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Activities of Elisabeth JEGGLE related to 2008/0211(COD)

Plenary speeches (4)

Protection of animals used for scientific purposes (debate)
2016/11/22
Dossiers: 2008/0211(COD)
Protection of animals used for scientific purposes (debate)
2016/11/22
Dossiers: 2008/0211(COD)
Protection of animals used for scientific purposes (debate)
2016/11/22
Dossiers: 2008/0211(COD)
Protection of animals used for scientific purposes (A7-0230/2010, Elisabeth Jeggle) (vote)
2016/11/22
Dossiers: 2008/0211(COD)

Reports (1)

REPORT Recommendation for second reading on the Council position at first reading with a view to the adoption of a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes PDF (133 KB) DOC (73 KB)
2016/11/22
Committee: AGRI
Dossiers: 2008/0211(COD)
Documents: PDF(133 KB) DOC(73 KB)

Amendments (37)

Amendment 163 #
Heinz KINDERMANN, Elisabeth JEGGLE
Proposal for a directive
Article 2 – paragraph 2 – point a
(a) live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms as from the last third of their normal development;
2009/03/16
Committee: AGRI
Amendment 169 #
Heinz KINDERMANN, Elisabeth JEGGLE
Proposal for a directive
Article 2 – paragraph 2 – point b
(b) live invertebrate animals, including independently feeding larval forms, of those species listed in Annex I.;
2009/03/16
Committee: AGRI
Amendment 175 #
Elisabeth JEGGLE, Michl EBNER, Heinz KINDERMANN
Proposal for a directive
Article 4 – paragraph 1
1. Where an internationally accepted and validated method of testing not involving the use of animals exists and may be used in placestead of a procedure, Member States shall ensure that the alternative method is used. Pursuant to this Directive, testing methods which involve the use of human embryonic and foetal cells shall not be regarded as alternatives.
2009/03/16
Committee: AGRI
Amendment 187 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 5 – paragraph 4 a (new)
4a. the protection of human health in the context of workers' or consumers' exposure to chemicals;
2009/03/16
Committee: AGRI
Amendment 198 #
Heinz KINDERMANN, Elisabeth JEGGLE
Proposal for a directive
Article 7 – paragraph 1 – point a
(a) the procedure has one of the purposes referred to in points (2)(a1), (2), (3) or (5) of Article 5;
2009/03/16
Committee: AGRI
Amendment 199 #
Heinz KINDERMANN, Elisabeth JEGGLE
Proposal for a directive
Article 7 – paragraph 1 – point a a (new)
(aa) as far as possible, the animals used should be bred specifically for testing purposes;
2009/03/16
Committee: AGRI
Amendment 203 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 8 – paragraph 1 – introductory phrase
1. NGiven their particularly high level of neurophysiological sensitivity and cognitive development, non-human primates shall not be used in procedures, with the exception of those procedures meeting the following conditions:
2009/03/16
Committee: AGRI
Amendment 204 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 8 – paragraph 1 – point a
(a) the procedure has one of the purposes referred to in points (1), (2)(a), (3) and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of life- threatening or debilitating clinical conditions in human beings or the purpose referred to in pointor (5) of Article 5;
2009/03/16
Committee: AGRI
Amendment 208 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 8 – paragraph 1 – point b
(b) there i applicant provides a scientific justification that the purpose of the procedure cannot be achieved by the use of other species than non-human primates.
2009/03/16
Committee: AGRI
Amendment 223 #
Elisabeth JEGGLE
Proposal for a directive
Article 11 a (new)
Article 11a Training For higher education and training purposes, the cadavers, tissue and organs of animals may be used only if they come from animals slaughtered in accordance with the provisions of Council Regulation (EC) No .../2009 [on the protection of animals at the time of killing]1. 1 OJ L .... [COM(2008)0553].
2009/03/16
Committee: AGRI
Amendment 227 #
Elisabeth JEGGLE, Michl EBNER
Proposal for a directive
Article 13 – paragraph 1
1. Member States shall ensure that a procedure is not carried out if another scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an animal, is recognised by Community legislationinternationally accepted and validated. 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. In no case shall a Member State be obliged to abandon animal testing if the only alternative testing method involves the use of human embryonic or foetal cells.
2009/03/16
Committee: AGRI
Amendment 240 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 15 – paragraph 2
2. Member States shall ensure that the procedures which are classified as "severe" are not performed ifnd which are likely to prolong the pain, suffering or distress is likely to be prolongedare performed only if it has been scientifically proven that the testing purpose cannot be achieved in another way and a positive ethical assessment has been carried out.
2009/03/16
Committee: AGRI
Amendment 248 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 16 – paragraph 1 – introductory phrase
1. Member States shall ensure that an animal already used in a procedure, when a different animal on which no procedures hasve previously been carried out could also be used, may be re-used in asubsequent unconnected new procedures only when all of the following conditions are met:it is established that it serves the principles of avoiding, reducing and refining animal experiments.
2009/03/16
Committee: AGRI
Amendment 252 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 16 – paragraph 1 – point a
(a) the previous procedure was classified as 'up to mild';deleted
2009/03/16
Committee: AGRI
Amendment 255 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 16 – paragraph 1 – point b
(b) it is demonstrated that its general state of health and well-being has been fully restordeleted;
2009/03/16
Committee: AGRI
Amendment 257 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 16 – paragraph 1 – point c
(c) the further procedure is classified as 'up to mild' or 'non-recovery'.deleted
2009/03/16
Committee: AGRI
Amendment 262 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 16 – paragraph 2
2. By way of derogation from paragraph 1, the competent authority, on the basis of scientific justification, may allow re-use of an animal 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'.deleted
2009/03/16
Committee: AGRI
Amendment 264 #
Heinz KINDERMANN, Elisabeth JEGGLE
Proposal for a directive
Article 17 – paragraph 1
1. A procedure shall be deemed to end when no further observations are to be made for that procedure or, as regards new genetically modified animal lines, when lack of adverse effects to animals can be scientifically demonstratthe second breeding generation is reached.
2009/03/16
Committee: AGRI
Amendment 277 #
Heinz KINDERMANN, Elisabeth JEGGLE
Proposal for a directive
Article 25 – paragraph 1
1. Member States shall ensure that each breeding, supplying and user establishment sets up a permanentnames a qualified person who is responsible for ethical review body.
2009/03/16
Committee: AGRI
Amendment 304 #
Heinz KINDERMANN, Elisabeth JEGGLE
Proposal for a directive
Article 35 – paragraph 2a (new)
2a. Member States may permit exceptions from the authorisation requirement for projects required by law.
2009/03/16
Committee: AGRI
Amendment 307 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 36 –paragraph 1 – point ca (new)
(ca) a scientifically justified statement that the research project is indispensable and ethically defensible and that the purposes of the project cannot be achieved using other methods or procedures.
2009/03/16
Committee: AGRI
Amendment 313 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 37 – paragraph 1 – introductory sentence
1. The ethical evaluationBefore authorisation is granted, it shall be verifyied that the project as described and scientifically justified by the applicant meets the following criteria:
2009/03/16
Committee: AGRI
Amendment 315 #
Elisabeth JEGGLE
Proposal for a directive
Article 37 – paragraph 1 – point a
(da) the project is scientifically justified or required by law, indispensable and ethically defensible;
2009/03/16
Committee: AGRI
Amendment 317 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 37 – paragraph 1 – point b
(fb) the purposes of the project justify the use of animals and cannot be achieved through other methods or procedures;
2009/03/16
Committee: AGRI
Amendment 318 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 37 – paragraph 1 – point c
(gc) the project is designed so as to enable procedures to be carried out win the most humane andaximum respect for animal welfare and in the most environmentally sensitive manner.
2009/03/16
Committee: AGRI
Amendment 320 #
Elisabeth JEGGLE
Proposal for a directive
Article 37 – paragraph 2 – point d
(d) a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress, and to the environment, where appropriate, is justifiedethically defensible by the expected advancement of science that ultimately benefits human beings, animals or the environment;
2009/03/16
Committee: AGRI
Amendment 322 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 37 – paragraph 3 – introductory sentence
3. The competent authority carrying out the ethical evaluation shall consider corresponding expertsise in particular in the following areas:
2009/03/16
Committee: AGRI
Amendment 324 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 37 – paragraph 4
4. Ethical evaluation shall be performed in a transparent manner, by integrating the opinion of independent partiesby integrating independent expertise whilst safeguarding intellectual property and confidential information.
2009/03/16
Committee: AGRI
Amendment 328 #
Elisabeth JEGGLE
Proposal for a directive
Article 38 – paragraph 1 – subparagraph 1
1. 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 beenOn the basis of the final report, a review of each project shall be conducted by the permanent ethical review body and the results shall be made available to the completed, bnt authority. On the bassessed retrospectively by the competent authorityis of those results, the competent authority may conduct its own review of each project.
2009/03/16
Committee: AGRI
Amendment 330 #
Elisabeth JEGGLE
Proposal for a directive
Article 38 – paragraph 1 – subparagraph 2
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.deleted
2009/03/16
Committee: AGRI
Amendment 331 #
Elisabeth JEGGLE
Proposal for a directive
Article 38 – paragraph 2 – introductory sentence
2. Retrospective assessment shall evaluateThe review shall establish the following:
2009/03/16
Committee: AGRI
Amendment 332 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 38 – paragraph 2 – point c
(c) whether there are elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.
2009/03/16
Committee: AGRI
Amendment 346 #
Heinz KINDERMANN, Elisabeth JEGGLE
Proposal for a directive
Article 41 – paragraph 4
4. Member States may allow the authorisation of multiple projects when those projects are required by law, or when standardised procedures are applied, the ethical assessment of which has already produced a positive result.
2009/03/16
Committee: AGRI
Amendment 356 #
Heinz KINDERMANN, Elisabeth JEGGLE
Proposal for a directive
Article 43 – paragraph 1
1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 360 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 shall apply.
2009/03/16
Committee: AGRI
Amendment 360 #
Elisabeth JEGGLE, Heinz KINDERMANN
Proposal for a directive
Article 43 – paragraph 2
2. Notwithstanding paragraph 1, in exceptional circumstances and where the project is non-routine, multi-disciplinary and innovative, the decision to grant an authorisation shall be taken and communicated to the user establishment within 60 days from the submission of the application.deleted
2009/03/16
Committee: AGRI
Amendment 385 #
Elisabeth JEGGLE
Proposal for a directive
Annexe I
Cyclostomes Cephalopods Decapod crustaceans of the infraorders Brachyura and Astacidea
2009/03/16
Committee: AGRI
Amendment 397 #
Elisabeth JEGGLE
Proposal for a directive
Annexe VII a (new)
ANNEX VIIa General Definitions of Degrees of Severity referred to in Article 15(1) In general: Unless the contrary is known or established it should be assumed that procedures that cause pain in humans also cause pain in animals. When determining the degree of severity of an intervention or procedure which is conducted on an animal a number of times (such as taking blood samples), it should not be automatically assumed that there is an accumulation of distress over time and that the degree of distress increases. The possibility of the distress decreasing as a result of familiarity and habituation, and the development of cooperative behaviour, should also be considered. No recovery: Severity Grade 0 Examples: - Experiments conducted under general anaesthesia without reawakening; - Putting to sleep humanely for the purpose of tissue retrieval. No pain or mild pain: Severity Grade 1 Interventions and manipulations in animals for experimental purposes as a result of which the animals experience no pain or short term mild pain, suffering, injury, or mild distress with no significant impairment of their general condition. Examples: – studies with differing feed compositions or with unphysiological diet, with minor clinical signs or symptoms. - keeping and training non-human primates with controlled access to food and drink and regular checks on state of health; - withdrawal of blood samples or injection (s.c., i.m., i.p., i.v.) of a drug. - repeated measurement of brain activity by means of transdural microelectrodes and appropriate habituation to the procedure; - superficial tissue biopsy and minimally invasive interventions under anaesthesia; – non-invasive scanning techniques, with or without sedation or anaesthesia of the animals – tolerability studies which give cause to expect short term, minor, local or systemic reactions – ECG recordings in conscious animals – observational studies such as open-field test, labyrinth tests, or staircase test – experiments under general anaesthesia without recovery Moderate: Severity Grade 2 Interventions and manipulations in animals for experimental purposes which subject the animals to short term moderate distress, or a moderately long to long-lasting episode of mild distress, pain, suffering, or injury, or significant impairment of general condition. Examples: – surgery under anaesthesia and appropriate analgesia – implantation of devices such as catheters, telemetry transmitters, minipumps under general anaesthesia – studies with unphysiological diet, with clinical signs or symptoms – untreated diabetes mellitus – frequent repeated blood sampling or administration of substances – induction of anxiety in animal models – acute toxicity tests, acute tolerability studies; range-finding studies, chronic toxicity/carcinogenicity tests with non- lethal endpoints – seizure models e.g. epilepsy studies – non-lethal animal models of cancer eg xenograft studies Moderate: Severity Grade 2 Interventions and manipulations in animals for experimental purposes which subject the animals to short term moderate distress, or a moderately long to long-lasting episode of mild distress, pain, suffering, or injury, or significant impairment of general condition. Examples: – surgery under anaesthesia and appropriate analgesia – implantation of devices such as catheters, telemetry transmitters, minipumps under general anaesthesia – studies with unphysiological diet, with clinical signs or – symptoms untreated diabetes mellitus – frequent repeated blood sampling or administration of substances – induction of anxiety in animal models – acute toxicity tests, acute tolerability studies; range-finding studies, chronic toxicity/carcinogenicity tests with non- lethal endpoints – seizure models e.g. epilepsy studies – non-lethal animal models of cancer eg xenograft studies Severe: Severity Grade 3 Interventions and manipulations in animals for experimental purposes which cause the animals severe to very severe distress, or subject them to a moderately long to long-lasting episode of moderate distress, severe pain, prolonged suffering or severe injury, or significant and persistent impairment of general condition. Examples: - lethal bacterial or viral infections if the studies extend to the symptomatic period of the infection; – chronic models of rheumatoid arthritis – genetically modified animals with lethal phenotypes (e.g. oncogenes), without early termination of the experiment – organ transplantation (eg. kidney, pancreas) – chronic models of severe neurological diseases, e.g. Parkinson’s disease
2009/03/16
Committee: AGRI
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