Procedure completed
2008/0211(COD) Protection of animals used for scientific purposes
Lead committee dossier: AGRI/7/02658
Legal Basis TFEU 114-p1
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | AGRI | JEGGLE Elisabeth (PPE) | |
| Lead | AGRI | PARISH Neil (PPE-DE) | |
| Opinion | ENVI | MATSAKIS Marios (ALDE) | |
| Opinion | ITRE | SEPPÄNEN Esko (GUE/NGL) |
Legal Basis TFEU 114-p1
Activites
- 2010/10/20 Final act published in Official Journal
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2010/09/22
Final act signed
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2010/09/22
End of procedure in Parliament
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2010/09/08
Debate in Parliament
- Debate in Parliament
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T7-0308/2010
summary
The European Parliament adopted a legislative resolution on the Council position at first reading with a view to the adoption of a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes.The European Parliament adopted the Council position as it stands.
- 2010/07/13 Committee recommendation tabled for plenary, 2nd reading
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2010/07/12
Vote in committee, 2nd reading
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2010/06/17
Committee referral announced in Parliament, 2nd reading
- #3018
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2010/06/03
Council Meeting
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06106/1/2010
summary
The Council states that its position confirms the objectives proposed by the Commission and incorporates the majority of the European Parliament's first-reading amendments, either verbatim, in part or in spirit. The Council's position also includes a number of changes other than those envisaged in the European Parliament's first-reading opinion. These changes have been thoroughly negotiated with the European Parliament, which has confirmed its provisional agreement on the full text by a letter.The main amendments to the Commission proposal are as follows:Authorisation of persons: with the aim of reducing administrative burden and in order to cater more efficiently for different types of operators, the Council removed the proposed mandatory authorisation of persons carrying out or supervising procedures. Instead it put the emphasis on the requirements on competence of staff. These requirements include the obligation to specify in the authorisation of each breeder, supplier and user a person responsible for ensuring the adequate education, competence and continuous training of the staff.Union Reference Laboratory: in line with an amendment of the Parliament, the Council strengthened the promotion of alternative methods at Union level by the introduction of a centralised Union Reference Laboratory, assigning it a set of responsibilities, including coordination and validation of alternative approaches and acting as a focal point for the exchange of information on their development.Safeguard clauses: the Council introduced two additional safeguard clauses to take into account possible future situations where, for scientifically justifiable grounds, Member States deem it is necessary to authorise the use of nonhuman primates in areas not linked with debilitating and life-threatening conditions in humans or to surpass the upper limit for severity of procedures. This authorisation could only be provisional and would be subject to a Union control procedure.Classification of the severity of procedures: sharing Parliament’s approach, the Council introduced into the Directive a system for a uniform classification of severity of procedures.
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06106/1/2010
summary
- #2986
- 2009/12/14 Council Meeting
- #2952
- 2009/06/22 Council Meeting
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2009/05/05
Results of vote in Parliament
- Results of vote in Parliament
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T6-0343/2009
summary
The European Parliament adopted by 540 votes to 66, with 34 abstentions, a legislative resolution amending, under the first reading of the codecision procedure, the proposal for a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes.The main amendments are as follows:Purpose: according to MEPs, this Directive shall apply to the accommodation and husbandry of animals used for scientific purposes, and shall cover all uses of animals in procedures that are likely to cause them pain, suffering, distress or lasting harm.Scope: the Directive shall apply to live non-human vertebrate animals, including embryonic or foetal forms of species of mammals as from the last third of their normal development. However, independently feeding larval forms shall be excluded from the scope. Alternative methods: where a method of testing or experimentation exists which, from a scientific point of view, is a satisfactory method or testing strategy for obtaining the result sought, Member States shall ensure that the alternative method is used, provided it is not prohibited in the Member State concerned. Pursuant to this Directive, testing methods which involve the use of human embryonic and foetal cells shall not be regarded as alternatives, in other words the Member States may take their own ethical decisions concerning the use of these methods of testing.MEPs request that Member States should ensure that funding is provided for training and research on, and development and implementation of, scientifically satisfactory methods or testing strategies that do not entail the use of animals.Humane method of killing: a new measure has been introduced stipulating that, when more humane methods of killing are developed, this will allow them to be used immediately instead of waiting several years for Annex V to be updated. National measures: this Directive shall not prevent Member States from applying or adopting stricter national measures seeking to improve the well-being and protection of animals used for scientific purposes.Non-human primates (NHP): the proposal bans the use of NHPs except in certain circumstances. There is no scientific justification for the special status granted to NHPs, so that basic research should be allowed, without being restricted to experiments designed to achieve specific medical research objectives. A new paragraph is inserted to introduce a review of the use of non-human primates in procedures which is to be conducted by the Commission every two years.Use of cadavers, tissue and organs of animals for training purposes: MEPs consider that, for higher education and training purposes, the cadavers, tissue and organs of animals may be used only if they come from animals slaughtered in accordance with the provisions of Council Regulation (EC) No .../2009 [on the protection of animals at the time of killing].Animals bred for use in procedures: MEPs consider that the recommendation made in the proposal only to source non-human primates from self sustaining colonies of F2 primates (the second generation bred in captivity) is a noble aim and one which in the long term will ensure that fewer animals are taken from the wild. However, the proposal is not practical within the timescale that the Commission has envisioned. Moreover, five years after the entry into force of this Directive, the Commission shall carry out a feasibility study ahead of any mandated move towards establishing a policy of only sourcing from F2 self sustaining colonies.Anaesthesia: Member States shall ensure that, where appropriate, all procedures are carried out under general or local anaesthesia or using other methods that may alleviate pain or minimise suffering.Severity classifications: in its proposal, the Commission identifies a number of severity clauses - "up to mild", "moderate" and "severe" or "non-recovery" - governing how experiments can be undertaken. However it does not define what the classifications are. MEPs wish to clarify this situation by including a new Annex VIIa called “General Definitions of Degrees of Severity”.MEPs note that the ban on "prolonged" "severe" procedures appears to preclude any "severe" category procedures, and could be highly restrictive. This is why they propose that Member States should ensure that the procedures classified as "severe" are scientifically justified, and ethically monitored if the pain, suffering or distress is likely to be more than transient. Such procedures must be exceptional and shall be subject to particular harm/benefit analysis and scrutiny by the competent authority.Reuse: the Parliament supports the principle of re-use but believes that current restriction will result in dramatic increase in numbers of animals used for experimental purposes. MEPs propose that an animal already used in the procedure may be re-used where the previous procedure performed on the animal is classified as ‘up to moderate’ as opposed to ‘up to mild’. In any event, an animal that has undergone a "severe" procedure should not be re-used. In contrast, those previously subjected to a "moderate" procedure should be permitted to undergo a further "moderate" procedure. The repeated re-use of the animal is supported by veterinary examination.Authorised persons: Member States shall ensure the mutual recognition of education and training qualifications and authorisation to conduct designated procedures. Where an establishment no longer complies with requirements set out in the Directive, the competent authority shall have the power to suspend or withdraw its authorisation, or take appropriate remedial action or require such action to be taken. There shall be appropriate procedures for the license-holders to appeal against any such decision.Each breeding, supplying and user establishment shall ensure that there is at least one trained person available at all times to look after the animals’ welfare.Tasks of the permanent ethical review body: MEPs consider it judicious to provide a yearly review of all projects classified as "severe" or those on non-human primates, and every 3 years for all other projects. Member States shall pay particular attention to the collection, collation and publication of records relating to projects classified as "severe" or those on non-human primates.Breeding strategy of non-human primates: the obligations shall only concern EU breeding and supplying establishments of non-human primates. Where the use of non-human primates is authorised, the Commission and the Member States shall take all necessary measures to ensure appropriate transport conditions.Monitoring inspections: the Commission shall undertake controls of the infrastructure and operation of national inspections as well as of the correct application of severity classifications in Member States. To that end, the Commission shall set up a system to monitor each Member State 's inspections and enforcement of this Directive on average once every three years, ensuring harmonised practices for the use and the care of animals used or intended to be used in scientific procedures.Project authorisation: MEPs consider that projects classified as "moderate" or "severe" or any projects involving non-human primates should not be carried out without a prior authorisation by the competent authority. All other projects shall be notified in advance to the competent authority following ethical review by the institution’s permanent ethical review body.Retrospective evaluation: it should be up to an ethical committee to decide whether a retrospective ethical evaluation is required, depending on objective criteria, whatever species is involved.Granting project authorisations: project authorisations shall be granted for a period not exceeding five years (instead of three years).Sharing of data: Member States shall ensure the sharing of data generated by procedures, including those which have taken place in the European Union prior to the coming into force of this Directive. Anyone seeking to rely on data owned by another shall, where appropriate, contribute towards the cost of producing such data.European Centre for the Validation of Alternative Methods: MEPs suggest that the remit of the European Centre for the Validation of Alternative Methods shall be extended so that it includes the co-ordination and promotion of the development and use of alternatives to animal procedures including applied and basic biomedical research and veterinary research and regulatory testing by, for instance, coordinating research undertaken to facilitate the development of alternatives to animal procedures by the National Centres or providing databases to facilitate the exchange of relevant information. Each Member State shall nominate a centre responsible for supporting the development, validation and promotion of alternatives to animal tests used for regulatory purposes, and facilities to develop and promote the use of alternatives to animal procedures undertaken for other purposes, such as basic and applied biomedical and veterinary research.Thematic review: the Commission shall conduct a thematic review of the use of animals in procedures every two years commencing two years after the entry into force of this Directive. The review shall examine the impact of developments in technological, scientific and animal welfare knowledge, and set targets for the implementation of validated replacement methods.In the periodic reviews, the Commission shall give priority to the reduction and elimination of procedures causing the greatest permissible pain, suffering, distress or lasting harm and those which are not designed to alleviate life-threatening or debilitating clinical conditions in human beings, with a view to the elimination of all procedures. The Commission shall take into account evolving public opinion about the use of animals in procedures in the periodic reviews.
- 2009/05/04 Debate in Parliament
- 2009/04/03 Committee report tabled for plenary, 1st reading/single reading
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2009/03/31
Vote in committee, 1st reading/single reading
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2009/02/19
Referral to associated committees announced in Parliament
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2008/12/04
Committee referral announced in Parliament, 1st reading/single reading
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2008/11/05
Legislative proposal published
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COM(2008)0543
summary
PURPOSE: to strengthen the protection of animals still used in scientific procedures in line with the European Union's Protocol on Animal Welfare.PROPOSED ACT: Directive of the European Parliament and of the Council.CONTENT: Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes was adopted to harmonise practices in the area of animal experimentation in the EU. However, due to a variety of weaknesses in that Directive, a number of Member States have established considerably more far-reaching measures in their national implementation whereas others apply only minimum rules. This uneven situation needs to be rectified to ensure that the objectives of the internal market are re-established. The proposal aims at ensuring a level playing field, throughout the EU, for industry and the research community, at the same time strengthening the protection of animals still used in scientific procedures in line with the EC Treaty's Protocol on Animal Welfare. Many provisions of the current directive are open to interpretation. The latter does not include ethical reviews or requirements to obtain authorisations for experiments. The directive does not explicitly address the internationally recognised Three R concept of Replacement, Reduction and Refinement to minimise the use of experimental animals. Replacement refers to replacing procedures which involve live animals with alternatives not using sentient animals. Reduction refers to reducing to a minimum the use of animals in procedures without compromising the quality of results. Refinement refers to using methods that avoid pain, suffering or distress or lasting harm to a bare minimum. This last 'R' also includes improving the care, treatment and living conditions of animals. Revising the directive will strengthen legislation in the area of animal experiments in the EU, reduce the use of experimental animals and ensure that those that are still used in experiments receive appropriate care and humane treatment. The main points of the proposal are as follows :the new directive will make it compulsory to carry out ethical reviews and require that experiments where animals are used be subject to authorisation;it will widen the scope of the directive to include specific invertebrate species and foetuses in their last trimester of development and also larvae and other animals used in basic research, education and training;it will also set minimum housing and care requirements;only animals of second or older generations should be used, subject to transitional periods, to avoid taking animals from the wild and exhausting wild populations;alternatives to testing on animals must be used when available and the number of animals used in projects be reduced to a minimum. Member States will be required to improve the breeding, accommodation and care measures and methods used in procedures so as to eliminate or reduce to a minimum any possible pain, suffering, distress or lasting harm caused to animals. These measures are based on the three R principle of replacing, reducing and refining the use of animals in experiments;the proposal provides for tightening of national inspections, not only to ensure compliance, but as a means to promote the exchange of best practices and implementation of the principles of the Three Rs.Scope: the proposed directive covers all live non-human vertebrate animals intended for experiments plus certain other species likely to experience pain. It also includes animals specifically bred so that their organs or tissue can be used in scientific procedures. It does not cover behavioural studies carried out on animals kept in zoos or those used in military experiments, or non-experimental, agricultural or clinical veterinary practices and trials. It also does not cover animals used in husbandry or practices for marking an animal.Non-human primates: specific provisions have been incorporated to reduce the use of non-human primates to an absolute minimum. A strict case-by-case scrutiny is imposed in cases where non-human primates are still the only suitable species. The proposal limits the use of non-human primates by prohibiting the use of Great Apes and restricting the use of other species of nonhuman primate to only specific fields of application. Furthermore, there are ambitious requirements on the origins of the animals and specific monitoring mechanisms are foreseen to ensure the effectiveness of the proposed measures, ultimately facilitating the move towards abolishing the use of non-human primates in scientific procedures. It is recognised, however, that current scientific knowledge will not allow us to achieve this goal in the near future.
- DG {'url': 'http://ec.europa.eu/dgs/environment/', 'title': 'Environment'}, POTOČNIK Janez
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COM(2008)0543
summary
Documents
- Legislative proposal published: COM(2008)0543
- Committee report tabled for plenary, 1st reading/single reading: A6-0240/2009
- Debate in Parliament: Debate in Parliament
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament, 1st reading/single reading: T6-0343/2009
- Debate in Council: 2952
- Debate in Council: 2986
- Council position published: 06106/1/2010
- Committee recommendation tabled for plenary, 2nd reading: A7-0230/2010
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 2nd reading: T7-0308/2010
- : Directive 2010/63
- : OJ L 276 20.10.2010, p. 0033
- : Corrigendum to final act 32010L0063R(01)
- : OJ L 163 22.06.2012, p. 0019
| Amendments | Dossier |
| 482 |
2008/0211(COD)
2009/02/23
ITRE
213 amendments...
Amendment 10 #
Proposal for a directive Recital 6 (6) It
Amendment 100 #
Proposal for a directive Article 15 – paragraph 2 2. Member States shall ensure that the procedures classified as "severe" are
Amendment 101 #
Proposal for a directive Article 16 Amendment 102 #
Proposal for a directive Article 16 – paragraph 1 1. Member States shall ensure that an animal already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used, may be re-used in a new procedure totally different from the previous procedure from a scientific point of view only when all of the following conditions are met: (a) the previous procedure was classified as '
Amendment 103 #
Proposal for a directive Article 16 – paragraph 1 – point a (a) the previous procedure was classified as
Amendment 104 #
Proposal for a directive Article 16 – paragraph 1 – point a (a) the previous procedure was classified as 'up to m
Amendment 105 #
Proposal for a directive Article 16 – paragraph 1 – point c (c) the further procedure is classified as
Amendment 106 #
Proposal for a directive Article 16 – paragraph 1 – point c (c) the further procedure is classified as 'up to m
Amendment 107 #
Proposal for a directive Article 16 – paragraph 1 – point c a (new) (ca) the repeated use of the animal is accompanied by veterinary inspections. Repeated interventions under the same protocol may be necessary in the context of longitudinal projects.
Amendment 108 #
Proposal for a directive Article 16 – paragraph 2 2. By way of derogation from paragraph 1, the competent authority, on the basis of scientific justification, may allow re-use of an animal
Amendment 109 #
Proposal for a directive Article 19 – introductory part Member States may allow animals used or intended to be used in procedures to be
Amendment 11 #
Proposal for a directive Recital 6 (6) It is necessary to include specific invertebrate species within the scope of this Directive,
Amendment 110 #
Proposal for a directive Article 19 – introductory part Member States may allow animals used or intended to be used in procedures to be
Amendment 111 #
Proposal for a directive Article 19 – introductory part Member States may allow animals used or intended to be used in procedures to be
Amendment 112 #
Proposal for a directive Article 20 – paragraph 1 – introductory part 1. Member States shall ensure that persons are authorised by the competent authority or the delegated authority before they carry out any of the following functions:
Amendment 113 #
Proposal for a directive Article 20 – paragraph 1 – introductory part 1. Member States shall ensure that persons are authorised by the competent authority or the delegated authority before they carry out any of the following functions:
Amendment 114 #
Proposal for a directive Article 20 – paragraph 3 3. All authorisations of persons shall be granted for a limited period of time, not exceeding five years. Member States shall ensure that the renewal of an authorisation of persons is only granted on the basis of demonstration of the requisite competence. Member States shall guarantee the mutual recognition of this competence and of the authorisation.
Amendment 115 #
Proposal for a directive Article 20 – paragraph 3 3. All authorisations of persons shall be granted for a limited period of time, not exceeding five years. Member States shall ensure that the renewal of an authorisation of persons is only granted on the basis of demonstration of the requisite competence. Member States shall guarantee the mutual recognition of this competence and of the authorisation.
Amendment 116 #
Proposal for a directive Article 20 – paragraph 3 3. All authorisations of persons shall be granted for a limited period of time, not exceeding five years. Member States shall
Amendment 117 #
Proposal for a directive Article 20 – paragraph 3 3. All authorisations of persons shall be granted for a limited period of time, not exceeding
Amendment 118 #
Proposal for a directive Article 22 – paragraph 1 1. Where an establishment no longer complies with requirements set out in this Directive, the competent authority shall suspend or withdraw its authorisation. Member States shall establish an appropriate mechanism for appeals against suspension or withdrawal of authorisation.
Amendment 119 #
Proposal for a directive Article 22 – paragraph 2 a (new) 2a. Where the authorisation is suspended or withdrawn, Member States shall establish a mechanism for appeals against the decision.
Amendment 12 #
Proposal for a directive Recital 7 Amendment 120 #
Proposal for a directive Article 22 – paragraph 2 a (new) 2a. Where the authorisation is suspended or withdrawn, Member States shall establish a mechanism for appeals against the decision.
Amendment 121 #
Proposal for a directive Article 23 – paragraph 2 2. The design, construction and method of functioning of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible,
Amendment 122 #
Proposal for a directive Article 25 – paragraph 2 2. The permanent ethical review body shall include as a minimum the designated veterinarian, the person(s) responsible for the welfare and care of the animals in the establishment and, in the case of a user establishment, as the scientific member a person with expertise in the "3Rs" (Replacement, Reduction, Refinement), and an independent lay person.
Amendment 123 #
Proposal for a directive Article 25 – paragraph 2 2. The permanent ethical review body shall include as a minimum the designated veterinarian, the person(s) responsible for the welfare and care of the animals in the establishment and, in the case of a user establishment, a scientific member, persons with expertise in the "3Rs" (Replacement, Reduction, Refinement), and an independent lay person.
Amendment 124 #
Proposal for a directive Article 25 – paragraph 2 2. The permanent ethical review body shall include the designated veterinarian, the person(s) responsible for the welfare and care of the animals in the establishment and, in the case of a user establishment, a scientific member and a person with expertise in the application of the principles of replacement, reduction and refinement.
Amendment 125 #
Proposal for a directive Article 25 – paragraph 2 2. The permanent ethical review body shall include as a minimum the designated veterinarian, the
Amendment 126 #
Proposal for a directive Article 25 – paragraph 2 2. The permanent ethical review body shall include as a minimum the designated veterinarian, the person(s) responsible for the welfare and care of the animals in the establishment and, in the case of a user establishment, a scientific member.
Amendment 127 #
Proposal for a directive Article 26 – paragraph 1 – introductory part 1. The permanent ethical review body that reviews protocols and procedures shall fulfil the following tasks:
Amendment 128 #
Proposal for a directive Article 26 – paragraph 1 – point d – introductory part (d) review
Amendment 129 #
Proposal for a directive Article 26 – paragraph 1 – point d – introductory part (d) review annually all projects classified as "severe" or on non-human primates and every three years the other projects which are of more than 12 months duration, focusing in particular on:
Amendment 13 #
Proposal for a directive Recital 7 (7) This Directive should
Amendment 130 #
Proposal for a directive Article 26 – paragraph 2 – subparagraph 2 The records shall be
Amendment 131 #
Proposal for a directive Article 27 – paragraph 1 1. Member States shall ensure that breeding and supplying establishments of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of non- human primates that have been bred in captivity. The Commission and the Member States shall take the necessary measures to support appropriate conditions of transport and shall draw up a common strategy to sustain the indispensable presence of non-human primates on Community territory.
Amendment 132 #
Proposal for a directive Article 27 – paragraph 1 1. Without prejudice to the principle of replacement, reduction and refinement, Member States shall ensure that breeding and supplying establishments of non- human primates have a strategy in place for increasing the proportion of animals that are the offspring of non-
Amendment 133 #
Proposal for a directive Article 27 – paragraph 1 1. Member States shall ensure that EU breeding
Amendment 134 #
Proposal for a directive Article 27 – paragraph 1 1. Member States shall ensure that breeding establishments of non-human primates in the Community and supplying establishments of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of non-
Amendment 135 #
Proposal for a directive Article 27 – paragraph 2 Amendment 136 #
Proposal for a directive Article 27 – paragraph 2 a (new) 2a. Member States shall take all steps necessary to ensure that as soon as practicable the use of non-human primates in procedures is discontinued.
Amendment 137 #
Proposal for a directive Article 29 – paragraph 1 – introductory part 1. Member States shall wherever possible ensure that all breeding, supplying and user establishments keep records of the following:
Amendment 138 #
Proposal for a directive Article 29 – paragraph 1 – point a (a) the number and the species of vertebrate animals bred, acquired, supplied, released or re-
Amendment 139 #
Proposal for a directive Article 32 – paragraph 1 1. Member States shall, as far as the care and accommodation of animals is concerned, ensure the following: (a) all animals are provided with accommodation, an environment,
Amendment 14 #
Proposal for a directive Recital 7 (7) This Directive should also cover embryonic and foetal forms of vertebrate animals,
Amendment 140 #
Proposal for a directive Article 32 – paragraph 2 2. For the purposes of points (a) and (b) of paragraph 1, Member States shall apply the care and accommodation standards set out in Annex IV as from
Amendment 141 #
Proposal for a directive Article 32 – paragraph 2 2. For the purposes of points (a) and (b) of paragraph 1, Member States shall apply the care and accommodation
Amendment 142 #
Proposal for a directive Article 32 – paragraph 3 3. Member States may a
Amendment 143 #
Proposal for a directive Article 32 – paragraph 3 3. Member States may allow exemptions to paragraph 2 for animal welfare reasons or for experimental protocol requirements.
Amendment 144 #
Proposal for a directive Article 32 – paragraph 3 3. Member States may allow exemptions to paragraph 2 for justified scientific reasons, veterinary reasons or animal welfare reasons.
Amendment 145 #
Proposal for a directive Article 33 – paragraph 3 – subparagraph 1 a (new) Member States shall take the necessary measures to ensure that the inspections do not jeopardise the scientific quality of the projects and the welfare of the animals, and do not take place under conditions that fail to comply with the other regulations in force.
Amendment 146 #
Proposal for a directive Article 34 – paragraph 1 1. The Commission may undertake controls of the infrastructure and operation of national inspections in Member States to ensure that severity classifications are applied correctly and uniformly in the EU territory.
Amendment 147 #
Proposal for a directive Article 34 – paragraph 1 1. The Commission
Amendment 148 #
Proposal for a directive Article 35 – paragraph 1 1. Member States shall ensure that projects are not carried out without a prior authorisation by the competent authority, unless they are subject only to obligatory notification.
Amendment 149 #
Proposal for a directive Article 35 – paragraph 1 1. Member States shall ensure that projects are not carried out without a prior
Amendment 15 #
Proposal for a directive Recital 8 a (new) (8a) In the light of scientific progress, the use of animal experiments is still one important approach to ensuring a very high quality of public health research.
Amendment 150 #
Proposal for a directive Article 35 – paragraph 2 2. Granting of authorisation shall be subject to favourable ethical evaluation
Amendment 151 #
Proposal for a directive Article 35 – paragraph 2 2. Granting of authorisation shall be subject to favourable ethical evaluation by the competent authority or, by delegation, by the permanent ethical review body that reviews protocols and procedures.
Amendment 152 #
Proposal for a directive Article 35 – paragraph 2 a (new) 2a. No formal authorisation shall be necessary for projects required by law, but these should be subject to favourable ethical evaluation.
Amendment 153 #
Proposal for a directive Article 35 – paragraph 2 a (new) 2a. No formal authorisation shall be necessary for projects required by law, but these should be subject to favourable ethical evaluation.
Amendment 154 #
Proposal for a directive Article 35 – paragraph 2 a (new) 2a. Ethical evaluation for all projects using non-human primates shall be conducted by a panel of independent experts appointed by the competent authority.
Amendment 155 #
Proposal for a directive Article 35 – paragraph 2 b (new) 2b. Authorisation shall not be granted for any project using non-human primates unless the application has been subject to public consultation.
Amendment 156 #
Proposal for a directive Article 35 – paragraph 2 c (new) 2c. The minimum period between publication of a notice of intention to consult pursuant to paragraph 2b and the deadline for receipt of responses shall not be less than 42 days.
Amendment 157 #
Proposal for a directive Article 36 – paragraph 1 – introductory part 1. The
Amendment 158 #
Proposal for a directive Article 36 – paragraph 1 – introductory part 1.
Amendment 159 #
Proposal for a directive Article 36 – paragraph 1 – point c a (new) (ca) 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.
Amendment 16 #
Proposal for a directive Recital 10 (10) 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 ultimately benefit human or animal health, or the environment. Therefore the use of animals in scientific procedures should only be considered where a non- animal alternative is not available. Use of animals
Amendment 160 #
Proposal for a directive Article 36 – paragraph 2 2. Member States may waive the requirement in paragraph 1(b) and permit the user establishment to submit a reduced project proposal covering only the ethical evaluation and elements listed in Article 41(2), provided that the project involves only procedures classified as "up to
Amendment 161 #
Proposal for a directive Article 37 – paragraph 1 1.
Amendment 162 #
Proposal for a directive Article 37 – paragraph 2 – point d (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
Amendment 163 #
Proposal for a directive Article 37 – paragraph 2 – point d (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 justified by the expected advancement of science that
Amendment 164 #
Proposal for a directive Article 37 – paragraph 2 – point d (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 justified by the expected advancement of science that
Amendment 165 #
Proposal for a directive Article 37 – paragraph 2 – point d (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 justified by the expected advancement of science that could ultimately be benefi
Amendment 166 #
Proposal for a directive Article 37 – paragraph 3 – introductory part 3. The competent authority carrying out the ethical evaluation shall consider corresponding expert
Amendment 167 #
Proposal for a directive Article 37 – paragraph 3 – introductory part 3. The competent authority carrying out the ethical evaluation shall consider corresponding expert
Amendment 168 #
Proposal for a directive Article 37 – paragraph 4 4. Ethical evaluation shall be performed
Amendment 169 #
Proposal for a directive Article 37 – paragraph 4 4. Ethical evaluation shall be performed
Amendment 17 #
Proposal for a directive Recital 10 (10) 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
Amendment 170 #
Proposal for a directive Article 37 – paragraph 4 4. Ethical evaluation shall be performed in a transparent manner, by integrating the opinion of independent parties, and by preserving confidentiality and protecting intellectual property and the safety of goods and persons.
Amendment 171 #
Proposal for a directive Article 37 – paragraph 4 4. Ethical evaluation shall be performed in a transparent manner, by integrating the opinion of independent parties. For intellectual property and security reasons, confidentiality should be ensured.
Amendment 172 #
Proposal for a directive Article 38 Amendment 173 #
Proposal for a directive Article 38 – paragraph 2 2. Retrospective assessment shall evaluate the following: (a) whether the objectives of the project were achieved and how they contribute to achieving the stated potential benefits; (b) the harms inflicted on animals including the numbers and species
Amendment 174 #
Proposal for a directive Article 38 – paragraph 2 – point b (b) harm inflicted on animals including the numbers and species of animals used and the
Amendment 175 #
Proposal for a directive Article 38 – paragraph 4 4. Without prejudice to paragraph 3, all projects involving only procedures classified
Amendment 176 #
Proposal for a directive Article 38 – paragraph 4 4. Without prejudice to paragraph 3, all projects involving only procedures classified as "
Amendment 177 #
Proposal for a directive Article 40 – paragraph 1 1. Subject to safeguarding confidential information, including those of the establishment and its staff, the non- technical project summary shall provide the following: (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
Amendment 178 #
Proposal for a directive Article 40 – paragraph 4 4.
Amendment 179 #
Proposal for a directive Article 41 – paragraph 2 – point d Amendment 18 #
Proposal for a directive Recital 13 (13) 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
Amendment 180 #
Proposal for a directive Article 41 – paragraph 2 – point d Amendment 181 #
Proposal for a directive Article 41 – paragraph 2 – point d Amendment 182 #
Proposal for a directive Article 41 – paragraph 3 3. Project authorisations shall be granted
Amendment 183 #
Proposal for a directive Article 41 – paragraph 4 4. Member States may allow the authorisation of multiple projects under one group authorisation when those projects are required by law.
Amendment 184 #
Proposal for a directive Article 42 – paragraph 1 1. The competent authority may amend or renew the project authorisation on the request of the user establishment or the scientific director of the project.
Amendment 185 #
Proposal for a directive Article 42 – paragraph 1 1. The competent authority may amend or renew the project authorisation on the request of the
Amendment 186 #
Proposal for a directive Article 42 – paragraph 2 2. Any
Amendment 187 #
Proposal for a directive Article 42 – paragraph 3 3. The competent authority may withdraw the project authorisation where the project is not carried out in accordance with the project authorisation and may cause a deterioration in animal welfare.
Amendment 188 #
Proposal for a directive Article 43 – paragraph 1 1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within
Amendment 189 #
Proposal for a directive Article 43 – paragraph 1 1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within
Amendment 19 #
Proposal for a directive Recital 16 (16) 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
Amendment 190 #
Proposal for a directive Article 43 – paragraph 1 1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 30 days from the submission of the application. Should the Member State fail to take a decision within that period, the authorisation shall be deemed to have been granted
Amendment 191 #
Proposal for a directive Article 43 – paragraph 1 1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 30 days from the submission of the application or the end of the consultation period specified in Article 35(2c), whichever is the later date. Should the Member State fail to take a decision within that period, the
Amendment 192 #
Proposal for a directive Article 43 – paragraph 2 Amendment 193 #
Proposal for a directive Article 43 – paragraph 2 Amendment 194 #
Proposal for a directive Article 43 a (new) Article 43a Public register The competent authority shall publish a register of all applications for project authorisation which shall include the following: (a) details of the applications for project authorisation; (b) details of any public consultation conducted; (c) the ethical evaluation; (d) the retrospective assessment, if conducted; (e) details of the project authorisation; and (f) details of any amendment, renewal and withdrawal of a project authorisation.
Amendment 195 #
Proposal for a directive Article 45 The Commission and Member States shall contribute
Amendment 196 #
Proposal for a directive Article 45 The Commission and Member States shall contribute
Amendment 197 #
Proposal for a directive Article 45 The Commission and Member States shall contribute by various means, particularly financial, to the development and scientific validation of alternative approaches that could provide the same or higher level of information as that obtained in procedures using animals but that do not involve the use of animals or use fewer animals or that entail less painful procedures and shall take such other steps as they consider appropriate to encourage research in this field.
Amendment 198 #
Proposal for a directive Article 45 a (new) Article 45a The Commission shall, by [one year after entry into force of this Directive], review and strengthen the role of the European Centre for the Validation of Alternative Methods to facilitate the development and use of alternatives to animal procedures. The European Centre for the Validation of Alternative Methods shall coordinate with the national reference laboratories referred to in Article 46 in order to: (a) develop a strategy on the implementation of the 3Rs approach (replacing, reducing and refining); (b) identify the need for research into alternative procedures; (c) provide advice and guidance and information on the 3Rs to competent authorities, the scientific community, the public and relevant stakeholders; (d) coordinate pre-validation and validation studies; (e) identify new alternative methods suitable for validation and specific requirements for their validation, in consultation with relevant national and international regulatory bodies; (f) facilitate the scientific endorsement and regulatory acceptance of alternatives to animal tests used for regulatory purposes.
Amendment 199 #
Proposal for a directive Article 45 a (new) Amendment 20 #
Proposal for a directive Recital 16 (16) 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
Amendment 200 #
Proposal for a directive Article 46 – paragraph 1 1. Each Member State shall, by [one year after entry into force of this Directive],
Amendment 201 #
Proposal for a directive Article 49 – paragraph 2 2. Member States shall collect
Amendment 202 #
Proposal for a directive Article 50 Amendment 203 #
Proposal for a directive Article 53 53. The Commission shall review this Directive by [
Amendment 204 #
Proposal for a directive Article 53 The Commission shall review this Directive by [
Amendment 205 #
Proposal for a directive Article 53 – paragraph 1 a (new) The Commission shall, in consultation with Member States, conduct a thematic review of the use of animals in procedures. The review shall be conducted every two years commencing two years after the entry into force of this Directive. The review shall consider the impact of developments in technological, scientific and animal welfare knowledge and set targets for the implementation of validated replacement methods.
Amendment 206 #
Proposal for a directive Article 53 a (new) Article 53a Regular review of the use of animals in procedures The Commission shall, in consultation with Member States, conduct a thematic review of the use of animals in procedures. The review shall be conducted every two years commencing two years after the entry into force of this Directive. The review shall consider the impact of developments in technological, scientific and animal welfare knowledge and set targets for the implementation of validated replacement methods.
Amendment 207 #
Proposal for a directive Article 54 – paragraph 1 - subparagraph 2 Member States
Amendment 208 #
Proposal for a directive Annex I • C
Amendment 209 #
Proposal for a directive Annex I • C
Amendment 21 #
Proposal for a directive Recital 16 (16) 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-
Amendment 212 #
Proposal for a directive Annex III – table – column 2 – line 2 to 4 [
Amendment 213 #
Proposal for a directive Annex III – table – column 2 – line 2 to 4 [
Amendment 214 #
Proposal for a directive Annex IV – introductory part Care and accommodation standards referred to in Article 32 The care and accommodation conditions should be tailored to the scientific objective.
Amendment 215 #
Proposal for a directive Annex IV – point 1 – introductory part 1. THE PHYSICAL FACILITIES The accommodation conditions should be tailored to the scientific objective.
Amendment 216 #
Proposal for a directive Annex IV – point 3 – introductory part 3. CARE The care should be tailored to the scientific objective.
Amendment 217 #
Proposal for a directive Annex IV – point 3 – point 3.5 – point a (a)
Amendment 218 #
Proposal for a directive Annex IV – point 3 – point 3.5 – point a (a)
Amendment 22 #
Proposal for a directive Recital 16 (16) 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 and only in cases where the procedures are carried out in relation to clinical conditions having a substantial impact on patients’ day-today functioning as being either life-threatening or debilitating, or for the preservation of the respective non-human primate species
Amendment 222 #
Proposal for a directive Annex VII a (new) Amendment 23 #
Proposal for a directive Recital 18 (18) The capture of non-human primates from the wild is highly stressful for the animals and increases the risk of injury and suffering during capture and transport.
Amendment 24 #
Proposal for a directive Recital 18 (18)
Amendment 25 #
Proposal for a directive Recital 21 (21) 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 level of pain, suffering, distress and lasting harm that is inflicted on the animals. To give greater precision as to how severity classes should be assigned, the Commission should develop
Amendment 26 #
Proposal for a directive Recital 22 (22) From the ethical standpoint, there should be an upper limit of pain, suffering and distress, above which animals should never 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 be
Amendment 27 #
Proposal for a directive Recital 23 (23) 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 only to those procedures where pain, distress and suffering
Amendment 28 #
Proposal for a directive Recital 23 a (new) (23a) In that it would reduce the number of animals required for experiments and greatly assist research, the extended re- use of animals should be permitted where a tracking, recording or transmitting device has been introduced by means of a surgical intervention under anaesthetic and where such intervention involves pain not exceeding the "low moderate" gradation.
Amendment 29 #
Proposal for a directive Recital 26 (26) The welfare of the animals used in procedures is highly dependent on the quality and professional competence of the personnel 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 the persons dealing with animals and with procedures involving animals, those activities should only be performed in establishments and by persons authorised by the competent authorities. The main focus should be on
Amendment 30 #
Proposal for a directive Recital 27 (27) 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.
Amendment 31 #
Proposal for a directive Recital 40 (40) To ensure that the public is informed, it is important that objective information on the projects using live animals is
Amendment 32 #
Proposal for a directive Recital 40 (40) 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 that information should not violate proprietary rights or expose confidential information. Therefore, with due consideration for security risks, user establishments should provide authorised access to anonymous non-technical summaries of those projects, including the results of any retrospective assessments
Amendment 33 #
Proposal for a directive Recital 41 (41) 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
Amendment 34 #
Proposal for a directive Recital 45 (45) 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 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 coordination and promotion of the development and use of alternatives to animal experiments.
Amendment 35 #
Proposal for a directive Recital 47 (47) 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 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.
Amendment 36 #
Proposal for a directive Recital 47 (47) 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 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.
Amendment 37 #
Proposal for a directive Recital 47 (47) 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 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.
Amendment 38 #
Proposal for a directive Article 2 – paragraph 2 2. This Directive shall apply to
Amendment 39 #
Proposal for a directive Article 2 – paragraph 2 2. This Directive shall apply to
Amendment 40 #
Proposal for a directive Article 2 – paragraph 2 2. This Directive shall apply to
Amendment 41 #
Proposal for a directive Article 2 – paragraph 2 – point a (a) live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms
Amendment 42 #
Proposal for a directive Article 2 – paragraph 2 – point b a (new) (ba) animals covered by point (a) or (b) which have been genetically manipulated, cloned or are the offspring of, the subsequent generation of or are from the line of an animal covered by point (a) or (b) which has been genetically manipulated or cloned.
Amendment 43 #
Proposal for a directive Article 2 – paragraph 3 Amendment 44 #
Proposal for a directive Article 2 – paragraph 3 3. This Directive shall apply to animals used in procedures, which are at an earlier stage of development than that referred to in point (a) of paragraph 2
Amendment 45 #
Proposal for a directive Article 3 – paragraph 6 a (new) 6a. 'competent authority' means the authority or authorities designated by each Member State as being responsible for supervising the enforcement of this Directive.
Amendment 46 #
Proposal for a directive Article 4 – paragraph 1 1. Where a method
Amendment 47 #
Proposal for a directive Article 4 – paragraph 1 1. Where a method of testing not involving the use of animals exists, provides equally relevant information and may be used in place of a procedure, Member States shall ensure that the alternative method is used.
Amendment 48 #
Proposal for a directive Article 4 – paragraph 3 a (new) 3a. Member States shall provide funding for training, research, development and implementation of replacement methods.
Amendment 49 #
Proposal for a directive Article 5 – point 2 – point b a (new) (ba) the improvement of the production conditions and welfare of animals reared for agricultural purposes.
Amendment 50 #
Proposal for a directive Article 5 – point 2 – point b a (new) (ba) the improvement of the production conditions and welfare of animals reared for agricultural purposes.
Amendment 51 #
Proposal for a directive Article 5 – point 2 – point b a (new) (ba) the improvement of the production conditions and welfare of animals reared for agricultural purposes.
Amendment 52 #
Proposal for a directive Article 5 – point 3 (3) the development, manufacture or testing of the quality, effectiveness and safety of
Amendment 53 #
Proposal for a directive Article 5 – point 3 a (new) (3a) the development, manufacture or testing of the quality, effectiveness and safety of substances or products, other than those referred to in point (3) having either of the aims referred to in point (2);
Amendment 54 #
Proposal for a directive Article 6 – title Amendment 55 #
Proposal for a directive Article 6 – title Amendment 56 #
Proposal for a directive Article 6 – title Amendment 57 #
Proposal for a directive Article 6 – paragraph 2 2. Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification that the purpose of the procedure cannot be achieved by the use of a humane method of killing. Notwithstanding any exemption, animals shall be killed with a minimum of pain, suffering and distress.
Amendment 58 #
Proposal for a directive Article 6 – paragraph 2 2. Competent authorities may grant
Amendment 59 #
Proposal for a directive Article 6 a (new) Article 6a 1. Procedures for the purpose of basic research may be carried out only if the following criteria are met: (a) the suffering experienced by the animal does not exceed the moderate level; (b) there is compelling justification that there is a realistic prospect that the results of the research will contribute to achieving the aims referred to in point (2) of Article 5.
Amendment 60 #
Proposal for a directive Article 6 a (new) Article 6a National measures This directive shall not prevent Member States from applying or adopting stricter national measures seeking to improve the well-being and protection of animals used for scientific purposes.
Amendment 61 #
Proposal for a directive Article 6 a (new) Article 6a Adoption of stricter measures This Directive shall not prevent Member States from applying or adopting stricter national measures aimed at improving the welfare and protection of animals used in experiments.
Amendment 62 #
Proposal for a directive Article 6 b (new) Article 6b This Directive shall not prevent Member States from applying or adopting stricter national measures aimed at improving the welfare and protection of animals used in experiments.
Amendment 63 #
Proposal for a directive Article 8 – paragraph 1 – introductory part 1.
Amendment 64 #
Proposal for a directive Article 8 – paragraph 1 – introductory part 1. Non-human primates and other animal species with an equally high level of neurophysiological sensitivity and cognitive ability to suffer shall not be used in procedures, with the exception of those procedures meeting the following conditions:
Amendment 65 #
Proposal for a directive Article 8 – paragraph 1 – point a (a) (a) the procedure has one of the purposes referred to in points (1), (2)(a), (3)
Amendment 66 #
Proposal for a directive Article 8 – paragraph 1 – point a (a) (a) the procedure has one of the purposes referred to in points (1), (2)(a), (3)
Amendment 67 #
Proposal for a directive Article 8 – paragraph 1 – point a (a) the procedure has one of the purposes referred to in points (1), (2)(a)
Amendment 68 #
Proposal for a directive Article 8 – paragraph 1 – point a (a) the procedure has one of the purposes referred to in points (1), (2)(a)
Amendment 69 #
Proposal for a directive Article 8 – paragraph 1 – point a (a) the procedure has one of the purposes referred to in points (1), (2)(a), (3) and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of life- threatening or debilitating clinical conditions in human beings or the purpose referred to in point (5) of Article 5, or is justified by the expected advancement of science that ultimately benefits human beings;
Amendment 70 #
Proposal for a directive Article 8 – paragraph 1 – point b (b) there is a scientific justification by the applicant to the competent national authority that the purpose of the procedure cannot be achieved by the use of other species than non-human primates.
Amendment 71 #
Proposal for a directive Article 8 – paragraph 1 – point b (b) there is a scientific justification by the applicant to the competent national authority or ethical review body that the purpose of the procedure cannot be achieved by the use of other species than non-human primates.
Amendment 72 #
Proposal for a directive Article 8 – paragraph 1 – point b a (new) (ba) the procedure is necessary for significant fundamental research justified by its potential for improved human health and quality of the human condition.
Amendment 73 #
Proposal for a directive Article 8 – paragraph 2 2. Notwithstanding paragraph 1, g
Amendment 74 #
Proposal for a directive Article 8 – paragraph 2 2. Notwithstanding paragraph 1,
Amendment 75 #
Proposal for a directive Article 8 – paragraph 2 2
Amendment 76 #
Proposal for a directive Article 8 – paragraph 2 2. Notwithstanding paragraph 1, great apes shall not be used in procedures
Amendment 77 #
Proposal for a directive Article 8 – paragraph 2 a (new) 2a. The Commission shall, in consultation with Member States, conduct a review of the use of non-human primates in procedures. The review shall be conducted every two years, commencing two years after the entry into force of this Directive. The review shall consider the impact of developments in technological, scientific and animal welfare knowledge and set targets for the implementation of validated replacement methods.
Amendment 78 #
Proposal for a directive Article 8 – paragraph 2 a (new) 2a. The Commission shall, in consultation with Member States, conduct a review of the use of non-human primates in procedures. The review shall be conducted every two years, commencing two years after the entry into force of this Directive. The review shall consider the impact of developments in technological, scientific and animal welfare knowledge and set targets for the implementation of validated replacement methods.
Amendment 79 #
Proposal for a directive Article 8 – paragraph 2 a (new) 2a. The Commission shall develop a strategy to establish a high-level group to review annually the use of non-human primates in procedures.
Amendment 80 #
Proposal for a directive Article 8 – paragraph 2 b (new) 2b. The Commission shall develop a strategy to establish a high level group to review annually the regulatory use of non-human primates with a view to ending this practice within five years of the date specified in Article 59.
Amendment 81 #
Proposal for a directive Article 9 – paragraph 2 Amendment 82 #
Proposal for a directive Article 9 – paragraph 2 2. Competent authorities may grant exemptions from paragraph 1 on the basis of
Amendment 83 #
Proposal for a directive Article 10 1.
Amendment 84 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 Amendment 85 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 Amendment 86 #
Proposal for a directive Article 10 – paragraph 2 Amendment 87 #
Proposal for a directive Article 10 – paragraph 2 a (new) Amendment 88 #
Proposal for a directive Article 13 – paragraph 1 1. Member States shall ensure that a procedure is not carried out if another scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an animal,
Amendment 89 #
Proposal for a directive Article 13 – paragraph 1 1. Member States shall ensure that a procedure is not carried out if another scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an animal, is recognised by Community legislation and internationally accepted. In the absence of such a method, a procedure may not be carried out if a scientifically satisfactory method or testing strategy for obtaining the result sought, including computer supported, in vitro and other methodologies, not entailing the use of an animal, is reasonably and practica
Amendment 90 #
Proposal for a directive Article 13 – paragraph 3 3. Death as the end-point in a procedure shall be
Amendment 91 #
Proposal for a directive Article 14 – paragraph 1 Amendment 92 #
Proposal for a directive Article 14 – paragraph 1 Amendment 93 #
Proposal for a directive Article 14 – paragraph 2 – introductory part 2.
Amendment 94 #
Proposal for a directive Article 14 – paragraph 2 – introductory part 2.
Amendment 95 #
Proposal for a directive Article 15 – paragraph 1 1. Member States shall ensure that all procedures are classified as 'up to mild', 'moderate'
Amendment 96 #
Proposal for a directive Article 15 – paragraph 1 1. Member States shall ensure that all procedures are classified as 'up to mild', 'low moderate', 'high moderate', 'severe' or 'non-recovery' on the basis of the duration and intensity of potential pain, suffering, distress and lasting harm, the frequency of intervention, the deprivation of ethological needs and the use of anaesthesia or analgesia or both.
Amendment 97 #
Proposal for a directive Article 15 – paragraph 2 2. Member States shall ensure that the procedures classified as "severe" are
Amendment 98 #
Proposal for a directive Article 15 – paragraph 2 Amendment 99 #
Proposal for a directive Article 15 – paragraph 2 2. Member States shall ensure that the procedures classified as "severe" are
source: PE-420.122
2009/03/16
AGRI
264 amendments...
Amendment 134 #
Proposal for a directive Recital 3 (3) On 24 November 1986 the Council adopted Directive 86/609/EEC in order to
Amendment 135 #
Proposal for a directive Recital 6 (6) It
Amendment 136 #
Proposal for a directive Recital 6 (6) It
Amendment 137 #
Proposal for a directive Recital 7 (7) This Directive should
Amendment 138 #
Proposal for a directive Recital 7 (7) This Directive should also cover embryonic and foetal forms of vertebrate animals,
Amendment 139 #
Proposal for a directive Recital 7 (7) This Directive should also cover embryonic and foetal forms of vertebrate animals,
Amendment 140 #
Proposal for a directive Recital 8 (8)
Amendment 141 #
Proposal for a directive Recital 13 (13) 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
Amendment 142 #
Proposal for a directive Recital 13 (13) 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
Amendment 143 #
Proposal for a directive Recital 16 (16) 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
Amendment 144 #
Proposal for a directive Recital 16 (16) 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
Amendment 145 #
Proposal for a directive Recital 16 (16) 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.
Amendment 146 #
Proposal for a directive Recital 18 (18) The capture of non-human primates from the wild is highly stressful for the animals and increases the risk of injury and
Amendment 147 #
Proposal for a directive Recital 18 (18) The capture of non-human primates from the wild is highly stressful for the animals and increases the risk of injury and suffering during capture and transport. In order to gradually end the capturing of animals from the wild for breeding purposes, only animals that are the
Amendment 148 #
Proposal for a directive Recital 18 (18) The capture of non-human primates from the wild is highly stressful for the animals and increases the risk of injury and suffering during capture and transport. In order to gradually end the capturing of animals from the wild for breeding purposes, only animals that are the offspring of an animal which has been bred in captivity should be made available for use in scientific procedures as soon as possible. Establishments breeding and supplying non-human primates in the European Union should therefore have a strategy in place to support and facilitate the progressive
Amendment 149 #
Proposal for a directive Recital 22 (22) From the ethical standpoint, there should be an upper limit of pain, suffering and distress, above which animals should never 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 be
Amendment 150 #
Proposal for a directive Recital 24 (24) At the end of the procedure, the most appropriate decision should be taken as regards 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,
Amendment 151 #
Proposal for a directive Recital 25 (25) Animal tissue and organs are used for the development of in vitro methods. To
Amendment 152 #
Proposal for a directive Recital 29 (29) Animal welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Each head of an establishment should therefore
Amendment 153 #
Proposal for a directive Recital 35 (35) To monitor compliance with this Directive, Member States should carry out a
Amendment 154 #
Proposal for a directive Recital 38 (38) It is also essential to ensure both on moral and scientific grounds that each use of animals is carefully evaluated on the scientific validity, usefulness and relevance of the expected result of that use. The likely harm to the animals should be
Amendment 155 #
Proposal for a directive Recital 40 (40) To ensure that the public is informed, it is important that objective information on the projects using live animals is
Amendment 156 #
Proposal for a directive Recital 40 (40) 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 that information should not violate proprietary rights or expose confidential information. Therefore, user establishments should provide
Amendment 157 #
Proposal for a directive Recital 40 (40) 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 that information should not violate proprietary rights or expose confidential information. Therefore, user establishments should provide anonymous non-technical summaries of those projects
Amendment 158 #
Proposal for a directive Recital 46 (46) 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
Amendment 159 #
Proposal for a directive Recital 47 (47) 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 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.
Amendment 160 #
Proposal for a directive Recital 47 (47) 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 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
Amendment 161 #
Proposal for a directive Recital 52 Amendment 162 #
Proposal for a directive Article 2 – paragraph 1 – subparagraph 1 1. This Directive shall apply
Amendment 163 #
Proposal for a directive Article 2 – paragraph 2 – point a (a) live non-human vertebrate animals
Amendment 164 #
Proposal for a directive Article 2 – Paragraph 2 – point a (a) live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms
Amendment 165 #
Proposal for a directive Article 2 – paragraph 2 – point a (a) live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms as from the last third of their normal development except for hens' eggs used for vaccine production and quality control;
Amendment 166 #
Proposal for a directive Article 2 – paragraph 2 – point a (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
Amendment 167 #
Proposal for a directive Article 2 – paragraph 2 – point a (a) live non-human vertebrate animals, including
Amendment 168 #
Proposal for a directive Article 2 – paragraph 2 – point b Amendment 169 #
Proposal for a directive Article 2 – paragraph 2 – point b (b) live invertebrate animals
Amendment 170 #
Proposal for a directive Article 2 – paragraph 3 3. This Directive shall apply to animals used in procedures, which are at an earlier stage of development than that referred to in point (a) of paragraph 2
Amendment 171 #
Proposal for a directive Article 2 – paragraph 4 – point d (d) practices that
Amendment 172 #
Proposal for a directive Article 3 – paragraph 1 (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
Amendment 173 #
Proposal for a directive Article 3 – point 6 a (new) (6a) '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;
Amendment 174 #
Proposal for a directive Article 3 – paragraph 6 b (new) (6b) 'ethical evaluation body' means a committee with the scientific, technical and civil competences required to deliver an enlightened ethical opinion on a project;
Amendment 175 #
Proposal for a directive Article 4 – paragraph 1 1. Where an internationally accepted and validated method of testing not involving the use of animals exists and may be used in
Amendment 176 #
Proposal for a directive Article 4 – paragraph 1 1. Where a method of testing not involving the use of animals exists and may be used in place of a procedure, Member States shall ensure that the alternative method is used.
Amendment 177 #
Proposal for a directive Article 4 – paragraph 1 1. Where a method of testing, experimentation or other scientific activity not involving the use of living animals exists
Amendment 178 #
Proposal for a directive Article 4 – paragraph 1 1. Where a method of testing not involving the use of animals exists and may be used in place of a procedure, Member States shall ensure that the alternative method is used, provided that the alternative method is not prohibited in the Member State concerned.
Amendment 179 #
Proposal for a directive Article 4 – paragraph 3 a (new) 3a. Member States shall ensure that funding is provided for training on, research on, development of and implementation of scientifically satisfactory methods or testing strategies that do not entail the use of animals
Amendment 180 #
Proposal for a directive Article 4 – paragraph 3 a (new) 3a. Member States shall provide funding for training, research, development and implementation of replacement methods.
Amendment 181 #
Proposal for a directive Article 4 – paragraph 3 b (new) 3b. Member States shall ensure that the aim of paragraph 1 is pursued by the competent authority when considering the authorisation of projects.
Amendment 182 #
Proposal for a directive Article 4 – paragraph 3 c (new) 3c. Member States shall provide training on the use of scientifically satisfactory methods or testing strategies that do not entail the use of animals, to appropriate persons and establishments, and promote such methods or testing strategies.
Amendment 183 #
Proposal for a directive Article 5 – paragraph 2 – point a (a) the avoidance, prevention, diagnosis or treatment (including the development of medical devices) of disease, ill-health or other abnormality or their effects in human
Amendment 184 #
Proposal for a directive Article 5 – paragraph 2 – point b a (new) (ba) the improvement of the production conditions and welfare of animals reared for agricultural purposes.
Amendment 185 #
Proposal for a directive Article 5 – paragraph 3 (3) the development, manufacture or testing of the quality, effectiveness and safety of
Amendment 186 #
Proposal for a directive Article 5 – paragraph 3 a (new) (3a) the development, manufacture or testing of the quality, effectiveness and safety of substances or products, other than those referred to in point (3), having either of the aims referred to in point (2);
Amendment 187 #
Proposal for a directive Article 5 – paragraph 4 a (new) 4a. the protection of human health in the context of workers' or consumers' exposure to chemicals;
Amendment 188 #
Proposal for a directive Article 5 – point 6 Amendment 189 #
Proposal for a directive Article 6 – title Amendment 190 #
Proposal for a directive Article 6 – title Amendment 191 #
Proposal for a directive Article 6 – title Amendment 192 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 1. Member States shall ensure that animals are killed in an authorised establishment, by an authorised person and with a minimum of pain, suffering and distress
Amendment 193 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 1. Member States shall ensure that animals are killed in an authorised establishment, by an authorised person and with a minimum of pain, suffering and distress and, in relation to the species included in Annex V, using the appropriate
Amendment 194 #
Proposal for a directive Article 6 – paragraph 2 2. Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification that the purpose of the procedure cannot be achieved by the use of a
Amendment 195 #
Proposal for a directive Article 6 a (new) Article 6a National measures This Directive shall be a reference framework for the Member States in the field of the protection of animals used for scientific purposes. However, the adoption or application of additional national measures aimed at improving animal welfare may be envisaged.
Amendment 196 #
Proposal for a directive Article 7 – introductory phrase 1. Endangered species listed in Annex A to Council Regulation (EC) No 338/9731 shall not be used in procedures
Amendment 197 #
Proposal for a directive Article 7 – paragraph 1 – point a Amendment 198 #
Proposal for a directive Article 7 – paragraph 1 – point a (a) the procedure has one of the purposes referred to in points (
Amendment 199 #
Proposal for a directive Article 7 – paragraph 1 – point a a (new) (aa) as far as possible, the animals used should be bred specifically for testing purposes;
Amendment 200 #
Proposal for a directive Article 7 – paragraph 1 – point b Amendment 201 #
Proposal for a directive Article 7 – paragraph 2 Amendment 202 #
Proposal for a directive Article 8 – paragraph 1 – introductory phrase 1. Non-human primates and other animal species with an equally high level of neurophysiological sensitivity and cognitive ability to suffer shall not be used in procedures, with the exception of those procedures meeting the following conditions:
Amendment 203 #
Proposal for a directive Article 8 – paragraph 1 – introductory phrase 1.
Amendment 204 #
Proposal for a directive Article 8 – paragraph 1 – point a (a) the procedure has one of the purposes referred to in points (1), (2)(a), (3)
Amendment 205 #
Proposal for a directive Article 8 – paragraph 1 – point a (a) the procedure has one of the purposes referred to in points (1), (2)(a), (3)
Amendment 206 #
Proposal for a directive Article 8 – paragraph 1 – point a (a) the procedure has one of the purposes referred to in points (1), (2)(a), (3) and
Amendment 207 #
Proposal for a directive Article 8 – paragraph 1 – point a (a) the procedure has one of the purposes referred to in points (1), (2)(a), (3) and
Amendment 208 #
Proposal for a directive Article 8 – paragraph 1 – point b (b) the
Amendment 209 #
Proposal for a directive Article 8 – paragraph 2 2. Notwithstanding paragraph 1, g
Amendment 210 #
Proposal for a directive Article 8 – paragraph 2 2. Notwithstanding paragraph 1, great apes shall not be used in procedures
Amendment 211 #
Proposal for a directive Article 8 – paragraph 2 a (new) 2a. Every two years, and for the first time two years after the entry into force of this Directive, the Commission shall, in consultation with Member States, conduct a review of the use of non-human primates in procedures and publish the results thereof. The review shall examine the impact of developments in technological, scientific and animal- welfare knowledge, and set targets for the implementation of validated replacement methods.
Amendment 212 #
Proposal for a directive Article 8 – paragraph 2 a (new) 2a. The Commission shall, within 12 months after the entry into force of this Directive, set up a high-level Committee, which shall include representatives of all stakeholders, to review the use of non- human primates and define replacement strategies. The Committee shall issue recommendations and report annually to the European Parliament and the Council on its activities.
Amendment 213 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 1.
Amendment 214 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 1. Member States shall ensure that only those animals belonging to the species listed in Annex II may
Amendment 215 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 1. Member States shall ensure that animals belonging to the species listed in Annex II may only be used in procedures where those animals have been bred for use in procedures or for agronomic purposes.
Amendment 216 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 Amendment 217 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 Amendment 218 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 Amendment 219 #
Proposal for a directive Article 10 – paragraph 2 2. Competent authorities may grant exemptions from paragraph 1 on the basis of a veterinary justification for reasons of animal welfare or of a scientific justification.
Amendment 220 #
Proposal for a directive Article 10 – paragraph 2 2. Competent authorities may grant exemptions from paragraph 1 on the basis of a scientific justification or reasons linked to animal welfare.
Amendment 221 #
Proposal for a directive Article 10 – paragraph 2 a (new) 2a. The Commission shall assess the welfare of the animals and the appropriateness of implementing the measures called for in paragraph 1 five years from the entry into force of this directive.
Amendment 222 #
Proposal for a directive Article 11 1. Stray and feral animals of domestic species shall not be used in procedures. 2. Animals shall not be used for school- teaching, higher-education and training purposes in general. 3. Animals shall not be used in procedures for testing arms and warfare systems. 4. Animals shall not be used for toxicological tests such as LD50 and LC50. 5. Animals shall not be used for producing monoclonal antibodies through the induction of ascites save where this is obligatory according to legislation or national or international pharmacopoeias.
Amendment 223 #
Proposal for a directive Article 11 a (new) Article 11a Training For higher education and training purposes, the cadavers, tissue and organs of animals may be used only if they come from animals slaughtered in accordance with the provisions of Council Regulation (EC) No .../2009 [on the protection of animals at the time of killing]1. 1 OJ L .... [COM(2008)0553].
Amendment 224 #
Proposal for a directive Article 11 a (new) Amendment 225 #
Proposal for a directive Article 12 – paragraph 1 – subparagraph 2 Amendment 226 #
Proposal for a directive Article 13 – paragraph 1 1. Member States shall ensure that a procedure is not carried out if another scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an animal, is recognised by Community legislation.
Amendment 227 #
Proposal for a directive Article 13 – paragraph 1 1. Member States shall ensure that a procedure is not carried out if another scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an animal, is
Amendment 228 #
Proposal for a directive Article 13 – paragraph 1 1. Member States shall ensure that a procedure is not carried out if another scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an animal, is recognised by Community legislation. In the absence of such a method, a procedure may not be carried out if a scientifically satisfactory method or testing strategy for obtaining the result sought, including computer supported, in vitro and other methodologies, not entailing the use of an animal, is reasonably and practicably available.
Amendment 229 #
Proposal for a directive Article 13 – paragraph 1 1. Member States shall ensure, as their first priority, that a procedure is not carried out if another scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an animal, is recognised by Community l
Amendment 230 #
Proposal for a directive Article 13 – paragraph 1 1. Member States shall ensure that a procedure is not carried out if another internationally recognised and scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of a
Amendment 231 #
Proposal for a directive Article 13 – paragraph 3 3. Death as the end-point in a procedure shall be avoided as far as possible and replaced by early and humane end-points. If death as the end-point is unavoidable, it shall be achieved using the least painful method possible and the procedure shall be designed so as to result in the deaths of as few animals as possible.
Amendment 232 #
Proposal for a directive Article 13 – paragraph 3 a (new) 3a. The activities referred to in paragraphs 1 and 2 are screened by the national laboratories referred to in Article 46.
Amendment 233 #
Proposal for a directive Article 14 – paragraph 1 1. Member States shall ensure that, where appropriate, all procedures are carried out under general or local anaesthesia or using other methods that may alleviate pain or minimise suffering.
Amendment 234 #
Proposal for a directive Article 14 – paragraph 2 – point b (b) where anaesthesia is incompatible with the purpose of the procedure
Amendment 235 #
Proposal for a directive Article 14 – paragraph 3 Amendment 236 #
Proposal for a directive Article 14 – paragraph 3 3. If the procedure is carried out without anaesthesia, analgesics or other appropriate methods shall be used where this would be beneficial to the animal to ensure that
Amendment 237 #
Proposal for a directive Article 14 – paragraph 5 5. An animal
Amendment 238 #
Proposal for a directive Article 14 – paragraph 5 5. An animal
Amendment 239 #
Proposal for a directive Article 15 – paragraph 1 1. Member States shall ensure that all procedures are classified in accordance with definitions established by the Commission with the involvement of stakeholders, including animal-welfare experts. The classification system should, at the minimum, define all procedures as 'up to mild', 'moderate', 'severe' or 'non- recovery' or may create a greater number of categories on the basis of the duration and intensity of potential pain, suffering, distress and lasting harm, the frequency of intervention, the deprivation of ethological needs and the use of anaesthesia or analgesia or both.
Amendment 240 #
Proposal for a directive Article 15 – paragraph 2 2. Member States shall ensure that the procedures which are classified as "severe" a
Amendment 241 #
Proposal for a directive Article 15 – paragraph 2 2. Member States shall ensure that the procedures classified as "severe" are
Amendment 242 #
Proposal for a directive Article 15 – paragraph 2 2. Member States shall ensure that the procedures classified as "severe" are not performed if the pain, suffering or distress is likely to be prolonged
Amendment 243 #
Proposal for a directive Article 15 – paragraph 2 2. Member States shall ensure that the procedures classified as "severe" are not performed if the pain, suffering or distress is likely to be prolonged unless there are any factors justifying the use of such procedures.
Amendment 244 #
Proposal for a directive Article 15 – paragraph 4 – subparagraph 1 4. The Commission shall establish the criteria for classification of procedures, and review every five years the definition of each classification and the number of classifications following consultation with stakeholders. New updated definitions shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 51(3).
Amendment 245 #
Proposal for a directive Article 15 – paragraph 4 – subparagraph 1 4. The Commission shall
Amendment 246 #
Proposal for a directive Article 15 – paragraph 4 – subparagraph 1 4. The Commission shall establish the criteria for classification of procedures, on the basis of international classifications and in line with best practices developed within the European Union.
Amendment 247 #
Proposal for a directive Article 15 – paragraph 4 – subparagraph 1 4. The Commission shall establish the criteria for classification of procedures in line with good practice developed in the EU.
Amendment 248 #
Proposal for a directive Article 16 – paragraph 1 – introductory phrase 1. Member States shall ensure that an animal already used in a procedure, when a different animal on which no procedures ha
Amendment 249 #
Proposal for a directive Article 16 – paragraph 1 – introductory phrase 1. Member States shall ensure that an animal already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used, may be re-used in a new procedure totally different from the previous procedure from a scientific point of view only when all of the following conditions are met:
Amendment 250 #
Proposal for a directive Article 16 – paragraph 1 – introductory phrase 1. Member States shall ensure that an animal already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used, may be subsequently re-used in a new unrelated procedure only when all of the following conditions are met:
Amendment 251 #
Proposal for a directive Article 16 – paragraph 1 – introductory phrase 1. Member States shall ensure that an animal already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used, may be subsequently re-used in a new unrelated procedure only when all of the following conditions are met:
Amendment 252 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 253 #
Proposal for a directive Article 16 – paragraph 1 – point a (a) the previous procedure was classified as '
Amendment 254 #
Proposal for a directive Article 16 – paragraph 1 – point a (a) the previous procedure was classified as 'up to m
Amendment 255 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 256 #
Proposal for a directive Article 16 – paragraph 1 – point b a (new) (ba) the distress suffered by the animal in the course of a new procedure is less than the distress suffered in the course of the previous procedure or less than the distress which would be suffered by a new animal;
Amendment 257 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 258 #
Proposal for a directive Article 16 – paragraph 1 – point c (c) the further procedure is classified as '
Amendment 259 #
Proposal for a directive Article 16 – paragraph 1 – point c (c) the further procedure is classified as 'up to m
Amendment 260 #
Proposal for a directive Article 16 – paragraph 1 – point c a (new) (ca) a prior veterinary inspection is made before the possible re-use.
Amendment 261 #
Proposal for a directive Article 16 – paragraph 1 – point c a (new) (ca) the repeated use of animals shall be accompanied by veterinary checks.
Amendment 262 #
Proposal for a directive Article 16 – paragraph 2 Amendment 263 #
Proposal for a directive Article 16 – paragraph 2 2. By way of derogation from paragraph 1, the competent authority, on the basis of scientific justification, may allow re-use of an animal
Amendment 264 #
Proposal for a directive Article 17 – paragraph 1 1. A procedure shall be deemed to end when no further observations are to be made for that procedure or, as regards new genetically modified animal lines, when
Amendment 265 #
Proposal for a directive Article 18 Member States shall encourage the establishment of programmes for the sharing of organs and tissues of animals killed by a humane method.
Amendment 266 #
Proposal for a directive Article 18 Member States shall encourage the establishment of programmes for the sharing of organs and tissues of animals killed by a humane method.
Amendment 267 #
Proposal for a directive Article 19 – introductory phrase Member States may allow animals used or intended to be used in procedures to be set free to their original habitat, returned to a husbandry system appropriate to the species, or re–homed provided that the following conditions are met:
Amendment 268 #
Proposal for a directive Article 20 – paragraph 1 – introductory part 1. Member States shall ensure that persons are authorised by the competent authority or the delegated authority before they carry out any of the following functions:
Amendment 269 #
Proposal for a directive Article 20 – paragraph 1 – introductory part 1. Member States shall ensure that persons are authorised by the competent authority or the delegated authority before they carry out any of the following functions:
Amendment 270 #
Proposal for a directive Article 20 – paragraph 2 – subparagraph 1 2. Member States shall ensure that, for the purposes of the authorisation, the persons referred to in paragraph 1 have the appropriate veterinary or scientific education and training and have
Amendment 271 #
Proposal for a directive Article 20 – paragraph 3 Amendment 272 #
Proposal for a directive Article 20 – paragraph 3 3. All authorisations of persons shall be granted for a limited period of time, not exceeding five years. Member States shall ensure that the renewal of an authorisation of persons is only granted on the basis of demonstration of the requisite competence. Member States shall guarantee the mutual recognition of this competence and of the authorisation.
Amendment 273 #
Proposal for a directive Article 22 – paragraph 1 1. Where an establishment no longer complies with requirements set out in this Directive, the competent authority shall have the power to suspend or withdraw its authorisation, or take appropriate remedial action or require such action to be taken. There shall be appropriate procedures for licensees to appeal against any such decision.
Amendment 274 #
Proposal for a directive Article 22 – paragraph 2 a (new) 2a. Where the authorisation is suspended or withdrawn, Member States shall establish a mechanism for appeals against the decision.
Amendment 275 #
Proposal for a directive Article 22 – paragraph 2 a (new) 2a. Where the authorisation is suspended or withdrawn, Member States shall establish a mechanism for appeals against the decision.
Amendment 276 #
Proposal for a directive Article 24 – paragraph 2 (new) 2a. Without prejudice to the generality of paragraph 1, each breeding, supplying and user establishment shall ensure that there is at least one trained person available at all times to care for the animals' welfare.
Amendment 277 #
Proposal for a directive Article 25 – paragraph 1 1. Member States shall ensure that each breeding, supplying and user establishment
Amendment 278 #
Proposal for a directive Article 26 – paragraph 1 – introductory phrase 1.
Amendment 279 #
Proposal for a directive Article 26 – paragraph 1 – introductory part 1. The permanent ethical review body that reviews protocols and procedures shall fulfil the following tasks:
Amendment 280 #
Proposal for a directive Article 27 – paragraph 1 1. Member States shall ensure that EU breeding and supplying establishments of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of non- human primates that have been bred in captivity.
Amendment 281 #
Proposal for a directive Article 27 – paragraph 2 Amendment 282 #
Proposal for a directive Article 30 – paragraph 1 – introductory sentence 1. Member States shall ensure that all breeding, supplying and user establishments keep, where possible, the following information on each dog, cat and non-
Amendment 283 #
Proposal for a directive Article 30 – paragraph 1 – introductory sentence 1. Member States shall ensure that all breeding, supplying and user establishments keep, where possible, the following information on each dog, cat and non-
Amendment 284 #
Proposal for a directive Article 32 – paragraph 1 – point d (d) the well-being and state of health of animals are observed on a daily basis by a competent person to prevent pain or avoidable pain, suffering, distress or lasting harm;
Amendment 285 #
Proposal for a directive Article 32 – paragraph 1 – point d (d) the well–being and state of health of animals are observed by a competent person to prevent
Amendment 286 #
Proposal for a directive Article 32 – paragraph 2 2. For the purposes of points (a) and (b) of
Amendment 287 #
Proposal for a directive Article 32 – paragraph 2 2. For the purposes of points (a) and (b) of paragraph 1, Member States shall apply the care and accommodation
Amendment 288 #
Proposal for a directive Article 32 – paragraph 3 Amendment 289 #
Proposal for a directive Article 33 – paragraph 2 – subparagraph 1 2. National inspections shall be carried out by the competent authority
Amendment 290 #
Proposal for a directive Article 33 – paragraph 2 – subparagraph 2 Amendment 291 #
Proposal for a directive Article 33 – paragraph 3 3. Member States shall ensure that the frequency and the extent of inspections are adequate to the number and species of animals housed, to the compliance record of the establishment with this Directive and, in the case of user establishments, to the number and types of projects carried out in those establishments. Member States shall take the necessary measures to ensure that the inspections do not jeopardise the scientific quality of the projects and the welfare of the animals, and do not take place under conditions that fail to comply with the other regulations in force.
Amendment 292 #
Proposal for a directive Article 33 – paragraph 3 3. Member States shall ensure that the frequency and the extent of inspections are adequate to the number and species of animals housed, to the compliance record of the establishment with this Directive and, in the case of user establishments, to the number and types of projects carried out in those establishments. Member States shall take the necessary measures to ensure that the inspections do not jeopardise the scientific quality of the projects and the welfare of the animals.
Amendment 293 #
Proposal for a directive Article 34 – paragraph 1 1. The Commission
Amendment 294 #
Proposal for a directive Article 34 – paragraph 1 1. The Commission
Amendment 295 #
Proposal for a directive Article 34 – paragraph 1 1. The Commission
Amendment 296 #
Proposal for a directive Article 35 – paragraph 1 1. Member States shall ensure that projects classified as 'severe' or any projects involving non-human primates are not carried out without a prior authorisation by the competent authority. All other projects shall be notified to the competent authority.
Amendment 297 #
Proposal for a directive Article 35 – paragraph 1 1. Member States shall ensure that projects classified as 'severe' or any projects involving non-human primates are not carried out without a prior authorisation by the competent authority. All other projects shall be notified to the competent authority.
Amendment 298 #
Proposal for a directive Article 35 – paragraph 1 1. Member States shall ensure that projects are not carried out without a prior authorisation by the competent authority or, by delegation, by the permanent ethical review body that reviews protocols and procedures.
Amendment 299 #
Proposal for a directive Article 35 – paragraph 2 2. Granting of authorisation shall be subject to favourable
Amendment 300 #
Proposal for a directive Article 35 – paragraph 2 2. Granting of authorisation shall be subject to favourable ethical evaluation by the competent authority or, by delegation, by the permanent ethical review body that reviews protocols and procedures.
Amendment 301 #
Proposal for a directive Article 35 – paragraph 2 2.
Amendment 302 #
Proposal for a directive Article 35 – paragraph 2 a (new) 2a. Projects required by law shall not need formal approval, provided that they do not involve 'severe' procedures or the use of non-human primates but are subject to favourable ethical evaluation. Or. it
Amendment 303 #
Proposal for a directive Article 35 – paragraph 2 a (new) 2a. Projects required by law shall not need formal approval, provided that they do not involve 'severe' procedures or the use of non-human primates but are subject to favourable ethical evaluation.
Amendment 304 #
Proposal for a directive Article 35 – paragraph 2a (new) 2a. Member States may permit exceptions from the authorisation requirement for projects required by law.
Amendment 305 #
Proposal for a directive Article 36 –paragraph 1 – introductory phrase 1. The user establishment or the person scientifically responsible for the project shall submit an application for the project authorisation, which shall include the following:
Amendment 306 #
Proposal for a directive Article 36 – paragraph 1 – point c (c)
Amendment 307 #
Proposal for a directive Article 36 –paragraph 1 – point ca (new) (ca) 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.
Amendment 308 #
Proposal for a directive Article 36 – paragraph 2 2. Member States may waive the requirement in paragraph 1(b) and permit the user establishment to submit a reduced project proposal covering only the information necessary for the ethical evaluation and elements listed in Article 41(2), provided that the project involves only procedures classified as "up to m
Amendment 309 #
Proposal for a directive Article 36 – paragraph 2 2. Member States may waive the requirement in paragraph 1(b) and permit the user establishment to submit a reduced project proposal covering only the information necessary for the ethical evaluation and elements listed in Article 41(2), provided that the project involves only procedures classified
Amendment 310 #
Proposal for a directive Article 36 – paragraph 2 2. Member States may waive the requirement in paragraph 1(b) and permit
Amendment 311 #
Proposal for a directive Article 36 – paragraph 2 a (new) 2a. The competent authority shall subject all applications to public consultation.
Amendment 312 #
Proposal for a directive Article 37 – paragraph 1 – introductory sentence 1.
Amendment 313 #
Proposal for a directive Article 37 – paragraph 1 – introductory sentence 1.
Amendment 314 #
Proposal for a directive Article 37 – paragraph 1 – point a (a) the project is scientifically justified
Amendment 315 #
Proposal for a directive Article 37 – paragraph 1 – point a (
Amendment 316 #
Proposal for a directive Article 37 – paragraph 1 – point b (b) the purposes of the project justify the use of animals and cannot be achieved through other methods or procedures;
Amendment 317 #
Proposal for a directive Article 37 – paragraph 1 – point b (
Amendment 318 #
Proposal for a directive Article 37 – paragraph 1 – point c (
Amendment 319 #
Proposal for a directive Article 37 – paragraph 1 – point c (c) the project is designed so as to enable procedures to be carried out in the most
Amendment 320 #
Proposal for a directive Article 37 – paragraph 2 – point d (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
Amendment 321 #
Proposal for a directive Article 37 – paragraph 3 – introductory phrase 3.
Amendment 322 #
Proposal for a directive Article 37 – paragraph 3 – introductory sentence 3. The competent authority carrying out the ethical evaluation shall consider corresponding expert
Amendment 323 #
Proposal for a directive Article 38 – paragraph 4 Amendment 324 #
Proposal for a directive Article 37 – paragraph 4 4. Ethical evaluation shall be performed
Amendment 325 #
Proposal for a directive Article 37 – paragraph 4 4. Ethical evaluation shall be performed in a transparent manner, by integrating the opinion of independent parties whilst respecting information confidentiality and intellectual property rights.
Amendment 326 #
Proposal for a directive Article 37 – paragraph 4 4. Ethical evaluation shall be performed in a transparent manner, by integrating the opinion of independent parties subject to the safeguarding of confidential information and protection of intellectual property.
Amendment 327 #
Proposal for a directive Article 37 – paragraph 4 a (new) 4a. Where a project is required by law, the requirement under paragraph 1(b) should not be applied in the ethical evaluation. Equally, paragraph 2 should not be applied when a project is required by law.
Amendment 328 #
Proposal for a directive Article 38 – paragraph 1 – subparagraph 1 1.
Amendment 329 #
Proposal for a directive Article 38 – paragraph 1 – subparagraph 1 1. The competent authority carrying out the ethical evaluation shall determine, on the basis of the harm-benefit analysis referred to in point (d) of Article 37(2), whether the project should, once it has been completed, be assessed retrospectively
Amendment 330 #
Proposal for a directive Article 38 – paragraph 1 – subparagraph 2 Amendment 331 #
Proposal for a directive Article 38 – paragraph 2 – introductory sentence 2.
Amendment 332 #
Proposal for a directive Article 38 – paragraph 2 – point c (c) whether there are elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.
Amendment 333 #
Proposal for a directive Article 38 – paragraph 3 Amendment 334 #
Proposal for a directive Article 38 – paragraph 4 4.
Amendment 335 #
Proposal for a directive Article 38 – paragraph 4 4. Without prejudice to paragraph 3, all projects involving only procedures classified as "
Amendment 336 #
Proposal for a directive Article 38 – paragraph 4 4. Without prejudice to paragraph 3, all projects involving only procedures classified as
Amendment 337 #
Proposal for a directive Article 40 – paragraph 1 – introductory phrase Subject to safeguarding confidential information, establishment and personnel details, the non-technical project summary shall provide the following:
Amendment 338 #
Proposal for a directive Article 40 – paragraph 1 – introductory sentence 1. Subject to safeguarding confidential information, company and personnel details, the non-technical project summary shall provide the following:
Amendment 339 #
Proposal for a directive Article 40 – paragraph 1 – point b (b) a demonstration
Amendment 340 #
Proposal for a directive Article 40 – paragraph 1 – point b b) a demonstration
Amendment 341 #
Proposal for a directive Article 40 – paragraph 1 – point b b) a demonstration
Amendment 342 #
Proposal for a directive Article 41 – paragraph 2 – point d d
Amendment 343 #
Proposal for a directive Article 41 – paragraph 2 – point d d
Amendment 344 #
Proposal for a directive Article 41 – paragraph 3 3. Project authorisations shall be granted for a period not exceeding f
Amendment 345 #
Proposal for a directive Article 41 – paragraph 4 4. 4. Member States
Amendment 346 #
Proposal for a directive Article 41 – paragraph 4 4. Member States may allow the authorisation of multiple projects when those projects are required by law, or when standardised procedures are applied, the ethical assessment of which has already produced a positive result.
Amendment 347 #
Proposal for a directive Article 42 – paragraph 1 1. The competent authority may amend or renew the project authorisation on the request of the user establishment. Amendments which do not affect animal welfare may be adopted by means of the ethical opinion procedure.
Amendment 348 #
Proposal for a directive Article 42 – paragraph 2 2. Any
Amendment 349 #
Proposal for a directive Article 42 – paragraph 2 2.
Amendment 350 #
Proposal for a directive Article 42 – paragraph 2 2. Any
Amendment 351 #
Proposal for a directive Article 42 – paragraph 2 2. Any amendment or renewal of a project authorisation shall be subject to a further
Amendment 352 #
Proposal for a directive Article 42 – paragraph 2a (new) Amendment 353 #
Proposal for a directive Article 42, paragraph 2 a (new) 2a. Amendments to 'mild or moderate' procedures which do not determine an increase in severity of those procedures shall be notified to the competent authority further to approval by the Ethics Committee.
Amendment 354 #
Proposal for a directive Article 42 – paragraph 5 a (new) 5a. Each amendment to 'severe' procedures, or to procedures which determine an increase in severity, is subject to a further favourable ethical evaluation and approval by the competent authority.
Amendment 355 #
Proposal for a directive Article 43 – paragraph 1 1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within
Amendment 356 #
Proposal for a directive Article 43 – paragraph 1 1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within
Amendment 357 #
Proposal for a directive Article 43 – paragraph 1 1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 30 days from the submission of the application. Should the Member State fail to take a
Amendment 358 #
Proposal for a directive Article 43 – paragraph 1 1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 30 days from the submission of the application. Should the Member State fail to take a decision within that period, or in the case of a minor amendment, the authorisation shall be deemed to have been granted, where the project concerned involves only procedures classified as "up to m
Amendment 359 #
Proposal for a directive Article 43 – paragraph 1 1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 30 days from the submission of the application. Should the Member State fail to take a decision within that period, or in the case of a minor amendment, the authorisation shall be deemed to have been granted, where the project concerned involves only procedures classified as "
Amendment 360 #
Proposal for a directive Article 43 – paragraph 2 Amendment 361 #
Proposal for a directive Article 43 – paragraph 2 Notwithstanding paragraph 1, in exceptional circumstances and where the project is non-routine, multi-disciplinary and innovative, the decision to grant an authorisation shall be taken and communicated to the user establishment within 60 days from the submission of the application. In some cases, the user establishment must be notified of the existence of exceptional circumstances within 30 days from the submission of the application.
Amendment 362 #
Proposal for a directive Article 43 – paragraph 2 2. Notwithstanding paragraph 1, in exceptional circumstances and where the project is non-routine, multi-disciplinary and innovative, the decision to grant an authorisation shall be taken and communicated to the user establishment within
Amendment 363 #
Proposal for a directive Article 43 – paragraph 2 2.
Amendment 364 #
Proposal for a directive Article 44 – paragraph 2 a (new) Amendment 365 #
Proposal for a directive Article 44 – paragraph 2 b (new) Amendment 366 #
Proposal for a directive Article 45 The Commission and Member States shall contribute
Amendment 367 #
Proposal for a directive Article 45 The Commission and Member States shall contribute financially to the development and, where appropriate, scientific validation of alternative approaches that could provide the same or higher level of information as that obtained in procedures using animals but that do not involve the use of animals or use fewer animals or that entail less painful procedures and shall take such other steps as they consider appropriate to encourage research in this field.
Amendment 368 #
Proposal for a directive Article 45 The Commission and Member States shall contribute by various means, particularly financial to the development and scientific validation of alternative approaches that could provide the same or higher level of information as that obtained in procedures using animals but that do not involve the use of animals or use fewer animals or that entail less painful procedures and shall take such other steps as they consider appropriate to encourage research in this field.
Amendment 369 #
Proposal for a directive Article 45 a (new) Article 45a European Centre for Validation of Alternative Methods 1) The Commission shall, 12 months after the entry into force of this Directive, review and strengthen the role of the European Centre for the Validation of Alternative Methods to facilitate the development and use of alternatives to animal procedures. The Centre referred to in paragraph 1 shall cooperate with the National Reference Centres for Alternative Methods described in Article 46 in order to: 1) develop a strategy for the implementation of the replacement, reduction and refinement approach; 2) identify what is required in order to carry out research into alternative procedures; 3) provide advice, guidance and information on replacement, reduction and refinement to competent authorities, the scientific community, the public and relevant stakeholders; 4) coordinate pre-validation and validation studies; 5) in consultation with relevant regulatory bodies, both national and international, identify new alternative methods suitable for validation as well as specific requirements for their validation; 6) facilitate the scientific endorsement and regulatory acceptance of alternatives to animal tests used for regulatory purposes.
Amendment 370 #
Proposal for a directive Article 46 – paragraph 1 1. Each Member State shall, by [one year
Amendment 371 #
Proposal for a directive Article 46 – paragraph 1 1. Each Member State shall, by [one year after entry into force of this Directive],
Amendment 372 #
Proposal for a directive Article 46 – paragraph 4 – point a (a) cooperate with the Commission in their area of competence and perform tasks to advance strategies to replace animal procedures;
Amendment 373 #
Proposal for a directive Article 46 – paragraph 4 – point b (b) participate in pre-validation and validation of alternative methods, where appropriate, under the co-ordination of the Commission;
Amendment 374 #
Proposal for a directive Article 47 – paragraph 1 1. Each Member State shall establish a national animal welfare and ethics committee that shall advise the competent authorities
Amendment 375 #
Proposal for a directive Article 47 – paragraph 2 2. The national animal welfare and ethics committees shall exchange information on the operation of
Amendment 376 #
Proposal for a directive Article 49 – paragraph 2 – subparagraph 1 2. Member States shall collect and make publicly available,
Amendment 377 #
Proposal for a directive Article 49 – paragraph 2 – subparagraph 2 Amendment 378 #
Proposal for a directive Article 50 Amendment 379 #
Proposal for a directive Article 53 – paragraph 1a (new) The Commission shall, in consultation with the Member States, conduct an evaluation of scientific progress made as a result of projects and procedures using animals in order to establish the scientific benefits of the projects and procedures in question. The review shall be conducted every five years commencing two years after the entry into force of this Directive. The review shall consider the impact of developments in technological, scientific and animal welfare knowledge and set targets for the implementation of validated replacement methods.
Amendment 380 #
Proposal for a directive Article 53 – paragraph 1 a (new) The Commission shall, in consultation with Member States, conduct a thematic review of the use of animals in procedures. The review shall be conducted every five years commencing two years after the entry into force of this Directive. The review shall examine the impact of developments in technological, scientific and animal welfare knowledge, and set targets for the implementation of validated replacement methods.
Amendment 381 #
Proposal for a directive Article 53 a (new) The Commission shall, in consultation with Member States and any relevant stakeholders, conduct a thematic review of the use of animals in procedures every two years commencing from two years after the entry into force of this Directive. The review shall examine the impact of developments in technological, scientific and animal welfare knowledge, and set targets for the implementation of validated replacement methods.
Amendment 382 #
Proposal for a directive Article 56 – paragraph 2 a (new) 2a. This Directive does not limit the right of Member States to apply or adopt stricter measures for the protection of animals used for scientific purposes, or to control or limit the use of animals for experiments.
Amendment 383 #
Proposal for a directive Annex I Invertebrate Species referred to in Article
Amendment 384 #
Proposal for a directive Annex I Invertebrate Species referred to in Article
Amendment 385 #
Proposal for a directive Annexe I Amendment 390 #
Proposal for a directive Annex III – dates – lines 2 to 4 [
Amendment 391 #
Proposal for a directive Annex IV – title Care and accommodation
Amendment 392 #
Proposal for a directive Annex IV – subtitle (new) The care and accommodation conditions should be tailored to the scientific objective.
Amendment 394 #
Proposal for a directive Annex V – title Amendment 395 #
Proposal for a directive Annex V – table 1 – title Table 1 -
Amendment 396 #
Proposal for a directive Annex V – table 5 – ‘Overall rating’ column – Carbon dioxide Amendment 397 #
Proposal for a directive Annexe VII a (new) source: PE-421.385
2010/06/30
AGRI
5 amendments...
Amendment 1 #
Council position Article 2 – paragraph 1 – subparagraph 1 1. Member States may, while observing the general rules laid down in the Treaty, maintain provisions in force on …*, aimed at ensuring more extensive protection of animals falling within the scope of this Directive than those contained in this Directive or adopt in the future provisions with that aim.
Amendment 2 #
Council position Article 2 – paragraph 1 – subparagraph 1 1. Member States may, while observing the general rules laid down in the Treaty, maintain or adopt provisions
Amendment 3 #
Council position Article 2 – paragraph 1 – subparagraph 2 Amendment 4 #
Council position Article 8 – paragraph 1 – subparagraph 2 A debilitating clinical condition for the purposes of this Directive means a substantial reduction in a person's normal physical or psychological ability to function.
Amendment 5 #
Council position Article 13 – paragraph 1 1. Without prejudice to national legislation prohibiting certain types of methods, Member States shall ensure that a procedure is not carried out if another method or testing strategy for obtaining the result sought, not entailing the use of a live animal, is recognised under the legislation of the Union. In the absence of such method, a procedure may not be carried out if a scientifically satisfactory method or testing strategy for obtaining the result sought, including computer supported, in vitro and other methodologies, not entailing the use of an animal, is reasonably and practicably available.
source: PE-445.661
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