the following aspects:
(a) whether the objectives of the project were achieved;
b. the damage suffered by the animals, including the numbers and types of experimental animals used, and the severity of the animal experiments; and
c. any elements that may contribute to the further practical application of Article 10 .
Before a user starts the execution of an animal test that is part of a project for which a project authorisation has been granted, its implementation shall be aligned with the animal welfare authority.
1 For projects that include terminal, light or moderately classified animal tests and where non-human primates are not used, a simplified procedure for obtaining a single administrative procedure may be applied to or under general management. project authorisation shall be adopted if:
a. Those projects are required to comply with legal requirements;
b. In those projects, animals are used for production or diagnostic purposes according to generally accepted methods; or
c. in those projects animals are killed solely for the benefit of obtaining organs or tissues.
2 Where the simplified procedure is applicable, a project shall be assessed in accordance with Article 10a, third and seventh member , and it is not exceeded by the first sentence of the eighth paragraph of Article 10a, paragraph 1.
3 In the event that a project, which has been assessed by the simplified procedure, is modified and the change may adversely affect animal welfare, the project can only be carried out when the central committee on animal welfare tests on animal welfare is carried out. Amendment has been given a positive opinion.
4 The articles 10a, first and sixth member , 10a1, fourth and fifth member and 10a5, fourth member , shall apply mutatis mutandis to a project to which the simplified procedure applies.
1 In case a project for which the Central Committee has already granted animal testing a project permit is modified and the change may adversely affect animal welfare, the change shall be submitted for review to the central committee. Commission on Animal Testing.
2 An amended project as referred to in paragraph 1 may only proceed if the Central Committee on Animal testing has given a favourable opinion on the modified project.
3 The amendment referred to in the first paragraph shall be assessed in accordance with Article 10a2 . Article 10a, third, seventh and eighth members , shall apply mutatis mutandis.
4 The Central Committee on Animal Testing may withdraw a project authorisation granted if it appears that the project is not carried out in accordance with the project authorisation granted for the project.
1 A animal test shall be classified by the user in the categories: terminal, light, moderate and severe on the basis of the criteria specified in the Directive.
2 It is prohibited to carry out an animal test leading to severe levels of pain, suffering, distress or lasting harm which is likely to be long-lasting and cannot be mitigated.
3 If, due to exceptional circumstances and scientifically justified reasons, it is necessary to carry out tests which result in severe pain, suffering or distress which are likely to be long-lasting and which cannot be softens, our Minister can grant a waiver from the second member for a period of up to five years. This period may be extended once for a period of five years.
1 It shall be prohibited to carry out an animal test other than in accordance with the project authorisation granted for the project, unless the amendment to the animal welfare body considers that it has no positive impact on animal welfare.
2 A change as referred to in paragraph 1 shall be notified to the Central Committee on Animal testing.
It is prohibited to carry out an animal test for the development of new, or testing of existing cosmetics for which rules have been established on the basis of the Commodity law .
1 It shall be prohibited to carry out an animal test using the following species:
-chimpanzee (pan troglodytes)
-bonobo (pan paniscus)
-orangutan (pongo pygmy)
-gorilla (gorilla gorilla).
2 Non-human primates other than those referred to in the first mentioned and referred to in paragraph 3 shall not be used in animal experiments unless it is demonstrated by scientific justification that the purpose of the animal test cannot be established. achieved by the use of animals belonging to a species other than a non-human primate species and the animal test one of the purposes mentioned in:
a. Article 1c, part b, first bullet point, or part c is intended and is to be carried out for the purpose of avoiding, preventing, diagnosing or treating diseases or potentially life-threatening diseases in humans; or
b. Article 1c, part a or e -To the end.
3 Without prejudice to paragraph 1, non-human primates belonging to species designated under or under a general measure of management shall not be used in a veterinary test unless it is demonstrated by scientific justification that the aim of the animal test cannot be achieved by using animals belonging to a species other than a non-human primate species and cannot be achieved by using animals belonging to another non-human primate species other than designated in the general measure of management and the animal test one of the Objectives referred to in:
a. Article 1c, part b, first bullet point, or part c , has the objective and is to be carried out for the purpose of avoiding, preventing, diagnosing or treating human or potentially life-threatening clinical conditions in humans; or
b. Article 1c, part e -To the end.
4 Animals other than non-human primates, and associated endangered species of endangered species designated by or under general measure, shall not be used in a animal test unless a scientific justification is provided for: provided evidence that the animal test is not intended to be achieved by the use of animals other than the endangered species of endangered species identified in the general measure of administration and the animal test one of the purposes mentioned in: Article 1c, part b, first bullet point, part c, or part e -To the end.
5 Without prejudice to the provisions of paragraph 1, non-human primates listed in the Directive shall be used in animal experiments only when they are descendants of non-human primates listed in the Directive, with effect from the dates laid down in the Directive. have been bred or come from self-established breeding colonies.
6 Fokkers of non-human primates apply a strategy which has the effect of increasing the proportion of animals that are descendant of non-human primates in captivity.
7 Without prejudice to paragraph 1, if there are reasonable scientific grounds to believe that the use of non-human primates for the purposes of the Article 1c, part b, first bullet point, or part c , said purposes, is essential for humans and does not take place for the purpose of avoiding, preventing, diagnosing or treating health-undermining or possibly life-threatening clinical conditions, Our Minister for a Grant a waiver for a period not exceeding five years to the extent that the purpose cannot be achieved through the use of a kind other than non-human primates. This period may be extended once for a period of five years.
1 Animals caught in the wild shall not be used in animal experiments.
2 By way of derogation from paragraph 1, a project permit may be granted for a project constituting a animal test referred to in paragraph 1 where it is demonstrated by scientific justification that the purpose of the project is to be Animal testing cannot be carried out with an animal bred for use in a animal test.
3 The catching of the animal in the wild is carried out by an expert person with methods that do not cause pain, suffering, distress or lasting harm in animals that are to be avoided.
4 Animals identified as being injured or in poor health by the catch or after the catch are to be examined by a veterinarian or other expert in this field. With regard to these animals, measures are being taken to ensure that animals are suffering as little as possible.
5 By way of derogation from paragraph 4, derogations may be made from the measures referred to in paragraph 4 if there is a scientific justification for such action.
1 Animal experiments shall be carried out in a device of a user.
2 By way of derogation from the first paragraph, a project permit may be granted for a project carrying out animal testing outside a user ' s establishment where it is demonstrated on the basis of a scientific justification that the purpose of the project is the animal test cannot be carried out where the animal test is carried out in an establishment of a user.
3 Animal tests are carried out only within the framework of a project.
1 Flock and wild animals shall not be used in animal experiments.
2 By way of derogation from the first paragraph, a project permit may be granted for a project using the animals referred to in paragraph 1, where:
a. there is an essential need for animal health and welfare tests of these animals or in the field of serious threats to the environment or health of humans and animals; and
b. by means of scientific justification, it is shown that the purpose of the animal test is to be achieved only by the use of a stray animal or a reindeer animal.
1 Animals belonging to the species designated in the Directive shall only be used in a animal test when these animals have been bred for use in animal experiments.
2 By way of derogation from paragraph 1, a project authorisation may be granted for a project in which animal experiments are carried out with animals which have not been bred for the purpose of using these animals in a veterinary test, if on the basis of a scientific justification has been demonstrated that the animal test is not intended to be achieved if an animal bred for use in animal experiments is used for that animal test.
1 It shall be prohibited to breed or deliver animals for animal testing without the authorisation of our Minister.
2 A licence as referred to in paragraph 1 may be refused only if the organisation and staff requirements laid down in or pursuant to a general measure of management are not fulfilled.
The Articles 3 to 7 shall be applicable mutatis mutandis.
3 With application of Article 28, first paragraph, final phrase, of the Services Act is Section 4.1.3.3 of the General Administrative Law Act does not apply to an application for authorisation as referred to in the first paragraph.
1 A animal test shall be conducted under general or local anaesthesia unless that is not possible, or when carrying out an animal test, painkillers or other good methods which are the pain, suffering, fear or distress of the disease are used. to minimise permanent damage to the animal. An animal test associated with the animal with severe pain which may cause severe pain shall not be carried out without anesthesia.
2 When the use of anaesthesia is used, the following shall be considered:
a. The administration of anesthesia for the animal is more traumatic than the animal test itself; and
b. The administration of anaesthesia is incompatible with the purpose of the animal test.
3 In an animal, no substance is administered which causes the animal to not show pain, or only to a reduced extent, when the animal is not given adequate anaesthesia or analgesia at the same time. If, by way of derogation from the preceding sentence, a substance is administered to an animal which does not allow the animal to show pain or only to a reduced degree of condition, the use of this substance shall be scientifically justified. The justification shall be accompanied by further information on the analgesic and analgesic protocol.
4 Animals that can suffer if anaesthesia has been worked out are treated preventively and postoperatively with painkillers or other appropriate pain management methods, provided they are compatible with the purpose of the animal test.
5 Once the goal of the animal test has been reached, appropriate measures shall be taken to minimise the suffering of the animal.
1 A animal test has been carried out when no further observations need to be made for that animal test or, as regards new genetically modified animal lines, when the offspring does not suffer as much or more, pain, suffering, distress, or lasting damage is seen or expected if, then, when insertion of a needle.
2 At the end of a animal test, a veterinarian or any other expert shall decide whether the animal is to be kept alive. An animal is killed if it is likely that it will continue to suffer a moderate or severe form of pain, suffering, fear, or continued harm.
3 If an animal is kept alive, it will receive the care and accommodation that fits in with his state of health.
1 As far as possible, the death as the endpoint of an animal test shall be avoided and replaced by a humane endpoint in an early phase.
2 When death as an endpoint of an animal test is unavoidable, the animal test shall be set up in such a way that:
a. To die as few animals as possible; and
b. the duration and intensity of the suffering of the animal are kept as small as possible and the death is painless as far as possible.
1 Animals are killed in the establishment of the breeder, supplier or user by an expert in such a way as to cause the animals as little pain, suffering and distress as little as possible. In the case of field studies, an animal outside the setting of the breeder, supplier or user may be killed by an expert.
2 For the purposes of killing the animals listed in the Directive, use is made of an appropriate method for the killing of such animals.
3 By way of derogation from the second paragraph, a project permit may be granted for a project using a method for killing animals, which is not included as an appropriate method in the Directive, if by means of a scientific justification has been demonstrated that the purpose of the animal test cannot be achieved by means of the methods laid down in the Directive. In addition, our Minister may grant an exemption or a derogation from the second paragraph if the different method of killing based on scientific justification is considered to be at least as humane as the appropriate methods set out in the Directive.
4 When an animal is to be killed for reasons of animal welfare, public health, public safety, animal health or the environment in an emergency situation, this may be done outside the setting of the breeder, supplier or user by another than an expert person. In this case, the second and third paragraphs shall not apply.
Animals used or intended to be used in a veterinary test may be released for adoption or reposted in their habitat or placed in a suitable animal husbandage system, if:
(a) the state of health of the animal permits;
b. there is no risk to public health, animal health or the environment; and
(c) appropriate measures have been taken to ensure the welfare of the animal.
When the breeder, supplier or user transfers to release to the adoption of animals used or intended to be used in an animal test, it shall apply an adoption procedure which provides for the socialization of the animals for adoption Animals to be released freely. In the case of wild animals, they shall pass through a reintegration programme, if necessary, before reentry into their habitat.
1 The breeder, the supplier and the user shall, without prejudice to their obligation to comply with the relevant regulations, be subject to an institution licence or exemption which is applicable to them, to ensure that they are adequately provided personnel and that the animals are properly cared for, treated and housed, in compliance with the rules to be laid down by or on the basis of general administrative measures.
2 To the rules referred to in paragraph 1, they may include rules relating to:
a. the competence and competence of those who care for and kill the animals;
b. the competence and competence of those carrying out animal testing;
c. the dimensions and construction of the lower-comes in which the animals are housed;
d. The cleaning and heating of the undercomens;
e. the feeding of the animals;
f. the possibility to derogate from the rules referred to in paragraph 1 due to scientific reasons or animal welfare reasons.
3 The breeder, supplier and the user shall have on the spot one or more persons who:
(a) be responsible for supervising the welfare and care of the animals in the establishment;
Ensure that personnel handling the animals have access to specific information concerning species housed in the establishment;
(c) ensure that staff are adequately trained and competent, are constantly trained and supervised until they have provided proof of the necessary qualifications.
4 The user has persons as intended in Article 10a1, first paragraph , which shall ensure that:
a. An end is made of unnecessary pain, suffering, distress or lasting damage caused to an animal during an animal test; and
b. a project is carried out in accordance with the project proposal on the basis of which a project permit has been granted and if that is not the case, appropriate measures will be taken to correct it and these measures will be implemented registered.
5 In the case of, or under general management, rules may be laid down in respect of persons referred to in paragraphs 3 and 4 of this paragraph.
1 Every breeder, supplier and user has one in the area of
veterinary medicine expert or, if appropriate, another suitably qualified expert, responsible for advisory duties on the welfare and treatment of the animals.
2 In the case of, or under general management, rules may be laid down in respect of the veterinarian or other expert referred to in the first paragraph.
1 The breeder, the supplier and the user shall set up an animal welfare authority.
2 By way of derogation from the first paragraph, categories of breeders, suppliers and users that are not required to set up an animal welfare authority may be identified by or under general measure of management. If they do not set up an animal welfare authority, they shall ensure that the tasks of the animal welfare body are carried out in a manner specified in the general measure of management.
3 The advice of the animal welfare authority and the relevant decisions shall be kept for at least three years.
1 The animal welfare body shall be composed of at least the following: Article 13f, third paragraph, part a , person or persons referred to. In the case of, or under a general measure of management, categories of experts which sit in the animal welfare authority may also be designated.
2 In the animal welfare authority of the user, in addition to the persons referred to in the first paragraph, a scientist shall sit.
3 The person intended in Article 14 shall present his insights to the animal welfare authority.
4 The nomination for a general measure of directors to be adopted under paragraph 1 shall not be made earlier than four weeks after the draft has been submitted to both Chambers of the States General.
1 The animal welfare authority shall carry out the following tasks:
a. provides personnel handling animal welfare advice in connection with the procurement, accommodation, care and use of the animals;
b. advises the staff on the application of the Article 1d the replacement, reduction and refinement requirement and shall keep it informed of the technical and scientific developments regarding the application of this Regulation;
(c) establish and review operational internal procedures for monitoring, reporting and follow-up to the welfare of the animals housed in the establishment;
d. follows the development and results of projects taking into account the effects on used animals, charts elements that can further contribute to replacement, reduction and refinement, and provides advice on that;
e. gives advice on adoption arrangements, including advice on the appropriate socialisation of animals to be released for adoption.
2 In the case of, or under general management, additional tasks may be assigned to the animal welfare body and may be subject to detailed rules relating to the tasks assigned to the animal welfare authority.
The breeder, the supplier and the user shall be required to record, record, retain, release or release animals and any project in which animals are used for breeding, acquisition, delivery, release or adoption; and provide information to our Minister, in accordance with or pursuant to or pursuant to any general measure of administration. In the case of or in accordance with the measure, further issues may be identified as to which note should be taken.
1 The breeder, the supplier and the user shall keep records for each dog, cat and non-human primate of the data designated by or under general management.
2 For each dog, cat and non-human primate, an individual life log file shall be maintained that accompanies the animal as long as the animal falls under the application of this law and complies with or pursuant to general management measure. requirements.
3 In the case of, or under general management, rules may be laid down concerning the affixing of marks to the animals referred to in paragraph 1 for the purpose of identification of such animals in connection with the maintenance of a Registration of these animals.
The operation of the decision to amend or withdraw an institution permit or exemption shall be suspended until the period of appeal has expired or, if appeal has been lodged, the appeal has been decided.
1 There is a central committee on animal testing. The task of the committee shall be to exercise the powers of the articles 10a, first paragraph , 18a, 1st Member and 18f, 1st Member .
2 The Commission shall be composed of a maximum of 15 members, including the Chairman. The committee shall keep to the Article 10a2 the project assessment shall, in particular, take into account the presence of expertise in the area and shall consist of persons who are competent in the field of:
a. Science and scientific uses to which the animals will be used, including replacement, reduction and refinement in the affected areas;
(b) the design of tests, including, where appropriate, the statistical aspects;
(c) experimental animal health practice or, where appropriate, veterinary practice in relation to wild animals;
(d) the holding and care of animals of the species to be used;
e. Ethics;
f. experimental animals and their protection;
g. Areas designated under or pursuant to general management measures.
3 The Commission may take into account the advice of independent and impartial experts who are not members of the Commission in the project evaluation.
4 The chairman and the other members of the committee are appointed for the term of five years. After the expiry of the period for which they have been appointed, they may be reappointed for the period of not more than five years.
5 The committee shall appoint one or more alternate members from among the members of the Committee.
6 An alternate member may be appointed for each member.
7 Our Minister shall make available to the Commission, for the purpose of carrying out the tasks referred to in paragraph 1.
8 The Committee shall regulate its rules of procedure. The rules of procedure shall contain a provision enabling the assessment of a project to be carried out in an independent and impartial manner.
9 The Framework Law on self-employed administrative bodies shall apply to the Commission in so far as decisions are taken by the Commission for the implementation of this Act.
10 Before a decision is taken on the application of Article 2 (3) , the committee is heard.
1 The Central Committee on Animal testing may recognise animal experimentation committees responsible for advising on the evaluation of project proposals, which are intended to be carried out by the Commission. Article 10a, third paragraph , in accordance with the provisions of or under this Act.
2 For recognition only a veterinary committee of which it is apparent from the Regulation shall:
a. that it is made up of at least seven members, including the chairman who is not in an employment relationship until the holder of an institution permit as referred to in Article 2 , on the assessment of whose project proposal is being given an opinion;
(b) that the Commission, when advising on the evaluation of a project proposal, takes particular account of the presence of expertise in the field and consists of persons who are competent in the field of:
-the fields of science and scientific applications for which the animals will be used, including replacement, reduction and refinement in the areas concerned;
-the design of tests, including, where appropriate, the statistical aspects;
-animal health practice or, where appropriate, veterinary practice in relation to wild animals,
-the holding and care of animals of the species to be used;
-ethics;
-experimental animals and their protection,
-areas designated under or pursuant to general management measures;
c. that at least two of the B the experts referred to are not involved in the conduct of animal testing;
d. that, in addition to the President, at least half the number of members are not in a employment relationship until the holder of an institution permit as intended in Article 2 , on the assessment of whose project proposal is being given an opinion;
e. that the other members, if they are involved in the performance of a project, do not participate in the preparation of the opinion on the project proposal;
f. that in drawing up the opinion, the Article 13f, third paragraph, part a , the person referred to as a consultant will be involved;
g. that the opinion on the evaluation of a project proposal takes place in an impartial, impartial and impartial manner.
and of which the Rules of Procedure for the remainder comply with requirements laid down by general management measures.
3 The committee may, when advising on the evaluation of a project proposal, take into account the advice of independent and impartial experts who are not members of the committee.
1 The central committee on animal testing shall recognise as intended: Article 18a, first paragraph , immediately to the knowledge of our Minister.
2 Of a recognition as referred to in Article 18a, first paragraph , the care of our minister is to be communicated in the State Gazette. The Articles 4, first and third paragraphs , and 6, first paragraph , shall apply mutatis mutandis, except that for Our Minister the Central Committee on Animal testing shall be read.
1 Each shall, upon request of the Central Committee on Animal testing, provide the information and information and provide it with access to the information and documents reasonably necessary for the implementation of the information and information required by the Commission. Article 18, first paragraph , these tasks.
The Central Committee on Animal testing may set a time limit within which the information, information or documents referred to in the first paragraph shall be provided.
An under Article 18a Member of the Committee on Animal Affairs and the Committee on Animal Affairs, as a result of a change in its rules of procedure, a written communication to
1 The Central Committee on Animal testing shall withdraw approval granted to a member of animal experimenter, if the animal experiments committee:
a. No longer meets the in Article 18a, second paragraph , terms and conditions laid down for the purpose of recognition;
b. Do not take or do not take sufficient account of the evaluation of a project proposal; Article 10a, third paragraph , or with the policy rules adopted by the Central Committee on Animal Testing on the Evaluation of Project Proposals.
2 The Central Committee on Animal Testing may withdraw recognition if the Animal Experiments Committee has been requested to deliver opinions on a number of opinions to be determined by general management measures within the time limit of one year.
3 The withdrawal shall be communicated in writing to the Animal Experiments Committee. Article 18b shall apply mutatis mutandis.
The members of the committee's committees shall be obliged to keep to the discretion of all those who have become known in their capacity, to the extent that they are not, in their capacity as they are empowered or required to communicate.
1 There is a National Committee for the Protection of Animals used for scientific purposes.
2 The national committee shall carry out the following tasks:
a. advises Our Minister, the Central Committee on Animal Testing and the Animal Welfare Bodies on the procurement, breeding, accommodation, care, and use of animals in animal experiments;
b. ensure the dissemination of best practices;
(c) exchange information on the functioning of animal welfare bodies, assess project proposals, and ensure the dissemination of best practice within the European Union, with the national committees of other Member States;
d. Other tasks assigned by Our Minister.
The national committee shall be composed of a maximum of 10 members. Article 12 of the Advisory Colleges Framework Law shall apply mutatis mutandis.
(4) For each member, an alternate member may be appointed.
5 The members of the Committee are appointed by Our Minister for a period of five years and may be suspended and dismissed by Our Minister. After the expiry of the period for which the members have been appointed, they may be reappointed for a maximum period of five years.
6 The Committee shall appoint one or two alternates to the Chair.
7 The Committee shall arrange for its rules of procedure.
8 Our Minister shall make available to the Commission, for the purpose of carrying out the tasks referred to in the second paragraph.
9 Article 2 of the Remuneration Advisory Colleges Act and Committees Act shall apply mutatis mutandis.
1 With the supervision of compliance with or under this law, the officials appointed by the decision of Our Minister shall be responsible.
2 Of a decision as referred to in paragraph 1 shall be communicated by means of a decision of the Official Gazette .
1 The supervisor shall be empowered to enter a dwelling without the consent of the occupant, with a view to the required equipment.
2 If for entering a place in the interest of a trial regulations are stated, take the Article 20 Officials as referred to above shall be in accordance with the requirements of that place.
1 The breeder, the supplier and the user shall keep all relevant documentation, including the project authorisation granted at least three years after the expiry of this permit and shall keep it at the disposal of Our Minister.
2 Without prejudice to the first paragraph, documentation on projects to be subject to an ex post assessment shall be retained at least until such assessment is completed.
Our Minister is empowered to impose a charge under administrative force to enforce the Article 5:20, 1st paragraph, of the General Law governing the administrative law obligation.
1 Violation of Article 1c , 1d , 1st , 2 , 9 , 10 , 10a, first and second members , 10a4, third member , 10a5, 1st Member , 10b, 2nd Member , 10c , 10d , 10th , 10f , 10g , 10h , 11 , 11a, 1st Member , 13 , 13a, second and third members , 13b , 13c , 13d , 13th , 13f , 14 , 14a , 14b , 14c , 15 , 15a and 23 , or a prescription, according to Article 6, second paragraph , 10a1, second member , 11a, second member , or 16, second paragraph , attached to an institution permit, project permit, recognition or exemption is punishable.
2 Act in violation of the Articles 1c , 1d , 1st , 2 , 10 , 10a, first and second members , 10a4, third member , 10a5, 1st Member , 10b, 2nd Member , 10c, 1st Member , 10d , 10th , 10f , 10h , 11 , 11a, 1st Member , 13 , 13a, second and third members , 13b , 13c and 13d , 13f, first, third member, part a, and fourth member -It's a felony. The other offences referred to in the first paragraph shall be offences.
3 The offences which are offences under the second paragraph shall be punished by imprisonment of up to six months or a fine of the fifth category; the offences committed under the second paragraph shall be punished Detained for a maximum period of three months or a fine of the fourth category.
With the detection of the Article 25 criminal offences are, except for the officials referred to in Article 141 of the Code of Criminal Procedure , in charge of Article 20 designated officials.
For the person, for whom at the time when Article 2, first paragraph The prohibition of animal testing in the field of its activities shall not be subject to the prohibition laid down in that paragraph for a period of three months from the date referred to in that paragraph and, if within that period, an application for authorisation as set out in Annex II to this Regulation shall be applied. that paragraph has been submitted, and not until the decision in which the application is decided has become final. Article 4, first paragraph , it shall not apply in respect of such an application.
Following the entry into force of the Act of (date) amending the Act on Animal Testing (Stb. yearsand number), the Animal proposal decision Include: Article 13f of this law.
This law can be cited as law on animal experiments.
1 Article 18 of this law shall enter into force from the day following the date of issuance of the State Sheet where it is placed.
2 Its various other provisions shall enter into force by time to be determined by Us.
Burdens and orders, which are in the State Sheet All ministerial departments, authorities, colleges and civil servants, with whom this is concerned, will keep their hands on the precise implementation.
Given at Paleize Soestdijk, 12 January 1977
JULIANA.
The Secretary of State for Health and Environmental Hygiene,
HENDRIKS.
Published on 22 February 1977.The Minister of Justice,
FROM AGT.
