PURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nThe Committee on\nAgriculture and Rural Development adopted the report drafted by\nJanusz WOJCIECHOWSKI (ECR, PL) on the proposal for a directive of\nthe European Parliament and of the Council amending Directive\n2000/75/EC as regards vaccination against bluetongue.
\nIt recommended that the\nEuropean Parliament's position at first reading, under the ordinary\nlegislative procedure, should be to amend the Commission proposal\nas follows:
\n- Members agree that the\nproposal should be based on Article 43(2) of the Treaty on the\nFunctioning of the European Union (TFEU). They stress that under\nthe Treaty of Lisbon, the legislative function is shared between\nParliament and the Council and in the field of agriculture the\nordinary legislative procedure applies;
\n- in addition, the date of\ntransposition of the Directive should be set at 30 June 2011\n(instead of 30 April 2011) and its provisions should apply from 1\nJuly 2011 at the latest (instead of 1 May 2011).
\nThe European Parliament\nadopted by 587 votes to 1, with 19 abstentions, a legislative\nresolution on the proposal for a directive of the European\nParliament and of the Council amending Directive 2000/75/EC as\nregards vaccination against bluetongue.
\nIt adopted its position at\nfirst reading under the ordinary legislative procedure. The\namendments adopted in plenary are the result of a compromise\nnegotiated between the European Parliament and the Council. They\namend the proposal as follows:
\n- the proposal should be\nadopted under the ordinary legislative procedure pursuant to\nArticle 43(2) of the Treaty on the Functioning of the European\nUnion;
\n- the date of transposition\nof the Directive is set at 30 June 2011 and its provisions shall\napply from 1 July 2011 at the latest;
\n- in order to enable the\nvaccination season 2011 to benefit from the new rules, this\nDirective should enter into force on the day following that of its\npublication in the Official Journal of the European\nUnion.
\nThe Council adopted its position at first reading with\na view to the adoption of the Directive of the European Parliament\nand of the Council amending Directive 2000/75/EC as regards\nvaccination against bluetongue.
\nThe Council's position confirms the objectives\nproposed by the Commission and incorporates the quasi-totality of\nthe European Parliament's first-reading amendments.
\nLegal basis: the\nCouncil shares the European Parliament's view that Article 43(2)\nof TFEU is the correct legal basis for this Directive. This\nline was confirmed by Coreper (Part I), which, following the advice\nof the Council Legal Service against the use of a derived legal\nbasis for this proposal, decided at its meeting on 26 January 2011\nto propose to the European Parliament such modification of the\nlegal basis by the co-legislators, as the Commission services were\nunable to commit to rapid re-submission of the proposal with this\nmodified legal basis.
\nThe Council's position introduces changes to the\nEuropean Parliament's first-reading opinion only in two\nareas:
\nThe Commission welcomes the Council position at first\nreading, which paves the way for an early second reading\nagreement.
\nThe European Parliament proposed amendments to the\nproposal, essentially modifying the legal base to Article\n43(2), and introducing new implementation dates to ensure\nenforcement in time for the vaccination season. None of those\namendments were controversial.
\nHowever the interinstitutional discussions on the\nquestion of correlation tables blocked any progress on the\nproposal. With regard to the request for a correlation table for\nthe present proposal, the Council is opposed to it.
\nGiven the delays in the adoption of the proposal due\nto the inter-institutional debate on the issue of correlation\ntables, the Council intends to postpone the proposed dates of\nadoption and publication of the national laws, regulations and\nadministrative provisions necessary to comply with this Directive\nand of application of those provisions. The Commission accepts this\npostponement which stays compatible with the next vaccination\nseason.
\nIn light of the limited number of amendments proposed\nto an existing Directive transposed in national law since a decade,\nand the resulting easy check on their transposition, the Commission\ncan accept that no provision on correlation tables is inserted in\nthis Directive.
\nThe European Parliament adopted a legislative\nresolution on the Council position at first reading with a view to\nthe adoption of a directive of the European Parliament and of the\nCouncil amending Directive 2000/75/EC as regards vaccination\nagainst bluetongue.
\nParliament approved, without amendment, the\nCouncil’s position at first reading.
\nThe European Parliament adopted a legislative\nresolution on the Council position at first reading with a view to\nthe adoption of a directive of the European Parliament and of the\nCouncil amending Directive 2000/75/EC as regards vaccination\nagainst bluetongue.
\nParliament approved, without amendment, the\nCouncil’s position at first reading.
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nThe Committee on\nAgriculture and Rural Development adopted the report drafted by\nJanusz WOJCIECHOWSKI (ECR, PL) on the proposal for a directive of\nthe European Parliament and of the Council amending Directive\n2000/75/EC as regards vaccination against bluetongue.
\nIt recommended that the\nEuropean Parliament's position at first reading, under the ordinary\nlegislative procedure, should be to amend the Commission proposal\nas follows:
\n- Members agree that the\nproposal should be based on Article 43(2) of the Treaty on the\nFunctioning of the European Union (TFEU). They stress that under\nthe Treaty of Lisbon, the legislative function is shared between\nParliament and the Council and in the field of agriculture the\nordinary legislative procedure applies;
\n- in addition, the date of\ntransposition of the Directive should be set at 30 June 2011\n(instead of 30 April 2011) and its provisions should apply from 1\nJuly 2011 at the latest (instead of 1 May 2011).
\nThe European Parliament\nadopted by 587 votes to 1, with 19 abstentions, a legislative\nresolution on the proposal for a directive of the European\nParliament and of the Council amending Directive 2000/75/EC as\nregards vaccination against bluetongue.
\nIt adopted its position at\nfirst reading under the ordinary legislative procedure. The\namendments adopted in plenary are the result of a compromise\nnegotiated between the European Parliament and the Council. They\namend the proposal as follows:
\n- the proposal should be\nadopted under the ordinary legislative procedure pursuant to\nArticle 43(2) of the Treaty on the Functioning of the European\nUnion;
\n- the date of transposition\nof the Directive is set at 30 June 2011 and its provisions shall\napply from 1 July 2011 at the latest;
\n- in order to enable the\nvaccination season 2011 to benefit from the new rules, this\nDirective should enter into force on the day following that of its\npublication in the Official Journal of the European\nUnion.
\nThe Council adopted its position at first reading with\na view to the adoption of the Directive of the European Parliament\nand of the Council amending Directive 2000/75/EC as regards\nvaccination against bluetongue.
\nThe Council's position confirms the objectives\nproposed by the Commission and incorporates the quasi-totality of\nthe European Parliament's first-reading amendments.
\nLegal basis: the\nCouncil shares the European Parliament's view that Article 43(2)\nof TFEU is the correct legal basis for this Directive. This\nline was confirmed by Coreper (Part I), which, following the advice\nof the Council Legal Service against the use of a derived legal\nbasis for this proposal, decided at its meeting on 26 January 2011\nto propose to the European Parliament such modification of the\nlegal basis by the co-legislators, as the Commission services were\nunable to commit to rapid re-submission of the proposal with this\nmodified legal basis.
\nThe Council's position introduces changes to the\nEuropean Parliament's first-reading opinion only in two\nareas:
\nThe Commission welcomes the Council position at first\nreading, which paves the way for an early second reading\nagreement.
\nThe European Parliament proposed amendments to the\nproposal, essentially modifying the legal base to Article\n43(2), and introducing new implementation dates to ensure\nenforcement in time for the vaccination season. None of those\namendments were controversial.
\nHowever the interinstitutional discussions on the\nquestion of correlation tables blocked any progress on the\nproposal. With regard to the request for a correlation table for\nthe present proposal, the Council is opposed to it.
\nGiven the delays in the adoption of the proposal due\nto the inter-institutional debate on the issue of correlation\ntables, the Council intends to postpone the proposed dates of\nadoption and publication of the national laws, regulations and\nadministrative provisions necessary to comply with this Directive\nand of application of those provisions. The Commission accepts this\npostponement which stays compatible with the next vaccination\nseason.
\nIn light of the limited number of amendments proposed\nto an existing Directive transposed in national law since a decade,\nand the resulting easy check on their transposition, the Commission\ncan accept that no provision on correlation tables is inserted in\nthis Directive.
\nThe Council adopted its position at first reading with\na view to the adoption of the Directive of the European Parliament\nand of the Council amending Directive 2000/75/EC as regards\nvaccination against bluetongue.
\nThe Council's position confirms the objectives\nproposed by the Commission and incorporates the quasi-totality of\nthe European Parliament's first-reading amendments.
\nLegal basis: the\nCouncil shares the European Parliament's view that Article 43(2)\nof TFEU is the correct legal basis for this Directive. This\nline was confirmed by Coreper (Part I), which, following the advice\nof the Council Legal Service against the use of a derived legal\nbasis for this proposal, decided at its meeting on 26 January 2011\nto propose to the European Parliament such modification of the\nlegal basis by the co-legislators, as the Commission services were\nunable to commit to rapid re-submission of the proposal with this\nmodified legal basis.
\nThe Council's position introduces changes to the\nEuropean Parliament's first-reading opinion only in two\nareas:
\nThe Council adopted its position at first reading with\na view to the adoption of the Directive of the European Parliament\nand of the Council amending Directive 2000/75/EC as regards\nvaccination against bluetongue.
\nThe Council's position confirms the objectives\nproposed by the Commission and incorporates the quasi-totality of\nthe European Parliament's first-reading amendments.
\nLegal basis: the\nCouncil shares the European Parliament's view that Article 43(2)\nof TFEU is the correct legal basis for this Directive. This\nline was confirmed by Coreper (Part I), which, following the advice\nof the Council Legal Service against the use of a derived legal\nbasis for this proposal, decided at its meeting on 26 January 2011\nto propose to the European Parliament such modification of the\nlegal basis by the co-legislators, as the Commission services were\nunable to commit to rapid re-submission of the proposal with this\nmodified legal basis.
\nThe Council's position introduces changes to the\nEuropean Parliament's first-reading opinion only in two\nareas:
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nThe European Parliament\nadopted by 587 votes to 1, with 19 abstentions, a legislative\nresolution on the proposal for a directive of the European\nParliament and of the Council amending Directive 2000/75/EC as\nregards vaccination against bluetongue.
\nIt adopted its position at\nfirst reading under the ordinary legislative procedure. The\namendments adopted in plenary are the result of a compromise\nnegotiated between the European Parliament and the Council. They\namend the proposal as follows:
\n- the proposal should be\nadopted under the ordinary legislative procedure pursuant to\nArticle 43(2) of the Treaty on the Functioning of the European\nUnion;
\n- the date of transposition\nof the Directive is set at 30 June 2011 and its provisions shall\napply from 1 July 2011 at the latest;
\n- in order to enable the\nvaccination season 2011 to benefit from the new rules, this\nDirective should enter into force on the day following that of its\npublication in the Official Journal of the European\nUnion.
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nThe European Parliament\nadopted by 587 votes to 1, with 19 abstentions, a legislative\nresolution on the proposal for a directive of the European\nParliament and of the Council amending Directive 2000/75/EC as\nregards vaccination against bluetongue.
\nIt adopted its position at\nfirst reading under the ordinary legislative procedure. The\namendments adopted in plenary are the result of a compromise\nnegotiated between the European Parliament and the Council. They\namend the proposal as follows:
\n- the proposal should be\nadopted under the ordinary legislative procedure pursuant to\nArticle 43(2) of the Treaty on the Functioning of the European\nUnion;
\n- the date of transposition\nof the Directive is set at 30 June 2011 and its provisions shall\napply from 1 July 2011 at the latest;
\n- in order to enable the\nvaccination season 2011 to benefit from the new rules, this\nDirective should enter into force on the day following that of its\npublication in the Official Journal of the European\nUnion.
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nThe Council adopted its position at first reading with\na view to the adoption of the Directive of the European Parliament\nand of the Council amending Directive 2000/75/EC as regards\nvaccination against bluetongue.
\nThe Council's position confirms the objectives\nproposed by the Commission and incorporates the quasi-totality of\nthe European Parliament's first-reading amendments.
\nLegal basis: the\nCouncil shares the European Parliament's view that Article 43(2)\nof TFEU is the correct legal basis for this Directive. This\nline was confirmed by Coreper (Part I), which, following the advice\nof the Council Legal Service against the use of a derived legal\nbasis for this proposal, decided at its meeting on 26 January 2011\nto propose to the European Parliament such modification of the\nlegal basis by the co-legislators, as the Commission services were\nunable to commit to rapid re-submission of the proposal with this\nmodified legal basis.
\nThe Council's position introduces changes to the\nEuropean Parliament's first-reading opinion only in two\nareas:
\nThe Council adopted its position at first reading with\na view to the adoption of the Directive of the European Parliament\nand of the Council amending Directive 2000/75/EC as regards\nvaccination against bluetongue.
\nThe Council's position confirms the objectives\nproposed by the Commission and incorporates the quasi-totality of\nthe European Parliament's first-reading amendments.
\nLegal basis: the\nCouncil shares the European Parliament's view that Article 43(2)\nof TFEU is the correct legal basis for this Directive. This\nline was confirmed by Coreper (Part I), which, following the advice\nof the Council Legal Service against the use of a derived legal\nbasis for this proposal, decided at its meeting on 26 January 2011\nto propose to the European Parliament such modification of the\nlegal basis by the co-legislators, as the Commission services were\nunable to commit to rapid re-submission of the proposal with this\nmodified legal basis.
\nThe Council's position introduces changes to the\nEuropean Parliament's first-reading opinion only in two\nareas:
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nThe European Parliament\nadopted by 587 votes to 1, with 19 abstentions, a legislative\nresolution on the proposal for a directive of the European\nParliament and of the Council amending Directive 2000/75/EC as\nregards vaccination against bluetongue.
\nIt adopted its position at\nfirst reading under the ordinary legislative procedure. The\namendments adopted in plenary are the result of a compromise\nnegotiated between the European Parliament and the Council. They\namend the proposal as follows:
\n- the proposal should be\nadopted under the ordinary legislative procedure pursuant to\nArticle 43(2) of the Treaty on the Functioning of the European\nUnion;
\n- the date of transposition\nof the Directive is set at 30 June 2011 and its provisions shall\napply from 1 July 2011 at the latest;
\n- in order to enable the\nvaccination season 2011 to benefit from the new rules, this\nDirective should enter into force on the day following that of its\npublication in the Official Journal of the European\nUnion.
\nPURPOSE: to amend the\nEuropean Union's legislative framework in order to ensure the\nbetter control of the spread of the bluetongue virus and\nreduce the burden on\nthe agricultural sector posed by that disease.
\nPROPOSED ACT:\nCouncil Directive.
\nBACKGROUND:\nCouncil Directive\n2000/75/EC of 20 November 2000 lays down specific provisions for\nthe control and eradication of bluetongue, including rules on\nvaccination. In the past, only sporadic incursions of certain\nserotypes of the bluetongue virus were recorded in the Union. Those\nincursions mainly occurred in the southern parts of the Union.\nHowever, after the adoption of Directive 2000/75/EC, and\nparticularly after the introduction into the Union of bluetongue\nvirus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue\nvirus has become more widespread in the Union, with the potential\nof becoming endemic in certain areas. It has therefore become\ndifficult to control the spread of that virus.
\nThe rules on\nvaccination against bluetongue laid down in Directive 2000/75/EC\nare based on experience of the use of so-called \"modified live\nvaccines\", or \"live attenuated vaccines\" that were the only\nvaccines available when that Directive was adopted.
\nIn recent years, as a\nresult of new technology, \"inactivated vaccines\" against bluetongue\nhave become available, which do not pose that risk to unvaccinated\nanimals. It is now widely accepted that vaccination with\ninactivated vaccines is the preferred tool for bluetongue control\nand the prevention of clinical disease in the Union. Under the\ncurrent rules, the use of vaccines against bluetongue is prohibited\noutside \"restricted zones\" where the disease has appeared and where\nanimal movement has been restricted.
\nPREFERRED OPTION AND\nASSESSMENT OF ITS IMPACTS: the Commission considers that the\namendment of the legislation is necessary to reflect the\ntechnological progress in the field of vaccine development. The\ncurrent obstacles for preventive vaccination outside areas\nsubjected to animal movement restrictions are not necessary when\nmodern safe \"inactivated vaccines\" are used. The proposed amendment\nwill facilitate decision making on bluetongue control strategies on\nthe basis of the specific situation within the Member States\nwithout unnecessary intervention by the Union.
\nLEGAL BASIS: the\nlegal basis of Directive 2000/75/EC is the second indent of Article\n15 of Council Directive 92/119/EEC of 17 December 1992 introducing\ngeneral Community measures for the control of certain animal\ndiseases and specific measures relating to swine vesicular disease.\nThis article provides that the Council may adopt specific\nprovisions relating to the control and eradication measures for any\nof the animal diseases listed in Annex I to the Directive, acting\non a qualified majority on a proposal from the\nCommission.
\nSince the basic act\nproviding for this legal basis is still in force, the legality of\nthe powers vested in the Council in this act are not affected by\nthe entry into force of the Lisbon Treaty and these powers remain\nsolely with the Council.
\nCONTENT: in order\nto ensure the better control of the spread of the bluetongue virus\nand reduce the burden on the agricultural sector posed by that\ndisease, it is appropriate to amend the current rules on\nvaccination laid down in Directive 2000/75/EC in order to take\naccount of the recent technological developments in vaccine\nproduction.
\nThe proposed\namendments should make the rules on vaccination more flexible and\nalso take into account the fact that inactivated vaccines are now\navailable, which can also be successfully used outside areas\nsubjected to animal movement restrictions.
\nThe use\nof live attenuated vaccines should not be excluded provided that\nappropriate precautionary measures are taken, as their use might\nstill be necessary under certain circumstances, such as following\nthe introduction of a new bluetongue virus serotype against which\ninactivated vaccines may not be available.
\nBUDGETARY\nIMPLICATION: the proposal has no implication for the European\nUnion's budget.
\nThe European Parliament\nadopted by 587 votes to 1, with 19 abstentions, a legislative\nresolution on the proposal for a directive of the European\nParliament and of the Council amending Directive 2000/75/EC as\nregards vaccination against bluetongue.
\nIt adopted its position at\nfirst reading under the ordinary legislative procedure. The\namendments adopted in plenary are the result of a compromise\nnegotiated between the European Parliament and the Council. They\namend the proposal as follows:
\n- the proposal should be\nadopted under the ordinary legislative procedure pursuant to\nArticle 43(2) of the Treaty on the Functioning of the European\nUnion;
\n- the date of transposition\nof the Directive is set at 30 June 2011 and its provisions shall\napply from 1 July 2011 at the latest;
\n- in order to enable the\nvaccination season 2011 to benefit from the new rules, this\nDirective should enter into force on the day following that of its\npublication in the Official Journal of the European\nUnion.
\n