Directive 2010/63/EU [1] is the European Union (EU) legislation "on the protection of animals used for scientific purposes" and is one of the most stringent ethical and welfare standards worldwide. [2]
The Directive repealed Directive 86/609/EEC. It became formally applied across the EU on 1 January 2013. It protects live non-human vertebrates including independently feeding larval forms and foetal forms of mammals from the last third of their normal development, and live cephalopods.
The Directive is based on the Council of Europe's European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (ETS123) established in 1986. The EU is a party to this convention as are several EU and non-EU members. [3]
The Directive repealed Directive 86/609/EEC. It took nearly two years to revise, beginning in November 2008. It was finalised and signed on 22 September 2010, coming into force on 9 November 2010. Member States were then allowed one year to transpose it into their own words before it became formally applied across the EU on 1 January 2013. [3] [4]
The ultimate aim of the Directive is to replace animals in research. [5]
Because it is a Directive, it allows Member States certain flexibility in transposition of national rules. The status of the implementation of the new Directive in the EU is described by the EC General Environment Directorate. [6] Purposes of this Directive are to provide scope (via Articles 1 & 3), harmonise the current EU understanding of what defines an animal (Article 1.3), map resources, identify competent people and authorities (Articles 47.5 & 48), establish a common framework, and promote collaboration of the Member States with the EC to promote animal welfare in the EU as a European value in Article 13 of the Treaty of the Functioning of the EU (TFEU).
Animal welfare is not an EU policy area per se as for example agriculture, fisheries and research, but rather that "In formulating and implementing the Union's agriculture, fisheries, transport, internal markets, research, technological development, and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage". As with most EU legislation when animal welfare is not respected; one must refer a complaint directly to the Member State. Promotion and use of alternative animal testing methods and 3Rs are written elsewhere within EU legislation (e.g. REACH, Cosmetics, PPP, Biocides ...). EU agencies (ECHA, EMA, EFSA) also contribute to the protection of laboratory animals used for scientific purposes.
In July 2013, the Commission announced the creation of European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) [8] EU-NETVAL's primary role is to provide support for the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) validation projects, including aspects of training and dissemination, and the identification of methods that have a potential to reduce, refine or replace animals used for scientific purposes. [9] Any EU laboratory is allowed to apply as long as they follow the eligibility criteria listed by the EC, such as sufficient scientific staff, adequate equipment and GLP/or ISO certificates. [10] As of March 2016, there are 38 test facilities: Belgium (3) Czech Republic (1), European Commission (1), Finland (1), France (3), (Germany) (6), Hungary (1), Italy (8), the Netherlands (2), Poland (2), Slovakia (1), Spain (3), Sweden (1), Switzerland (2) and the United Kingdom (2). [11]
Animal testing, also known as animal experimentation, animal research and in vivo testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study. This approach can be contrasted with field studies in which animals are observed in their natural environments or habitats. Experimental research with animals is usually conducted in universities, medical schools, pharmaceutical companies, defense establishments and commercial facilities that provide animal-testing services to industry. The focus of animal testing varies on a continuum from pure research, focusing on developing fundamental knowledge of an organism, to applied research, which may focus on answering some question of great practical importance, such as finding a cure for a disease. Examples of applied research include testing disease treatments, breeding, defense research and toxicology, including cosmetics testing. In education, animal testing is sometimes a component of biology or psychology courses. The practice is regulated to varying degrees in different countries.
The Animals Act 1986, sometimes referred to as ASPA, is an Act of the Parliament of the United Kingdom passed in 1986, which regulates the use of animals used for research in the UK. The Act permits studies to be conducted using animals for procedures such as breeding genetically modified animals, medical and veterinary advances, education, environmental toxicology and includes procedures requiring vivisection, if certain criteria are met. Revised legislation came into force on 1 January 2013. The original act related to the 1986 EU Directive 86/609/EEC which was updated and replaced by EU Directive 2010/63/EU
The Dangerous Substances Directive was one of the main European Union laws concerning chemical safety, until its full replacement by the new regulation CLP Regulation (2008), starting in 2016. It was made under Article 100 of the Treaty of Rome. By agreement, it is also applicable in the EEA, and compliance with the directive will ensure compliance with the relevant Swiss laws. The Directive ceased to be in force on 31 May 2015 and was repealed by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
The Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases is a directive of the European Union in the field of copyright law, made under the internal market provisions of the Treaty of Rome. It harmonises the treatment of databases under copyright law and the sui generis right for the creators of databases which do not qualify for copyright.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
Phytogenics are a group of natural growth promoters or non-antibiotic growth promoters used as feed additives, derived from herbs, spices or other plants. The term phytogenic feed additives was coined by an Austrian multinational feed additives company named Delacon, and was first introduced to the market in the 1980s.
The European Union Computer Programs Directive controls the legal protection of computer programs under the copyright law of the European Union. It was issued under the internal market provisions of the Treaty of Rome. The most recent version is Directive 2009/24/EC.
Alternatives to animal testing are the development and implementation of test methods that avoid the use of live animals.
The European Chemicals Bureau (ECB) was the focal point for the data and assessment procedure on dangerous chemicals within the European Union (EU). The ECB was located in Ispra, Italy, under the responsibility of the Institute for Health and Consumer Protection (IHCP) of the Joint Research Centre (JRC) of the European Commission. In 2008 the ECB completed its mandate. Some of its activities were taken over by the European Chemicals Agency (ECHA); others remained within the Joint Research Centre's Institute for Health & Consumer Protection (IHCP). Tasks of the former ECB still managed by JRC-IHCP include: the Review Programme on the risk assessment of Biocides, the development of a methodology for the future Regulation on the Prioritisation of Chemical Substances and its corresponding Environmental Quality Standards (EQS); the harmonisation of testing methods and 'non-testing methods'.
The CLP Regulation is a European Union regulation from 2008, which aligns the European Union system of classification, labelling and packaging of chemical substances and mixtures to the Globally Harmonised System (GHS). It is expected to facilitate global trade and the harmonised communication of hazard information of chemicals and to promote regulatory efficiency. It complements the 2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation and replaces the current system contained in the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC).
Animal testing regulations are guidelines that permit and control the use of non-human animals for scientific experimentation. They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
Animals used by laboratories for testing purposes are largely supplied by dealers who specialize in selling them to universities, medical and veterinary schools, and companies that provide contract animal-testing services. It is comparatively rare that animals are procured from sources other than specialized dealers, as this poses the threat of introducing disease into a colony and confounding any data collected. However, suppliers of laboratory animals may include breeders who supply purpose-bred animals, businesses that trade in wild animals, and dealers who supply animals sourced from pounds, auctions, and newspaper ads. Animal shelters may also supply the laboratories directly. Some animal dealers, termed Class B dealers, have been reported to engage in kidnapping pets from residences or illegally trapping strays, a practice dubbed as bunching.
Fund for the Replacement of Animals in Medical Experiments (FRAME) is a charity based in Nottingham, UK. FRAME promotes consideration of the ethical and scientific issues involved in the use of laboratory animals for medical research, and the adoption of the Three Rs strategy of alternatives to animal testing.
The European Partnership for Alternative Approaches to Animal Testing (EPAA) promotes the application of Russell and Burch’s 3Rs principles in meeting regulatory requirements for products such as pharmaceuticals, chemicals, soaps, detergents and cosmetics. The EPAA covers research and development, as well as the use of 3Rs approaches in regulatory compliance and communication and dissemination.
The Three Rs (3Rs) are guiding principles for more ethical use of animals in product testing and scientific research. They were first described by W. M. S. Russell and R. L. Burch in 1959. The 3Rs are:
European consumer law concerns consumer protection within Europe, particularly through European Union law and the European Convention on Human Rights.
Council Regulation (EC) No 1/2005 is European Council legislation introduced in 2004 which relates to protecting the welfare of animals during transportation. The full title is Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97. It applies to the transport of live vertebrate animals carried out within the European Community.
A pesticide, also called Plant Protection Product (PPP), which is a term used in regulatory documents, consists of several different components. The active ingredient in a pesticide is called “active substance” and these active substances either consist of chemicals or micro-organisms. The aims of these active substances are to specifically take action against organisms that are harmful to plants. In other words, active substances are the active components against pests and plant diseases.
The European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, sometimes simply referred to as the animal experimentation convention or laboratory animals convention, is an animal welfare treaty of the Council of Europe regarding animal testing, adopted on 18 March 1986 in Strasbourg, and effective since 1 January 1991.
