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Delen
In preparation of the Working Party of 11 and 12 June 2009, delegations will find attached a table
comparing (articles only):
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-the original Commission proposal
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-oucome of the European Parliament's first reading.
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Proposal for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on the protection of animals used for scientific purposes
Articles
The following table of comparison has been drafted in the context of the preparation for the discussion with the European Parliament.
It does not constitute an official document in the context of the co-decision procedure.
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CHAPTER I GENERAL PROVISIONS
Article 1 Article 1 Subject matter Subject matter
This Directive establishes measures for the protection of animals used or intended to be used for scientific purposes. To that end, it lays down rules on the following: (1) the replacement and reduction of the use of animals in procedures and the refinement of the breeding, accommodation, care and use of animals in procedures;
(2) the origin, breeding, marking, care
and accommodation of animals;
(3) the functioning of breeding,
supplying or user establishments;
(4) the evaluation and authorisation of
projects involving the use of animals in procedures.
Article 2 Article 2 Scope Scope
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1.This Directive shall apply where Amendment 28 Article 2 paragraph 1 subparagraph 1 1. This Directive shall apply to the
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animals are used or intended to be used in procedures, or where they are bred specifically so that their organs or tissues may be used for scientific purposes. accommodation and husbandry of animals used or intended to be used in procedures or where they are bred specifically so that their organs or tissues may be 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. The elimination of pain, suffering, distress or lasting harm by the successful use of anaesthesia, analgesia or other methods shall not exclude the use of an animal in procedures from the scope of this Directive.
Amendment 29
Article 2 paragraph 1 - subparagraph 2
Where there is any pain, suffering, distress or lasting harm, its elimination by the successful use of anaesthesia, analgesia or other methods shall not exclude the use of an animal in procedures from the scope of this Directive.
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2.This Directive shall apply to the Amendment 30 following animals: Article 2 paragraph 2 point a (a) live non-human vertebrate animals, (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; including independently feeding larval forms and embryonic or foetal forms of species of mammals as from the last third of their normal development;
Amendment 31
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Article 2 paragraph 2 point b (b) live invertebrate animals of those
(b) live invertebrate animals,
including independently feeding larval forms, of those species listed in Annex I. species of orders listed in Annex I.
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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, if the animal is to be allowed to live beyond that stage of development and is likely to experience pain, suffering, distress or lasting harm after it has reached that stage of development.
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4.This Directive shall not apply to the Amendment 32 Article 2 paragraph 4 introductory part
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4.Other than the general checks on
following: breeding facilities, this Directive shall not apply to the following :
(a) non-experimental, agricultural or clinical veterinary practices and trials;
(b) practices undertaken for the
purposes of recognised animal husbandry;
(c) practices undertaken for the Amendment 33
primary purpose of marking an Article 2 paragraph 4 point d 10605/09
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animal. (d) practices that do not cause pain, (d) practices that are not invasive
suffering, distress or lasting harm.
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5.This Directive shall apply without
prejudice to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products.
Article 3 Article 3 Definitions Definitions
For the purposes of this Directive the following definitions shall apply:
Amendment 34
(1) 'procedure' means any use of an Article 3 point 1
animal for experimental or other scientific purposes, with known or unknown outcome, which may cause the animal pain, suffering distress or lasting harm, including any course of action intended, or liable, to result in the birth of an animal in any such condition or in the creation of a new genetically modified animal line; (1) 'procedure' means any use of an animal for experimental or other scientific purposes, with known or unknown outcome, which may or may not cause the animal pain, suffering distress or lasting harm and includes any course of action intended, or liable, to result in the birth of an animal in any such condition or in the creation of a new genetically modified animal line;
(2) 'project' means a programme of work
having a defined scientific objective and involving one or more procedures;
(3) 'establishment' means any
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installation, building, group of buildings or other premises and may include a place that is not wholly enclosed or covered and mobile facilities; (4) 'breeding establishment' means any
establishment where animals are bred with a view to their use in procedures or for the use of their tissue or organs for scientific purposes;
(5) 'supplying establishment' means any
establishment, other than a breeding establishment, from which animals are supplied with a view to their use in procedures or for the use of their tissue or organs for scientific purposes;
Amendment 35
(6) 'user establishment' means any Article 3 point 6 a (new)
establishment where animals are used in procedures. (6a) 'competent authority' means the
authority or authorities designated by each Member State as being responsible for supervising the enforcement of this Directive;
Amendment 36
Article 3 point 6 b (new)
(6b) 'ethical approach' means the
approach which precedes experimentation and consists of
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assessing the scientific and societal grounds for using animals, with reference to humankind's duty to respect animals as living, sentient beings;
Amendment 37
Article 3 point 6c (new)
(6c) 'competent person' means any person
who is considered by a Member State to be competent to perform the relevant function described in this Directive;
Amendment 38
Article 3 point 6d (new)
(6d) 'husbandry' means all those activities
required to breed and maintain phenotypically normal animals, whether for scientific or other purposes, but which do not themselves constitute experiments;
Amendment 39
Article 3 point 6e (new)
(6e) 'practice' means any non-
experimental activity or any scientific activity which does not constitute an
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experiment;
Amendment 40
Article 3 point 6f (new)
(6f) 'properly anaesthetised' means
deprived of sensation by means of anaesthesia, whether local or general, which is as effective as those used in good veterinary practice;
Amendment 41
Article 3 point 6g (new)
(6g) 'protocol' means a series of
procedures that constitute an experiment with a defined objective;
Amendment 42
Article 3 point 6h (new)
(6h) 'regulated procedure' means any
experimental or other scientific procedure, which is likely to have the effect of causing a protected animal pain, suffering, distress or lasting harm;
Amendment 43
Article 3 point 6i (new)
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(6i) ) `re-use' means the use of an animal
already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used;
Amendment 44
Article 3 point 6j (new)
(6j) 'confidential information' means
information, the non-consensual release of which could prejudice the legitimate commercial or other interests of its owner or a third party.
Article 4 Article 4
Replacement, reduction and refinement Replacement, reduction and refinement Amendment 170 Article 4 paragraph 1
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1.Where a method of testing not 1. Where a method of testing,
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. experimentation or other scientific activity not involving the use of living animals exists which, from a scientific point of view, is a satisfactory method or testing strategy for obtaining the result sought and which may be used in place of a procedure, Member States shall ensure that the alternative method is used, provided it is not prohibited in the Member State concerned.
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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. 2. Member States shall ensure that the
number of animals used in projects is reduced to the minimum without compromising the objectives of the project.
Amendment 46
Article 4 paragraph 3 a (new)
3a. Member States shall ensure that 3. Member States shall ensure refinement
of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals. 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.
Amendment 47
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 48
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Article 4 paragraph 3 c (new)
3c. Member States shall ensure that
training is provided 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.
Article 5 Article 5 Purposes of procedures Purposes of procedures
Procedures may be carried out for the following purposes only: (1) basic research for the advancement of knowledge in biological or behavioural sciences;
(2) translational or applied research with
either of the following aims: (a) the avoidance, prevention,
diagnosis or treatment of disease, ill-health or other abnormality or their effects in human beings, animals or plants;
(b) the assessment, detection,
regulation or modification of physiological conditions in human beings, animals or plants; Amendment 49 Article 5 point 2 point b a (new)
(ba) the improvement of the production
conditions and welfare of animals reared for agricultural purposes;
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(3) the development, manufacture or
testing of the quality, effectiveness and safety of drugs, food- and feed-stuffs and other substances or products having either of the aims referred to in point (2);
(4) the protection of the natural
environment in the interests of the health or welfare of human beings or animals; Amendment 50 Article 5 point 4 a (new)
(5) research aimed at preservation of the 4a. the protection of human health in the context of workers' or consumers' exposure to chemicals;
Amendment 51
Article 5 point 5
(5) research aimed at preservation, health
species; and welfare of the species;
(6) higher education or training; (7) forensic inquiries.
Article 6 Article 6 Humane methods of killing Humane methods of killing
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1.Member States shall ensure that Amendment 52 Article 6 paragraph 1 subparagraph 1
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1.Member States shall ensure that animals
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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 humane method of killing as set out in that Annex. However, in case of a field study an animal may be killed outside of an authorised establishment. 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 an appropriate humane method of killing as set out in that Annex or by such other methods as are scientifically demonstrated to be at least as humane. Where a more humane method of killing is possible and readily available, it may be used even if it is not included in Annex V.
Amendment 53
Article 6 paragraph 2
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2.Competent authorities may grant 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. 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 or that other methods providing better animal protection have been developed. otwithstanding any exemption, animals shall be killed with a minimum of pain, suffering and distress. 3. Paragraph 1 shall not apply where an
animal has to be killed in emergency
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circumstances for animal welfare reasons. Member States shall determine the emergency circumstances referred to in the first subparagraph.
Amendment 54 Article 6 a (new)
ational 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. CHAPTER II PROVISIONS ON THE USE OF CERTAIN ANIMALS IN PROCEDURES Article 7 Article 7
Endangered species other than non-human Endangered species other than non-human primates primates
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1.Endangered species listed in Annex A 10605/09
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to Council Regulation (EC) No 338/97 1
shall not be used in
procedures, with the exception of those procedures meeting the following conditions:
(a) the procedure has one of the
purposes referred to in points (2)(a), (3) or (5) of Article 5;
(b) there is a scientific justification
that the purpose of the procedure cannot be achieved by the use of species other than those listed in that Annex.
Amendment 55
Article 7 paragraph 1 point b a (new)
(ba) as far as possible, the animals used
should be bred specifically for testing purposes;
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2.This article shall not apply to any species of non-human primates.
Article 8 Article 8 on-human primates on-human primates
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1.Non-human primates shall not be used Amendment 56 Article 8 paragraph 1 introductory phrase
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1.Given their particularly high level of
in procedures, with the exception of those procedures meeting the neurophysiological sensitivity and cognitive development, non-human
1
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following conditions: primates shall not be used in procedures, with the exception of those procedures meeting the following conditions:
Amendment 57
Article 8 paragraph 1 point a
(a) the procedure has one of the (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; purposes referred to in points (1), (2)(a), (3) or (5) of Article 5;
Amendment 58
Article 8 paragraph 1 point b
(b) there is a scientific justification (b) the applicant provides a scientific
that the purpose of the procedure cannot be achieved by the use of other species than non-human primates. and ethical justification that the purpose of the procedure cannot be achieved by the use of other species than non-human primates.
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2.Notwithstanding paragraph 1, great
apes shall not be used in procedures, subject to the use of the safeguard clause in Article 50.
Amendment 59
Article 8 paragraph 2 a (new)
2a. Every two years, and for the first time
two years after the entry into force of
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this Directive, the Commission shall, in consultation with Member States, conduct a review of the use of nonhuman 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.
Article 9 Article 9 Animals taken from the wild Animals taken from the wild
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1.Animals taken from the wild shall not be used in procedures.
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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 an animal which has been bred for use in procedures.
Article 10 Article 10
Animals bred for use in procedures Animals bred for use in procedures
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1.Member States shall ensure that
animals belonging to the species listed in Annex II may only be used in Amendment 60 Article 10 paragraph 1 subparagraph -
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procedures where those animals have been bred for use in procedures. However, as from the dates set out in Annex III, Member States shall ensure that non-human primates listed in that Annex may only be used in procedures where they are the offspring of nonhuman primates which have been bred in captivity. 1 (new)
The Commission shall carry out an animal welfare assessment and a feasibility evaluation of implementation of the requirements set out in subparagraphs 1 and 2, five years after the entry into force of this Directive.
Amendment 61
Article 10 paragraph 1 subparagraph 2
Where feasibility is established, as from the dates to be set in Annex III in light of the evaluation referred to in subparagraph -1, Member States shall ensure that non-human primates listed in that Annex may only be used in procedures where they are sourced from selfsustaining colonies.
Amendment 62
Article 10 paragraph 2
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2.Competent authorities may grant 2. Competent authorities may grant
exemptions from paragraph 1 on the basis of a scientific justification. exemptions from paragraph 1 on the basis of a veterinary justification for reasons of animal welfare or on the basis of a scientific justification.
Article 11 Article 11
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species species
Stray and feral animals of domestic species shall not be used in procedures. Amendment 63 Article 11 a (new)
Use of cadavers, tissue and organs of
animals for training purposes
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) o .../2009 [on the protection of animals at the time of killing] 1
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1 OJ L .... [COM(2008)0553].
CHAPTER III PROCEDURES Article 12 Article 12 Procedures Procedures
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1.Member States shall ensure that Amendment 64 Article 12 paragraph 1 subparagraph 1
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1.Member States shall ensure that
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procedures are always carried out in user establishments. The competent authority may grant an exemption from the first subparagraph on the basis of scientific justification. procedures are always carried out in establishments as defined in Article 3.
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2.Procedures may be carried out only
within the framework of a project.
Article 13 Article 13
Methods used in procedures Methods used in procedures
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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.
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2.In a choice between procedures, those
which use the minimum number of animals, involve animals with the
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lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be selected.
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3.Death as the end-point in a procedure
shall be avoided as far as possible and replaced by early and humane endpoints. If death as the end-point is unavoidable, the procedure shall be designed so as to result in the deaths of as few animals as possible.
Article 14 Article 14
Anaesthesia Anaesthesia
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1.Member States shall ensure that all Amendment 65 Article 14 paragraph 1
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1.Member States shall ensure that, where
procedures are carried out under general or local anaesthesia. appropriate, all procedures are carried out under general or local anaesthesia or using other methods that may alleviate pain or minimise suffering. 2. By way of derogation from paragraph
1, procedures may be carried out without anaesthesia in the following conditions: (a) where anaesthesia is judged to be
more traumatic to the animal than the procedure itself;
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(b) where anaesthesia is incompatible
with the purpose of the procedure unless the procedure involves serious injuries that may cause severe pain.
Amendment 66
Article 14 paragraph 2 point ca (new)
(ca) where analgesics are used to prevent
or control potentially severe pain.
Amendment 67
Article 14 paragraph 3
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3.If the procedure is carried out without
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3.If the procedure is carried out without
anaesthesia, analgesics or other appropriate methods shall be used to ensure that unavoidable pain, suffering and distress are kept to a minimum. anaesthesia, analgesics or other appropriate methods shall be used wherever this would be beneficial to the animal to ensure that unavoidable pain, suffering and distress are kept to a minimum. 4. Member States shall ensure that
animals are not given any drug to stop or restrict them from showing pain without an adequate level of anaesthesia or analgesia. In those cases, a scientific justification shall be provided, accompanied by the details of the anaesthetic or analgesic regime. Amendment 68
Article 14 paragraph 5
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5.An animal, which may suffer 5. An animal, which may suffer pain once
considerable pain once anaesthesia has worn off, shall be treated with preemptive and post-operative analgesics anaesthesia has worn off, shall be treated with pre-emptive and postoperative analgesics or other 10605/09
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or other appropriate pain-relieving methods, provided that it is compatible with the purpose of the procedure. Where the treatment with analgesics is not possible, the animal shall be immediately killed by a humane method. appropriate pain-relieving methods, provided that it is compatible with the purpose of the procedure. Where the treatment with analgesics is not possible, the animal shall be immediately killed by a humane method. Article 15 Article 15
Classification of severity of procedures Classification of severity of procedures
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1.Member States shall ensure that all Amendment 69 Article 15 paragraph 1
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1.Member States shall ensure that all
procedures are classified as 'up to mild', 'moderate', 'severe' or 'nonrecovery' 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. procedures are classified as 'up to mild', 'moderate' or 'severe' in conformity with Annex VIIa.
Amendments 70 and 175
Article 15 paragraph 2
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2.Member States shall ensure that the
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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. 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 10605/09
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particular harm/benefit analysis and scrutiny by the competent authority. 3. Procedures performed under general
anaesthesia, at the end of which and without a possibility to recover consciousness the animal is killed using humane method, shall be classified as "non-recovery".
Amendments 71 and 185
Article 15 paragraph 4 subparagraph 1
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4.The Commission shall, within 12
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4.The Commission shall establish the
criteria for classification of procedures. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall by [within 18 months from the entry into force of this Directive] be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 51(3). months from the date of entry into force of this Directive, complete the criteria for classification of procedures as referred to in Annex VIIa on the basis of international classifications and in line with best practices developed within the European Union. Such criteria shall include an upper limit of severity beyond which procedures on animals will be prohibited.
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Article 16 Article 16 Re-use Re-use
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1.Member States shall ensure that an Amendment 72 Article 16 paragraph 1 introductory part
Member States shall ensure that an animal on which a procedure has already been carried out, when a different animal on which no preparatory or other procedure has previously been carried out could instead be used, may be re-used in subsequent unrelated new procedures only when all of the following conditions are met:
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 only when all of the following conditions are met: (a) the previous procedure was
Amendment 73
Article 16 paragraph 1 point a
(a) the previous procedure was classified as
classified as 'up to mild'; 'up to moderate';
(b) it is demonstrated that its general
state of health and well-being has been fully restored; Amendment 74 Article 16 paragraph 1 point c
(c) the further procedure is classified (c) the further procedure is classified as 'up
as 'up to mild' or 'non-recovery'. to moderate' or 'non-recovery'. The reuse of animals shall be accompanied by veterinary examinations.
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2.By way of derogation from paragraph Amendment 75 Article 16 paragraph 2
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2.By way of derogation from paragraph
1, the competent authority, on the basis of scientific justification, may allow reuse of an animal as long as the animal is not used more than once after having undergone a procedure entailing severe pain, distress or equivalent suffering and the further procedure is classified as 'up to mild' or as 'non-recovery'. 1, the competent authority, on the basis of scientific justification, may allow reuse of an animal where the previous procedure performed on the animal is classified as'up to moderate' and the further procedure is classified as 'up to moderate' or as 'non-recovery'. Article 17 Article 17
End of the procedure End of the procedure
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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 lack of adverse effects to animals can be scientifically demonstrated.
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2.At the end of a procedure, a decision
shall be taken by a veterinarian or by another competent person on whether the animal shall be kept alive or killed by a humane method.
Amendment 76
Article 17 paragraph 3
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lasting pain or distress. when it is likely to remain in lasting pain or distress. 4. Where an animal is to be kept alive, it
shall receive the care and accommodation appropriate to its state of health and be placed under the supervision of a veterinarian or another competent person.
Article 18 Article 18
Sharing organs and tissues Sharing organs and tissues
Member States shall establish programmes for the sharing of organs and tissues of animals killed by a humane method. Amendment 77 Article 18
Member States shall encourage the establishment of programmes for the sharing of organs and tissues of animals killed by a humane method.
Article 19 Article 19
Setting free of animals and re-homing Setting free of animals and re-homing
Member States may allow animals used or intended to be used in procedures to be set free or re-homed provided that the following conditions are met: Amendment 78 Article 19 introductory phrase
Member States may allow animals used or intended to be used in procedures to be released into their original habitat, returned to a husbandry system
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appropriate to the species, or rehomed provided that the following conditions are met: (a) the state of health of the animal allows
it; Amendment 79
(b) there is no danger to public health or Article 19 point c the environment; (c) the maximum possible care has been (c) the maximum possible care has been
taken to safeguard the well-being of the animal. taken to safeguard the well-being of the animal, including an assessment of the animal's behaviour and its ability to adapt to highly variable environmental conditions.
Amendment 80
Article 19 point c a (new)
(ca) the animals concerned are not
genetically modified experimental animals or non-human primates.
CHAPTER IV AUTHORISATION
Section 1 Authorisation of persons Article 20 Article 20
Authorisation of persons Authorisation of persons
Amendment 81 Article 20 paragraph 1 introductory part
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1.Member States shall ensure that 1. Member States shall ensure that
persons are authorised by the competent authority before they carry out any of the following functions: (a) the carrying out of procedures on persons are authorised by the competent authority or the delegated authority before they carry out any of the following functions:
animals, including their killing by a humane method;
(b) the supervision or design of
procedures and projects;
(c) the supervision of those taking Amendment 82
care of animals. Article 20 paragraph 2 subparagraph 1
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2.Member States shall ensure that, for 2. Member States shall ensure that, for the
the purposes of the authorisation, the persons referred to in paragraph 1 have the appropriate education and training and have demonstrated the requisite competence. Persons carrying out the functions referred to in point (b) of paragraph 1 shall have received instruction in a scientific discipline relevant to the work being undertaken and shall be capable of handling and taking care of the species concerned. purposes of the authorisation, the persons referred to in paragraph 1 have the appropriate veterinary or scientific education and training and have evidence of the requisite competence.
Amendment 83
Article 20 paragraph 3
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3.All authorisations of persons shall be 3. All authorisations of persons shall be
granted for a limited period of time, not exceeding five years. Member granted for a limited period, not exceeding five years. Member States 10605/09
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States shall ensure that the renewal of an authorisation of persons is only granted on the basis of demonstration of the requisite competence. shall ensure that the renewal of an authorisation of persons is only granted on the basis of evidence of the requisite competence. Member States shall ensure the mutual recognition of education and training qualifications and authorisation to conduct designated procedures. 4. Member States shall publish, on the
basis of the elements set out in Annex VI, minimum requirements with regard to education, training and requirements for obtaining, maintaining and demonstrating requisite competence.
Section 2 Requirements for establishments Article 21 Article 21
Authorisation of establishments Authorisation of establishments
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1.Member States shall ensure that all
breeding, supplying and user establishments are authorised by and registered with the competent authority. An authorisation shall be given to an establishment only if it has been inspected by the competent authority
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and found to comply with the requirements of this Directive.
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2.The authorisation shall specify the type
of establishment and the person responsible for the establishment and for compliance with the provisions of this Directive.
Article 22 Suspension and withdrawal of
authorisation
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1.Where an establishment no longer Amendment 84 Article 22 paragraph 1
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1.Where an establishment no longer
complies with requirements set out in this Directive, the competent authority shall suspend or withdraw its authorisation. 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 the licenseholders to appeal against any such decision. 2. Member States shall ensure that, where
the authorisation is suspended or withdrawn, the welfare of the animals housed in the establishment is not adversely affected.
Article 23 Article 23
Requirements for installations and Requirements for installations and equipment equipment
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1.Member States shall ensure that all breeding, supplying and user
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establishments have installations and equipment suited to the species of animals housed and, where procedures are carried out, to the performance of the procedures. Amendment 85
Article 23 paragraph 2
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2.The design, construction and method 2. The design, construction and method of
of functioning of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible, obtaining consistent results with the minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm. functioning of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible, with the minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm.
Article 24 Article 24
Requirements for personnel in Requirements for personnel in establishments establishments
Each breeding, supplying and user establishment shall have sufficient trained staff, including as a minimum: (1) persons responsible on site for the welfare and care of the animals bred, kept or used in the establishment, who shall ensure the following:
(a) the staff dealing with animals have
access to the information specific
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to the species housed in the establishment; (b) the projects are carried out in
accordance with the project authorisation;
(c) any procedure in the course of
which any unnecessary distress, pain or suffering is being inflicted on an animal is stopped;
(d) in the event of non-compliance
with the project authorisation, the appropriate measures to rectify the non-compliance are taken, recorded and reported to the permanent ethical review body.
(2) a designated veterinarian with
expertise in laboratory animal medicine charged with advisory duties in relation to the well-being and treatment of the animals.
Amendment 86
Article 24 point 2a (new)
2a. Without prejudice to the generality of
point 1, 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.
Article 25 Article 25
Permanent ethical review body Permanent ethical review body
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1.Member States shall ensure that each 10605/09
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breeding, supplying and user establishment sets up a permanent ethical review body. Amendment 87
Article 25 paragraph 2
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2.The permanent ethical review body 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. 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 and a person with expertise in the application of the principles of replacement, reduction and refinement.
Article 26 Article 26
Tasks of permanent ethical review body Tasks of permanent ethical review body
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1.The permanent ethical review body Amendment 88 Article 26 paragraph 1 introductory
phrase
-
1.Having regard to the objectives of this
shall fulfil the following tasks: Directive, and in particular Article 4, the permanent ethical review body shall fulfil the following tasks :
(a) provide ethical advice to the staff
dealing with animals on matters related to the welfare of animals in relation to their acquisition,
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accommodation, care and use; (b) advise the staff of the
establishment on the application of the requirement of replacement, reduction and refinement and keep it informed on the latest technical and scientific developments on the application of those requirements;
(c) establish and review internal
operational processes as regards monitoring, reporting and follow up in relation to the welfare of animals housed or used in the establishment;
(d) review annually all projects which
Amendment 89
Article 26 paragraph 1 point d
introductory part
(d) review annually all projects classified
are of more than 12 months duration, focusing in particular on: as "severe" or those on non-human primates, and every 3 years all other projects which are of more than 12 months duration, focusing in particular on:
the numbers, species and life
stages of animals used in the preceding year; the justification for the Amendment 90
numbers, species and life stages of animals needed for Article 26 paragraph 1 point d indent 2 a (new)
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the subsequent year; - the scientific progress of the project; the use of humane methods of
killing and how new developments in relation to the use of animals in procedures have been taken into account;
(e) based on the review referred to in
point (d) or, in the case of deviations from the project authorisation, examine whether the project authorisation needs to be submitted for amendment or renewal;
(f) advise on re-homing schemes, in
particular in relation to the appropriate socialisation of the animals to be re-homed.
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2.Member States shall ensure that the
records of any advice given to the establishment by the permanent ethical review body and decisions taken regarding that advice are kept. The records shall be submitted to the competent authority upon request.
Amendment 91
Article 26 paragraph 2 subparagraph 2
The records shall be made available to the competent authority upon request. Member States shall pay particular attention to the collection, collation and publication of records relating to projects classified as
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"severe" or those on non-human primates in order to provide information which can improve animal welfare and further the principles of replacement, reduction and refinement.
Article 27 Article 27
Breeding strategy for non-human primates Breeding strategy for non-human primates
-
1.Member States shall ensure that Amendment 92 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. breeding and supplying establishments of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of nonhuman primates that have been bred in captivity. Where the use of nonhuman primates is authorised, the Commission and the Member States shall take all necessary measures to ensure appropriate transport conditions. 2. Establishments acquiring non-human
Amendment 93
Article 27 paragraph 2
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2.EU establishments acquiring non-
primates shall supply proof to the competent authority, on request, that the establishment from which animals human primates shall supply proof to the competent authority, on request, that the establishment from which 10605/09
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have been acquired have a breeding strategy in place. animals have been acquired have a breeding strategy in place. Article 28 Article 28
Re-homing scheme Re-homing scheme
Where Member States allow re-homing as referred to in Article 19, the breeding, supplying and user establishments from which animals are intended to be re-homed shall have a re-homing scheme in place that ensures socialisation of the animals that are re-homed. Article 29 Article 29
Records on animals Records on animals
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1.Member States shall ensure that all Amendment 94 Article 29 paragraph 1 introductory part
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1.Member States shall, where possible,
breeding, supplying and user establishments keep records of the following: ensure that all breeding, supplying and user establishments keep records of the following: Amendment 95
Article 29 paragraph 1 point a
(a) the number and the species of
(a) the number and the species of
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(b) the origin of the animals, including whether they are bred for use in procedures;
(c) the dates on which the animals are
acquired, supplied, released or rehomed;
(d) the name and address of the Amendment 96
supplying establishment and the date of their arrival; Article 29 paragraph 1 point e (e) the name and address of the the
(e) the name and address of the
recipient of animals; establishment receiving the animals; (f) the number and species of animals
which have died or have been killed using a humane method in the establishment.
-
2.The records referred to in paragraph 1
shall be kept for a minimum of three years and shall be submitted to the competent authority upon request.
Article 30 Article 30
Information on dogs, cats and non-human Information on dogs, cats and non-human primates primates
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1.Member States shall ensure that all
breeding, supplying and user establishments keep the following information on each dog, cat and nonhuman primate: (a) identity;
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(b) place of birth; (c) whether it is bred for use in procedures;
(d) in the case of a non-human
primate, whether it is the offspring of non-human primates that have been bred in captivity.
Amendment 97
Article 30 paragraph 2 subparagraph 1
-
2.Each non-human primate shall have an Each dog, cat and non-human primate shall have an individual history file, which follows the animal throughout its life. Member States shall ensure the adequate and consistent implementation of this Directive. individual history file, which follows the animal throughout its life. The file shall be established at birth and shall cover detailed reproductive, medical and social information on the individual animal.
Amendment 98
Article 30 paragraph 2 subparagraph 2
The file shall be established at birth and shall cover any relevant reproductive, medical and social information on the individual animal.
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3.The information referred to in
paragraph 1 shall be kept for a minimum of three years after the death of the animal and shall be submitted to the competent authority upon request.
Article 31 Article 31 Marking Marking 10605/09
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1.Each dog, cat or non-human primate in
any breeding, supplying or user establishment shall, except in the cases referred to in paragraph 2, be provided, before it is weaned, with an individual identification mark in the least painful manner possible.
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2.Where a dog, cat or non-human
primate is transferred from one establishment to another before it is weaned, and it is not practicable to mark it beforehand, a full documentary record, specifying in particular its mother, must be maintained by the receiving establishment until it is so marked.
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3.Where an unmarked dog, cat or non-
human primate is taken into an establishment for the first time it shall be marked as soon as possible.
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4.The establishment shall provide, on
request by the competent authority, reasons for the animal being unmarked.
Article 32 Article 32
Care and accommodation Care and accommodation
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1.Member States shall, as far as the care and accommodation of animals is Amendment 99 10605/09
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concerned, ensure the following: Article 32 paragraph 1 point a (a) all animals are provided with (a) all animals are provided with
accommodation, an environment, at least some freedom of movement, food, water and care which are appropriate to their health and well-being; accommodation, an environment, freedom of movement, food, water and care which are appropriate to their health and well-being and which allow them to satisfy their ethological as well as physical needs; (b) any restrictions on the extent to
which an animal can satisfy its physiological and ethological needs are limited to a minimum;
(c) the environmental conditions in
Amendment 100
which animals are bred, kept or used are checked daily; Article 32 paragraph 1 point d (d) the well-being and state of health of
(d) the well-being and state of health
of animals are observed by a competent person to prevent pain or avoidable suffering, distress or lasting harm; animals are observed by a competent person at least once a day to prevent pain or avoidable suffering, distress or lasting harm; (e) arrangements are made to ensure Amendment 101
Article 32 paragraph 1 point e
(e) arrangements are made to ensure that
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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 the dates provided for in that Annex.
Amendment 102
Article 32 paragraph 3
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3.Member States may allow exemptions 3. Member States may allow exemptions
to paragraph 2 for animal welfare reasons. to paragraph 2 for justified scientific reasons, veterinary reasons or animal welfare reasons.
Amendment 168
Article 32 paragraph 3 a (new)
3a. In those procedures whose purpose is
described in Article 5(2)(ba), the animal species of agricultural interest listed in Annex IVa may be housed in normal breeding conditions as defined by the current agricultural practices of the Member States and the applicable rules.
Section 3 Inspections Article 33 Article 33
ational inspections ational inspections
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1.Member States shall ensure that all breeding, supplying and user
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establishments are subject to inspections on the compliance of those establishments with this Directive. Amendment 103
Article 33 paragraph 2 subparagraph 1
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2.National inspections shall be carried 2. National inspections shall be carried
out by the competent authority at least twice a year. At least one of the inspections shall be unannounced. out by the competent authority on average once a year, with the competent authority adapting the frequency of inspection on the basis of a risk analysis for each establishment. 3. Member States shall ensure that the Amendment 104
Article 33 paragraph 3
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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. 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
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4.Records of all inspections shall be kept regulations in force.
Amendment 105
Article 33 paragraph 4
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4.Records of all inspections, including
for at least five years. details of any failure to meet the requirements of this Directive, shall be kept by each Member State's competent authority for at least five years. 5. Member States shall ensure that an
appropriate infrastructure with sufficient numbers of trained inspectors is in place to carry out inspections.
-
6.Member States shall establish
programmes for joint inspections by Member States.
Article 34 Article 34
Controls of national inspections Controls of national inspections
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1.The Commission may undertake Amendments 186 and 176 Article 34 paragraph 1
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1.The Commission shall undertake
controls of the infrastructure and operation of national inspections in Member States. controls of the infrastructure and operation of national inspections as well as of the correct application of 10605/09
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2.The Member State in the territory 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. which the control is being carried out shall give all necessary assistance to the experts of the Commission in carrying out their duties. The Commission shall inform the competent authority of the Member State concerned of the results of the control.
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3.The competent authority of the
Member State concerned shall take measures to take account of the results of the control.
Section 4 Requirements for projects Article 35 Article 35
Authorisation of projects Authorisation of projects
Amendment 167 10605/09
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1.Member States shall ensure that Article 35 paragraph 1 1. Member States shall ensure that
projects are not carried out without a prior authorisation by the competent authority. projects classified as "moderate" or "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 in advance to the competent authority following ethical review by the institution's permanent ethical review body. 2. Granting of authorisation shall be
Amendment 108
Article 35 paragraph 2
-
2.Granting of authorisation shall be
subject to favourable ethical evaluation by the competent authority. subject to favourable independent ethical and scientific evaluation by the competent authority.
Article 36 Article 36
Application for the project authorisation Application for the project authorisation
-
1.The user establishment shall submit an Amendment 109 Article 36 paragraph 1 introductory part
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1.When required, the user establishment
application for the project authorisation, which shall include the following: or the person scientifically responsible for the project shall submit an application for the project authorisation, which shall include the
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following:
(a) project proposal; (b) non-technical project summary; (c) information on the elements set Amendment 110
Article 36 paragraph 1 point ca (new)
out in Annex VII.
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2.Member States may waive the (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.
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 mild" and does not use non-human primates.
Article 37 Article 37
Ethical evaluation Ethical evaluation
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1.The ethical evaluation shall verify that Amendment 111 Article 37 paragraph 1 point a
the project meets the following criteria: (a) the project is scientifically (a) the project is scientifically justified, justified or required by law; indispensable and ethically defensible; Amendment 112
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Article 37 paragraph 1 point b (b) the purposes of the project justify the
(b) the purposes of the project justify
the use of animals; use of animals and cannot be achieved through other methods or procedures; (c) the project is designed so as to
Amendment 113
Article 37 paragraph 1 point c
(c) the project is designed so as to enable
enable procedures to be carried out in the most humane and environmentally sensitive manner. procedures to be carried out with maximum respect for animal welfare and in the most environmentally sensitive manner. 2. The ethical evaluation shall consider in
particular the following: (a) an evaluation of the objectives of
the project, the predicted scientific benefits or educational value;
(b) an assessment of compliance of
the project with the requirement of replacement, reduction and refinement;
Amendment 114
(c) an assessment of the classification Article 37 paragraph 2 point d of the severity of procedures; (d) a harm-benefit analysis of the project, (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 to assess whether the harm to the animals in terms of suffering, pain and distress, and to the environment, where appropriate, is ethically defensible in light of the expected advancement of
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expected advancement of science that ultimately benefits human beings, animals or the environment; science that may ultimately benefit human beings, animals or the environment;
(e) an assessment of any scientific Amendment 115
justification referred to in Articles 6, 7, 8, 9, 10, 12, 14 and 16. Article 37 paragraph 3 introductory sentence
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3.The competent authority carrying out 3. The competent authority carrying out the
the ethical evaluation shall consider experts in particular in the following areas: ethical evaluation shall consider corresponding expertise in particular in the following areas: (a) the areas of scientific use for which animals will be used;
(b) experimental design, including
statistics where appropriate;
(c) veterinary practice in laboratory
animal science or wildlife veterinary practice where appropriate;
(d) animal husbandry and care, in
relation to the species that are intended to be used;
(e) practical application of the
requirement of replacement, reduction and refinement;
(f) applied ethics; (g) environmental science, where
Amendment 116
appropriate. Article 37 paragraph 4
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4.Ethical evaluation shall be performed 4. Ethical evaluation shall be performed in 10605/09
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in a transparent manner, by integrating the opinion of independent parties. a transparent manner by integrating independent expertise whilst safeguarding intellectual property and confidential information as well as the safety of goods and persons. Article 38 Article 38
Retrospective assessment Retrospective assessment
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1.The ethical evaluation shall determine, Amendment 117 Article 38 paragraph 1 subparagraph 1
-
1.The competent authority carrying out
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 by the competent authority. 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.
If a retrospective assessment is deemed appropriate, the ethical evaluation shall determine, in relation to the project concerned, the deadline by which the retrospective assessment is to take place.
Amendment 118
Article 38 paragraph 2 introductory
sentence
-
2.Retrospective assessment shall 2. Retrospective assessment shall
evaluate the following: (a) whether the objectives of the establish the following:
project were achieved;
(b) harm inflicted on animals
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including the numbers and species of animals used and the severity of the procedures; Amendment 119 Article 38 paragraph 2 point c
(c) whether there are elements that may
(c) elements that may contribute to
the further implementation of the requirement of replacement, reduction and refinement. contribute to the further implementation of the requirement of replacement, reduction and refinement. 3. All projects using non-human primates shall undergo a retrospective assessment.
Amendment 120
-
4.Without prejudice to paragraph 3, all Article 38 paragraph 4 4. All projects involving only procedures
projects involving only procedures classified as "up to mild" shall be exempted from the requirement for a retrospective assessment. classified as "up to moderate" shall be exempted from the requirement for a retrospective assessment. Article 39 Article 39
Records of ethical evaluation Records of ethical evaluation
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1.The establishment shall keep records
of ethical evaluation for at least three years from the expiry date of authorisation of the project and shall submit those records to the competent authority upon request.
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2.However, records of ethical evaluation
for projects which have to undergo retrospective assessment shall be kept
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until the retrospective assessment has been completed.
Article 40 Article 40
on-technical project summaries on-technical project summaries
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1.Subject to safeguarding confidential Amendment 121 Article 40 paragraph 1 introductory
phrase
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1.Subject to safeguarding confidential
information, the non-technical project summary shall provide the following: information, establishment and personnel details, 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; Amendment 122
Article 40 paragraph 1 point b
(b) a demonstration that the principles of
(b) a demonstration of compliance
with the requirement of replacement, reduction and refinement. replacement, reduction and refinement have been observed where practicable.
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2.On the basis of the results of the ethical
evaluation, the user establishment shall specify in the non-technical project summary whether a project is to undergo a retrospective assessment and by which deadline.
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3.The user establishment shall update the
non-technical project summary with the results of retrospective assessment. Amendment 123 Article 40 paragraph 4
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4.Member States shall make publicly 4. Member States shall make publicly
available the non-technical project summaries of authorised projects and any updates to them. available anonymous versions of the non-technical project summaries of authorised projects and any updates to them.
Amendment 178
Article 40 paragraph 4 a (new)
4a. Subject to the safeguarding of
confidential and personal information, Member States shall make publicly available non-personal information regarding infringements of this Directive, national laws and authorisations.
Article 41 Article 41
Granting of project authorisation Granting of project authorisation
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1.The project authorisation shall be
limited to the procedures which have been subject to an ethical evaluation and to the severity classifications assigned to those procedures.
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2.The project authorisation shall identify
the following:
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(a) the persons in the establishment responsible for the overall implementation of the project;
(b) the user establishments in which
the project will be undertaken;
(c) in the case of field studies, the user
establishment which is responsible for the project;
(d) at least one person demonstrating
species specific knowledge. Amendment 124
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3.Project authorisations shall be granted Article 41 paragraph 3 3. Project authorisations shall be granted
for a period not exceeding four years. for a period not exceeding five years. 4. Member States may allow the Amendment 125
Article 41 paragraph 4
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4.Member States may allow the
authorisation of multiple projects when those projects are required by law. authorisation of multiple projects when those projects are required by law, or when standardised procedures are applied, the ethical evaluation of which has already produced a positive result. 5. User establishments shall keep records
of all project authorisations for at least three years from the expiry date of the authorisation and shall submit those records to the authority upon request.
Article 42 Article 42
Amendment, renewal and withdrawal of a Amendment, renewal and withdrawal of a 10605/09
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project authorisation project authorisation
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1.The competent authority may amend or Amendment 126 Article 42 paragraph 1
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1.The competent authority may amend or
renew the project authorisation on the request of the user establishment. renew the project authorisation on the request of the user establishment or the person in charge of the project. 2. Any amendment or renewal of a
Amendment 127
Article 42 paragraph 2
-
2.Any amendment or renewal of a project
project authorisation shall be subject to a further favourable ethical evaluation. authorisation shall be subject to a further ethical evaluation. Amendment 128
Article 42 paragraph 2a (new)
2a. Amendments to mild or moderate
procedures that do not increase the severity of the procedure may be made by the permanent ethical review body but must be communicated to the competent authority within one week of such change.
Amendment 129
Article 42 paragraph 3
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3.The competent authority may withdraw 3. The competent authority may withdraw
the project authorisation where the project is not carried out in accordance with the project authorisation. the project authorisation where the project is not carried out in accordance with the project authorisation and may cause a deterioration in animal welfare standards. 4. Where a project authorisation is
withdrawn, the welfare of the animals used or intended to be used in the project shall not be adversely affected.
-
5.Member States shall establish and
publish detailed conditions for amendment and renewal of project authorisations.
Article 43 Article 43
Authorisation decisions Authorisation decisions
-
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, where the project concerned involves only procedures classified as "up to mild" and non-human primates are not used. In all other cases, no such presumption
Amendments 131 and 187
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shall apply. Article 43 paragraph 2 2. deleted otwithstanding paragraph 1, in
exceptional circumstances and where the project is non-routine, multidisciplinary 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.
CHAPTER V AVOIDANCE OF DUPLICATION AND ALTERNATIVE APPROACHES Article 44 Article 44
Unnecessary duplication of procedures Unnecessary duplication of procedures
-
1.Each Member State shall accept data Amendment 132 Article 44 paragraph 1
-
1.Each Member State shall accept from
that are required by law and generated by procedures recognised by Community legislation from another Member State, unless further procedures need to be carried out regarding that data for the protection of public health, safety or the environment. another Member State data that are generated by procedures recognised by, or which take place under, Community legislation.
Amendment 180
Article 44 paragraph 2
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2.Outside the area of testing required by 2. Member States shall ensure the sharing
law, subject to safeguarding confidential information, the Member States shall ensure the sharing of data generated by procedures. 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.
Amendment 134
Article 44 paragraph 2 a (new)
2a. Subject to the safeguarding of
confidential information, 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 the Directive. A person seeking to rely on data owned by another shall where appropriate contribute towards the intrinsic cost of such data.
Amendment 135
Article 44 paragraph 2 b (new)
2b. Before applying for a project
authorisation, a person intending to carry out a procedure must take all
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reasonable steps to ascertain whether data relevant to the proposed project already exists and, if so, to access such data (including contributing towards the cost thereof), and Member States shall similarly verify whether such data exists before granting an authorisation.
Amendment 136
Article 44 paragraph 2 c (new)
2c. Member States shall not authorise a
procedure where a person has not taken reasonable steps to comply with paragraph 2b.
Amendment 137
Article 44 paragraph 2 d (new)
2d. Where relevant data is reasonably
available, Member States shall only grant authorisation for a project where this is necessary for the protection of the public.
Article 45 Article 45
Alternative approaches Alternative approaches
Amendment 138 Article 45
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The Commission and Member States shall contribute to the development and 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. The Commission and Member States shall contribute financially and otherwise to the development and, where appropriate, the scientific validation of alternative approaches intended to provide a comparable 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. It is appropriate to establish large-scale veterinary biobanks to support the principles of replacement, reduction and refinement using surplus tissue taken as part of clinical procedures.
Article 45a European Centre for the Validation of
Alternative Methods
Amendment 139 Article 45a (new)
The remit of the European Centre for the Validation of Alternative Methods shall be extended so that it includes the coordination and promotion of the development and use of alternatives to animal procedures including applied and
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basic biomedical research and veterinary research and regulatory testing by performing the following functions: (a) coordinate research undertaken to
facilitate the development of alternatives to animal procedures by the ational Centres for Alternative Methods described in Article 46;
(b) conduct research to facilitate the
development of alternatives to animal procedures;
(c) commission research in fields likely to
yield information that will facilitate the replacement, reduction or refinement of animal procedures;
(d) in consultation with relevant
stakeholders, create and implement strategies to replace, reduce and refine animal procedures;
(e) make available information on
alternatives to animal procedures through regular reporting to the public, to stakeholders and to Member State authorities;
(f) provide databases to facilitate the
exchange of relevant information including information on available alternative methods and information contributed voluntarily by researchers which would otherwise remain
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unpublished, but which could prevent duplication of unsuccessful animal studies;
(g) coordinate pre-validation and
validation studies undertaken by the
ational Centres for Alternative
Methods in accordance with Article 46 of this Directive;
(h) conduct validation and pre-validation
studies where appropriate;
(i) in consultation with relevant
regulatory bodies and stakeholders, create and implement strategies to replace, reduce and refine animal tests used for regulatory purposes;
(j) facilitate the scientific endorsement
and regulatory acceptance of alternatives to animal tests used for regulatory purposes;
(k) inform relevant regulatory authorities
when pre-validation and validation studies begin, and when alternative test methods achieve scientific endorsement and regulatory acceptance, and make this information available to the public and stakeholders through dedicated websites.
Article 46 Article 46
ational reference laboratories for ational reference laboratories for 10605/09
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alternative methods alternative methods
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1.Each Member State shall, by [one year Amendment 140 Article 46 paragraph 1
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1.Each Member State shall, by [one year
after entry into force of this Directive], designate a national reference laboratory for the validation of alternative methods replacing, reducing and refining the use of animals. after entry into force of this Directive], 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. 2. Member States may only designate as
national reference laboratories those that are accredited in accordance with Directive 2004/10/EC.
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3.The national reference laboratories shall fulfil the following requirements: (a) they shall have suitably qualified
staff with adequate training in alternative methods and validation process and techniques applied in their area of competence;
(b) they shall possess the equipment
and products needed to carry out the tasks assigned to them;
(c) they shall have an appropriate
administrative infrastructure;
(d) they shall ensure that their staff
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respect the rules on confidentiality. 4. The national reference laboratories
shall perform the following functions: Amendment 141 Article 46 paragraph 4 point a
(a) cooperate with the Commission in (a) cooperate with the Commission in
their area of competence; their area of competence and perform tasks to advance strategies for replacing animal procedures; (b) participate in pre-validation and
Amendment 142
Article 46 paragraph 4 point b
(b) participate in pre-validation and
validation of alternative methods under the co-ordination of the Commission; validation of alternative methods, where appropriate, under the coordination of the Commission; (c) communicate information on the
availability and application of alternative methods received from the Commission to the relevant authorities of the Member State;
Amendment 143
Article 46 paragraph 4 point d
(d) provide scientific and technical
(d) provide scientific and technical
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methods; acceptance and implementation of alternative methods; (e) provide training on the use of
Amendment 144
Article 46 paragraph 4 point e
(e) provide training on the use of
alternative methods to persons referred to in Article 20(1). alternative methods to persons referred to in Article 20(1) and, if required, to user establishments. 5. National reference laboratories shall
Amendment 145
Article 46 paragraph 4 point e a (new)
ea) communicate developments on
alternative methods and inform the public of positive and negative outcomes.
Amendment 193
Article 46 paragraph 4 a (new)
4a. The national centres shall work with
all relevant stakeholders to further the aim of replacing all animal procedures.
declare any conflict of interest on any task being undertaken.
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6.Each Member State shall communicate
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the name and address of their reference laboratory to the Commission. The Commission shall make publicly available the list of national reference laboratories.
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7.After consulting the national reference
laboratories, the Commission shall set the priorities for the validation studies and allocate the tasks between those laboratories for carrying out those studies.
Article 47 Article 47
ational animal welfare and ethics ational animal welfare and ethics committee committee
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1.Each Member State shall establish a
national animal welfare and ethics committee that shall advise the competent authorities and permanent ethical review bodies in matters dealing with the acquisition, breeding, accommodation, care and use of animals in procedures and ensure sharing of best practices.
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2.The national animal welfare and ethics
committees shall exchange information on the operation of permanent ethical review bodies and ethical evaluation and share best practices within the
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Community.
CHAPTER VI FINAL PROVISIONS Article 48 Article 48
Adaptation of annexes to technical Adaptation of annexes to technical progress progress
The Commission may adapt Annexes II to VII to technical and scientific progress. Those measures, designed to amend nonessential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 51(4). Article 49 Reporting Article 49 Reporting
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1.Member States shall by [within six
years from transposition date], and every five years thereafter, send the information on the implementation of this Directive and in particular Articles 10(1), 25 , 27, 33, 37, 38, 40 and 44 thereof to the Commission.
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2.Member States shall collect and make
publicly available, on an annual basis, statistical information on the use of animals in procedures, including
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information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures. Member States shall submit that statistical information to the Commission by [three years from transposition date] and every year thereafter. Amendment 147
Article 49 paragraph 2 subparagraph 2
Member States shall make that statistical information publicly available and submit it to the Commission by [three years from transposition date] and thereafter at intervals not exceeding two years.
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3.The Commission shall by [within 18
months from the entry into force of this Directive] establish a common format for submitting the information referred to in paragraph 2 in accordance with the regulatory procedure referred to in Article 51(2).
Article 50 Article 50
Safeguard clause Safeguard clause
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1.Where a Member State has justifiable
grounds for believing that action is essential for the preservation of the species or in relation to an unexpected outbreak of a life-threatening or debilitating clinical condition in human beings, it may authorise the use of great apes in procedures having one of the purposes referred to in Article 5(2)(a), (3) or 5; provided that the
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purpose of the procedure cannot be achieved by the use of other species than great apes or by the use of alternative methods. However, the reference to Article 5(2)(a) shall not be taken to include the reference to animals or plants.
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2.The Member State shall immediately
inform the Commission and the other Member States thereof, giving reasons for its decision and submitting evidence of the situation as described in paragraph 1 on which the provisional measure is based.
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3.The Commission shall take a decision
in accordance with the procedure referred to in Article 51(2) within 60 days of receipt of the information from the Member State. This decision shall either: (a) authorise the provisional measure
for a time period defined in the decision; or
(b) require the Member State to
revoke the provisional measure.
Article 51 Article 51 Committee Committee
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Committee.
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2.Where reference is made to this
paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
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3.The period laid down in Article 5(6) of
Decision 1999/468/EC shall be set at three months.
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4.Where reference is made to this
paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 52 Article 52
Commission report Commission report
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1.By [seven years after transposition
date] and every five years thereafter , the Commission shall, based on the information received from the Member States under Article 49(1), submit to the European Parliament and the Council a report on the implementation of this Directive.
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2.By [seven years after transposition
date] and every three years thereafter
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the Commission shall, based on the statistical information submitted by Member States under Article 49(2), submit to the European Parliament and the Council a summary report on that information.
Article 53 Article 53 Review Review
The Commission shall review this Directive by [10 years after the date of entry into force] taking into account advancement in development of alternative methods not entailing the use of animals, and in particular of non-human primates, and propose any amendments, where appropriate. Amendment 148 Article 53
The Commission shall review this Directive by [5 years after the date of entry into force] taking into account advancement in development of alternative methods not entailing the use of animals, and in particular of non-human primates, and propose any amendments, where appropriate.
Article 53a Thematic review
Amendment 194 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 two years after the entry into force of this Directive. The
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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 lifethreatening 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.
Article 54 Article 54
Competent authorities Competent authorities
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1.Each Member State shall designate one
or more competent authorities responsible for the implementation of this Directive. Member States may designate bodies other than public authorities for the implementation of this Directive. Bodies thus designated shall be considered competent authorities for
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the purposes of this Directive.
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2.Member States shall inform the
Commission of the names and addresses of the competent authorities by [three months after Entry into Force of this Directive], at the latest. Member States shall inform the Commission of any changes to the names and addresses of the competent authorities. The Commission shall make publicly available the list of the competent authorities.
Article 55 Article 55 Penalties Penalties
The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by [(the date specified in Article 56)] at the latest and shall notify the Commission without delay of any subsequent amendment affecting them. 10605/09
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Article 56 Article 56
Transposition Transposition
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1.Member States shall adopt and publish,
by [18 months from the Entry into Force of this Directive] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions from [1 January of the year following the date of transposition as specified in the first subparagraph].
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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2.Member States shall communicate to
the Commission the text of the main
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provisions of national law which they adopt in the field covered by this Directive.
Article 57 Article 57 Repeal Repeal
Directive 86/609/EEC is repealed with effect from [the date referred to in the second subparagraph of Article [56(1)]. References to the repealed Directive shall be construed as references to this Directive. Article 58 Article 58
Transitional provisions Transitional provisions
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1.Member States shall not apply laws;
regulations and administrative provisions adopted in accordance with Articles 35 to 43 to projects which have been started before [the date referred to in the second subparagraph of Article [56(1)] and the duration of which does not extend beyond [three years after the date referred to in the second subparagraph of Article [56(1)].
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2.Projects which have been started
before [the date referred to in the second subparagraph of Article [56(1)] and the duration of which extends beyond [three years after the date
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referred to in the second subparagraph of Article [56(1)] shall obtain project authorisation by [three years after the date referred to in the second subparagraph of Article [56(1)].
Article 59 Article 59
Entry into force Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 60 Article 60 Addressees Addressees
This Directive is addressed to the Member States. Done at Brussels, For the European Parliament The President For the Council The President
ANNEX: see Commission proposal
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- 5 nov '08COM(2008)543 - Bescherming van dieren die voor wetenschappelijke doeleinden worden gebruikt
- 18 sep '08COM(2008)553 - Bescherming van dieren bij het doden
- 26 sep '02COM(2002)530 - Voorstel voor een Richtkijn van het Europees Parlement en de Raad betreffende de harmonisatie van nationale wetgevinginzake de toepassing van de beginselen van goede laboratoriumpraktijken en het toezicht op de toepassing ervan voor tests op chemische stoffen
- 24 jun '98COM(1998)380 - Voorwaarden voor de uitoefening van de aan de Commissie verleende uitvoeringsbevoegdheden
- 13 nov '91COM(1991)448 - Bepalingen inzake het bezit van en de handel in specimens van in het wil levende dier- en plantesoorten
- 18 dec '85COM(1985)637 - Bescherming van dieren die voor experimentele en andere wetenschappelijke doeleinden worden gebruikt
- 6 okt '72COM(1972)851 - Harmonisatie van nationale wetgeving met betrekking tot kosmetische produkten
