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Ordinance To The Law On Animal Experiments

Original Language Title: Bekendtgørelse af lov om dyreforsøg

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Table of Contents
Chapter 1 Animal trials
Chapter 2 Animal testing rules
Chapter 3 Animal test surveillance.
Chapter 3 a Mandatory digital communication
Chapter 4 Penalty and revocation of authorisations, etc.
Chapter 5 Entry into force and transitional rules, etc.

Publication of the Law on Animal experiments 1)

In this case, the animal testing law is announced, cf. Law Order no. 253 of 8. March 2013, with the changes resulting from paragraph 12 of Law No 1459 of 17. December, 2013.

Chapter 1

Animal trials

§ 1. Use of vertebrates, including mammals fed in the final third of their normal development, and octopus for experiments may only be authorised by the Animal test. The same applies to the use of mammals foetuses at a previous stage of development for testing if it is likely that the fetus as a result of the tests carried out will experience pain, suffering, distress or lasting but, after it has reached the final stage ; -third of its normal development.

Paragraph 2. In the case of tests, any use of animals for scientific or educational purposes may be presumed to be associated with pain, suffering, anxious or lasting, but to the animal equivalent to or stronger than the introduction of a needle in compliance with good veterinary practice causes.

Paragraph 3. Authorisation of animal tests may only be granted for the purposes of the following purposes :

1) the prevention of disease, ill health or other abnormality and its effects on humans, animals and plants, including the production of medicinal products, substances and products, and the testing of their quality, effectiveness and safety ;

2) diagnosis and treatment of disease, poor state of health or other abnormality and the effects thereof in humans, animals and plants ;

3) the assessment, detection, adjustment or change of physiological conditions in humans, animals and plants ;

4) protection of the environment,

5) the improvement of the welfare of animals and of the production conditions for animals raised for agricultural purposes ;

6) research, including basic research and research with a view to species conservation ;

7) education and training at universities and higher education or training at equivalent level and in the teaching of persons to concern themselves with animal experiments, or

8) Forensics.

Paragraph 4. No authorization may be granted for the carrying out of animal tests by means of finished cosmetic products or constituents or compositions thereof, if the study is carried out in order to satisfy the requirements of the safety of cosmetic products.

Paragraph 5. The animal test facility may refuse to allow animal testing if the study is not considered to be of significant use, including if the strain on which the animal is exposed is not a target of the value of the test and the added value of the product.

Paragraph 6. In the course of the examination of an application for authorisation for animal experiments, the animal test may allow an attempted demonstration on the supervision provided that it is suitably considered to be safe.

Paragraph 7. The Minister for Food, Agriculture and Fisheries 2) may lay down rules on the use of animals other than those referred to in paragraph 1. 1 for tests, in whole or in part, must be subject to the law or to be notified to the Animal test.

Paragraph 8. In the case of cloning and genetically modified vertebrates and by using cloned and genetically modified vertebrates for animal testing, which fall under the laws of cloning and the re-modification of animals, etc., this law applies.

§ 1 a. The other provisions of this Act may, irrespective of the other provisions of this law, allow animals used in an experiment to be unleashed if the purpose of the experiment is to be carried out. However, permission shall be granted only if the supervision is satisfied that everything has been done to ensure the well-being of animals and, where the animal health of the animals permits, and there is no danger to public health or the environment.

Paragraph 2. Any attempt to unleash animals may not be permitted in purely underage or educational purposes.

§ 2. Permission to test animal tests can only be provided to named natural or legal persons who may be presumed to be able to ensure that the tests are carried out in a sound manner.

Paragraph 2. If the holder of the authorization is a legal person, it shall designate one or more persons responsible for

1) the execution of the study,

2) supervision of the welfare and care of the animals ;

3) training and training for the personnel involved in animal testing and the care of experimental animals.

Paragraph 3. The animal test subject may permit the responsibility of the part of the animal test activity, which relates to the direction and operation of the information and the facilities of the stables and the facilities and the care of the animals, the institution or the undertaking or an employed person or person who has the responsibility of the animals ; the necessary vocational training. The journal entry must also be allowed to be admitted to anyone other than the holder of the permit. The Minister for Food, Agriculture and Fisheries may lay down detailed rules on this subject.

§ 3. Authorisation shall be given to the specified types of experiments and species of animals. The number of animals that may be used for experiments shall be indicated on the authorization. However, such restrictions may be granted without such restrictions when special conditions are to be given.

Paragraph 2. The permit must indicate the level of pain, suffering, anxious or permanent, but, as individual animals must be subjected, by experiment as terminals, easily dentified, moderating or significantly incriminating.

Paragraph 3. Terms and conditions may be laid down for the authorisation, including the conduct of the tests, the use of the animals, the housing and the accommodation of the animals and the directions of the experimental facilities.

Paragraph 4. In addition to the provisions of paragraph 1, 1-3 of this information must be indicated in the permit :

1) Permit holder name.

2) In which institution or undertaking the tests must be carried out.

3) The timing of any test evaluation.

4) Name of the investigator (s).

5) Name of the installation and operation of the parties responsible for the intake and operation of the test rooms.

6) Name of the person or person responsible for the competence of the staff engaged in animal testing or the care of experimental animals.

7) Name on the person or persons responsible for the care of the animals and the welfare of the animals.

8) Name of person or person responsible for the journal leading.

9) Name of the veterinarian or other competent person who is assigned to the institution or the undertaking to advise the welfare and behaviour of the study animals.

§ 3 a. The Minister for Food, Agriculture and Fisheries may lay down rules concerning the authorisation of animal tests for the purpose of the fulfilment or use of the European Community acts relating to matters covered by that law.

Chapter 2

Animal testing rules

§ 4. The holder of the authorization shall only allow the trials to be performed by others, provided that they have the necessary vocational training and work under the management and supervision of the holder of the permit.

§ 5. The lakes must be carried out and shall be provided for in appropriate rooms.

Paragraph 2. Facilities and equipment for conducting experiments must be designed and used in a manner that may be expected to lead to the use of ferrest animals, causing at least pain, suffering, anxious or lasting, but which are most likely to lead to satisfactory results.

§ 6. In the case of any tests, the choice of animal species must be carefully assessed and justified on request grounds for the Animal test. To the extent possible, animal species must be used that are at least predisposed to experience pain, suffering, anxious or lasting, but. In the case of options between different approaches, it must be chosen to result in the use of least expensive animals, suffering from suffering, suffering, distress or lasting life, and which are most likely to lead to satisfactory results.

Paragraph 2. When possible, early and humane terminus should be used for an attempt rather than death as a final point. Where death is inevitable, the study must be carried out so that the least animals die, that the duration and intensity of animal suffering will be limited as much as possible and that a painless death as far as possible is guaranteed.

Paragraph 3. Animals may not be used for experimental purposes for which the use of cell, tissue or organ cultures or other methods must be considered equally suitable. The applicant shall demonstrate that the knowledge which can be achieved by conducting tests is not wholly or partially achieved without the use of animal tests, and that there is no knowledge of knowledge already known.

§ 7. Animal trials may only be carried out where the animal is locally or universally stunned, cf. however, paragraph 1 2 and painkillers or other measures are used in order to limit pain, suffering, anxious or lasting, but as much as possible.

Paragraph 2. The anesthesia of the estimated is to be more incriminating to an animal than the experiment itself, or is anaesthetic not compatible with the experiment, it may be omitted.

Paragraph 3. Medicinal products which prevent or limit the ability of animals to express pain must not be used without the concurrent use of appropriate anaesthesia or anesthesia.

Paragraph 4. Animals must not experience strong pain, the other intense suffering or intense anxiety and must be put down if the condition is assumed to include the termination of the anaesthesia and the lindrous treatment. If an animal at the end of an attempt must be assumed to remain in a state of moderate pain, suffering or anxiety in the end of the anesthetic and the firing treatment, or if an animal is expected to be lasting but, then it must be put down.

Paragraph 5. If the purpose of the experiment is demonstrations by studies, an experiment must be made to be capable of being associated with pain, always use universal tranquilized animals, and these must always be killed before the end of the anaesthesia.

§ 8. (Aphat)

§ 9. In accordance with the rules laid down by the Minister for Food, Agriculture and Fisheries, the conduct of records and reports shall be furbished, and shall be submitted to the Animal test subject. Duty of this shall be the holder of the authorization, unless the decision has been taken in accordance with Article 2 (2). This may be determined by the rules to ensure that the records are kept on a computer.

Paragraph 2. In addition, the test carried out shall provide details of the tests on the tests provided for in the synet.

Chapter 3

Animal test surveillance.

§ 10. The study is conducted by the Council for Animal trials composed of a President who shall be a judge, and 10 other members.

Paragraph 2. The Minister for Food, Agriculture and Fisheries shall appoint the President of the Council and the other members. A member shall be appointed in accordance with the opinion of the Health and Health Research Council, one member after the Opinion of the Research Council for Technology and Production, one member after the opinion of the Board of Health, one member after the opinion of the Danish Industry Committee, Member following the opinion of the major disease-fighting associations, one member after the Opinion of the Animal Ethics Council and four members, in accordance with the opinion of the animal protection associations.

Paragraph 3. The Minister for Food, Agriculture and Fisheries shall, where possible, by the composition of the Council shall ensure that, among the members of the Council, people are aware of the professional disciplines which are of particular importance to the tasks assigned to them ; Animal testing.

Paragraph 4. The Council members are being appointed for four years at a time.

Paragraph 5. The Minister for Food, Agriculture and Fisheries may lay down rules of procedure for the Council. It may be decided that certain decisions may be taken by a sample of the members of the Council, by the President or by the secretariat.

Paragraph 6. The members of the Council for Animal Control, which do not perform their duties as part of their service activities, shall be paid and reimbursed for the benefit of equality with non-State employees who receive separate payment. The cost of this is borne by the state.

§ 11. The Council and persons authorised by the Council shall at any time without a court order against appropriate identification of appropriate identification of access to the laboratory rooms and other premises where experimental animals are placed, in order to provide information for the purpose of supervision. A demonstration of the permitted attempt may be carried out in the case of supervision.

Paragraph 2. The operator shall provide guidance and assistance under the supervision provided for in paragraph 1 and under the supervision of the tests and the assistance provided for in paragraph 1. 1.

§ 12. The Council may make a statement about the execution of the tests, the use of animals, of the animals and the accommodation and the accommodation of the experimental facilities. The Council may also ensure that tests must not be carried out unless representatives of the Council are present. 1. and 2. the period shall apply, irrespective of the terms and conditions given to the authorization.

§ 13. Decisions of the animal test body under the law or in accordance with the rules laid down by the law may not be brought to the second administrative authority.

§ 14. Oversight emits an annual report on its activities. The Minister for Food, Agriculture and Fisheries publishes the report.

§ 15. In the case of permits for animal testing at § 1, DKK 2,500. For each of the following commenced years, DKK 500.

Paragraph 2. The amounts referred to in paragraph 1. 1 conferred on the panting.

Paragraph 3. The Minister for Food, Agriculture and Fisheries may lay down detailed rules on authorisations under this law, including the payment of fees.

Chapter 3 a

Mandatory digital communication

§ 15 a. The Minister for Food, Agriculture and Fisheries may lay down rules on written communications to and from the Ministry of Food, Agriculture and Fisheries concerning matters covered by this law or by rules issued under this law, shall : conducted digitally.

Paragraph 2. The Minister may lay down detailed rules on digital communications, including the use of specific IT systems, special digital formats and digital signature el.lign.

Paragraph 3. A digital message is considered to have arrived when it is available for the message address.

§ 15 b. The Minister for Food, Agriculture and Fisheries may lay down rules that decisions and other documents which have been made exclusively or issued on the basis of electronic data processing may be issued alone with the Ministry of the Ministry of dispatch.

§ 15 c. Where, pursuant to this law or rules issued pursuant to this law, a document issued by others other than the Minister for Food, Agriculture and Fisheries must be signed, this requirement may be met by means of a technique which, ensure unambiguous identification of the person who issued the document, cf. however, paragraph 1 2. Such documents are treated as a person with a personal signature document.

Paragraph 2. The Minister may lay down detailed rules on the deviation of regulatory requirements, including that the requirement for personal signatures may not be waisted for certain types of documents.

Chapter 4

Penalty and revocation of authorisations, etc.

§ 16. Unless higher penalties have been inflised on other legislation, penalty of fine or imprisonment shall be punished for the last four months of the sentence of the penalty ;

1) in violation of section 1 (1). 1, sections 4-5, section 7, section 9 (4). 2, or Section 11 (3). 2,

2) override terms and conditions for a permission ; or

3) overrides a palpud after paragraph 12.

Paragraph 2. The provisions laid down in accordance with the law may be subject to penalty of penalties for infringements of the provisions laid down in the regulations.

Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

§ 17. The animal test may be revoked if there has been a serious or repeated infringement of the rules or conditions applicable to the experimental and animal treatment, or the corresponding dismissal of the animals.

Paragraph 2. The animal test must ensure that the withdrawal of the revocation does not impair the welfare of experimental animals.

§ 18. The Minister for Food, Agriculture and Fisheries may, after obtained the opinion of the Animal reproductive system, the following rules shall be laid down :

1) the acquisition of animals for experiments and other scientific purposes, including the prohibition of trials on stray dogs and cats and caught wild animals ;

2) the care and storage of laboratory animals and animals bred to use their organs or tissues for scientific purposes ;

3) the execution of the test ;

4) qualification requirements for persons who perform tests or who are appropriate to animals or animals which are bred to use their organs or tissues for scientific purposes ;

5) experiments in the training or training exercise ;

6) institutions or undertakings which use, rearing or supply animals for experiments or other scientific purposes ;

7) the deliberate release and relocation of test animals ; and

8) the creation of an advisory committee on the protection of animals used for scientific purposes.

Paragraph 2. The Minister for Food, Agriculture and Fisheries may, in addition, after obtained the opinion of the Animal Test Authority, the rules concerning the animal experimental surveillance activities of the animal test facility and the prohibition of tests which are deemed to be superfluous because of other tests here, landed or abroad.

§ 19. The right of access to public access to documents shall not include access to being made aware of the identity, including names, addresses and telephone numbers, of the persons performing or taking care of animals for such purposes.

Chapter 5

Entry into force and transitional rules, etc.

20. The law shall enter into force on 1. October 1987.

Paragraph 2. Law No 220 of 18. May 1977 on animal testing is hereby repealed.

Paragraph 3. (Aphat)

§ § 21-22. (Transitional provisions, excluded)

-23. The law does not apply to the Faroe Islands and Greenland.


Law No 1081 of 20. December 1995 (Presumality, unleashed) 3) includes the following entry into force :

§ 2

The law shall enter into force on 1. January 1996


Law No 433 of 31. May 2000 (Amendments as a result of the sentencing law, the abolition of staples and the parole of life sentences, etc.) 4) includes the following entry into force :

§ 30

The law shall enter into force on 1. July 2001.


Law No 315 of 5. In May 2004, the marketing ban on cosmetic products tested with animal testing, the prohibition of the execution of animal experiments with finished cosmetic products and the publication of certain information on cosmetic products, etc.) 5) includes the following entry into force :

§ 3

The law shall enter into force on 1. July 2004.


Law No 550 of 24. June 2005 on the cloning and remodification of animals and so on. 6) includes the following entry into force :

§ 4. The law shall enter into force on 1. October 2005.


Law No 612 of 14. June 2011 (Implementation of new Animal Experimental Directive etc.) 7) includes the following entry into force :

§ 3

Paragraph 1. Paragraph 1. The law shall enter into force on 1. January 2013.

Paragraph 2. (Udelades)


Law No 1459 of 17. December 2013 (Mandatory digital communication, amendment of the complaint provisions as a result of ressoring transfer and others) 8) includes the following entry into force :

§ 17

Paragraph 1. The law shall enter into force on 1. January 2014.

Paragraph 2. (Udelades)

The Ministry of Food, Agriculture and Fisheries, the 15th. May 2014

Dan Jørgensen

-Birthe Schubart

Official notes

1) The law provides for the implementation of parts of the European Parliament and of the Council Directive 2003 /15/EC of 27. In February 2003 amending Council Directive 76 /768/EEC on the approximation of the laws of the Member States relating to cosmetic products, the Community Official Journal of 2003, no. On the 66, page 26-35, and parts of the European Parliament and Council Directive 2010 /63/EC of 22. September 2010 on the protection of animals used for scientific purposes, the EU Official Journal of 2010, nr. L 276, page 33-79.

2) The Rescuing of Animals for Animal testing, the Council for Animal experiments and the Pretrial Commission, is by the Conveneous Resolution of 14. December 2011 from the Minister of Justice to the Minister for Food, Agriculture and Fisheries. The Minister for Justice has changed : 'The Minister for Food, Agriculture and Fisheries', the Minister for Justice has changed : 'The Minister for Food, Agriculture and Fisheries' is replaced by '.

3) The law is related to § 1 a.

4) The law relates to section 16 (1). 1.

5) The law applies to the insertion of footnote to the title of the law, and the insertion of a new paragraph. 3 in section 1, which shall result in paragraph 1. Three-five, turns to paragraph. 4-6. The amendment also relates to the insertion of section 3 a.

6) The law applies to the insertion of Section 1 (1). 7.

7) The amendment relates to the amendment of the footnote and section 1 (1). 1. The amendment also relates to insertion into section 1 of a new paragraph. The second paragraph is paragraph 2. Paragraph 2-7 shall become paragraph 1. 3-8. Section 1 (1). Two-four, that is paragraph 1. 3-5, change. Section 2 (2). the first paragraph shall be deleted and replaced by a new paragraph. 1 and a new paragraph. The second paragraph is paragraph 2. Two becomes the first paragraph. 3. A new paragraph is inserted in section 3. The second paragraph is paragraph 2. 2 and 3 shall be paragraph 1. 3 and 4. Section 3, paragraph 3. paragraph 4 shall be amended and in section 5. 2. Section 6 (2). Paragraph 1 shall be amended and replaced by a new paragraph. The second paragraph is paragraph 2. Two becomes the first paragraph. 3, and a new period is added. Section 7 (2). Paragrol 1 to 3 shall be repealed and replaced by paragraph 1. Paragraph 1-4, which means that paragraph 1 The fourth paragraph is paragraph 4. 5. In section 9 (4), ONE, TWO. Act. the reference to section 2 is changed. ~ 10 (1)) Paragraph 1 and 2, section 16 (2). Paragraph 1 and paragraph. 3, amended. in section 17, paragraph 17 shall be inserted Article 18 (2) and Section 18 (1). 1, change.

8) The law applies to the insertion of Chapter 3 a.