Whereas it is appropriate to reduce to a minimum the number of animals used for experimental purposes, in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of the laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (8);

all experimental animals shall be provided with housing, an environment, at least some freedom of movement, food, water and care which are appropriate to their health and well-being;

If, however, systemic absorption is demonstrated during therapeutic experimentation, toxicity tests shall be carried out on animals, including where necessary, foetal toxicity tests.

The specific α 2 – adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.

COUNCIL DECISION of 23 March 1998 concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes

Whereas there exist between the national laws at present in force for the protection of animals used for certain experimental purposes disparities which may affect the functioning of the common market;

Whereas the administration of large doses of colza oil to experimental animals has been shown to produce undesirable effects, but whereas it has not been demonstrated that such effects can occur in man;

The Community shall approve the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes, subject to a reservation in respect of Article 28(1) thereof.

Council Decision of 22 July 2003 concerning the conclusion of the Protocol of Amendment to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes

Sub-acute/Sub-chronic toxicity comprises the adverse effects occurring in experimental animals as a result of repeated daily dosing with, or exposure to, a chemical for a short part of their expected lifespan

C ) TO REFRAIN FROM APPLYING THE PROVISIONS OF THIS DIRECTIVE TO COMPOUND FEEDINGSTUFFS WHERE A SPECIAL LABEL MARKING GIVES PROOF THAT THEY ARE INTENDED FOR ANIMALS KEPT FOR SCIENTIFIC OR EXPERIMENTAL PURPOSES .

Repeated dose/Sub-chronic toxicity comprises the adverse effects occurring in experimental animals as a result of repeated daily dosing with, or exposure to, a chemical for a short part of their expected life-span.

In animals, liposome-encapsulated doxorubicin reduced the distribution to heart and gastrointestinal mucosa compared with conventional doxorubicin, while antitumoural efficacy in experimental tumours was maintained.

COUNCIL DIRECTIVE of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes

The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes.

Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(5) has established common rules for the use of animals for experimental purposes within the Community and laid down the conditions under which such experiments must be carried out in the territory of the Member States.

If practical experience shows the substances and preparations to be capable of inducing a sensitization reaction in a substantial number of persons by skin contact, or on the basis of a positive response in experimental animals.

Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes

Whereas on 24 November 1986 the Council adopted Directive 86/609/EEC(4) on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, setting out common rules incorporating the principles, objectives and main provisions of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes;

Each batch of the feedingstuffs used in the experimental studies on animals must be analysed for the concentration of the relevant active substances using an appropriate method and a report of the analytical results must be provided.

Recalling that the aim of the Council of Europe is to achieve a greater unity between its members and that it wishes to cooperate with other States in the protection of live animals used for experimental and other scientific purposes;

specific animal health requirements, for imports into the Community, and the nature and content of accompanying documents for animals intended for zoos, circuses, amusement parks or experimental laboratories, according to the species;

As expected from the heterologous protein nature of the hormone, lutropin alfa raised an antibody response in experimental animals after a period that reduced the measurable serum LH levels but did not fully prevent its biological action.

Whereas in the conditions governing approval of bodies, institutes or centres, references should be made, if they keep animals intended for experimental laboratories, to Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (2), in order to align these conditions in the Community and for third countries;

Point mutations are the cause of many human genetic diseases and there is substantial evidence that point mutations in oncogenes and tumour suppressor genes of somatic cells are involved in tumour formation in humans and experimental animals.

For the reasons above, and given the specificity of trade in animals imported under certain non-commercial transactions, it is appropriate already to exclude equidae and animals for shows, exhibitions, scientific (including conservation or experimental) purposes and circuses from the scope of Decision 79/542/EEC.

Member States shall also ensure that all tests on animals are conducted in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulation and administrative provisions of the Member States regarding the protection of animals for experimental and other scientific purposes.

In particular, persons carrying out or supervising the conduct of experiments shall have received instruction in a scientific discipline relevant to the experimental work being undertaken and be capable of handling and taking care of laboratory animals;

Member States shall also ensure that all tests on animals are conducted in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulation and administrative provisions of the Member States regarding the protection of animals for experimental and other scientific purposes(1).

'experiment' means any use of an animal for experimental or other scientific purposes which may cause it pain, suffering, distress or lasting harm, including any course of action intended, or liable, to result in the birth of an animal in any such condition, but excluding the least painful methods accepted in modern practice (i.e. 'humane' methods) of killing or marking an animal;

On 24 November 1986 the Council adopted Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(3), setting out common rules incorporating the principles, objectives and main provisions of the European Convention of 18 March 1986 for the protection of vertebrate animals used for experimental and other scientific purposes (hereinafter referred to as the Convention).

This Decision shall not apply to imports of non-domesticated animals for shows or exhibitions where such animals are not regularly kept or bred, and those non-domesticated animals forming part of circuses, or intended for scientific including conservation or experimental purposes in a body, institute or centre that has been approved in accordance with Annex C to Directive 92/65/EEC.

The procedure provided for in Article 18 shall be used to stipulate specific animal health requirements for imports into the Community and the nature and content of accompanying documents for products referred to in Annex I intended for experimental laboratories.

On 23 March 1998 the Council adopted Decision 1999/575/EC concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes(4) (hereinafter referred to as the Convention).

whereas such harmonization should ensure that the number of animals used for experimental or other scientific purposes is reduced to a minimum, that such animals are adequately cared for, that no pain, suffering, distress or lasting harm are inflicted unnecessarily and ensure that, where unavoidable, these shall be kept to the minimum;

Whereas the number of animals used for experiments should be reduced to a minimum, in accordance with the provisions of Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(7);

Directive 2003/65/EC of the European Parliament and of the Council of 22 July 2003 amending Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes

Whereas assessment of the safety of use of the ingredients employed in cosmetics and of the final product should take account of the requirements of Directive 86/609/EEC (5), which concerns the protection of animals used for experimental and other scientific purposes, and in particular Article 7 (2) thereof;

Chromosome mutations and related events are the cause of many human genetic diseases and there is substantial evidence that chromosome mutations and related events causing alterations in oncogenes and tumour suppressor genes of somatic cells are involved in cancer induction in humans and experimental animals.

In application of Article 34(1) of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes, the European Community states that it does not consider itself bound by the requirements to communicate statistical data laid down in Article 28(1) of the said Convention.

Council Directive 86/609/EEC(5) of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(6) provides that an animal test shall not be carried out if an alternative method is available.

Whereas resources devoted to the conduct of tests on vertebrate animals should not be dissipated as a result of the differences in the laws of the Member States and whereas considerations of public interest and Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (4) militate against needless repetition of tests on animals;

The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(12).

According to Article 7(2) of Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(4), an experiment entailing the use of animals shall not be performed if another scientifically satisfactory method to obtain the result sought is reasonably and practicably available.

This applies especially for animal protection which requires that the number of experiments on animals be restricted in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(5).

The aim of this Directive is to ensure that where animals are used for experimental or other scientific purposes the provisions laid down by law, regulation or administrative provisions in the Member States for their protection are approximated so as to avoid affecting the establishment and functioning of the common market, in particular by distorsions of competition or barriers to trade.

On 23 March 1998 the Council adopted Decision 1999/575/EC concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes(4) and made a Declaration that the European Community does not consider itself bound by the requirements to communicate statistical data laid down in Article 28(1) of the said Convention.

Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version)(22); and Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(23).

are required under exceptional circumstances for the advancement of science or for essential biomedical purposes pursuant to Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes where the species in question proves to be the only one suitable for those purposes and where there are no specimens of the species which have been born and bred in captivity;

are required under exceptional circumstances for the advancement of science or for essential biomedical purposes pursuant to Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (6) where the species in question proves to be the only one suitable for those purposes and where there are no specimens of the species which have been born and bred in captivity;