2008/0211(COD)

Protection of animals used for scientific purposes (repeal. Directive 86/609/EEC)

Procedure completed

2008/0211(COD) Protection of animals used for scientific purposes (repeal. Directive 86/609/EEC)
RoleCommitteeRapporteurShadows
Lead AGRI JEGGLE Elisabeth (EPP)
Lead AGRI PARISH Neil (PPE-DE)
Opinion ENVI MATSAKIS Marios (ALDE)
Opinion ITRE SEPPÄNEN Esko (GUE/NGL)
Lead committee dossier: AGRI/7/02658
Legal Basis TFEU TFEU 114-p1
Subjects
Links

Activites

  • 2010/10/20 Final act published in Official Journal
  • 2010/09/22 Final act signed
  • 2010/09/22 End of procedure in Parliament
  • 2010/09/08 Text adopted by Parliament, 2nd reading
    • T7-0308/2010 summary
    • Results of vote in Parliament
  • 2010/07/13 Committee recommendation tabled for plenary, 2nd reading
  • 2010/07/12 Vote in committee, 2nd reading
  • 2010/06/30 Committee draft report
  • 2010/06/17 Committee referral announced in Parliament, 2nd reading
  • 2010/06/15 Commission communication on Council's position
    • COM(2010)0324 summary
    • DG Environment, POTOČNIK Janez
  • #3018
  • 2010/06/03 Council Meeting
    • 06106/1/2010 summary
  • 2010/05/31 Council statement on its position
  • #3013
  • 2010/05/10 Council Meeting
  • #2986
  • 2009/12/14 Council Meeting
  • #2952
  • 2009/06/22 Council Meeting
  • 2009/05/13 Economic and Social Committee: opinion, report
  • 2009/05/05 Text adopted by Parliament, 1st reading/single reading
    • T6-0343/2009 summary
    • Results of vote in Parliament
  • 2009/05/05 Commission response to text adopted in plenary
  • 2009/05/04 Debate in Parliament
  • 2009/04/03 Committee report tabled for plenary, 1st reading/single reading
  • 2009/03/31 Vote in committee, 1st reading/single reading
  • 2009/02/19 Referral to associated committees announced in Parliament
  • 2009/02/18 Committee draft report
  • 2008/12/04 Committee referral announced in Parliament, 1st reading/single reading
  • 2008/11/05 EP officialisation
  • 2008/11/05 Legislative proposal
    • COM(2008)0543 summary
    • SEC(2008)2410
    • SEC(2008)2411
    • DG Environment, POTOČNIK Janez

Documents

Votes

Rapport PARISH A6-0240/2009 - AM 57

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 408 6 2 5 8 218 163 4 2 0
Against 219 78 30 9 6 12 17 31 36 0
Abstain 19 1 0 2 9 4 2 0 1 0

Rapport PARISH A6-0240/2009 - AM 146

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 315 71 1 3 5 221 10 2 2 0
Against 317 13 29 7 13 14 174 30 37 0
Abstain 16 0 1 6 5 2 1 0 1 0

Rapport PARISH A6-0240/2009 - AM 155

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 402 9 2 3 7 226 147 6 2 0
Against 233 77 28 6 12 9 37 27 37 0
Abstain 18 0 1 7 3 4 2 0 1 0

Rapport PARISH A6-0240/2009 - AM 156

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 386 7 2 3 7 219 142 5 1 0
Against 231 77 28 6 10 7 39 28 36 0
Abstain 17 0 0 7 3 3 3 0 1 0

Rapport PARISH A6-0240/2009 - AM 191

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 151 13 28 7 9 6 25 26 37 0
Against 477 72 2 4 10 224 155 8 2 0
Abstain 20 0 0 5 4 5 4 1 1 0

Rapport PARISH A6-0240/2009 - AM 172=189rev=196

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 183 25 25 7 13 11 34 29 39 0
Against 440 59 2 3 7 225 138 6 0 0
Abstain 19 0 2 6 1 2 7 0 1 0

Rapport PARISH A6-0240/2009 - AM 188

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 255 80 31 9 17 10 39 30 39 0
Against 366 3 0 0 4 223 135 1 0 0
Abstain 18 1 0 7 2 1 5 1 1 0

Rapport PARISH A6-0240/2009 - AM 174

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 291 5 27 9 4 9 174 27 36 0
Against 336 81 2 2 8 225 9 7 2 0
Abstain 18 0 1 5 10 1 0 0 1 0

Rapport PARISH A6-0240/2009 - AM 70

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 420 11 2 4 17 223 146 14 3 0
Against 221 75 28 6 6 12 37 21 36 0
Abstain 11 0 1 6 0 2 1 0 1 0

Rapport PARISH A6-0240/2009 - AM 175

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 385 75 29 8 17 15 175 33 33 0
Against 246 10 0 2 3 220 6 2 3 0
Abstain 13 1 1 5 3 2 0 0 1 0

Rapport PARISH A6-0240/2009 - AM 176

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 380 79 28 10 11 15 173 25 39 0
Against 253 6 2 5 9 221 3 7 0 0
Abstain 4 0 1 0 2 0 0 0 1 0

Rapport PARISH A6-0240/2009 - AM 167

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 398 19 2 4 13 220 126 12 2 0
Against 218 64 27 5 8 12 48 18 36 0
Abstain 12 1 2 4 2 0 2 0 1 0

Rapport PARISH A6-0240/2009 - AM 178

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 393 78 29 11 12 12 178 34 39 0
Against 245 8 0 0 8 225 3 1 0 0
Abstain 9 0 1 4 3 0 0 0 1 0

Rapport PARISH A6-0240/2009 - AM 179PC

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 157 12 24 7 5 12 33 28 36 0
Against 467 74 5 3 10 224 142 7 2 0
Abstain 23 0 1 5 8 1 7 0 1 0

Rapport PARISH A6-0240/2009 - résolution législative

2009/05/05
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 540 69 29 10 19 222 161 28 2 0
Against 66 13 0 5 2 3 6 0 37 0
Abstain 34 3 3 0 2 2 17 6 1 0
AmendmentsDossier
5 2008/0211(COD) Protection of animals used for scientific purposes (repeal. Directive 86/609/EEC)
2010/06/30 AGRI 5 amendments...
source: PE-445.661

History

(these mark the time of scraping, not the official date of the change)

2012-02-09
activities added
  • body
    EP
    date
    2008-11-05
    type
    EP officialisation
  • date
    2008-11-05
    docs
    body
    EC
    commission
    • DG
      Environment
      Commissioner
      POTOČNIK Janez
    type
    Legislative proposal
  • date
    2008-12-04
    body
    EP
    type
    Committee referral announced in Parliament, 1st reading/single reading
    committees
  • date
    2009-02-18
    docs
    • url
      http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE418.310
      type
      Committee draft report
      title
      PE418.310
    body
    EP
    type
    Committee draft report
  • date
    2009-02-19
    body
    type
    Referral to associated committees announced in Parliament
  • date
    2009-03-31
    text
    • The Committee on Agriculture and Rural Development adopted the report drawn up by Neil PARISH (EPP-ED, UK) amending, under the first reading of the codecision procedure, the proposal for a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes.

      The main amendments were as follows:

      Purpose: according to MEPs, this Directive shall apply to the 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.

      Scope: the Directive should apply to live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms of species of mammals as from the last third of their normal development.

      Alternative methods: pursuant to this Directive, testing methods which involve the use of human embryonic and foetal cells shall not be regarded as alternatives.

      MEPs request that Member States should ensure that funding is provided for training and research on, and development and implementation of, scientifically satisfactory methods or testing strategies that do not entail the use of animals.

      Humane method of killing: a new measure has been introduced stipulating thatwhen more humane methods of killing are developed, this will allow them to be used immediately instead of waiting several years for Annex V to be updated.

      National measures: this Directive shall not prevent Member States from applying or adopting stricter national measures seeking to improve the well-being and protection of animals used for scientific purposes.

      Non-human primates (NHP): the proposal bans the use of NHPs except in certain circumstances. There is no scientific justification for the special status granted to NHPs, so that basic research should be allowed, without being restricted to experiments designed to achieve specific medical research objectives. A new paragraph is inserted to introduce a review of the use of non-human primates in procedures which is to be conducted by the Commission every two years.

      Animals bred for use in procedures: MEPs consider that the recommendation made in the proposal only to source non-human primates from self sustaining colonies of F2 primates (the second generation bred in captivity) is a noble aim and one which in the long term will ensure that fewer animals are taken from the wild. However, the proposal is not practical within the timescale that the Commission has envisioned. Moreover, five years after the entry into force of this Directive, the Commission shall carry out A feasibility study should therefore be conducted ahead of any mandated move towards establishing a policy of only sourcing from F2 self sustaining colonies.

      Severity classifications: the Commission identifies a number of severity clauses, "up to mild"

      "moderate" and "severe" governing how experiments can be undertaken, however it does not define what the classifications are. MEPs wish to clarify this situation by including a new Annex VIIa called "General Definitions of Degrees of Severity".

      MEPs note that the ban on "prolonged" "severe" procedures appears to preclude any "severe" category procedures, and could be highly restrictive. This is why they propose that Member States should ensure that the procedures classified as "severe" are scientifically justified, and ethically monitored if the pain, suffering or distressis likely to be prolonged. Such procedures

      must be exceptional and shall be subject to particular harm/benefit analysis and scrutiny by the competent authority.

      Reuse: MEPs support the principle of re-use however they believe that current restriction will result in dramatic increase in numbers of animals used for experimental purposes. They propose that an animal already used in the procedure may be re-used where the previous procedure performed on the animal is classified as 'up to moderate' as opposed to 'up to mild'. An animal that has undergone a "severe" procedure should not be re-used.

      In contrast those previously subjected to a "moderate" procedure should be permitted to undergo a further "moderate" procedure. The repeated re-use of the animal is supported by veterinary examination.

      Authorised persons: Member States shall ensure the mutual recognition of education and training qualifications and authorisation to conduct designated procedures.

      Tasks of the permanent ethical review body: MEPs consider it judicious to provide a yearly review of all projects classified as "severe" or those on non-human primates, and every 3 years for all other projects.

      Breeding strategy of non-human primates: EU establishments acquiring non-human primates shall supply proof to the competent authority, on request, that the establishment from which animals have been acquired have a breeding strategy in place. The Commission and the Member States should also take the necessary measures to support appropriate transport conditions for nonhuman primates on the territory of the European Union.

      Project authorisation:  the Commission may undertake controls of the infrastructure and operation of national inspections in Member States and to ensure that severity classifications are applied correctly and uniformly within the territory of the EU. Member States shall ensure that projects classified as "severe" or any projects involving non-human primates are not carried out without a prior authorisation by the competent authority. All other projects shall be notified in advance to the competent authority following ethical review by the institution's permanent ethical review body.

      Retrospective evaluation: it should be up to an ethical committee to decide whether a retrospective ethical evaluation is required, depending on objective criteria, whatever species is involved.

      Granting project authorisations: project authorisations shall be granted for a period not exceeding five years.

      European Centre for the Validation of Alternative Methods: MEPs suggest that the remit of the European Centre for the Validation of Alternative Methods shall be extended so that it includes the co-ordination and promotion of the development and use of alternatives to animal procedures including applied and basic biomedical research and veterinary research and regulatory testing by, for instance, coordinating research undertaken to facilitate the development of alternatives to animal procedures by the National Centres or providing databases to facilitate the exchange of relevant information.

      Each Member State shall nominate a centre responsible for supporting the development, validation and promotion of alternatives to animal tests used for regulatory purposes, and facilities to develop and promote the use of alternatives to animal procedures undertaken for other purposes, such as basic and applied biomedical and veterinary research.

    body
    EP
    committees
    type
    Vote in committee, 1st reading/single reading
  • date
    2009-04-03
    docs
    • url
      http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2009-0240&language=EN
      type
      Committee report tabled for plenary, 1st reading/single reading
      title
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    body
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    Committee report tabled for plenary, 1st reading/single reading
  • date
    2009-05-04
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    Debate in Parliament
  • date
    2009-05-05
    docs
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    EP
    type
    Text adopted by Parliament, 1st reading/single reading
  • date
    2009-05-05
    docs
    • url
      http://www.europarl.europa.eu/oeil/spdoc.do?i=17120&j=0&l=en
      type
      Commission response to text adopted in plenary
      title
      SP(2009)3616
    body
    EC
    commission
    • DG
      Environment
      Commissioner
      POTOČNIK Janez
    type
    Commission response to text adopted in plenary
  • date
    2009-05-13
    docs
    • url
      http://eescopinions.eesc.europa.eu/eescopiniondocument.aspx?language=EN&docnr=0874&year=2009
      title
      CES0874/2009
      type
      Economic and Social Committee: opinion, report
      celexid
      CELEX:52009AE0874:EN
    body
    ESOC
    type
    Economic and Social Committee: opinion, report
  • body
    CSL
    meeting_id
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    text
    • The Council took note of the Presidency progress report on the Commission proposal for a Directive of the European Parliament and of the Council on the protection of animals used for scientific purposes.

    council
    Agriculture and Fisheries
    date
    2009-06-22
    type
    Council Meeting
  • body
    CSL
    meeting_id
    2986
    text
    • The Council took note of the state of play of negotiations with the European Parliament, under the codecision procedure, on the proposal for a Directive on the protection of animals used for scientific purposes.

      The Parliament delivered its opinion at first reading on 5 May 2009.

    council
    Agriculture and Fisheries
    date
    2009-12-14
    type
    Council Meeting
  • date
    2010-05-10
    body
    CSL
    type
    Council Meeting
    council
    Education, Youth, Culture and Sport
    meeting_id
    3013
  • date
    2010-05-31
    docs
    • url
      http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=9968%2F10&fc=REGAISEN&srm=25&md=100
      type
      Council statement on its position
      title
      09968/2010
    body
    CSL
    type
    Council statement on its position
  • body
    CSL
    meeting_id
    3018
    docs
    • url
      http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=6106%2F10&fc=REGAISEN&srm=25&md=100
      text
      • The Council states that its position confirms the objectives proposed by the Commission and incorporates the majority of the European Parliament's first-reading amendments, either verbatim, in part or in spirit. The Council's position also includes a number of changes other than those envisaged in the European Parliament's first-reading opinion. These changes have been thoroughly negotiated with the European Parliament, which has confirmed its provisional agreement on the full text by a letter.

        The main amendments to the Commission proposal are as follows:

        Authorisation of persons: with the aim of reducing administrative burden and in order to cater more efficiently for different types of operators, the Council removed the proposed mandatory authorisation of persons carrying out or supervising procedures. Instead it put the emphasis on the requirements on competence of staff. These requirements include the obligation to specify in the authorisation of each breeder, supplier and user a person responsible for ensuring the adequate education, competence and continuous training of the staff.

        Union Reference Laboratory: in line with an amendment of the Parliament, the Council strengthened the promotion of alternative methods at Union level by the introduction of a centralised Union Reference Laboratory, assigning it a set of responsibilities, including coordination and validation of alternative approaches and acting as a focal point for the exchange of information on their development.

        Safeguard clauses: the Council introduced two additional safeguard clauses to take into account possible future situations where, for scientifically justifiable grounds, Member States deem it is necessary to authorise the use of nonhuman primates in areas not linked with debilitating and life-threatening conditions in humans or to surpass the upper limit for severity of procedures. This authorisation could only be provisional and would be subject to a Union control procedure.

        Classification of the severity of procedures: sharing Parliament's approach, the Council introduced into the Directive a system for a uniform classification of severity of procedures.

      type
      Council position published
      title
      06106/1/2010
    council
    Justice and Home Affairs (JHA)
    date
    2010-06-03
    type
    Council Meeting
  • date
    2010-06-15
    docs
    • url
      http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=0324
      text
      • The Commission notes that out of 167 amendments adopted by the Parliament, 76 were acceptable to the Commission either fully, in part or in principle.

        41 amendments were accepted by the Commission and incorporated to varying degrees in the Council's position. These include the introduction of a new Annex providing detailed criteria for the four severity classes of procedures, criteria which were originally envisaged as part of implementing acts. However, the Commission welcomed this amendment and convened an expert meeting to agree on the detailed criteria. This allowed the annex to be updated by the Presidency with the latest expert understanding of the severity classes.

        44 amendments were rejected by the Commission but have been incorporated in full, in part or in principle in the Council's position. These are all considered acceptable by the Commission as they do not endanger the original objectives or, if altering these objectives marginally, could still be acceptable in the spirit of compromise to reach an early second reading political agreement:

        • in addition to vertebrate species including their larval forms, the scope now covers foetal forms only of mammals from the last third of their development and cephalopods as the only group of invertebrate animals. The Commission can accept this in the spirit of overall compromise;
        • the final agreement allows for the maintenance of stricter measures, but not the adoption of new ones;
        • Parliament asked for a feasibility study to be carried out on the sole use of second or higher generation purpose-bred non-human primates, and a modification of the deadline set out by the Commission for sole use of these animals. The Commission will conduct a further study to analyse the feasibility of sourcing animals only from self-sustaining colonies;
        • the text now allows for a systematic re-use of animals already subject to 'moderate' procedures where the subsequent procedure can also be of 'moderate' severity. However, all Three Rs (the principle of replacement, reduction and refinement of the use of animals in procedures) have to be balanced when projects are evaluated, including decisions on re-use, and thus this amendment can be acceptable to the Commission;
        • the text text puts the emphasis on risk analysis, however, requiring a minimum of one third of user establishments to be inspected annually, with the exceptions of breeders, suppliers and users of non-human primates which require annual inspections. An appropriate proportion of inspections shall be carried out without prior notice;
        • Member States may now allow the authorisation of multiple generic projects which are also carried out for production or diagnostic purposes with established methods, in addition to those carried out to satisfy regulatory requirements.

        18 amendments were accepted in full, in part or in principle by the Commission but not incorporated in the Council's position. However, it is important to note that a number of these were considered to be already covered in other articles or an Annex and thus considered superfluous. In light of the political agreement, these amendments are unlikely to be re-tabled.

        37 amendments were rejected by both institutions. As a result of the political agreement on the text, these amendments are unlikely to be re-tabled.

        The Council's position also included a number of amendments over and above those set out in the European Parliament's first reading. These amendments concern: (i) the authorisation of persons; (ii) EU reference laboratory; (iii) safeguard clauses; (iv) the classification of procedures according  to their degree of severity.

        The Commission concludes that the final text retains all key objectives that the Commission had set for the revision; namely to address the current problems of the uneven playing field, to fully incorporate the principle of the "Three Rs", including the promotion of the alternatives to animal testing, and to improve significantly the welfare of the animals still needed for scientific purposes. Parliament's first reading placed a lot of emphasis on the reduction of administrative burden and the continuity and viability of European research and industry relying still on the use of animals.

        The Council has addressed Parliament's concerns by providing for more flexible rules for the implementation of project authorisation as well as for re-use of animals and by agreeing on a risk management based inspection scheme to ensure appropriate enforcement and compliance with the revised Directive. The concerns of administrative burden have inter alia been taken into account in more generous transposition times of the housing and care standards as well as in the way in which animal welfare bodies are to be implemented.

        Lastly, both institutions voiced the need for further promotion of alternatives to animal testing. In response an EU reference laboratory for the validation of alternative methods, supported by Member States' efforts to bring in further resources in terms of suitable specialised laboratories, is envisaged.

        The Commission supports the common position which strikes the right balance between the needs of the industry and research community whilst upgrading and harmonising the animal welfare standards for animals used or intended to be used for scientific purposes.

      title
      COM(2010)0324
      type
      Commission communication on Council's position
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      CELEX:52010PC0324:EN
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    EC
    commission
    • DG
      Environment
      Commissioner
      POTOČNIK Janez
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    Commission communication on Council's position
  • date
    2010-06-17
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    EP
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    Committee referral announced in Parliament, 2nd reading
    committees
  • date
    2010-06-30
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    • url
      http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE443.087
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      Committee draft report
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    Committee draft report
  • date
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    text
    • The Committee on Agriculture and Rural Development adopted the recommendation drawn up by Elisabeth JEGGLE (EPP, DE) at 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.

      The committee recommended that the European Parliament adopts the Council position as it stands.

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    EP
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  • date
    2010-07-13
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    • url
      http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2010-0230&language=EN
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      Committee recommendation tabled for plenary, 2nd reading
      title
      A7-0230/2010
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    EP
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    Committee recommendation tabled for plenary, 2nd reading
  • date
    2010-09-08
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    EP
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    Text adopted by Parliament, 2nd reading
  • date
    2010-09-22
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    type
    Final act signed
  • date
    2010-09-22
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    EP
    type
    End of procedure in Parliament
  • date
    2010-10-20
    text
    • PURPOSE: to strengthen the protection of animals used for scientific purposes and contribute to the reduction of animal use and ensure that the animals used in experiments receive appropriate care and humane treatment.

      LEGISLATIVE ACT: Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes.

      CONTENT: the Council adopted a draft directive for the protection of animals used for scientific purposes, aimed at strengthening the protection of animals whilst allowing research to continue playing a key role in the fight against diseases.

      To recall, Council Directive 86/609/EEC was adopted in order to eliminate disparities between laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Since the adoption of that Directive, further disparities between Member States have emerged.

      This new Directive provides for more detailed rules in order to reduce such disparities by approximating the rules applicable in that area and to ensure a proper functioning of the internal market.

      Subject matter and scope: this Directive establishes measures for the protection of animals used for scientific or educational purposes. To that end, it lays down rules on the following:

      (a) 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;

      (b) the origin, breeding, marking, care and accommodation and killing of animals;

      (c) the operations of breeders, suppliers and users;

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

      This Directive shall apply where animals are used or intended to be used in procedures, or bred specifically so that their organs or tissues may be used for scientific purposes. This Directive shall apply until the animals have been killed, rehomed or returned to a suitable habitat or husbandry system.

      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.

      This Directive shall apply to the following animals: (a) live non-human vertebrate animals, including: (i) independently feeding larval forms; and (ii) foetal forms of mammals as from the last third of their normal development (as there is scientific evidence showing that such forms in the last third of the period of their development are at an increased risk of experiencing pain, suffering and distress, which may also affect negatively their subsequent development); (b) live cephalopods (as there is scientific evidence of their ability to experience pain, suffering, distress and lasting harm).

      Methods of killing: the methods selected should avoid, as far as possible, death as an end-point due to the severe suffering experienced during the period before death. Where possible, it should be substituted by more humane end-points using clinical signs that determine the impending death, thereby allowing the animal to be killed without any further suffering.

      Principle of the three Rs (replacement, reduction and refinement): Member States shall ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of a procedure. Member States shall ensure that the number of animals used in projects is reduced to a minimum without compromising the objectives of the project. They shall also 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.

      Project evaluation: comprehensive project evaluation, taking into account ethical considerations in the use of animals, forms the core of project authorisation and should ensure the implementation of principles of replacement, reduction and refinement in those projects.

      Non-human primates: the keeping and use of non-human primates for scientific purposes will be subject to tight restrictions. Experiments with great apes such as chimpanzees, gorillas and orangutans will be prohibited; a Member State may however allow exceptionally the use of great apes if it has justifiable reasons for believing that it is essential for the survival of the species itself or because of an unexpected outbreak of a life-threatening or debilitating disease in human beings. As a general rule, animals taken from the wild will not be allowed to be used in experiments, with some exceptions. The directive will also progressively require that non-human primates may only be used if they are the offspring of animals which have been bred in captivity or if they are sourced from self-sustaining colonies.

      Inspections by the Member States: Member States shall ensure that the competent authorities carry out regular inspections of all breeders, suppliers and users, including their establishments, to verify compliance with the requirements of this Directive.

      Alternative approaches: the Commission and the Member States shall contribute to the development and validation of alternative approaches which could provide the same or higher levels of information as those obtained in procedures using animals, but which do not involve the use of animals or use fewer animals or which entail less painful procedures, and they shall take such other steps as they consider appropriate to encourage research in this field. The Commission shall take appropriate action with a view to obtaining international acceptance of alternative approaches validated in the Union.

      Union Reference Laboratory: it shall be responsible, inter alia, for: (i) coordinating and promoting the development and use of alternatives to procedures including in the areas of basic and applied research and regulatory testing; (ii) promoting dialogue between legislators, regulators, and all relevant stakeholders. The Union Reference Laboratory may collect charges for the services it provides that do not directly contribute to the further advancement of replacement, reduction and refinement (three Rs).

      Safeguard clauses: two safeguard clauses are included in the Directive to take into account of possible future situations where, for scientifically justifiable grounds, Member States deem it is necessary to authorise the use of nonhuman primates in areas not linked with debilitating and life-threatening conditions in humans or to surpass the upper limit for severity of procedures. This authorisation could only be provisional and would be subject to a Union control procedure.

      Classification of the severity of procedures: Member States shall ensure that all procedures are classified as 'non-recovery', 'mild', 'moderate', or 'severe' on a case- by-case basis using the assignment criteria set out in Annex VIII. The severity of a procedure shall be determined by the degree of pain, suffering, distress or lasting harm expected to be experienced by an individual animal during the course of the procedure. Subject to the use of the safeguard clause, Member States shall ensure that a procedure is not performed if it involves severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated.

      Reporting: Member States shall by 10 November 2018, and every 5 years thereafter, send the information on the implementation of this Directive to the Commission. They shall collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures. The Commission shall by 10 May 2012 establish a common format for submitting the information.

      Commission report: by 10 November 2019 and every 5 years thereafter, the Commission shall report on the implementation of this Directive. By 10 November 2019 and every 3 years thereafter, it shall present a summary report on that information.

      Review: the Commission shall review this Directive by 10 November 2017, taking into account advancements in the development of alternative methods not entailing the use of animals, in particular of non-human primates, and shall propose amendments, where appropriate. The Commission shall, where appropriate, and in consultation with the Member States and stakeholders, conduct periodic thematic reviews of the replacement, reduction and refinement of the use of animals in procedures, paying specific attention to non-human primates, technological developments, and new scientific and animal-welfare knowledge.

      Transitional provisions: Member States shall not apply laws, regulations and administrative provisions adopted in accordance with Articles 36 to 45 (Requirements for projects) to projects which have been approved before 1 January 2013 and the duration of which does not extend beyond 1 January 2018. Projects which have been approved before 1 January 2013 and the duration of which extends beyond 1 January 2018 shall obtain project authorisation by 1 January 2018.

      ENTRY INTO FORCE: 10/11/2010.

      TRANSPOSITION: 10/11/2012.

    type
    Final act published in Official Journal
    docs
committees added
  • body
    EP
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    True
    committee
    AGRI
    date
    2009-07-21
    committee_full
    Agriculture and Rural Development
    rapporteur
    • group
      EPP
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      JEGGLE Elisabeth
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    2008-12-01
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    Agriculture and Rural Development (Associated committee)
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      PARISH Neil
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      SEPPÄNEN Esko
links added
National parliaments
European Commission
other added
  • body
    EC
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    Environment
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    POTOČNIK Janez
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dossier_of_the_committee
AGRI/7/02658
reference
2008/0211(COD)
subtype
Legislation
legal_basis
  • Treaty on the Functioning of the EU TFEU 114-p1
stage_reached
Procedure completed
instrument
Directive
title
Protection of animals used for scientific purposes (repeal. Directive 86/609/EEC)
type
COD - Ordinary legislative procedure (ex-codecision)
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subject

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© European Union, 2011 – Source: European Parliament