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POLICIES AND REGULATIONS

International Animal-Related Policies and Regulations

Useful Resources
many of the following sections copied from and/or linked to:
Animal experimentation – Legislation and Protection (MS Word doc) Dr J Belot
NKCA (Netherlands Knowledge Centre on Alternatives to Animal Use

COUNCIL OF EUROPE

1949 Treaty of London, establishing the Council of Europe

European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific PurposesStrasbourg, 18.III.1986
The fundamental principle of the convention is the acceptance of the use of animals in experiments but also the reduction of that use by replacing experiments by alternative methods.

The Protocol amending the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes [ETS 170]
The protocol of amendment aims to introduce a simplified procedure that will help up-date the terms of the convention, to take account of the development of scientific understanding and practice since the Convention was opened for signature in 1986. These terms concern the norms set by the convention for care and accommodation of laboratory animals, as well as the presentation of statistical data on animal experimentation.

EUROPEAN UNION

European Centre for the Validation of Alternative Methods

EU Directive 86/609/EEC (PDF file)
Aim of directive is to harmonise national regulations in order to avoid distortion and unfair competition within the Community. The provisions of the Directive are based upon the Convention ETS 123.

Revision of Directive 86/609/EEC (PDF file)

European Convention for the protection of vertebrate animals used for experimental and other scientific purposes

Regulations pertaining to the production and marketing of cosmetics

European Union Directives (World Animal Net)

European Union - Research and Innovation

Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003
Amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)

OECD: Organisation for Economic and Commercial Development

Guidance Document on the Recognition, Assessment, and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation (PDF)

AUSTRALIA

Australian Code of Practice for the Care and Use of Animals for Scientific Purposes 2004
Regional authorities (Queens land, New South Wales, Victoria, Tasmania South Australia, Western Australia, Northern Territory…) have the responsibility for the control of animal experimentation as laid down by several animal welfare acts (Animal Protection Act, Animal Research Act, Prevention of Cruelty to Animals Act, Animal Welfare Act…). Codes of practice define that experiments on animals may only be performed if the procedures are designed in order to avoid or minimise pain or distress to animals. When this cannot be avoided, anaesthetics must be used, and when appropriate anaesthesia is not possible, the endpoint of the experiment must be as early as possible. Each institution using animals for scientific purposes must establish an Animal Experimentation Ethics Committee (AEEC) the terms of reference of which are all ethical and animal welfare aspects. The Australian and New Zealand Council for the Care of Animals in Research and Teaching (ANZCCART) promotes in both countries standards of care for animals used in research and teaching and encourages discussion of related ethical issues.

Australian animal welfare legislation

Australian animal welfare codes of practice

Australian Regulations & Guidelines

AUSTRIA

Federal Act on the Protection of Animals (Animal Protection Act TSchG) (PDF file)

English and German (PDF file)
In Austria the Animal Testing Act (1988) regulates animal testing and how to get permission for carrying out tests on live animals. Codes of practice provide the Animal Experimentation Ethic Committees with guidance for the animal experimentation. Any scientific procedure on live animals must be designed as to avoid or minimise pain or distress on the animals. When pain or distress is caused by the experiment, anaesthetics must be used. If the procedure requires that no pain relief drug may be used, clear endpoint limits to the experiments must be defined. When unpredicted signs of pain or distress occur during a procedure, the pain must be alleviated without delay; if not, the animal must be humanely killed.

BELGIUM

Animal Experimentation - Legislation and Protection (compiled by Dr. Jean Belot)
Belgium as a member of the European Community must follow the provisions of the Directive 86/609 in its national legislation. Legal requirements to use alternative methods are found in the Convention ETS 123 (article 6, 1°; Directive 86/609, article 7, 2°; Law of 14 august 1986, article 24). The leading principle is the concept of the 3R’s of Russel and Burch.
Those 3R’s are assured in the Law. Replacement principle is covered by point 2 of article 24 (“experiments on animals are forbidden if any valid alternative method not using animals is available”), Reduction is considered in points 1 and 3 of article 24 (“experiments on animals must be strictly limited” and “procedures demanding less number of animals must be selected”) and Refinement is followed in points 3 and 4 of article 24 (“less painful methods and less sensitive animal species must be selected” and “anaesthetics must be used when painful procedures are carried out”).

BRAZIL

COBEA (Colégio Brasileiro de Experimentação Animal)

CANADA

The animal welfare is controlled by the Criminal Code at a federal level. In some provinces (Alberta, Ontario, Saskatchewan, Quebec) specific provincial bills deal with the animal experimentation. In 1968 the Council of Medical Research in Canada decided to establish Canadian Council of Animal Care (CCAC). The mission of the CCAC is to formulate guidelines in animal experimentation and also to carry out control missions in the research facilities. The guidelines establish that animals may not be subjected to unnecessary suffering. Specific guidelines determine the endpoint of an experiment and specify that in experiments involving animals, any actual or potential pain, distress, or discomfort should be minimised or alleviated by choosing the earliest endpoint that is compatible with the scientific objectives of the research. Fixing of this endpoint by the investigator should involve consultation with the Animal Care Committee.

Canadian Guidelines and Legislation

CHINA

Regulation Updates: Consulate and China Daily

CZECH REPUBLIC

The Animal Protection Act states that the experiments on live animals have to be approved by the Central Commission for Animal Welfare (CCAW). The state authorities are supposed to control the respect of the provisions of that Act by means of professional commissions that are mandatory in the research institutions.

State Veterinary Administration of the Czech Republic, Animal Welfare

FINLAND

The Statute on Animal Experimentation (1985) requires that institutions involved in research and animal experimentation dispose on a Committee of Animal Experimentation. Experiments causing severe distress or pain need a special approval of the Provincial State Office.

National Animal Laboratory Center

Animal Diseases and Welfare in Finland, 1999

FRANCE

French Legislation

Several decrees (1988) regulate the use of live animals in the scientific procedures. Most experiments must be assessed and endorsed by scientific or ethical committees. A code of good laboratory practice has to be respected by the laboratories.

GERMANY

Animal Welfare Act

German Legislation (Michigan State University)
The Animal Welfare Act demands ethical justification of the experiments on animals in research and scientific purposes. Committees are set up to assist the authorities in deciding whether to authorise experiments on animals. The scientific and ethical aspects are discussed before granting any licence to research facilities to carry out experiments.

GREECE

According to the National Legislation local veterinary directorates are responsible for the scientific evaluation of the experiments on animals. Those directorates consider the ethical aspects of the experiments and when necessary the opinion of other experts can be required before granting any licence to carry out an experiment.

INDIA

Indian Council of Medical Research, New Dehli

Biomedical Ethics - Laboratory Animal Welfare
Parliamentarians voted to set up a Committee for the Control and Supervision of Experiments in India (CPCSEA). The first CPCSEA was constituted in 1964 with representatives from the medical and veterinary professions.

Prevention of the Cruelty to Animals Act, 1960
Animal Welfare Board of India

IRELAND

The Minister for Health and Children licences the use of live animals in medical and scientific experiments. It is the policy of the Department of Health and Children to keep the level of experimentation on live animals to the minimum and to ensure that no pain, suffering, distress or lasting harm are inflicted unnecessarily. Ireland like the other European countries supports the work of the European Commission who established a European Centre for the Validation of Alternative Methods (ECVAM) that encourages the development and validation of alternative techniques
European Communities (Amendment of Cruelty to Animals Act, 1876) Regulations, 1994 (not currently available)
Policy Briefing on Use of Animals in Research. European Science Foundation Sep. 2000 (not currently available)

ITALY

The Veterinary Department of the Ministry of Health grants the licence to carry out animal experimentation. The authorisation is based on the scientific background of the project but the procedures involving pain or stress to animals without anaesthesia need a specific approval.

Italian Legislation (PDF file)

ICARE - The Italian Project

JAPAN

The law concerning the protection and control of experimental animals (law 105 of October 1973) declares that experimental research or other scientific purposes is to use methods that cause minimum pain possible to animals within the limits imposed by the said purposes (article 11). An Animal Protection Council debates important matters relating to animal protection and advises the prime minister’s office where necessary.

Institute for Animal Experimentation

Law for the Humane Treatment and Management of Animals

Law Concerning the Protection and Control of Animals (English translation)

KOREA

Korean Animal Protection Law

NETHERLANDS

There is a reference in the law to the 3 R's:it is forbidden to perform animal experiments when an alternative is available, when it can be done with less discomfort and /or with less animals.

The Dutch Animal Experimentation Act (1977) demands the research establishments to request a licence from the Ministry of Welfare, Public Health and Cultural Affairs prior to carry out any experiment. Research plans must be approved by local ethical review committees that have to consider the benefit emanating from an experiment and whether this justifies the distress caused to the animals used in the procedure. The pain assessment is prospective and a system of research plan review based on the cost-benefit principle is also into practice.

Netherlands Experiments on Animals Act (NKCA)

Dutch Experiments on Animals Act Legislation

Animal Experimentation Legislations

NEW ZEALAND

A National Animal Ethics Advisory Committee (NAEAC) has been established in 1984 and covers the use of animals in research, teaching and testing. In addition to that National Committee an Australian and New Zealand Council for the Care of Animals in Research and Teaching (ANZCCART) has been set up. Since 1998 all organisations manipulating live animals for the purpose of research, testing, teaching or the production of biological agents are required to respect a new code of ethical conduct recommended by the National Committee and approved by the relevant authorities. A specific justification is required for all procedures with potential to cause pain or distress and the steps taken to avoid or minimise pain or distress must be detailed. The Code of Ethical conduct also provides guidelines for pain or distress assessment and advises that animals should always be given the benefit of any doubt concerning pain relief.

Animal welfare Act (New Zealand)

Code of Recommendations and Minimum Standards for the Care and Use of Animals for Scientific Purposes (New Zealand)

Biosecurity: Animal Welfare

NORWAY

The Ministry of Agriculture through the Norwegian Animal Welfare Act regulates animal experimentation in Norway. The Act states that experiments may not be performed without a special permission being granted by the National Animal Research Authority (NARA).

Norwegian Animal Welfare Act

Norwegian Legislation

NORECOPA Guidelines A to Z

POLAND

Local Scientific Committees assess the experiments to be carried out on live animals.

Poland Animal Protection Act

Polish legislation

PORTUGAL

The Act for the Protection of Animals requires a justification of all the scientific and research procedures carried out on animals.

Protection of Animals Law

RUSSIA

Russian Academy of Sciences

SLOVENIA

The Law on Animal Health shows provisions dealing with experiments on animals. Licences to experiment on live animals are regulated through a directive. Animal Experiments Boards operate in the main institutions that are involved in animal experimentation. These boards include ethics committees that give the consent to approve research projects.

Animal Welfare legislation

SOUTH AFRICA

South African Society of Animal Science

SPAIN

Legislation

SWEDEN

The Swedish system of regulating animal research comes under a general law controlling animal welfare the Animal Welfare Act (1988). Animals may only be used for scientific research or education, the diagnosis of diseases, the production of drugs or chemical products or for other similar purposes where the activity is organised in such a way as not to subject the animals to greater suffering than is absolutely necessary. When considering specific cases the Ethical committees shall weigh the importance of the experiment against the suffering inflicted on the animal. Before a vertebrate animal is used for scientific purposes the animal shall, if the use may involve physical or mental suffering, be anaesthetized. Where possible, an analgesic or tranquilliser shall be used in such cases to alleviate the animal’s suffering, in order to ensure that the animal is not subjected to severe pain, severe anxiety or any other severe suffering.

Swedish Legislation

Swedish Animal Welfare Agency

Animal Protection Act

SWITZERLAND

The Law on the Protection of Animals (1978) clearly states that no unjustifiable painful or distressing experiments can be carried out on animals. Only strictly limited painful procedures are allowed on experimental animals. The Federal Veterinary Office regularly issues guidelines to inform the relevant regional and local authorities on the recent technical and ethical development in the field of animal experimentation. A code of conduct for all scientists and other people involved in practising the animal experimentation has been formulated by the Swiss Academy of Medical Sciences and the Swiss Academy of Sciences (Ethical Principles and Guidelines for Scientific Experiments on Animals).

Swiss Legislation

Swiss Federal Act on Animal Protection

ICARE Swiss Project

TAIWAN

Taiwan Animal Protection Law

Taiwan Animal Protection

UK

The Animals for Scientific Procedures Act (1986) provides guidance on the application for Project Licences. The application form requires details on description of the procedures and the assessment of potential severity of the experiments. The Act requires that a project licence cannot be granted unless the likely adverse effects (pain, suffering, distress or lasting harm) of the procedures have been weighed against the benefit likely to accrue as a result of the proposed programme of work. Licence holders must always familiarise themselves with the signs of pain, discomfort and distress in the species they are using. Suffering can be controlled by reliable analgesia and care and licence holders are required to minimise any pain, suffering or distress.

UK Animals (Scientific Procedures) Act

UK Animals (Animal Legislation)

Examples of 3Rs

UNITED STATES

Animal Welfare Act

Animal Care Regulations

Animal Care Policy Manual

NIH Plan for the Use of Animals in Research

NIH Revitalization Act (section on use of animals in research)

Health Research Extension Act of 1985 "Animals in Research"

U.S. Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

Guide for the Care and Use of Laboratory Animals
The use of animals in research is controlled by the Health Research Expansion Act and by the Animal Welfare Act (AWA). The AWA was issued in 1966 and amended in 1976 and 1980. The amendments set standards to minimise pain or distress of animals and requires researchers to consider alternatives to painful procedures. The Animal and Plant Health Inspection Service (APHIS) currently carry out a process to re-define pain or distress of animals.

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