(1)

Animal welfare is a Community value that is enshrined in the Protocol on the protection and welfare of animals annexed to the Treaty.

(2)

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 (3). By becoming a Party to that Convention, the Community acknowledged the importance of the protection and welfare of animals used for scientific purposes at international level.

(3)

On 24 November 1986 the Council adopted Directive 86/609/EEC (4) in order to eliminate disparities between laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Since the adoption of that Directive, further disparities between Member States have emerged. Certain Member States have adopted national implementing measures that ensure a high level of protection of animals used for scientific purposes while others only apply the minimum requirements laid down in Directive 86/609/EEC. Accordingly, this Directive should provide for more detailed rules in order to reduce such disparities and to ensure a proper functioning of the internal market.

(4)

The European Parliament, in its report of ║ 5 December ║ 2002 on Directive 86/609/EEC, called for the Commission to come forward with a proposal for a revision of that Directive with more stringent and transparent measures in the area of animal experimentation.

(5)

New scientific knowledge is available on factors influencing animal welfare as well as the capacity of ║ animals to sense and express pain, suffering, distress and lasting harm. It is therefore necessary to improve the welfare of animals used in scientific procedures by raising the minimum standards for the protection of such animals in line with the latest scientific developments.

(6)

It is desirable to include specific invertebrate species within the scope of this Directive, where there is scientific evidence of the potential ability of such species to experience pain, suffering, distress and lasting harm.

(7)

This Directive should also cover embryonic and foetal forms of vertebrate animals, in cases where there is scientific evidence showing that such forms in the last third of their development have an increased risk of experiencing pain, suffering and distress, which may also affect negatively their subsequent development. Scientific evidence has also shown that procedures on embryonic and foetal forms of species of mammals at an earlier stage of development could result in pain, suffering, distress or lasting harm, should the developmental forms be allowed to live beyond the first two thirds of their development.

(8)

▐ The use of live animals continues to be necessary to protect human health, animal health and the environment , within current scientific limitations. However this Directive represents an important step towards achieving the goal of the full replacement of procedures on live animals for scientific purposes as soon as it is scientifically possible to do so. To that end, this Directive seeks to facilitate and promote the advancement of alternative methods and to ensure a high level of protection for animals used in procedures. This Directive should be reviewed regularly in light of evolving scientific and animal protection measures.

(9)

In light of scientific progress, the use of animal experiments remains an important means of ensuring a very high standard of research into public health.

(10)

The care and use of live animals for scientific purposes is governed by internationally established principles of replacement, reduction and refinement. To ensure that the way in which animals are bred, cared for and used in procedures in the Community is in line with that of the other international and national standards outside the Community, the replacement, reduction and refinement should be considered systematically when implementing this Directive. The Commission should ensure a high level of transparency in relation to the use of animals and in terms of reporting to the public on the implementation of animal protection measures and progress made towards replacing animal methods.

(11)

Animals have an intrinsic value in themselves which must be respected. There are also ethical concerns of the general public as regards the use of animals in procedures. Therefore, the animals should always be treated as sentient creatures and their use in scientific procedures should be restricted to areas which advance science and fundamental knowledge, since this may ultimately benefit e.g. human or animal health, or the environment. The use of animals in scientific procedures should therefore only be considered where a non-animal alternative is not available. Use of animals for scientific procedures in other areas under Community competence should be prohibited.

(12)

The principles of replacement, reduction and refinement should be implemented through a strict hierarchy of the requirement to use alternative methods. Where no alternative method is recognised by Community legislation, numbers of animals may be reduced by resorting to other methods which are reasonably and practically available, and by implementing testing strategies, such as use of in vitro and other methods that would reduce and refine the use of animals.

(13)

In accordance with the objectives of the Communication of 23 January 2006 from the Commission to the European Parliament and the Council ‘Community Action Plan on the Protection and Welfare of Animals 2006 – 2010’, the Commission should endeavour to promote the welfare of animals used for scientific purposes internationally, in particular by seeking promotion of the replacement, reduction and refinement of animal procedures through the World Organisation for Animal Health (OIE), and by seeking to add animal welfare standards to the criteria assessed in order to establish compliance with Good Laboratory Practice (GLP).

(14)

The choice of methods and the species to be used have a direct impact on both the numbers of animals used and their welfare. The choice of methods should therefore ensure the selection of the method that is able to provide most adequate results and likely to cause the minimum pain, suffering or distress. Such selected methods should use the minimum number of animals that would provide ▐ reliable results and choose the species with the lowest degree of neurophysiological sensitivity that are optimal for the extrapolation into target species.

(15)

The methods selected should avoid, as far as possible, death as an end-point due to severe suffering caused by the approaching death. Where possible, it should be substituted by more humane end-points using clinical signs that determine the impending death thereby allowing the animal to be killed by a humane method without any further suffering.

(16)

The use of inappropriate methods for killing an animal can cause significant pain, distress and suffering to the animal. The level of competence of the person carrying out this operation is equally important. Animals should therefore be killed only by a trained and authorised person using a humane method that is considered appropriate to the species.

(17)

It is necessary to ensure that the use of animals in procedures does not pose a threat to biodiversity. Therefore, the use of endangered species in procedures should be limited to a strict minimum to cover essential biomedical reasons as well as research aimed at the preservation of those species.

(18)

With current scientific knowledge the use of non-human primates in scientific procedures is still necessary in biomedical research. Due to their genetic proximity to human beings and to their highly developed social skills, the use of non-human primates in scientific procedures raises specific ethical and practical problems in terms of meeting their behavioural, environmental and social needs in a laboratory environment. Furthermore, the use of non-human primates is of the highest concern to the public. Therefore the use of non-human primates should only be allowed in those essential biomedical areas for the benefit of human beings for which no other replacement alternative methods are yet available ▐, or for the preservation of the respective non-human primate species. Fundamental research in some areas of the biomedical sciences can provide important new information relevant, at some future stage, to many life-threatening and debilitating human conditions. ▐

(19)

The use of great apes, as the closest species to human beings with the most advanced social and behavioural skills, should only be allowed in research aimed at the preservation of those species and where action in relation to a life-threatening, debilitating condition endangering human beings is warranted, and no other species or alternative method could suffice for the aims of the procedure. The Member State claiming such a need should provide the necessary information for the Commission to take a decision.

(20)

▐ In order to gradually end the capturing of animals from the wild for breeding purposes, a thorough scientific study should be conducted as soon as possible on the feasibility of limiting the animals used to those from self-sustaining colonies. Establishments breeding and supplying non-human primates should therefore have a strategy in place to support and facilitate the progressive move towards that goal.

(21)

There is a need for certain species of vertebrate animals used in procedures to be bred specifically for use in procedures so that their genetic, biological and behavioural background is well-known to persons undertaking the procedures. Such knowledge both increases the scientific quality and reliability of the results and decreases the variability, ultimately resulting in fewer procedures and reduced animal use. Furthermore, for reasons of animal welfare and conservation, the use of animals taken from the wild in procedures should be limited only to cases where the purpose of the procedures cannot be achieved using animals bred specifically for use in procedures.

(22)

Since the background of stray and feral animals of domestic species is not known, and capture and placement into establishments increases distress for those animals, they should not be used in procedures.

(23)

To enhance transparency, facilitate the project authorisation and provide tools for monitoring compliance, a severity classification of procedures should be introduced on the basis of estimated levels of pain, suffering, distress and lasting harm that is inflicted on the animals. ▐

(24)

From the ethical standpoint, there should be an upper limit of pain, suffering and distress, above which animals should not be subjected in scientific procedures. To that effect, the performance of procedures that result in severe pain, suffering or distress and which is likely to be prolonged, should not ordinarily be permitted . When developing a common format for reporting purposes, instead of the predicted severity at the time of the ethical evaluation, the actual severity experienced by the animal should be taken into account.

(25)

The number of animals used in procedures could be reduced by performing procedures on animals more than once, where this does not detract from the scientific objective or result in poor animal welfare. However, the re-use of animals should be judged against minimising any adverse affects on their welfare, taking into account the lifetime experience of the individual animal. As a result of this potential conflict, the re-use of animals should be considered on a case-by-case basis and limited to only those procedures where the cumulative pain, distress and suffering are ethically justified .

(26)

At the end of an authorised procedure, the most appropriate decision should be taken with regard to the future of the animal on the basis of animal welfare and potential risks to the environment. The animals whose welfare would be compromised should be killed using a humane method. In some cases, animals should be set free or animals such as dogs and cats should be allowed to be re-homed in families as there is a high level of public concern as to the fate of such animals. Should establishments allow re-homing, it is essential that there is a scheme in place to provide the appropriate socialisation of those animals in order to promote successful re-homing as well as to avoid unnecessary distress to the animals and to guarantee public safety.

(27)

Animal tissue and organs are used for the development of in vitro methods. To implement the principle of reduction, it is desirable for Member States to establish programmes for sharing the organs and tissue of animals that are killed using humane methods.

(28)

The welfare of the animals used in procedures is highly dependent on the quality and professional competence of persons supervising procedures, as well as of those performing procedures or supervising those taking care of the animals on a daily basis. In order to secure an adequate degree of competence of ║ persons dealing with animals and with procedures involving animals, such activities should only be performed in establishments, and by persons, authorised by the competent authorities. The main focus should be on obtaining and maintaining an adequate level of competence which should be demonstrated before authorising those persons or renewing their authorisation. Authorisation by a competent authority and proof of the successful completion of relevant training courses should be mutually recognised by all Member States.

(29)

Establishments should have adequate installations and equipment in place to meet the accommodation requirements of the animal species concerned and to allow the procedures to be performed efficiently and with the least distress both to the animals directly concerned and their animal companions . The establishments should operate only if they are authorised by the competent authorities.

(30)

To ensure the ongoing monitoring of animal welfare needs, appropriate veterinary care should be available at all times and a staff member should be made responsible for the care and welfare of animals in each establishment.

(31)

Animal welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Each establishment should therefore have a permanent ethical review body in place with the primary task of focusing on ethical debate at establishment level, fostering a climate of care and providing tools for practical application and timely implementation of the recent technical and scientific developments in relation to the principles of replacement, reduction and refinement to enhance the life-time experience of the animals. The decisions of the permanent ethical review body should be properly documented and open to scrutiny during inspections.

(32)

In order to enable the competent authorities to monitor compliance with this Directive, each establishment should , where possible, maintain accurate records on the numbers of animals, their origins and fate.

(33)

Non-human primates with highly developed social skills, as well as dogs and cats, should have a personal history file from birth covering the duration of their lives in order to be able to receive the care, accommodation and treatment that meet their individual needs and characteristics.

(34)

The accommodation and care of the animals should be based on the specific needs and characteristics of each species.

(35)

On 15 June 2006 the Fourth Multilateral Consultation of Parties to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes adopted a revised Appendix A which sets out guidelines for accommodation and care of experimental animals. Commission Recommendation 2007/526/EC of 18 June 2007 on guidelines for the accommodation and care of animals used for experimental and other scientific purposes (5) incorporated those guidelines.

(36)

There are differences in the requirements for the accommodation and care of animals between Member States, which contribute to the distortion of the internal market. Furthermore, some of those requirements no longer reflect the most recent knowledge on the impacts of accommodation and care conditions on both the animal welfare and the scientific results of procedures. It is therefore necessary to establish in this Directive the minimum requirements on accommodation and care subject always to developments based on new scientific evidence .

(37)

To monitor compliance with this Directive, Member States should carry out at least one inspection annually in each establishment. To ensure public confidence and promote transparency at least one inspection ║ must be unannounced. Programmes for joint inspections by Member States should be established to foster an environment of sharing good practice and expertise.

(38)

To assist the Member States in the enforcement of this Directive and on the basis of the findings in the reports on the operation of the national inspections, the Commission should, where appropriate, carry out controls of the national inspection systems. Member States should address any weaknesses identified in the findings of these controls.

(39)

Comprehensive ethical evaluation of projects using animals, which forms the core of the project authorisation, should ensure implementation of principles of replacement, reduction and refinement in those projects.

(40)

It is also essential to ensure both on moral and scientific grounds that each use of animals is carefully evaluated in terms of the scientific validity, usefulness and relevance of ▐ that use. The likely harm to the animals should be balanced against the expected benefits of the project. Therefore, an ▐ ethical evaluation, independent of those in charge of the study, should be carried out as part of the authorisation process of projects involving the use of live animals. Effective implementation of an ethical evaluation should also allow for an appropriate assessment of the use of any new scientific experimental techniques as they emerge.

(41)

In certain cases, due to the nature of the project, the type of species used and the likelihood of achieving the desired objectives of the project, it might be necessary to carry out a retrospective assessment. Since projects may vary significantly in terms of complexity, length, as well as the delay for obtaining the results, it is necessary that the decision as to whether retrospective assessment should be carried out takes those aspects fully into account.

(42)

To ensure that the public is informed, it is important that objective information on the projects using live animals is made publicly available. The format of such information should not violate proprietary rights or expose confidential information. Therefore, user establishments should provide the competent authority with data, which may be qualitative or quantitative, concerning the use of live animals and make such data publicly available.

(43)

To manage risks to human and animal health and the environment, Community legislation provides that substances and products can only be marketed after appropriate safety and efficacy data have been submitted. Some of those requirements can be fulfilled only by resorting to animal testing, hereinafter referred to as ‘regulatory testing’. It is necessary to introduce specific measures in order to increase the use of alternative approaches and to eliminate unnecessary duplication of regulatory testing. For that purpose Member States should recognise the validity of test data produced using test methods provided for in Community legislation.

(44)

To reduce the unnecessary administrative workload and enhance the competitiveness of Community research and industry, it should be possible to authorise multiple regulatory testing procedures under one group authorisation, albeit without exempting those procedures from ethical evaluation.

(45)

To ensure effective examination of authorisation applications and to enhance the competitiveness of Community research and industry, a time-limit should be set for the competent authorities to evaluate project proposals and take decisions on authorisation of those projects. In order not to compromise the quality of the ethical evaluation, additional time may be required for more complex project proposals due to the number of disciplines involved, the novel characteristics and more complex techniques of the proposed project. However, extension of deadlines for ethical evaluation should remain an exception.

(46)

The availability of alternative methods is highly dependent on the progress of the research into the development of alternatives. The Community Framework Programmes for Research and Technological Development have provided increasing funding for projects which aim to replace, reduce and refine the use of animals in procedures. Therefore, in order to increase competitiveness of research and industry in the Community, the Commission and the Member States should contribute to the development and validation of alternative approaches.

(47)

The European Centre for the Validation of Alternative Methods is established within the Joint Research Centre of the Commission and coordinates the validation of alternative approaches in the Community. However, there is an increasing need for new methods to be developed and proposed for validation. To provide the necessary mechanisms at Member State level, a reference laboratory for the validation of alternative methods should be designated by each Member State. Member States should designate reference laboratories which are accredited in accordance with Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (6) in order to ensure coherent and comparable quality of the results. In addition, the remit of the European Centre for the Validation of Alternative Methods should be extended to include the co-ordination and promotion of the development and use of alternatives to animal experiments.

(48)

There is a need to ensure a coherent approach to ethical evaluation and ethical review strategies at national level. Member States should establish national animal welfare and ethics committees to give advice to the competent authorities and permanent ethical review bodies of establishments in order to promote the principles of replacement, reduction and refinement. Therefore, the network of national animal welfare and ethics committees should play a role in the exchange of best practice at Community level.

(49)

The technical and scientific advancements in biomedical research can be rapid as can the increase in knowledge of factors influencing animal welfare. It is therefore necessary to provide for a review of this Directive. Such a review , based on the results of peer-assessed scientific studies, should examine possible replacement of the use of animals, and in particular non-human primates, as a matter of priority where it is possible, taking into account the advancement of science.

(50)

The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7).

(51)

In particular, power should be conferred on the Commission to establish the criteria for classification of procedures and to adapt Annexes II to IX to scientific and technical progress. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, inter alia by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(52)

Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.

(53)

Directive 86/609/EEC should therefore be repealed.

(54)

Benefits to animal welfare from applying project authorisation retrospectively, and the related administrative costs, can only be justified for long term ongoing projects. Therefore, it is necessary to include transitional measures for ongoing short and medium term projects to avoid the need for a retrospective authorisation with only limited benefits.

(55)

Since the objectives of this Directive, namely the harmonisation of legislation on use of animals for scientific purposes, cannot be sufficiently achieved by the Member States and can therefore, by reason of scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,

(1)

the replacement and reduction of the use of animals in procedures and the refinement of the breeding, accommodation, care and use of animals in procedures;

(2)

the origin, breeding, marking, care and accommodation of animals;

(3)

the functioning of breeding, supplying or user establishments;

(4)

the evaluation and authorisation of projects involving the use of animals in procedures.

(a)

live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms of species of mammals as from the last third of their normal development;

(b)

live invertebrate animals ▐ of those species of orders listed in Annex I.

(a)

non-experimental, agricultural or clinical veterinary practices and trials;

(b)

practices undertaken for the purposes of recognised animal husbandry;

(c)

practices undertaken for the primary purpose of marking an animal;

(d)

practices that do not cause pain, suffering, distress or lasting harm.

(1)

‘procedure’ means any use of an animal for experimental or other scientific purposes, with known or unknown outcome, which may or may not cause the animal pain, suffering distress or lasting harm and includes any course of action intended, or liable, to result in the birth of an animal in any such condition or in the creation of a new genetically modified animal line;

(2)

‘project’ means a programme of work having a defined scientific objective and involving one or more procedures;

(3)

‘establishment’ means any installation, building, group of buildings or other premises and may include a place that is not wholly enclosed or covered and mobile facilities;

(4)

‘breeding establishment’ means any establishment where animals are bred with a view to their use in procedures or for the use of their tissue or organs for scientific purposes;

(5)

‘supplying establishment’ means any establishment, other than a breeding establishment, from which animals are supplied with a view to their use in procedures or for the use of their tissue or organs for scientific purposes;

(6)

‘user establishment’ means any establishment where animals are used in procedures;

(7)

‘competent authority’ means the authority or authorities designated by each Member State as being responsible for supervising the enforcement of this Directive;

(8)

‘ethical approach’ means the approach which precedes experimentation and consists of assessing the scientific and societal grounds for using animals, with reference to humankind's duty to respect animals as living, sentient beings;

(9)

‘competent person’ means any person who is considered by a Member State to be competent to perform the relevant function described in this Directive;

(10)

‘husbandry’ means all those activities required to breed and maintain phenotypically normal animals, whether for scientific or other purposes, but which do not themselves constitute experiments;

(11)

‘practice’ means any non-experimental activity or any scientific activity which does not constitute an experiment;

(12)

‘properly anaesthetised’ means deprived of sensation by means of anaesthesia, whether local or general, which is as effective as those used in good veterinary practice;

(13)

‘protocol’ means a series of procedures that constitute an experiment with a defined objective;

(14)

‘regulated procedure’ means any experimental or other scientific procedure, which is likely to have the effect of causing a protected animal pain, suffering, distress or lasting harm;

(15)

‘re-use’ means the use of an animal already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used;

(16)

‘confidential information’ means information, the non-consensual release of which could prejudice the legitimate commercial or other interests of its owner or a third party.

(1)

basic research for the advancement of knowledge in biological or behavioural sciences;

(2)

translational or applied research with any of the following aims:

(3)

the development, manufacture or testing of the quality, effectiveness and safety of drugs, food- and feed-stuffs and other substances or products having any of the aims referred to in point (2);

(4)

the protection of the natural environment in the interests of the health or welfare of human beings or animals;

(5)

the protection of human health in the context of workers’ or consumers’ exposure to chemicals;

(6)

research aimed at preservation, health and welfare of the species;

(7)

higher education or training;

(8)

forensic inquiries.

(a)

the procedure has one of the purposes referred to in points (2)(a), (3) or (6) of Article 5;

(b)

there is a scientific justification that the purpose of the procedure cannot be achieved by the use of species other than those listed in that Annex;

(c)

as far as possible, the animals used should be bred specifically for testing purposes.

(a)

the procedure has one of the purposes referred to in points (1), (2)(a), (3) or (6) of Article 5;

(b)

the applicant provides a scientific and ethical justification that the purpose of the procedure cannot be achieved by the use of other species than non-human primates.

(a)

where anaesthesia is judged to be more traumatic to the animal than the procedure itself;

(b)

where analgesics are used to prevent or control potentially severe pain ;

(c)

where anaesthesia is incompatible with the purpose of the procedure unless the procedure involves serious injuries that may cause severe pain.

(a)

the previous procedure was classified as up to ‘ moderate ’;

(b)

it is demonstrated that its general state of health and well-being has been fully restored;

(c)

the further procedure is classified as up to ‘ moderate ’ or ‘non-recovery’. The re-use of animals shall be accompanied by veterinary examinations.

(a)

the state of health of the animal allows it;

(b)

there is no danger to public health or the environment;

(c)

the maximum possible care has been taken to safeguard the well-being of the animal , including an assessment of the animal's behaviour and its ability to adapt to highly variable environmental conditions ;

(d)

the animals concerned are not genetically modified experimental animals or non-human primates.

(a)

the carrying out of procedures on animals, including their killing by a humane method;

(b)

the supervision or design of procedures and projects;

(c)

the supervision of those taking care of animals.

(1)

persons responsible on site for the welfare and care of the animals bred, kept or used in the establishment, who shall ensure the following:

(2)

a designated veterinarian with expertise in laboratory animal medicine charged with advisory duties in relation to the well-being and treatment of the animals.

(a)

provide ethical advice to the staff dealing with animals on matters related to the welfare of animals in relation to their acquisition, accommodation, care and use;

(b)

advise the staff of the establishment on the application of the requirement of replacement, reduction and refinement and keep it informed on the latest technical and scientific developments on the application of those requirements;

(c)

establish and review internal operational processes as regards monitoring, reporting and follow up in relation to the welfare of animals housed or used in the establishment;

(d)

review annually all projects classified as ‘severe’ or those on non-human primates, and every three years all other projects which are of more than 12 months duration, focusing in particular on:

(e)

based on the review referred to in point (d) or, in the case of deviations from the project authorisation, examine whether the project authorisation needs to be submitted for amendment or renewal;

(f)

advise on re-homing schemes, in particular in relation to the appropriate socialisation of the animals to be re-homed.

(a)

the number and the species of vertebrate animals bred, acquired, supplied, released or re-homed;

(b)

the origin of the animals, including whether they are bred for use in procedures;

(c)

the dates on which the animals are acquired, supplied, released or re-homed;

(d)

the name and address of the supplying establishment and the date of their arrival;

(e)

the name and address of the the establishment receiving the animals;

(f)

the number and species of animals which have died or have been killed using a humane method in the establishment.

(a)

identity;

(b)

place of birth;

(c)

whether it is bred for use in procedures;

(d)

in the case of a non-human primate, whether it is the offspring of non-human primates that have been bred in captivity.

(a)

all animals are provided with accommodation, an environment, ▐ freedom of movement, food, water and care which are appropriate to their health and well-being and which allow them to satisfy their ethological as well as physical needs ;

(b)

any restrictions on the extent to which an animal can satisfy its physiological and ethological needs are limited to a minimum;

(c)

the environmental conditions in which animals are bred, kept or used are checked daily;

(d)

the well-being and state of health of animals are observed by a competent person at least once a day to prevent pain or avoidable suffering, distress or lasting harm;

(e)

arrangements are made to ensure that any avoidable defect or suffering discovered is eliminated as quickly as possible.

(a)

project proposal;

(b)

non-technical project summary;

(c)

information on the elements set out in Annex VIII;

(d)

a scientifically justified statement that the research project is indispensable and ethically defensible and that the purposes of the project cannot be achieved using other methods or procedures.

(a)

the project is scientifically justified , indispensable and ethically defensible ;

(b)

the purposes of the project justify the use of animals and cannot be achieved through other methods or procedures ;

(c)

the project is designed so as to enable procedures to be carried out with maximum respect for animal welfare and in the most environmentally sensitive manner.

(a)

an evaluation of the objectives of the project, the predicted scientific benefits or educational value;

(b)

an assessment of compliance of the project with the requirement of replacement, reduction and refinement;

(c)

an assessment of the classification of the severity of procedures;

(d)

a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress, and to the environment, where appropriate, is ethically defensible in light of the expected advancement of science that may ultimately benefit human beings, animals or the environment;

(e)

an assessment of any scientific justification referred to in Articles 6, 8, 9, 10, 11, 14, 16 and 18.

(a)

the areas of scientific use for which animals will be used;

(b)

experimental design, including statistics where appropriate;

(c)

veterinary practice in laboratory animal science or wildlife veterinary practice where appropriate;

(d)

animal husbandry and care, in relation to the species that are intended to be used;

(e)

practical application of the requirement of replacement, reduction and refinement;

(f)

applied ethics;

(g)

environmental science, where appropriate.

(a)

whether the objectives of the project were achieved;

(b)

harm inflicted on animals including the numbers and species of animals used and the severity of the procedures;

(c)

whether there are elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.

(a)

information on the objectives of the project, including the likelihood of achieving them, the potential harm, and details of the number and types of animals to be used;

(b)

a demonstration that the principles of replacement, reduction and refinement have been observed where practicable .

(a)

the persons in the establishment responsible for the overall implementation of the project;

(b)

the user establishments in which the project will be undertaken;

(c)

in the case of field studies, the user establishment which is responsible for the project;

(d)

at least one person demonstrating species specific knowledge.

(a)

coordinate research undertaken to facilitate the development of alternatives to animal procedures by the National Centres for Alternative Methods described in Article 49;

(b)

conduct research to facilitate the development of alternatives to animal procedures;

(c)

commission research in fields likely to yield information that will facilitate the replacement, reduction or refinement of animal procedures;

(d)

in consultation with relevant stakeholders, create and implement strategies to replace, reduce and refine animal procedures;

(e)

make available information on alternatives to animal procedures through regular reporting to the public, to stakeholders and to Member State authorities;

(f)

provide databases to facilitate the exchange of relevant information including information on available alternative methods and information contributed voluntarily by researchers which would otherwise remain unpublished, but which could prevent duplication of unsuccessful animal studies;

(g)

coordinate pre-validation and validation studies undertaken by the National Centres for Alternative Methods in accordance with Article 49 of this Directive;

(h)

conduct validation and pre-validation studies where appropriate;

(i)

in consultation with relevant regulatory bodies and stakeholders, create and implement strategies to replace, reduce and refine animal tests used for regulatory purposes;

(j)

facilitate the scientific endorsement and regulatory acceptance of alternatives to animal tests used for regulatory purposes;

(k)

inform relevant regulatory authorities when pre-validation and validation studies begin, and when alternative test methods achieve scientific endorsement and regulatory acceptance, and make this information available to the public and stakeholders through dedicated websites.

(a)

they shall have suitably qualified staff with adequate training in alternative methods and validation process and techniques applied in their area of competence;

(b)

they shall possess the equipment and products needed to carry out the tasks assigned to them;

(c)

they shall have an appropriate administrative infrastructure;

(d)

they shall ensure that their staff respect the rules on confidentiality.

(a)

cooperate with the Commission in their area of competence and perform tasks to advance strategies for replacing animal procedures;

(b)

participate in pre-validation and validation of alternative methods , where appropriate, under the co-ordination of the Commission;

(c)

communicate information on the availability and application of alternative methods received from the Commission to the relevant authorities of the Member State;

(d)

provide scientific and technical assistance to the relevant authorities and to user establishments, within and between the Member States, for the acceptance and implementation of alternative methods;

(e)

provide training on the use of alternative methods to persons referred to in Article 22(1) and, if required, to user establishments ;

(f)

communicate developments on alternative methods and inform the public of positive and negative outcomes.

(a)

authorise the provisional measure for a time period defined in the decision; or

(b)

require the Member State to revoke the provisional measure.