32 Amendments of Heinz KINDERMANN related to 2008/0211(COD)
Amendment 163 #
Proposal for a directive
Article 2 – paragraph 2 – point a
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;
Amendment 169 #
Proposal for a directive
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) live invertebrate animals, including independently feeding larval forms, of those species listed in Annex I.;
Amendment 175 #
Proposal for a directive
Article 4 – paragraph 1
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.
Amendment 187 #
Proposal for a directive
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4a. the protection of human health in the context of workers' or consumers' exposure to chemicals;
Amendment 198 #
Proposal for a directive
Article 7 – paragraph 1 – point a
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;
Amendment 199 #
Proposal for a directive
Article 7 – paragraph 1 – point a a (new)
Article 7 – paragraph 1 – point a a (new)
(aa) as far as possible, the animals used should be bred specifically for testing purposes;
Amendment 203 #
Proposal for a directive
Article 8 – paragraph 1 – introductory phrase
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:
Amendment 204 #
Proposal for a directive
Article 8 – paragraph 1 – point a
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;
Amendment 208 #
Proposal for a directive
Article 8 – paragraph 1 – point b
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.
Amendment 216 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 2
Article 10 – paragraph 1 – subparagraph 2
Amendment 226 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Member States shall ensure that a procedure is not carried out if another scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an animal, is recognised by Community legislation. In the absence of such a method, a procedure may not be carried out if a scientifically satisfactory method or testing strategy for obtaining the result sought, including computer supported, in vitro and other methodologies, not entailing the use of an animal, is reasonably and practicably available.
Amendment 240 #
Proposal for a directive
Article 15 – paragraph 2
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.
Amendment 248 #
Proposal for a directive
Article 16 – paragraph 1 – introductory phrase
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.
Amendment 252 #
Proposal for a directive
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 255 #
Proposal for a directive
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 256 #
Proposal for a directive
Article 16 – paragraph 1 – point b a (new)
Article 16 – paragraph 1 – point b a (new)
(ba) the distress suffered by the animal in the course of a new procedure is less than the distress suffered in the course of the previous procedure or less than the distress which would be suffered by a new animal;
Amendment 257 #
Proposal for a directive
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
Amendment 262 #
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
Amendment 264 #
Proposal for a directive
Article 17 – paragraph 1
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.
Amendment 271 #
Proposal for a directive
Article 20 – paragraph 3
Article 20 – paragraph 3
Amendment 277 #
Proposal for a directive
Article 25 – paragraph 1
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.
Amendment 304 #
Proposal for a directive
Article 35 – paragraph 2a (new)
Article 35 – paragraph 2a (new)
2a. Member States may permit exceptions from the authorisation requirement for projects required by law.
Amendment 307 #
Proposal for a directive
Article 36 –paragraph 1 – point ca (new)
Article 36 –paragraph 1 – point ca (new)
(ca) a scientifically justified statement that the research project is indispensable and ethically defensible and that the purposes of the project cannot be achieved using other methods or procedures.
Amendment 313 #
Proposal for a directive
Article 37 – paragraph 1 – introductory sentence
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:
Amendment 317 #
Proposal for a directive
Article 37 – paragraph 1 – point b
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;
Amendment 318 #
Proposal for a directive
Article 37 – paragraph 1 – point c
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.
Amendment 322 #
Proposal for a directive
Article 37 – paragraph 3 – introductory sentence
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:
Amendment 324 #
Proposal for a directive
Article 37 – paragraph 4
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.
Amendment 332 #
Proposal for a directive
Article 38 – paragraph 2 – point c
Article 38 – paragraph 2 – point c
(c) whether there are elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.
Amendment 346 #
Proposal for a directive
Article 41 – paragraph 4
Article 41 – paragraph 4
4. Member States may allow the authorisation of multiple projects when those projects are required by law, or when standardised procedures are applied, the ethical assessment of which has already produced a positive result.
Amendment 356 #
Proposal for a directive
Article 43 – paragraph 1
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.
Amendment 360 #
Proposal for a directive
Article 43 – paragraph 2
Article 43 – paragraph 2