{"change_dates":[],"dossier":{"amendments":[{"authors":"Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-18","location":[["Proposal for a regulation","Title"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:10"},"new":["Proposal for a","REGULATION OF THE EUROPEAN","PARLIAMENT AND OF THE COUNCIL","on the import, manufacture, placing on the","market and use of medicated feed and","repealing Council Directive 90/167/EEC","(Text with EEA relevance)"],"old":["Proposal for a","REGULATION OF THE EUROPEAN","PARLIAMENT AND OF THE COUNCIL","on the manufacture, placing on the market","and use of medicated feed and repealing","Council Directive 90/167/EEC","(Text with EEA relevance)"],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"18","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-19","justification":"In view of the liberties which the Commission is taking to negotiate the transatlantic\n\n agreement, and the impenetrable nature of the negotiations themselves, its proposals for\n legislation likely to lay the groundwork for regulatory convergence with the US on subjects as\n essential as food, health, animal welfare or the environment cannot be adopted in the form of\n regulations. This amendment to switch from a regulation to a directive applies throughout the\n text; adopting it will necessitate corresponding changes throughout.","location":[["Proposal for a regulation","Title"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:10"},"new":["Proposal for a","DIRECTIVE OF THE EUROPEAN","PARLIAMENT AND OF THE COUNCIL","on the manufacture, placing on the market","and use of medicated feed and repealing","Council Directive 90/167/EEC","(Text with EEA relevance)"],"old":["Proposal for a","REGULATION OF THE EUROPEAN","PARLIAMENT AND OF THE COUNCIL","on the manufacture, placing on the market","and use of medicated feed and repealing","Council Directive 90/167/EEC","(Text with EEA relevance)"],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"19","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Mich\u00e8le Rivasi, Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-20","location":[[" Proposal for a regulation","Title"]],"meps":[96743,96752],"meta":{"created":"2019-07-03T06:28:10"},"new":["Proposal for a","REGULATION OF THE EUROPEAN","PARLIAMENT AND OF THE COUNCIL","on the manufacture, placing on the market,","use of medicated feed and traceability of","active substances in the ecosystems and","repealing Council Directive 90/167/EEC","(Text with EEA relevance)"],"old":["Proposal for a","REGULATION OF THE EUROPEAN","PARLIAMENT AND OF THE COUNCIL","on the manufacture, placing on the market","and use of medicated feed and repealing","Council Directive 90/167/EEC","(Text with EEA relevance)"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"20","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-21","location":[[" Proposal for a regulation","Citation 5 a (new)"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:10"},"new":["Having regard to the European","Parliament\u2019s own initiative report entitled","\u2018Safer healthcare in Europe: improving","patient safety and fighting antimicrobial","resistance\u2019 (A8-9999/2015 of","XX/yy/2015),"],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"21","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-22","location":[["Proposal for a regulation","Recital 2"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:10"},"new":["(2) Livestock production, animal health","and welfare, occupy a very important place","in the agriculture of the Union. The rules","concerning medicated feed have significant","influence on the keeping and on the rearing","of animals, including non-food producing","animals, and on the production of products","of animal origin."],"old":["(2) Livestock production occupies a very","important place in the agriculture of the","Union. The rules concerning medicated","feed have significant influence on the","keeping and on the rearing of animals,","including non-food producing animals, and","on the production of products of animal","origin."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"22","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-23","location":[["Proposal for a regulation","Recital 2"]],"meps":[36392],"meta":{"created":"2019-07-03T06:28:10"},"new":["(2) Livestock production occupies an","important place in the agriculture of the","Union. The rules concerning medicated","feed have significant influence on the","keeping and on the rearing of animals,","including non-food producing animals, and","on the production of products of animal","origin."],"old":["(2) Livestock production occupies a very","important place in the agriculture of the","Union. The rules concerning medicated","feed have significant influence on the","keeping and on the rearing of animals,","including non-food producing animals, and","on the production of products of animal","origin."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"23","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-24","location":[["Proposal for a regulation","Recital 3"]],"meps":[36392],"meta":{"created":"2019-07-03T06:28:10"},"new":["(3) The pursuit of a high level of protection","of human health is one of the fundamental","objectives of food law, as confirmed in","Regulation (EC) No 178/2002 of the","European Parliament and of the Council,","and the general principles laid down in that","Regulation should apply to the placing on","the market and use of feed without","prejudice to more specific Union","legislation. In addition, the protection of","animal health constitutes one of the general","objectives of EU food law.","__________________","4","Regulation (EC) No 178/2002 of the","European Parliament and of the Council of","28 January 2002 laying down the general","principles and requirements of food law,","establishing the European Food Safety","Authority and laying down procedures in","matters of food safety (OJ L 31, 1.2.2002,","p. 1)."],"old":["(3) The pursuit of a high level of protection","of human health is one of the fundamental","objectives of food law, as laid down in","Regulation (EC) No 178/2002 of the","European Parliament and of the Council4,","and the general principles laid down in that","Regulation should apply to the placing on","the market and use of feed without","prejudice to more specific Union","legislation. In addition, the protection of","animal health constitutes one of the general","objectives of EU food law.","__________________","4","Regulation (EC) No 178/2002 of the","European Parliament and of the Council of","28 January 2002 laying down the general","principles and requirements of food law,","establishing the European Food Safety","Authority and laying down procedures in","matters of food safety (OJ L 31, 1.2.2002,","p. 1)."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"24","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-25","location":[[" Proposal for a regulation","Recital 3 a (new)"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:11"},"new":["(3a) Prevention of disease is better than","cure. Medicinal treatments, especially","with antimicrobials, should never replace","good husbandry, bio-security and","management practices."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"25","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-26","justification":" The US Food and Drug Administration's data are particularly alarming and must be brought\n to elected representatives' attention because this proposal may be part of a process of\n regulatory convergence with the United States without being expressly presented as such.","location":[["Proposal for a regulation","Recital 3 a (new)"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:11"},"new":["(3a) Given that objective, and in view of","the current negotiations between the","Union and the United States of America","(US) on, in particular, animals farmed for","the production of food intended for","human consumption, information should","be available on the practices of the","Union's potential partner. In that context,","on 10 April 2015 the US Food and Drug","Administration (FDA) published a","report1a on the use of antimicrobials in","food-producing animals over the period","2009-2013. The report provides statistics","on antimicrobials used in food-producing","animals and regarded as medically","important in human medical therapy. The","following points are made:","(1) 99% of antimicrobials sold and","distributed in the US are used in domestic","livestock farming;","(2) antimicrobials medically important in","human medical therapy account for 62%","of antimicrobials sold;","(3) 74% of antimicrobials medically","important in human medical therapy are","administered in medicated feed;","(4) only 28% of antimicrobials sold are","sold solely for therapeutic purposes; the","FDA declines, on confidentiality grounds,","to give figures for the volume for","production purposes only; accordingly,","72% of antimicrobials are sold either","solely for production indications or for","both production and therapeutic","indications;","(5) 98% of antimicrobials medically","important in human medical therapy are","sold over the counter;","(6) tetracycline is an antibiotic on the","World Health Organisation's schedule of","essential medicines and, in the form","administered in medicated feed, alone","accounts for 39% of all antimicrobials","sold and 62% of antimicrobials medically","important in human medical therapy; its","use increased by 24% between 2009 and","2013;","(7) administration, in medicated feed, of","antimicrobials medically important in","human medical therapy increased by 20%","between 2009 and 2012 and by 9%","between 2012 and 2013.","__________________","1a","http://www.fda.gov/downloads/ForIndustr","y/UserFees/AnimalDrugUserFeeActADU","FA/UCM440584.pdf"],"old":["",""],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"26","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-27","justification":"There are currently very few medicated feeds available on the market for pet animals. As pet\nanimals generally live in households under the care of their owner, and often with other pet\nanimals, there would be certain risks associated with treatment with medicated feed. It would\nbe difficult to ensure that other pets in the household do not have access to the medicated feed\nand that the correct amount of food is consumed by the target animal.","location":[[" Proposal for a regulation","Recital 4"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:11"},"new":["(4) Pet animals should be excluded from","the general scope of this Regulation.","However, there should be the possibility to","adopt clearly defined conditions under","which medicated feed may be used to treat","pet animals as a delegated act."],"old":["(4) Experience with the application of","Directive 90/167/EEC has shown that","further measures should be taken to","strengthen the effective functioning of the","Internal Market and to explicitly give and","improve the possibility to treat non-food","","","producing animals by medicated feed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"27","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-28","location":[["Proposal for a regulation","Recital 4"]],"meps":[124851],"meta":{"created":"2019-07-03T06:28:11"},"new":["(4) Experience with the application of","Directive 90/167/EEC has shown that","further measures should be taken to","strengthen the effective functioning of the","Internal Market and to explicitly give the","possibility to treat non-food producing","animals by medicated feed under clearly","defined conditions."],"old":["(4) Experience with the application of","Directive 90/167/EEC has shown that","further measures should be taken to","strengthen the effective functioning of the","Internal Market and to explicitly give and","improve the possibility to treat non-food","producing animals by medicated feed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"28","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-29","location":[["Proposal for a regulation","Recital 6"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:11"},"new":["(6) As a type of feed, medicated feed falls","within the scope of Regulation (EC) No","183/2005 of the European Parliament and","of the Council6, of Regulation (EC) No","767/2009 of the European Parliament and","of the Council7, of Regulation (EC) No","1831/2003 of the European Parliament and","of the Council8 and of Directive","2002/32/EC of the European Parliament","and of the Council9. Specific provisions for","medicated feed and intermediate products","should be established concerning facilities","and equipment, personnel, manufacture","quality control, animal welfare, storage","and transport, record-keeping, complaints","and product recalls, the application of","procedures based on the hazard analysis","and critical control points (HACCP)","principles and labelling.","__________________","6","Regulation (EC) No 183/2005 of the","European Parliament and of the Council of","12 January 2005 laying down requirements","for feed hygiene (OJ L 35, 8.2.2005, p. 1).","7","Regulation (EC) No 767/2009 of the","European Parliament and of the Council of","13 July 2009 on the placing on the market","and use of feed (OJ L 229, 1.9.2009, p. 1).","8","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition (OJ L 268, 18.10.2003, p.","29).","9","Directive 2002/32/EC of the European","Parliament and of the Council of 7 May","2002 on undesirable substances in animal","feed (OJ L 140, 30.5.2002, p. 10)."],"old":["(6) As a type of feed, medicated feed falls","within the scope of Regulation (EC) No","183/2005 of the European Parliament and","of the Council6, of Regulation (EC) No","","","767/2009 of the European Parliament and","of the Council7, of Regulation (EC) No","1831/2003 of the European Parliament and","of the Council8 and of Directive","2002/32/EC of the European Parliament","and of the Council9. Specific provisions for","medicated feed and intermediate products","should be established concerning facilities","and equipment, personnel, manufacture","quality control, storage and transport,","record-keeping, complaints and product","recalls, the application of procedures based","on the hazard analysis and critical control","points (HACCP) principles and labelling.","__________________","6","Regulation (EC) No 183/2005 of the","European Parliament and of the Council of","12 January 2005 laying down requirements","for feed hygiene (OJ L 35, 8.2.2005, p. 1).","7","Regulation (EC) No 767/2009 of the","European Parliament and of the Council of","13 July 2009 on the placing on the market","and use of feed (OJ L 229, 1.9.2009, p. 1).","8","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition (OJ L 268, 18.10.2003, p.","29).","9","Directive 2002/32/EC of the European","Parliament and of the Council of 7 May","2002 on undesirable substances in animal","feed (OJ L 140, 30.5.2002, p. 10)."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"29","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-30","location":[[" Proposal for a regulation","Recital 7"]],"meps":[36392],"meta":{"created":"2019-07-03T06:28:11"},"new":["(Does not affect English version.)"],"old":["(7) Medicated feed imported into the","Union must satisfy the general obligations","laid down in Article 11 of Regulation (EC)","No 178/2002 and the import conditions","laid down in Regulation (EC) No 183/2005","and in Regulation (EC) No 882/2004 of the","European Parliament and of the Council10.","Within this framework, medicated feed","imported into the Union is to be considered","as falling within the scope of this","Regulation.","__________________","10","Regulation (EC) No 882/2004 of the","European Parliament and of the Council of","29 April 2004 on official controls","performed to ensure the verification of","compliance with feed and food law, animal","health and welfare rules (OJ L 165,","30.4.2004, p. 1) (Corrigendum : OJ L 191,","28.5.2004, p. 1).."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"30","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Mich\u00e8le Rivasi, Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-31","location":[["Proposal for a regulation","Recital 8"]],"meps":[96743,96752],"meta":{"created":"2019-07-03T06:28:11"},"new":["(8) Without prejudice to the general","obligations laid down in Article 12 of","Regulation (EC) No 178/2002 concerning","exports of feed to third countries, the","provisions of this Regulation should apply","to medicated feed and intermediate","products which are manufactured, stored,","transported or placed on the market within","the Union with the intention to be","exported. However, the specific","requirements concerning prescription and","use of medicated feed and intermediate","products should not apply to products","intended to be exported. Requirements","concerning labelling should not apply","where the requirements for labelling are","more stringent in the export country than","in the EU."],"old":["(8) Without prejudice to the general","obligations laid down in Article 12 of","Regulation (EC) No 178/2002 concerning","exports of feed to third countries, the","provisions of this Regulation should apply","to medicated feed and intermediate","products which are manufactured, stored,","transported or placed on the market within","the Union with the intention to be","exported. However, the specific","requirements concerning labelling,","","prescription and use of medicated feed and","intermediate products should not apply to","products intended to be exported."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"31","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-32","location":[[" Proposal for a regulation","Recital 9"]],"meps":[36392],"meta":{"created":"2019-07-03T06:28:11"},"new":["(9) Medicated feed should be manufactured","exclusively with authorised veterinary","medicinal products and the compatibility of","all compounds used should be ensured for","the purpose of safety and efficacy of the","product. Additional specific requirements","or instructions for the inclusion of the","veterinary medicinal products into feed","should be foreseen to ensure a safe and","efficient treatment of the animals."],"old":["(9) Medicated feed should be manufactured","only with authorised veterinary medicinal","products and the compatibility of all","compounds used should be ensured for the","purpose of safety and efficacy of the","product. Additional specific requirements","or instructions for the inclusion of the","veterinary medicinal products into feed","should be foreseen to ensure a safe and","efficient treatment of the animals."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"32","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-33","location":[[" Proposal for a regulation","Recital 9"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:11"},"new":["(9) Medicated feed should be manufactured","only with authorised veterinary medicinal","products and the compatibility of all","compounds used should be ensured for the","purpose of safety and efficacy of the","product. Additional specific requirements","or instructions for the inclusion of the","veterinary medicinal products into feed","should be foreseen to ensure a safe and","efficient treatment of the animals. The","inclusion rates set should as a matter of","principle be geared to a farm\u2019s average","needs. To take account of the specific","features of the small-scale farming sector,","and in particular to enable small or","remote farms to optimise livestock care, it","should be permissible to retain established","control systems provided it is ensured that","the prescription, production and use of","medicated feed take place under the","instructions and supervision of a","veterinarian and are subject to an","external process control."],"old":["(9) Medicated feed should be manufactured","only with authorised veterinary medicinal","products and the compatibility of all","compounds used should be ensured for the","purpose of safety and efficacy of the","","product. Additional specific requirements","or instructions for the inclusion of the","veterinary medicinal products into feed","should be foreseen to ensure a safe and","efficient treatment of the animals."],"orig_lang":"de","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"33","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sirpa Pietik\u00e4inen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-34","location":[["Proposal for a regulation","Recital 9 a (new)"]],"meps":[40599],"meta":{"created":"2019-07-03T06:28:11"},"new":["(9a) Flock medication in feed and water","often increases the unnecessary use of","antibiotics and therefore individual","injections of antibiotics should be","preferred."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"34","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sirpa Pietik\u00e4inen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-35","location":[["Proposal for a regulation","Recital 9 b (new)"]],"meps":[40599],"meta":{"created":"2019-07-03T06:28:11"},"new":["(9b) Effects of the use of medicated feed","on the medicalisation of the environment","should be further studied."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"35","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Tom\u00e1\u0161 Zdechovsk\u00fd","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-36","justification":"Each article should contain a single provision or rule. Its structure must be as simple as\npossible.","location":[[" Proposal for a regulation","Recital 12"]],"meps":[124713],"meta":{"created":"2019-07-03T06:28:12"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \"carry-over\" is used","specifically to designate the transfer of","traces of an active substance contained in a","medicated feed to a non-target feed, while","the term \"cross-contamination\" is to be","considered as a contamination resulting","from a carry-over or from the transfer in","feed of any unintended substance."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over\u2019 is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination\u2019 is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing","practice and the ALARA (As Low As","Reasonably Achievable) principle.","General limits should be set out in this","","Regulation, taking into account the","unavoidable carry-over and the risk","caused by the active substances","concerned."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"36","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-37","location":[["Proposal for a regulation","Recital 12"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:12"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over\u2019 is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination\u2019 is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be prohibited in","order to protect animal health, human","health and the environment."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over\u2019 is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination\u2019 is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","","application of good manufacturing","practice and the ALARA (As Low As","Reasonably Achievable) principle.","General limits should be set out in this","Regulation, taking into account the","unavoidable carry-over and the risk","caused by the active substances","concerned."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"37","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-38","location":[[" Proposal for a regulation","Recital 12"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:12"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \"carry-over\" is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\"cross-contamination\" is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. General limits","should be set out in this Directive, taking","into account the unavoidable carry-over","and the risk caused by the active","substances concerned."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \"carry-over\" is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\"cross-contamination\" is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","","and the ALARA (As Low As Reasonably","Achievable) principle. General limits","should be set out in this Regulation, taking","into account the unavoidable carry-over","and the risk caused by the active","substances concerned."],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"38","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-39","justification":" The maximum level of active substances in non-target feed depends on the dosage of the\n Veterinary Medicinal Product in the previous batch of Medicated Feed. This would increase\n the administrative burden for the manufacturing plant in ensuring the control of compliance\n with the lawful level of active substances. It is more appropriate to establish a harmonised\n limit for the presence of active substances in non-target feed, independent of the dosage of the\n previous batch of Medicated Feed.","location":[["Proposal for a regulation","Recital 12"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:12"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over\u2019 is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination\u2019 is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum limits for levels of","carry-over for active substances contained","in non-target feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. In the interim, a","general maximum limit should be set out","in this Regulation, taking into account the","unavoidable carry-over and the risk caused","by the active substances concerned."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over\u2019 is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination\u2019 is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. General limits","should be set out in this Regulation, taking","","into account the unavoidable carry-over","and the risk caused by the active","substances concerned."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"39","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-40","location":[[" Proposal for a regulation","Recital 12"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:12"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over\u2019 is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","'cross-contamination' is to be considered as","a contamination resulting from a carry-over","or from the transfer in feed of any","unintended substance. Carry-over should","be avoided or reduced to an absolute","minimum. In order to protect animal","health, human health and the environment,","maximum levels of carry-over for active","substances contained in medicated feed","should be established, based on a scientific","risk assessment performed by the European","Food Safety Authority and taking into","account the application of good","manufacturing practice and the ALARA","(As Low As Reasonably Achievable)","principle. General limits should be set out","in this Regulation, taking into account the","unavoidable carry-over and the risk caused","by the active substances concerned."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over\u2019 is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination\u2019 is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. General limits","should be set out in this Regulation, taking","into account the unavoidable carry-over","and the risk caused by the active","substances concerned."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"40","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Tom\u00e1\u0161 Zdechovsk\u00fd","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-41","location":[["Proposal for a regulation","Recital 12 a (new)"]],"meps":[124713],"meta":{"created":"2019-07-03T06:28:12"},"new":["(12a) Carry-over of active substances","contained in medicated feed to non-target","feed should be avoided or kept as low as","possible. In order to protect animal","health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing","practice and the ALARA (As Low As","Reasonably Achievable) principle.","General limits should be set out in this","Regulation, taking into account the","unavoidable carry-over and the risk","caused by the active substances","concerned."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"41","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-42","justification":" Deviations of the labelled content automatically lead to misleading information for the user.\n Therefore, the labelling itself should be as precise as possible.","location":[[" Proposal for a regulation","Recital 13"]],"meps":[96743],"meta":{"created":"2019-07-03T06:28:12"},"new":["(13) Labelling of medicated feed should","comply with the general principles laid","down in Regulation (EC) No 767/2009 and","be subject to specific labelling","requirements in order to provide the user","with the information necessary to correctly","administer the medicated feed."],"old":["(13) Labelling of medicated feed should","comply with the general principles laid","down in Regulation (EC) No 767/2009 and","be subject to specific labelling","requirements in order to provide the user","with the information necessary to correctly","administer the medicated feed. Similarly,","limits for the deviations of the labelled","content of medicated feed from the actual","content should be established."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"42","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-43","location":[[" Proposal for a regulation","Recital 13"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:12"},"new":["(13) Labelling of medicated feed should","comply with the general principles laid","down in Regulation (EC) No 767/2009 and","be subject to specific labelling","requirements in order to provide the user","with the information necessary to correctly","administer the medicated feed. Deviations","of the labelled content of medicated feed","from the actual content should be","prohibited."],"old":["(13) Labelling of medicated feed should","comply with the general principles laid","down in Regulation (EC) No 767/2009 and","be subject to specific labelling","requirements in order to provide the user","with the information necessary to correctly","administer the medicated feed. Similarly,","limits for the deviations of the labelled","content of medicated feed from the actual","content should be established."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"43","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Ivan Jakov\u010di\u0107","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-44","location":[["Proposal for a regulation","Recital 14"]],"meps":[124754],"meta":{"created":"2019-07-03T06:28:13"},"new":["(14) Medicated feed should be marketed in","specially labelled sealed containers for","safety reasons and to protect the user\u2019s","interest."],"old":["(14) Medicated feed should be marketed in","sealed containers for safety reasons and to","protect user\u2019s interest."],"orig_lang":"hr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"44","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-45","justification":"Existing derogations under Article 23 of Regulation (EC) No 767/2009 for the transport of\nfeed should be included in this proposed regulation, to ensure consistency with current\ntransport arrangements for medicated feed in certain Member States.","location":[["Proposal for a regulation","Recital 14"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:13"},"new":["(14) Medicated feed should be marketed in","sealed containers for safety reasons and to","protect user's interest, but appropriate","derogations should be provided for in so","far as the application of that requirement","is not necessary to protect human or","animal health or consumer interests and","would represent excessive burden for the","feed business operators."],"old":["(14) Medicated feed should be marketed in","sealed containers for safety reasons and to","protect user's interest."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"45","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Piernicola Pedicini, Eleonora Evi, Marco Affronte","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-46","location":[[" Proposal for a regulation","Recital 15 a (new)"]],"meps":[124844,124779,124797],"meta":{"created":"2019-07-03T06:28:13"},"new":["(15a) Although it could, potentially,","resolve the administration problems","encountered by pet owners, the","administration of medicated feed to pets","should be the subject of further research,","in particular in order to assess the risks of","over-administration and under-","administration;"],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"46","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" James Nicholson, Richard Ashworth, Julie Girling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-47","justification":" The persons authorised to prescribe certain veterinary medicines should be determined by the\n relevant national authorities. Those with suitable qualifications, recognised by the Member\n State in which they reside, shall not be prohibited from prescribing and supplying certain\n veterinary medicines.","location":[[" Proposal for a regulation","Recital 16 a (new)"]],"meps":[1318,28132,96956],"meta":{"created":"2019-07-03T06:28:13"},"new":["(16a) In order to ensure that the lines of","distribution and the supply of veterinary","medicines are not restricted, where","Member States have a legally defined,","professionally qualified animal medicines","advisor, they shall continue to prescribe","and supply certain veterinary medicines."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"47","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-48","location":[["Proposal for a regulation","Recital 17"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:13"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. The prescription can only","be issued by a veterinarian after he/she","has examined the animal and made a","diagnosis. A written or electronic","prescription is always required to be","presented to the manufacturer or the feed","business operator."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"48","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-49","location":[["Proposal for a regulation","Recital 17"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:13"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription. The prescription","can only be given by a veterinarian after","examination of the animal and when a","diagnosis is made, or if the veterinarian","has personal knowledge of the condition","of the animal. A written or electronic","prescription is always required when the","medicine is dispensed by anyone other","than the veterinarian. However, the","possibility to manufacture medicated feed","before a prescription is presented to the","manufacturer should not be excluded."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"49","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-50","location":[[" Proposal for a regulation","Recital 17"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:13"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"50","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-51","location":[[" Proposal for a regulation","Recital 17"]],"meps":[36392],"meta":{"created":"2019-07-03T06:28:13"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use must be","subject to presentation of a valid veterinary","prescription which has been issued after","examination of the animals to be treated.","However, the possibility to manufacture","medicated feed before a prescription is","presented to the manufacturer should not","be excluded."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"51","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sirpa Pietik\u00e4inen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-52","location":[["Proposal for a regulation","Recital 17"]],"meps":[40599],"meta":{"created":"2019-07-03T06:28:13"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued for a limited period of time after","examination of the animals to be treated.","However, the possibility to manufacture","medicated feed before a prescription is","presented to the manufacturer should not","be excluded."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"52","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-53","justification":"In conjunction with Article 15(5), the Commission's proposals as currently drafted imply a\nphysical examination of the animals by the person issuing the prescriptions. Such an\n\n arrangement is often impracticable, given the rapid and severe nature of some animal\n diseases.","location":[["Proposal for a regulation","Recital 17"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:14"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription. However, the","possibility to manufacture medicated feed","before a prescription is presented to the","manufacturer should not be excluded."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"53","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Mich\u00e8le Rivasi, Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-54","justification":" Such a provision can lead to harmful loopholes in access to the market of active substances.","location":[[" Proposal for a regulation","Recital 17"]],"meps":[96743,96752],"meta":{"created":"2019-07-03T06:28:14"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"54","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-55","location":[[" Proposal for a regulation","Recital 18"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:14"},"new":["(18) In order to ensure a particularly","prudent use of medicated feed for food-","producing animals and therefore provide","the basis for the assurance of a high level","of protection of public health, including","animal health, specific conditions","concerning the use and the validity of the","prescription, compliance with the","withdrawal period and record-keeping by","the animal holder should be provided for."],"old":["(18) In order to ensure a particularly","prudent use of medicated feed for food-","producing animals and therefore provide","the basis for the assurance of a high level","of protection of public health, specific","conditions concerning the use and the","validity of the prescription, compliance","with the withdrawal period and record-","keeping by the animal holder should be","","provided for."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"55","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-56","location":[["Proposal for a regulation","Recital 18"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:14"},"new":["(18) In order to ensure a prudent use, by","which is meant appropriate use of","medicines according to prescription, of","medicated feed for food-producing and","non-food producing animals and therefore","provide the basis for the assurance of a","high level of protection of public health,","specific conditions concerning the use and","the validity of the prescription, compliance","with the withdrawal period and record-","keeping by the animal holder should be","provided for."],"old":["(18) In order to ensure a particularly","prudent use of medicated feed for food-","producing animals and therefore provide","the basis for the assurance of a high level","of protection of public health, specific","conditions concerning the use and the","validity of the prescription, compliance","with the withdrawal period and record-","keeping by the animal holder should be","provided for."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"56","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-57","location":[["Proposal for a regulation","Recital 19"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","In particular, preventive use or use to","enhance the performance of food-","producing animals should not be allowed","and the necessary measures should be","taken to prevent the import of any live","animals, carcases, meat, and prepared","meals and dishes based on meat which","have been treated for such purposes."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed.",""],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"57","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Biljana Borzan","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-58","location":[[" Proposal for a regulation","Recital 19"]],"meps":[112748],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit or","prohibit the use of medicated feed","containing antimicrobials for food-","producing animals, especially in the case","of certain new or antimicrobials critically","important for humans. Preventive use or","use to enhance the performance of food-","producing animals should in particular not","be allowed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"58","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-59","location":[[" Proposal for a regulation","Recital 19"]],"meps":[124851],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials. Preventive use or use to","enhance the performance of food-","producing animals should in particular not","be allowed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing","animals. Preventive use or use to enhance","","the performance of food-producing animals","should in particular not be allowed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"59","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-60","justification":"The use of medicated feed as a route for administering a veterinary medicinal product should\nbe subject to the same conditions as any other veterinary medicinal product. The regulation\non feed must not introduce a restriction that contradicts an authorisation under the regulation\non veterinary medicinal products.","location":[["Proposal for a regulation","Recital 19"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","The prophylactic use of antibiotics should","not be authorised except in cases where","there is a high risk of infection and it is","allowed under the conditions of use","already defined in the authorisation for","the same medicinal product."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"60","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-61","location":[["Proposal for a regulation","Recital 19"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials. Preventive use or use to","enhance the performance of animals should","in particular not be allowed."],"old":["(19) Taking into account the serious public","","","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing","animals. Preventive use or use to enhance","the performance of food-producing","animals should in particular not be","allowed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"61","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Fredrick Federley, Marit Paulsen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-62","justification":" Medicated feed is often used for treating groups of animals. Individual treatment should\n always be considered before treatment with medicated feed containing antimicrobial\n veterinary medicine is conducted.","location":[[" Proposal for a regulation","Recital 19"]],"meps":[124989,4270],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Group treatment with medicated feed","containing antimicrobial veterinary","medicinal products should only be used in","justifiable cases where individual","treatment is not appropriate. Preventive","(prophylactic) use or use to enhance the","performance of animals should in","particular not be allowed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"62","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-63","location":[["Proposal for a regulation","Recital 19"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","In particular, the ban on the use of","antibiotics as growth promoters should be","confirmed, preventive use or use to","enhance the performance of food-","producing animals should not be allowed,","and all economic incentives that could","result in over-use of antibiotics","administered through feed should be","removed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"63","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-64","justification":" A total ban on preventative use could have adverse implications on animal health and\n welfare, particularly in cases where diseases emerge and spread rapidly. Preventative use\n should however only be allowed in precise and defined conditions, under the auspices of the\n epidemiological and clinical knowledge of the person who issued the prescription.","location":[["Proposal for a regulation","Recital 19"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","The use of antimicrobials in medicated","feed to enhance the performance of","animals should never be allowed. The use","of antimicrobials in medicated feed before","a disease is diagnosed or clinical signs are","present should only be allowed in very","exceptional circumstances and under","prescription on the basis of the","epidemiological and clinical knowledge of","the person who issued the prescription. It","should never be applied routinely nor to","compensate for poor hygiene or for","inadequate husbandry conditions"],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed.",""],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"64","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-65","location":[[" Proposal for a regulation","Recital 19"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Antibiotics critically important for human","use should not be used at all. Preventive","use or use to enhance the performance of","food-producing animals should in","particular not be allowed. Metaphylaxis","for large animals such as pigs and cows","should not be allowed, as they should be","treated individually."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"65","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-66","location":[[" Proposal for a regulation","Recital 19"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should be prohibited."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"66","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Lynn Boylan, Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-67","location":[["Proposal for a regulation","Recital 19 a (new)"]],"meps":[124984,124863],"meta":{"created":"2019-07-03T06:28:14"},"new":["(19a) The One Health concept, endorsed","by the World Health Organisation,","recognises that human health, animal","health and ecosystems are interconnected","and it is therefore essential for both","animal and human health to ensure","prudent use of antimicrobial medicines in","food-producing animals."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"67","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-68","location":[["Proposal for a regulation","Recital 19 a (new)"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:15"},"new":["(19a) Notes with great concern the high","number of animals infected with bacteria","that are resistant to antibiotics, and the","risk of carry-over of these bacteria from","infected meat to consumers."],"old":[""],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"68","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Lynn Boylan, Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-69","location":[[" Proposal for a regulation","Recital 19 b (new)"]],"meps":[124984,124863],"meta":{"created":"2019-07-03T06:28:15"},"new":["(19b) The WHO has identified food","products of animal origin as the main","potential route of contamination for","transmission of resistant bacteria and","resistant genes from food-producing","animals to humans."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"69","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-70","location":[[" Proposal for a regulation","Recital 19 b (new)"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:15"},"new":["(19b) The issue of off-label use of","antibiotics is a concern for animal","medicine as well as human medicine."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"70","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Ivan Jakov\u010di\u0107","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-71","location":[[" Proposal for a regulation","Recital 20"]],"meps":[124754],"meta":{"created":"2019-07-03T06:28:15"},"new":["(20) A system for the collection of unused","or expired products should be put in place","in order to control any risk that such","products might raise with regard to the","protection of animal health, human health","or the environment. Member States should","set up such a system as and where","necessary, in cooperation with regional","and local authorities."],"old":["(20) A system for the collection of unused","or expired products should be put in place","in order to control any risk that such","products might raise with regard to the","protection of animal, human health or the","environment."],"orig_lang":"hr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"71","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-72","location":[["Proposal for a regulation","Recital 20"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:15"},"new":["(20) A system for the collection of unused","or expired products should be put in place","in order to control any risk that such","products might raise with regard to the","protection of animal, human health or the","environment. Collection points should","keep records on the return of","unconsumed medicated feed containing","antimicrobial veterinary medicinal","products."],"old":["(20) A system for the collection of unused","or expired products should be put in place","in order to control any risk that such","products might raise with regard to the","protection of animal, human health or the","environment."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"72","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Mich\u00e8le Rivasi, Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-73","location":[["Proposal for a regulation","Recital 20 a (new)"]],"meps":[96743,96752],"meta":{"created":"2019-07-03T06:28:15"},"new":["(20a) A register of the prescriptions of","active substances should be kept up to","date at the level of competent authorities","for water management, for the sake of","traceability of the dissemination of","chemicals in the ecosystems."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"73","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-74","location":[[" Proposal for a regulation","Recital 21"]],"meps":[124851],"meta":{"created":"2019-07-03T06:28:15"},"new":["(21) In order to comply with the objective","of this Regulation and to take into account","technical progress and scientific","developments, the power to adopt acts in","accordance with Article 290 of the Treaty","on the Functioning of the European Union","should be delegated to the Commission in","respect of the establishment of specific","carry-over limits, the conditions under","which medicated feed may be used to treat","non-food producing animals and of the","amendment to the Annexes to this","Regulation. Those Annexes concern","provisions on feed business operators","obligations related to the manufacture,","storage, transport and placing on the","market of medicated feed and intermediate","products, the incorporation of the","veterinary medicinal product into feed, the","labelling particulars for medicated feed and","intermediate products, the permitted","tolerances for the compositional labelling","of medicated feed or intermediate products","and the specimen form to be used for the","veterinary prescription. The Commission,","when preparing and drawing-up delegated","acts, should ensure a simultaneous, timely","and appropriate transmission of relevant","documents to the European Parliament and","Council."],"old":["(21) In order to comply with the objective","of this Regulation and to take into account","technical progress and scientific","developments, the power to adopt acts in","accordance with Article 290 of the Treaty","on the Functioning of the European Union","should be delegated to the Commission in","respect of the establishment of specific","carry-over limits and of the amendment to","the Annexes to this Regulation. Those","Annexes concern provisions on feed","business operators obligations related to","the manufacture, storage, transport and","placing on the market of medicated feed","and intermediate products, the","incorporation of the veterinary medicinal","product into feed, the labelling particulars","for medicated feed and intermediate","products, the permitted tolerances for the","compositional labelling of medicated feed","or intermediate products and the specimen","form to be used for the veterinary","prescription. The Commission, when","preparing and drawing-up delegated acts,","should ensure a simultaneous, timely and","appropriate transmission of relevant","","documents to the European Parliament and","Council."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"74","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-75","location":[["Proposal for a regulation","Recital 21"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:15"},"new":["(21) In order to comply with the objective","of this Regulation and to take into account","technical progress and scientific","developments, the power to adopt acts in","accordance with Article 290 of the Treaty","on the Functioning of the European Union","should be delegated to the Commission in","respect of the amendment to the Annexes","to this Regulation. Those Annexes concern","provisions on feed business operators","obligations related to animal health and","welfare, the manufacture, storage, transport","and placing on the market of medicated","feed and intermediate products, the","incorporation of the veterinary medicinal","product into feed, the labelling particulars","for medicated feed and intermediate","products, the permitted tolerances for the","compositional labelling of medicated feed","or intermediate products and the specimen","form to be used for the veterinary","prescription. The Commission, when","preparing and drawing-up delegated acts,","should ensure a simultaneous, timely and","appropriate transmission of relevant","documents to the European Parliament and","Council."],"old":["(21) In order to comply with the objective","of this Regulation and to take into account","technical progress and scientific","developments, the power to adopt acts in","accordance with Article 290 of the Treaty","on the Functioning of the European Union","should be delegated to the Commission in","respect of the establishment of specific","carry-over limits and of the amendment to","the Annexes to this Regulation. Those","Annexes concern provisions on feed","business operators obligations related to","the manufacture, storage, transport and","placing on the market of medicated feed","and intermediate products, the","incorporation of the veterinary medicinal","product into feed, the labelling particulars","for medicated feed and intermediate","products, the permitted tolerances for the","compositional labelling of medicated feed","or intermediate products and the specimen","form to be used for the veterinary","prescription. The Commission, when","preparing and drawing-up delegated acts,","should ensure a simultaneous, timely and","appropriate transmission of relevant","documents to the European Parliament and","Council."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"75","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-76","justification":" The second part of the amendment follows on from the amendment to recital 3.","location":[[" Proposal for a regulation","Recital 24"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:15"},"new":["(24) Since the Union is conducting","negotiations with a partner whose","practices are far removed from the","Union's objectives, the objective of this","Directive, namely ensuring a high level of","protection of human and animal health,","providing adequate information for users","and strengthening the effective functioning","of the internal market, can be sufficiently","achieved by the Member States only. In","accordance with the principle of","proportionality as set out in Article 5 of the","Treaty on European Union, this Directive","does not go beyond what is necessary to","achieve that objective."],"old":["(24) Since the objective of this Regulation,","namely ensuring a high level of protection","of human and animal health, providing","adequate information for users and","strengthening the effective functioning of","the internal market, cannot be sufficiently","achieved by the Member States and can","therefore be better achieved at Union","level, the Union may adopt measures, in","accordance with the principle of","subsidiarity as set out in Article 5 of the","Treaty on European Union. In accordance","with the principle of proportionality, as set","out in that Article, this Regulation does","not go beyond what is necessary in order to","achieve that objective,"],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"76","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-77","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:15"},"new":["This Directive shall apply to:"],"old":["This Regulation shall apply to:"],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"77","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-78","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point a"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:15"},"new":["(a) the manufacture, storage and transport","of medicated feed and intermediate","products intended for pets, non-food","producing animals and food-producing","animals;"],"old":["(a) the manufacture, storage and transport","of medicated feed and intermediate","products;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"78","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-79","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point b"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:15"},"new":["(b) the placing on the market, including","import, and use of medicated feed and","intermediate products intended for pets,","non-food producing animals and food-","producing animals;"],"old":["(b) the placing on the market, including","import, and use of medicated feed and","intermediate products;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"79","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Mich\u00e8le Rivasi, Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-80","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point c"]],"meps":[96743,96752],"meta":{"created":"2019-07-03T06:28:15"},"new":["(c) the export to third countries of","medicated feed and intermediate products.","However, Articles 15, 16 and 17 shall not","apply to medicated feed and intermediate","products whose label indicates that they are","intended for export to third countries.","Article 9 shall not apply where the","requirements for labelling are more","stringent in the export country than in the","EU."],"old":["(c) the export to third countries of","medicated feed and intermediate products.","However, Articles 9, 15, 16 and 17 shall","not apply to medicated feed and","intermediate products whose label","indicates that they are intended for export","to third countries."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"80","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-81","justification":" Certain labelling requirements such as the obligation to include the phrase \u2018medicated feed\u2019\n\nshould also be mandatory where the feed is intended for export. This obligation will make it\neasier for the competent authorities to carry out their monitoring tasks in order to guarantee\nthe proper functioning of the internal market and correct controls on products intended for\nexport to third countries.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point c"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:15"},"new":["c) the export to third countries of","medicated feed and intermediate products.","However, the following articles shall not","apply to medicated feed and intermediate","products whose label indicates that they are","intended for export to third countries:","- Article 9, except as provided for in","Annex III, point 1, and","- Articles 15, 16 and 17."],"old":["c) the export to third countries of","medicated feed and intermediate products.","However, Articles 9, 15, 16 and 17 shall","not apply to medicated feed and","intermediate products whose label","indicates that they are intended for export","to third countries."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"81","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-82","justification":"Risks associated with the use of medicated feed to treat pet animals include: consumption of\nand over dosing if pet animals are able to access supplies of medicated feed which is not\nsecurely stored. In addition, if the animal does not eat the required portion of medicated feed\nwithin a certain amount of time, the active ingredient may never reach the appropriate\ntherapeutic level. The Commission should be empowered to adopt delegated acts with respect\nto clearly defined conditions under which medicated feed may be used to treat pet animals,\nmedicated feed by non-target animals in multi-pet households; over or under dosing if the\ncorrect amount of food is not given by owners; under dosing if animals which are ill eat less\nthan normal","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 a (new)"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:16"},"new":["This Regulation shall not apply to pet","animals unless a delegated act is adopted","in accordance with Articles 16a and 19."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"82","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pavel Poc","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-83","justification":" It is important to mention explicitly the scope of the present proposal for a regulation distinct\n to the proposal of the Regulation on Veterinary Medicinal Product.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 a (new)"]],"meps":[96715],"meta":{"created":"2019-07-03T06:28:16"},"new":["This Regulation shall not apply to","finished veterinary medicinal products to","be orally administered that have been","approved for use via feed or drinking","water."],"old":["",""],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"83","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Ulrike M\u00fcller","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-84","justification":" It is important to mention explicitly that the scope of the present proposal for a regulation is\n distinct from the proposal for a Regulation on Veterinary Medicinal Products, and that it will\n not entail any extra costs for small and medium-sized farms.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 a (new)"]],"meps":[124862],"meta":{"created":"2019-07-03T06:28:16"},"new":["This Regulation shall not apply to","finished medicinal products to be orally","administered that have been approved for","use via feed or drinking water.","Accordingly, the approval requirement set","out in Recital 16 shall not apply to farms","which use such medicinal products for","their own herd."],"orig_lang":"de","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"84","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-85","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 a (new)"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:16"},"new":["Without prejudice to the adoption of","delegated acts under Article 16a and","Article 19, this Regulation shall not apply","to pets."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"85","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pavel Poc, Daciana Octavia S\u00e2rbu","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-86","justification":"Medicated feed will also be used for non-food producing animals, (such as fur and pet\nanimals) so it is important to clarify that, in both the scope of the regulation and the\ndefinitions that apply.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point c"]],"meps":[96715,33989],"meta":{"created":"2019-07-03T06:28:16"},"new":["(c) the definitions of 'food-producing","animal', 'non-food producing animals',","'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"old":["(c) the definitions of 'food-producing","animal', 'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","'labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"86","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-87","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point c a (new)"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:16"},"new":["(ca) the definition of \u2018pet\u2019: the species","listed in Annex I to Regulation (EU) No","576/2013 of 12 June 2013;"],"old":[""],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"87","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-88","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point d"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:16"},"new":["(d) the definition of 'establishment' and","'feed business operator' as laid down in","Article 3 of Regulation (EC) No 183/2005;"],"old":["(d) the definition of 'establishment' as laid","down in Article 3 of Regulation (EC) No","183/2005;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"88","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-89","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point f a (new)"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:16"},"new":["fa) the definition of \u2018antimicrobial' as laid","down in Article 4 of Regulation","XXXX/201X of the European Parliament","and of the Council on veterinary","medicinal products."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"89","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-90","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point f b (new)"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:16"},"new":["fb) the definition of \u2018antibiotic' as laid","down in Article 4 of Regulation","XXXX/201X of the European Parliament","and of the Council on veterinary","medicinal products."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"90","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-91","justification":"To tighten up the definition and avoid possible confusion in practice. The term \u2018intermediate\nmedicated feed\u2019 is more appropriate than \u2018product\u2019, since it concerns a feed rather than a\nmedicinal product.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point b"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:16"},"new":["b) ' intermediate medicated feed ' : a","mixture of one or more veterinary","medicinal products with one or more feed","materials, intended to be used for the","manufacture of medicated feed;"],"old":["b) ' intermediate product ' : a mixture of","one or more veterinary medicinal products","with one or more feeds, intended to be used","for the manufacture of medicated feed;"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"91","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-92","justification":" We are proposing that this definition be deleted from the proposal for a regulation under\n review and included in the regulation on veterinary medicinal products, since the concept of\n \u2018active substance\u2019 applies to all medicinal products.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point c"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:16"},"new":["deleted"],"old":["c) ' active substance ' : a substance with a","pharmacological activity;"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"92","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-93","justification":" It should be made clear that non-target feed is a medicated feed which contains traces of\n other medicinal products resulting from technically unavoidable carry-over. The definition as\n it stands would create uncertainties in application. The definition needs to be improved to\n ensure the correct application of Article 7 on carry-over limits and cross contamination.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point d"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:16"},"new":["d) ' non-target feed ' : medicated feed","which is not intended to contain a specific","veterinary medicinal product;"],"old":["d) ' non-target feed ' : feed which is not","intended to contain a specific veterinary","medicinal product;"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"93","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-94","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point f"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:17"},"new":["deleted"],"old":["(f) 'feed business operator': any natural","or legal person responsible for ensuring","that the requirements of this Regulation","are met within the feed business under","their control;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"94","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-95","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point g"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:17"},"new":["(g) 'distributor': any feed business operator","that supplies medicated feed, packaged and","ready for use, to other distributors and","directly to the animal holder;"],"old":["(g) 'distributor': any feed business operator","that supplies medicated feed, packaged and","ready for use, to the animal holder;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"95","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-96","justification":"Medicated feed for pets is a recent innovation, and account must be taken of the possible\nexistence of different distribution channels in addition to those distributing medicated feed for\nlivestock.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point g"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:17"},"new":["g) ' distributor ' : any feed business","operator that supplies medicated feed,","packaged and ready for use, to the animal","holder or, in the case of non-food","producing animals, to other distributors","who are authorised to distribute","veterinary medicinal products;"],"old":["g) ' distributor ' : any feed business","operator that supplies medicated feed,","packaged and ready for use, to the animal","holder;"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"96","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-97","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point h"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:17"},"new":["h) ' mobile mixer ' : a feed business","operator with a feed establishment","consisting of a specifically equipped","mobile system for the manufacture of","medicated feed, who travels in order to","provide services to different animal","holdings."],"old":["h) ' mobile mixer ' : a feed business","operator with a feed establishment","consisting of a specifically equipped lorry","for the manufacture of medicated feed;"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"97","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-98","justification":" To differentiate mobile mixers, which travel to various animal holdings to provide a service,\n from mixers owned by farmers who manufacture feed for use on their own farms, dealt with in\n Article 2(2)(i).","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point h"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:17"},"new":["h) ' mobile mixer ' : a feed business","operator with a feed establishment","consisting of a specifically equipped","mobile system for the manufacture of","medicated feed, who travels in order to","provide services to different animal","holdings;"],"old":["h) ' mobile mixer ' : a feed business","operator with a feed establishment","consisting of a specifically equipped lorry","for the manufacture of medicated feed;"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"98","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-99","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:17"},"new":["i) ' on-farm mixer ' : a feed business","operator manufacturing medicated feed","intended exclusively for animals on his or","her farm."],"old":["i) ' on-farm mixer ' : a feed business","operator manufacturing medicated feed on","the farm of use."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"99","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-100","justification":"To differentiate between farmers who manufacture their own feed and mobile mixers which\ntravel between farms to manufacture medicated feed at the farmers\u2019 request.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:17"},"new":["i) ' on-farm mixer ' : a feed business","operator manufacturing medicated feed","intended exclusively for animals on his or","her farm."],"old":["i) ' on-farm mixer ' : a feed business","operator manufacturing medicated feed on","the farm of use."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"100","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-101","justification":" The introduced definition is used by the European Medicines Agency in their paper entitled\n \"Answers to the requests for scientific advice on the impact on public health and animal\n health of the use of antibiotics in animals\", reference number EMA/381884/2014.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i a (new)"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:17"},"new":["(ia) 'antimicrobials': an active substance","of synthetic or natural origin which","destroys microorganisms, suppresses their","growth or their ability to reproduce in","animals or humans."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"101","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pavel Poc, Claudiu Ciprian T\u0103n\u0103sescu, Daciana Octavia S\u00e2rbu","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-102","justification":" Definition of the \u00b4antimicrobials\u00b4 should be amended to clearly express and clarify the extent\n and coverage of this important category (keeping also in mind the fact that resistance\n development is an issue not only for anti-bacterials, but also for other substances as listed in\n the above mentioned definition). The introduced definition was adopted by HMA (Heads of\n Medicines Agencies) in October 2012.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i a (new)"]],"meps":[96715,96847,33989],"meta":{"created":"2019-07-03T06:28:17"},"new":["(ia) \u201eantimicrobials\" mean any","compound with a direct action on","microorganisms used for treatment or","prevention of infections. Antimicrobials","include anti-bacterials, anti-virals,","antifungals and anti-protozoals."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"102","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-103","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i a (new)"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:17"},"new":["(ia) 'antimicrobials: any compound with a","direct action on microorganisms used for","treatment or prevention of infections.","Antimicrobials include anti-","bacterials/antibiotics, anti-virals,","antifungals and anti-protozoals."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"103","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-104","justification":"A definition for metaphylaxis ('group treatment', instead of 'control treatment') is needed.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i a (new)"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:17"},"new":["(ia) 'group treatment (metaphylaxis)':","treatment of a group of animals, after a","diagnosis of a clinical disease in part of","the group has been made, with the aim of","treating the clinically sick animals and","controlling the spread of disease to","animals in close contact and at risk which","may already be (sub-clinically) infected."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"104","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pavel Poc, Claudiu Ciprian T\u0103n\u0103sescu, Daciana Octavia S\u00e2rbu","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-105","justification":" It should be clearly defined the claimed use of the medicated feed as \u00b4treatment\u00b4\n (curative/therapeutic use) or the \u00b4metaphylaxis\u00b4 (control treatment). Proposed definition was\n adopted by EPRUMA (European Platform for the Responsible Use of Medicines in Animals)\n in May 2013. (In the case that the definition will be introduced in the regulation related\n veterinary medicinal products, cross link to this regulation might be appropriate to be\n introduced.)","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i b (new)"]],"meps":[96715,96847,33989],"meta":{"created":"2019-07-03T06:28:17"},"new":["(ib) 'curative (therapeutic) treatment':","treatment of an ill animal or group of","animals, when a diagnosis of a disease or","an infection has been made;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"105","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-106","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i b (new)"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:17"},"new":["(ib) 'curative (therapeutic) treatment':","treatment of an ill animal or group of","animals, when a diagnosis of a disease or","an infection has been made;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"106","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pavel Poc, Claudiu Ciprian T\u0103n\u0103sescu, Daciana Octavia S\u00e2rbu","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-107","justification":"In order to clarify the term \"preventive use\", a precise distinction between the different forms\nof treatment was added. The introduced definition was adopted by EPRUMA (European\nPlatform for the Responsible Use of Medicines in Animals) in May 2013. (In the case that the\ndefinition will be introduced in the regulation related veterinary medicinal products, cross\nlink to this regulation might be appropriate to be introduced.)","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i c (new)"]],"meps":[96715,96847,33989],"meta":{"created":"2019-07-03T06:28:18"},"new":["(ic) 'control treatment (metaphylaxis)':","treatment of a group of animals, after a","diagnosis of a clinical disease in part of","the group has been made, with the aim of","treating the clinically sick animals and","controlling the spread of disease to","animals in close contact and at risk which","may already be (sub-clinically) infected;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"107","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-108","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i c (new)"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:18"},"new":["(ic) 'control treatment (metaphylaxis)':","treatment of a group of animals, after a","diagnosis of a clinical disease in part of","the group has been made, with the aim of","treating the clinically sick animals and","controlling the spread of disease to","animals in close contact and at risk which","may already be (sub-clinically) infected;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"108","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pavel Poc, Claudiu Ciprian T\u0103n\u0103sescu, Daciana Octavia S\u00e2rbu","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-109","justification":" In order to clarify the term \"preventive use\", a precise distinction between the different forms\n of treatment was added. The introduced definition was adopted by EPRUMA (European\n Platform for the Responsible Use of Medicines in Animals) in May 2013. (In the case that the\n definition will be introduced in the regulation related veterinary medicinal products, cross\n link to this regulation might be appropriate to be introduced.)","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i d (new)"]],"meps":[96715,96847,33989],"meta":{"created":"2019-07-03T06:28:18"},"new":["(id) 'preventive treatment (prophylaxis)':","treatment of an animal or a group of","animals before the emergence of clinical","signs of a disease, in order to prevent the","occurrence of a disease or an infection."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"109","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-110","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i d (new)"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:18"},"new":["(id) 'preventive treatment (prophylaxis)':","treatment of an animal or a group of","animals before the emergence of clinical","signs of a disease, in order to prevent the","occurrence of a disease or an infection;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"110","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-111","location":[["Proposal for a regulation","Chapter 2 \u2013 title"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:18"},"new":["Manufacture, storage, transport, import and","placing on the market"],"old":["Manufacture, storage, transport and","placing on the market"],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"111","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Mich\u00e8le Rivasi, Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-112","location":[["Proposal for a regulation","Chapter 2 \u2013 title"]],"meps":[96743,96752],"meta":{"created":"2019-07-03T06:28:18"},"new":["Manufacture, storage, transport, placing on","the market, traceability of the active","substances in the ecosystems"],"old":["Manufacture, storage, transport and","placing on the market"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"112","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sylvie Goddyn, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau, Jean-Fran\u00e7ois Jalkh","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-113","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1"]],"meps":[21331,124750,124767,125684,124770],"meta":{"created":"2019-07-03T06:28:18"},"new":["Feed business operators established in the","Union or in third countries trading with","Union Member States shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I.","Live animals, carcases, meat and","prepared meals and dishes based on meat","shall not be imported unless the","provisions of this Directive are strictly","complied with."],"old":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I.","",""],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"113","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-114","justification":" On-farm mixing of medicated feed containing antimicrobial veterinary medicinal products\n should not be allowed.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:18"},"new":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I. Holders of","food-producing animals shall not be","allowed to prepare their own medicated","feed containing antimicrobial veterinary","medicinal products."],"old":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"114","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-115","justification":"To facilitate the distribution of feed intended for pets so that this can be done through\nveterinarians or pharmacies authorised to distribute veterinary medicinal products, without\nimposing an unnecessary administrative burden on this type of distributor and on\nadministrations resulting from an obligation to meet the same requirements as feed business\noperators.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 a (new)"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:18"},"new":["1a. Distributors who supply medicated","feed solely for non-food producing","animals, distributed in sealed bags on","prescription and sent to the holders of the","animals, shall be exempt from the","requirements applying to feed business","operators."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"115","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-116","justification":"In implementing Regulation (EC) No 183/2005, primary feed producers already comply with\nthe principles of the HACCP in the records they keep. It should remain possible to use these\nrecords.","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 1"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:18"},"new":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall put in place, implement and","maintain a permanent written procedure or","procedures based on the hazard analysis","and critical control points (hereinafter: '","HACCP ' ) system as provided for in","Regulation (EC) No 183/2005. Established","control systems for on-farm mixers may","be retained, provided it is ensured that the","principles of the HACCP are complied","with."],"old":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall put in place, implement and","maintain a permanent written procedure or","procedures based on the hazard analysis","and critical control points (hereinafter: '","HACCP ' ) system as provided for in","Regulation (EC) No 183/2005."],"orig_lang":"de","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"116","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-117","justification":" It is not technically possible to avoid carry-over absolutely in a multi-purpose feed mill.\n Therefore Article 7(1) should restate the importance of minimising carry-over in accordance\n with the ALARA principle.","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 1"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:18"},"new":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall apply measures in","accordance with Article 3 and 4 to avoid or","minimise carry-over in accordance with","the ALARA principle."],"old":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall apply measures in","accordance with Article 3 and 4 to avoid","carry-over."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"117","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-118","justification":" The amendment adopts the term used in Regulation No 183/2005 on feed hygiene.","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 1"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:18"},"new":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall apply measures in","accordance with Article 3 and 4 to","minimise carry-over."],"old":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall apply measures in","accordance with Article 3 and 4 to avoid","carry-over."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"118","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-119","justification":"In keeping with recital 12, which states that carry-over \u2018should be avoided or kept as low as\npossible\u2019.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 1"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:19"},"new":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall apply measures in","accordance with Article 3 and 4 to avoid or","minimise carry-over."],"old":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall apply measures in","accordance with Article 3 and 4 to avoid","carry-over."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"119","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-120","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 1"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:19"},"new":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall apply measures in","accordance with Article 3 and 4 to prevent","carry-over."],"old":["1. Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall apply measures in","accordance with Article 3 and 4 to avoid","carry-over."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"120","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-121","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:19"},"new":["deleted"],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific carry-over limits for active","substances."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"121","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-122","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:19"},"new":["The Commission shall submit proposals to","the European Parliament for the","establishment of specific carry-over limits","for active substances."],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific carry-over limits for active","substances."],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"122","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-123","justification":"The implementing act procedure should be used, as is the case in Article 6(2).","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:19"},"new":["The Commission shall be empowered to","adopt implementing acts in accordance","with Article 19 concerning the","establishment of specific carry-over limits","for active substances.","Those implementing acts shall be adopted","in accordance with the examination","procedure referred to in Article 20(2)."],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific carry-over limits for active","substances.","",""],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"123","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-124","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:19"},"new":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific carry-over limits for active","substances in non-target feed on the basis","of a scientific risk assessment by the","European Food Safety Authority (EFSA)."],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific carry-over limits for active","substances."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"124","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Paul Brannen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-125","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[124954],"meta":{"created":"2019-07-03T06:28:19"},"new":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","carry-over limits for specific active","substances in order to avoid risk for","animal health, human health or the","environment."],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific carry-over limits for active","substances."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"125","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-126","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:19"},"new":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific carry-over limits for active","substances to avoid risk for animal health,","human health or the environment."],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific carry-over limits for active","substances."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"126","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-127","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:19"},"new":["deleted"],"old":["Where no specific carry-over limits have","been set for an active substance, the","following carry-over limits shall apply:","(a) for antimicrobial active substances,","1% of the active substance in the last","batch of medicated feed or of intermediate","product produced before the production of","non-target feed;","(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"127","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Paul Brannen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-128","justification":"The proposed 1% carry-over limit goes beyond the principle of proportionality and technical\nfeasibility.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 introductory part"]],"meps":[124954],"meta":{"created":"2019-07-03T06:28:19"},"new":["Where no specific carry-over limits have","been set for an active substance, the carry-","over limit of 3% of the active substance in","the last batch of medicated feed or of","intermediate product produced before the","production of non-target feed shall apply."],"old":["Where no specific carry-over limits have","been set for an active substance, the","following carry-over limits shall apply:"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"128","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-129","justification":"The maximum percentage of carry-over should be set on the basis of scientific data in keeping\nwith the proportionality principle, in line with good manufacturing practice. It is\ntechnologically difficult to achieve a 1% limit.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 introductory part"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:19"},"new":["Where no specific carry-over limits have","been set for an active substance, a carry-","over limit of 3% of the active substance in","medicated feed to non-target feed shall","apply."],"old":["Where no specific carry-over limits have","been set for an active substance, the","following carry-over limits shall apply:"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"129","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-130","justification":" Current laboratory methods for medicines are not sufficiently developed to measure low level\n contamination at the carry-over thresholds proposed for antimicrobial active substances.\n Therefore, it is more appropriate for a general maximum limit for the presence of active\n substances in non-target feed, until specific carry-over limits are established after a scientific\n risk assessment by EFSA.","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 introductory part"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:20"},"new":["Where no specific carry-over limits have","been set for an active substance in non-","target feed, a general maximum limit of","3% of the active substance in the last","batch of medicated feed or intermediate","product produced shall apply."],"old":["Where no specific carry-over limits have","been set for an active substance, the","following carry-over limits shall apply:"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"130","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Paul Brannen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-131","justification":"The proposed 1% carry-over limit goes beyond the principle of proportionality and technical\nfeasibility.","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[124954],"meta":{"created":"2019-07-03T06:28:20"},"new":["deleted"],"old":["(a) for antimicrobial active substances,","1% of the active substance in the last","batch of medicated feed or of intermediate","product produced before the production of","non-target feed;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"131","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-132","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:20"},"new":["deleted"],"old":["(a) for antimicrobial active substances,","1% of the active substance in the last","batch of medicated feed or of intermediate","product produced before the production of","non-target feed;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"132","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-133","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:20"},"new":["deleted"],"old":["(a) for antimicrobial active substances,","1% of the active substance in the last","batch of medicated feed or of intermediate","product produced before the production of","non-target feed;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"133","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-134","justification":" The maximum percentage of carry-over should be set on the basis of scientific data in keeping\n with the proportionality principle, in line with good manufacturing practice. It is\n technologically difficult to achieve a 1% limit.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:20"},"new":["deleted"],"old":["a) for antimicrobial active substances, 1%","of the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed;"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"134","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-135","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:20"},"new":["deleted"],"old":["a) for antimicrobial active substances, 1%","of the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed;"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"135","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-136","justification":"The carry-over limit should be reduced to 0,1% of the active substance to ensure that\nunneeded exposure to antimicrobials is reduced as far as technically feasible. Thorough\ncleaning of production lines, separation of production lines into antimicrobial and non-\nantimicrobial ones, and pre-packaging doses and packs of doses for transport will help\nachieve this target.","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:20"},"new":["(a) for antimicrobial active substances,","0.1% of the active substance in the last","batch of medicated feed or of intermediate","product produced before the production of","non-target feed;"],"old":["(a) for antimicrobial active substances, 1%","of the active substance in the last batch of","","medicated feed or of intermediate product","produced before the production of non-","target feed;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"136","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-137","justification":"The average carry over in the feed industry is around 5%","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:20"},"new":["(a) for antimicrobial active substances, 2%","of the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed;"],"old":["(a) for antimicrobial active substances, 1%","of the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed;"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"137","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Paul Brannen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-138","justification":" The proposed 1% carry-over limit goes beyond the principle of proportionality and technical\n feasibility.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[124954],"meta":{"created":"2019-07-03T06:28:20"},"new":["deleted"],"old":["(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"138","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-139","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:20"},"new":["deleted"],"old":["(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"139","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-140","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:20"},"new":["deleted"],"old":["(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","","target feed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"140","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-141","justification":"The maximum percentage of carry-over should be set on the basis of scientific data in keeping\nwith the proportionality principle, in line with good manufacturing practice. It is\ntechnologically difficult to achieve a 1% limit.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:20"},"new":["deleted"],"old":["b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"141","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-142","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:20"},"new":["(b) for the other active substances, 4% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"old":["(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"142","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-143","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:20"},"new":["(b) for all active substances, 3% of the","active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"old":["(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"143","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Mich\u00e8le Rivasi, Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-144","justification":" Such a provision can lead to harmful loopholes in access to the market of active substances.","location":[[" Proposal for a regulation","Article 8"]],"meps":[96743,96752],"meta":{"created":"2019-07-03T06:28:21"},"new":["Article 8 deleted","Anticipated production"],"old":["Medicated feed and intermediate products","may be manufactured and stored before","the prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers or in case of manufacture","of medicated feed or intermediate","products from veterinary medicinal","products in accordance with Articles 10 or","11 of Directive 2001/82/EC."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"144","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-145","justification":"Medicated feed needs to be made available for minor species and aquaculture, because\nexceptional prescriptions are often used owing to the fact that not enough authorised\nmedicines are available for them. The original wording prohibits the prior manufacture of\nmedicated feed prescribed under the \u2018exceptional prescription system\u2019 used for minor species\n(rabbits, goats, sheep and fish) and minor uses.","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:21"},"new":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","mobile mixers."],"old":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers or in case of manufacture","of medicated feed or intermediate","products from veterinary medicinal","products in accordance with Articles 10 or","11 of Directive 2001/82/EC."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"145","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-146","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:21"},"new":["Medicated feed and intermediate products","may not be manufactured and stored before","the prescription referred to in Article 15 is","issued."],"old":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers or in case of manufacture","of medicated feed or intermediate","products from veterinary medicinal","products in accordance with Articles 10 or","11 of Directive 2001/82/EC."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"146","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-147","justification":" Prior manufacture allows manufacturers to plan ahead and thereby avoid \u2018carry-over\u2019. We\n cannot deprive minor species of this method of treatment.","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:21"},"new":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued."],"old":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers or in case of manufacture","of medicated feed or intermediate","products from veterinary medicinal","products in accordance with Articles 10 or","11 of Directive 2001/82/EC."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"147","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-148","justification":"Medicated feed which is fed directly to the animals by an on-farm mixer does not need to be\nspecially and additionally labelled.","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:21"},"new":["1. In addition to Article 11(1), Articles 12","and 14 of Regulation (EC) No 767/2009,","the labelling of medicated feed and","intermediate products, where these are not","fed directly to livestock, shall comply with","Annex III to this Regulation."],"old":["1. In addition to Article 11(1), Articles 12","and 14 of Regulation (EC) No 767/2009,","the labelling of medicated feed and","intermediate products shall comply with","Annex III to this Regulation."],"orig_lang":"de","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"148","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-149","justification":"Many of the requirements laid down in Annex III to this proposal are already established in\nArticles 15 and 17 of Regulation (EC) No 767/2009. We are proposing that this article should\ninclude a reference to the provisions in that regulation that relate to the labelling and\ncirculation of feed.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:21"},"new":["1. In addition to Article 11(1) and Articles","12, 14, 15 and 17 of Regulation (EC)","No 767/2009, the labelling of medicated","feed and intermediate products shall","comply with Annex III to this Regulation."],"old":["1. In addition to Article 11(1), Articles 12","and 14 of Regulation (EC) No 767/2009,","the labelling of medicated feed and","intermediate products shall comply with","Annex III to this Regulation."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"149","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-150","justification":" We are proposing that all labelling information should be included in a single document (in a\n manner similar to that specified in Regulation (EC) No 767/2009). If the reference to various\n documents is maintained, it would make it difficult for the competent authorities to check\n compliance with labelling rules, and could also make it difficult to monitor the traceability of\n medicated feed.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 2"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:21"},"new":["2. Where containers are used instead of","packages, they shall be accompanied a","document complying with paragraph 1."],"old":["2. Where containers are used instead of","packaging material, they shall be","accompanied by documents complying","with paragraph 1."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"150","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-151","justification":" Deviations of the labelled content automatically lead to misleading information for the user.\n Therefore, the labelling itself should be as precise as possible.","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T06:28:21"},"new":["deleted"],"old":["3. Permitted tolerances for discrepancies","between the labelled compositional values","of a medicated feed or an intermediate","product and the values analysed in","official controls performed in accordance","with Regulation (EC) No 882/2004 are as","set out in Annex IV."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"151","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-152","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 3"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:21"},"new":["3. Discrepancies between the labelled","compositional values of a medicated feed","or an intermediate product and the values","analysed in official controls won't be","permitted."],"old":["3. Permitted tolerances for discrepancies","between the labelled compositional values","of a medicated feed or an intermediate","product and the values analysed in official","controls performed in accordance with","","Regulation (EC) No 882/2004 are as set","out in Annex IV."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"152","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Ivan Jakov\u010di\u0107","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-153","location":[["Proposal for a regulation","Article 10"]],"meps":[124754],"meta":{"created":"2019-07-03T06:28:21"},"new":["Medicated feed and intermediate products","shall be placed on the market only in","properly labelled and sealed packages or","containers. Packages or containers shall be","sealed in such a way that, when the","package or container is opened, the seal is","damaged and cannot be reused."],"old":["Medicated feed and intermediate products","shall be placed on the market only in","sealed packages or containers. Packages or","containers shall be sealed in such a way","that, when the package or container is","opened, the seal is damaged and cannot be","reused."],"orig_lang":"hr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"153","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-154","justification":" Existing derogations under Article 23 of Regulation (EC) No 767/2009 for the transport of\n feed should be included in this proposed regulation, to ensure consistency with current\n transport arrangements for medicated feed in certain Member States.","location":[["Proposal for a regulation","Article 10"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:21"},"new":["Medicated feed and intermediate products","shall be placed on the market only in","sealed packages or containers. Packages or","containers shall be sealed in such a way","that, when the package or container is","opened, the seal is damaged and cannot be","reused. Appropriate derogations should be","provided for in so far as the application of","that requirement is not necessary to","protect human or animal health or","consumer interests and would represent","excessive burden for the feed business","operators."],"old":["Medicated feed and intermediate products","shall be placed on the market only in","sealed packages or containers. Packages or","containers shall be sealed in such a way","that, when the package or container is","opened, the seal is damaged and cannot be","reused."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"154","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-155","justification":" (Does not affect the English version.)","location":[[" Proposal for a regulation","Article 10"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:21"},"new":["(Does not affect the English version.)"],"old":["Medicated feed and intermediate products","shall be placed on the market only in","sealed packages or containers. Packages or","containers shall be sealed in such a way","that, when the package or container is","opened, the seal is damaged and cannot be","reused."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"155","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-156","justification":"The requirements of Council Directive 90/167/EEC ought to be maintained. This proposal\nneeds to be in line with Article 114 of the new proposal for a regulation on veterinary\nmedicinal products.","location":[[" Proposal for a regulation","Article 11"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:21"},"new":["Article 11 deleted","Intra Union trade"],"old":["Where the Member State of manufacture","of medicated feed is not the same as the","","Member State where it is used by the","animal holder, the veterinary medicinal","product shall be authorised in accordance","with Directive 2001/82/EC in the Member","State of use."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"156","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-157","location":[["Proposal for a regulation","Article 11 \u2013 title"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:22"},"new":["Intra-Union trade and trade with third","countries"],"old":["Intra Union trade"],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"157","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-158","location":[["Proposal for a regulation","Article 11 \u2013 paragraph 1 a (new)"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:22"},"new":["Where medicated feed is manufactured in","a third country, the veterinary medicinal","product shall be authorised by the","Member State of use and by any Member","State in which the products derived from","the animals treated are consumed,","including in instances where the","manufacturer's head office is established","in a Member State."],"old":["",""],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"158","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Mich\u00e8le Rivasi, Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-159","justification":" In order to improve the efficiency of water management, the competent authorities need to\n know which active substances are disseminated into water.","location":[[" Proposal for a regulation","Article 11 a (new)"]],"meps":[96743,96752],"meta":{"created":"2019-07-03T06:28:22"},"new":["Article 11a","Traceability of the active substances","disseminated in the ecosystems","The prescription givers shall fill in a","register of the prescriptions of active","substances. The register shall be kept up","to date at the level of competent","authorities for water management, for the","sake of traceability of the dissemination of","chemicals in the ecosystems."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"159","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-160","location":[[" Proposal for a regulation","Article 12"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:22"},"new":["Feed business operators manufacturing,","storing, transporting or placing on the","market medicated feed or intermediate","products shall ensure that establishments","under their control are approved by the","competent public authority."],"old":["Feed business operators manufacturing,","storing, transporting or placing on the","market medicated feed or intermediate","","products shall ensure that establishments","under their control are approved by the","competent authority."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"160","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-161","justification":"On-farm mixers are already registered with the authorities. An additional approval procedure\ngoes against the principle of administrative simplification and cost saving for businesses.","location":[["Proposal for a regulation","Article 12"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:22"},"new":["Feed business operators manufacturing,","storing, transporting or placing on the","market medicated feed or intermediate","products shall ensure that establishments","under their control are approved by the","competent authority. Where on-farm","mixers include medicinal products solely","for use on their own farms, they shall","notify their activity to the competent","authority."],"old":["Feed business operators manufacturing,","storing, transporting or placing on the","market medicated feed or intermediate","products shall ensure that establishments","under their control are approved by the","competent authority."],"orig_lang":"de","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"161","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Fredrick Federley, Marit Paulsen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-162","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 1"]],"meps":[124989,4270],"meta":{"created":"2019-07-03T06:28:22"},"new":["1. The supply of medicated feed to animal","holders shall be subject to the presentation","and, in case of manufacturing by on-farm","mixers, the possession of a veterinary","prescription issued by a veterinarian and","to the conditions laid down in paragraphs 2","to 6."],"old":["1. The supply of medicated feed to animal","holders shall be subject to the presentation","and, in case of manufacturing by on-farm","","","mixers, the possession of a veterinary","prescription and to the conditions laid","down in paragraphs 2 to 6."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"162","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-163","justification":" Only duly qualified veterinarians must be authorised to produce diagnoses and issue\n prescriptions.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 2"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:22"},"new":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The veterinarian issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"old":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. 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The","","","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"164","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-165","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:22"},"new":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The veterinary agent issuing","the prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"old":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"165","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-166","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:22"},"new":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The veterinarian issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"old":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"166","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-167","justification":" A veterinary prescription shall contain the elements as suggested in the current Commission\n proposal on veterinary medicinal products.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 2"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:22"},"new":["2. The prescription shall contain the","information set out in Article 110 of the","Regulation of the European Parliament","and the Council on veterinary medicinal","products1 a . The original prescription shall","be kept by the manufacturer or, where","appropriate, the distributor. The person","issuing the prescription and the animal","holder shall keep a copy of the","prescription. The original and copies shall","be kept for three years from the date of","issuance.","__________________","1a Commission proposal COM(2014)558","final"],"old":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"167","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-168","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 2 \u2013 subparagraph 1 a (new)"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:22"},"new":["Metaphylactic use of medicated feed shall","be duly justified by the veterinarian","issuing the prescription. To that end,","prescribing veterinarians shall assess the","health and hygiene conditions at animal","holdings, including aquaculture holdings,","and the preventive bio-safety measures","taken there."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"168","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-169","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2 a (new)"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:22"},"new":["2a. Prescribing veterinarians may not sell","medicated feed."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"169","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-170","justification":" This regulation needs to be fully in line with the legislation on veterinary medicinal products\n and should under no circumstances place one way of administering veterinary medicated\n products above another. That is why we are proposing that the paragraph should be deleted.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 3"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:23"},"new":["deleted"],"old":["3. With the exception of medicated feed","for non-food producing animals,","medicated feed shall not be used for more","than one treatment under the same","prescription."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"170","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-171","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 4"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:23"},"new":["deleted"],"old":["4. The prescription shall be valid for a","maximum period of six months for non-","food producing animals and three weeks","for food-producing animals."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"171","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-172","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 4"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:23"},"new":["4. The prescription shall be valid for a","maximum period of six months for non-","food-producing animals in the case of","medicated feed not containing","antimicrobials, and three weeks for food-","producing animals and antimicrobial-","containing feed prescribed for non-food-","producing animals."],"old":["4. The prescription shall be valid for a","maximum period of six months for non-","food producing animals and three weeks","for food-producing animals."],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"172","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-173","justification":"Persons issuing the prescriptions should retain the capability to determine the validity of the\nprescription on the basis of their clinical and epidemiological knowledge. Restricting the\nperiod of prescription and the amount of medicated feed that can be supplied in one order\nmay cause an excessive administrative burden to both the persons issuing the prescription\nand those using the feed.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 4"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:23"},"new":["4. The prescription shall be valid only for","the period determined by the person who","issued the prescription."],"old":["4. The prescription shall be valid for a","maximum period of six months for non-","food producing animals and three weeks","for food-producing animals."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"173","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-174","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds and","after having knowledge of the feeding","systems the possibilities of mixing and","other relevant farm specificities.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used.","",""],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"174","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-175","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[124851],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","veterinarian who issued the prescription","and only for a diagnosed disease. The","veterinarian who issued the prescription","shall verify that this medication is justified","for the target animals on veterinary","grounds. Furthermore he shall ensure that","the administration of the veterinary","medicinal product concerned is not","incompatible with another treatment or use","and that there is no contra-indication or","interaction where several medicinal","products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"175","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-176","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","veterinarian who issued the prescription","and only for a diagnosed disease. The","veterinarian who issued the prescription","shall verify that this medication is justified","for the target animals on veterinary","grounds. Furthermore he shall ensure that","the administration of the veterinary","medicinal product concerned is not","incompatible with another treatment or use","and that there is no contra-indication or","interaction where several medicinal","products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"176","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-177","justification":"Medicated feed can be used to administer any kind of veterinary medicinal product, including\nvaccines and anti-parasite treatments. It is in any case up to the vet to choose the best\ntreatment for animals among the various existing routes of administration.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription. The","person who issued the prescription shall","verify that this medication is justified for","the target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"177","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-178","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","veterinary agent who issued the","prescription and only for a diagnosed","disease. The veterinary agent who issued","the prescription shall verify that this","medication is justified for the target","animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"178","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Fredrick Federley, Marit Paulsen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-179","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[124989,4270],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","veterinarian who issued the prescription","and only for a diagnosed disease. The","veterinarian who issued the prescription","shall verify that this medication is justified","for the target animals on veterinary","grounds. Furthermore he shall ensure that","the administration of the veterinary","medicinal product concerned is not","incompatible with another treatment or use","and that there is no contra-indication or","interaction where several medicinal","products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used.",""],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"179","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-180","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used. The","off-label use of medicated feed with","antimicrobials authorised for human use","only shall be forbidden."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"180","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-181","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","veterinarian who issued the prescription","and only for a diagnosed disease. The","veterinarian who issued the prescription","shall verify that this medication is justified","for the target animals on veterinary","grounds. Furthermore he shall ensure that","the administration of the veterinary","medicinal product concerned is not","incompatible with another treatment or use","and that there is no contra-indication or","interaction where several medicinal","products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"181","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-182","justification":" In conjunction with Recital 17, the Commission's proposals as currently drafted imply a\n physical examination of the animals by the person issuing the prescription. Such an\n arrangement is often impracticable, given the rapid and severe nature of some animal\n diseases, and furthermore would undermine the clinical and epidemiological knowledge of\n the person issuing the prescription.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for a group of animals under","the care of the person who issued the","prescription and only for the diagnosed","disease. The person who issued the","prescription shall verify that this","medication is justified for the target","animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"182","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-183","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:23"},"new":["5. The prescribed medicated feed may be","used only for the group of animals","inspected by the person who issued the","prescription. The person who issued the","prescription shall verify that this","medication is justified for the target","animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"183","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-184","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5 \u2013 subparagraph 1 a (new)"]],"meps":[124851],"meta":{"created":"2019-07-03T06:28:24"},"new":["Veterinarians qualified to prescribe","medicated feed in accordance with","applicable national law shall not retail","medicated feed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"184","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-185","justification":" We are proposing that the wording of the proposal should be made more concise so that it is\n easier to understand.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 6"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:24"},"new":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","the inclusion rate of the active substance of","the veterinary medicinal product per kg of","medicated feed."],"old":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","the inclusion rate of the veterinary","medicinal product calculated on the basis","of the relevant parameters."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"185","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-186","justification":" There is a need to distinguish between feed containing antimicrobial veterinary medicinal\n products or not. There should be no on-farm mixing of medicated feed with antimicrobial\n veterinary medicinal products.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:24"},"new":["1. For medicated feed containing","antimicrobial veterinary medicinal","products, feed business operators","supplying such medicated feed to the","holder of food-producing animals shall","ensure that the quantities supplied or mixed","do not exceed:"],"old":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed:"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"186","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-187","justification":"In this paragraph, the Commission gives feed business operators a responsibility that should\nactually be that of the vet alone, as he or she is the professional who must decide on the\nlength of the treatment and the quantity to supply on the basis of the conditions of use\nestablished in the authorisation.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:24"},"new":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed the quantities","determined in the prescription.","The quantities required for treatment","shall be determined in accordance with","the conditions of use established in the","authorisation to place on the market the","veterinary medicinal products included in","the prescription."],"old":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed:"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"187","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-188","justification":" Currently, some antimicrobial products are prescribed for a period longer than two weeks.\n Not only would a two week limit increase the administrative burden for those using medicated\n feed, but finishing the treatment course early may increase the possibility of antimicrobial\n resistance. Feed business operators should supply medicated feed on the basis of the\n prescription issued by the person assessing the clinical condition.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:24"},"new":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed the quantities","provided for in the prescription."],"old":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed:",""],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"188","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-189","justification":" It must be for the vet to determine the length of treatment, and therefore also the quantity that\n is to be supplied, on the basis of the authorised conditions of use set out in the notice\n accompanying the veterinary medicinal products that must be included in the corresponding\n veterinary prescription. The length of treatment cannot be established by means of legislation,\n given the differences between species, their physiological conditions, the conditions of\n administration, etc.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:24"},"new":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed the quantities","required for treatment, which shall be","determined in accordance with the","conditions of use established in the","authorisation to place on the market the","veterinary medicinal products included in","the prescription."],"old":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed:"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"189","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-190","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point a"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:24"},"new":["deleted"],"old":["(a) the quantities provided in the","prescription and"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"190","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-191","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point a"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:24"},"new":["deleted"],"old":["(a) the quantities provided in the","prescription and"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"191","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-192","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point a"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:24"},"new":["deleted"],"old":["(a) the quantities provided in the","prescription and"],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"192","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-193","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:24"},"new":["deleted"],"old":["(b) the quantities required for one","month's treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"193","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-194","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:24"},"new":["deleted"],"old":["(b) the quantities required for one","month's treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"194","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-195","justification":"Restricting the quantity of medicated feed to be supplied for the treatment, and establishing\nthe length of that treatment, should be the sole responsibility of the vet.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:24"},"new":["deleted"],"old":["(b) the quantities required for one","month\u2019s treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"195","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-196","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:24"},"new":["deleted"],"old":["(b) the quantities required for one","month\u2019s treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"196","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-197","justification":"The Regulation on Medicated Feed and Regulation on Veterinary Medicinal Products are\nlinked. It is therefore important to reference the conditions for use and duration as indicated\nin the VMP Regulation in this proposal. There are instances in which a treatment with an\n\n antimicrobial takes longer than two weeks, the MF regulation needs to take that into account","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:24"},"new":["(b) the quantities required for one month's","treatment or in case of medicated feed","containing antimicrobial veterinary","medicinal products the quantities required","for a duration mentioned in the summary","of the product characteristics, unless","specifically licensed otherwise under","COM(2014) 556 final, 2014/0255 (COD)."],"old":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"197","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Paul Brannen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-198","justification":" Some antimicrobial products are prescribed for a period of up to three weeks. Premature\n finishing of the treatment may exacerbate antimicrobial resistance.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[124954],"meta":{"created":"2019-07-03T06:28:24"},"new":["(b) the quantities required for one month's","treatment or three weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"old":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"198","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-199","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 a (new)"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:24"},"new":["1a. Before repeated prescription, it is","necessary for the veterinarian to evaluate","how the effected animals reacted to the","treatment and whether or not the","treatment can be stopped or needs to be","continued or changed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"199","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Annie Schreijer-Pierik","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-200","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 a (new)"]],"meps":[125030],"meta":{"created":"2019-07-03T06:28:25"},"new":["1a. Before a repeated prescription, it is","necessary for the veterinarian to do a","sensitivity check and to evaluate if the","treatment can be stopped or needs to be","continued or changed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"200","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-201","justification":"Need to introduce a separate paragraph for medicated feed not containing antimicrobial\nveterinary medicinal products (where on farm-mixing is tolerable).","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 a (new)"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:25"},"new":["1a. For medicated feed not containing","antimicrobial veterinary medicinal","products, feed business operators","supplying medicated feed to the holder of","food-producing animals, or on-farm","mixers of medicated feed for food-","producing animals shall ensure that the","quantities supplied or mixed do not","exceed the quantities provided in the","prescription."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"201","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-202","justification":" Clear conditions should be set with regard to metaphylaxis.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 b (new)"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:25"},"new":["1b. Member States shall ensure that","holders of food-producing animals apply","the preventive measures listed in Annex","Va before resorting to the use of","medicated feed containing antimicrobials","for metaphylaxis.","Or. en","(This amendment is linked to the amendment introducing a new Annex Va.)"],"old":["","",""],"peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"202","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-203","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:25"},"new":["2. Since there is a direct link between","good animal husbandry and a responsible","use of veterinary medicines, medicated","feed containing antimicrobial veterinary","medicinal products shall never be used to","prevent diseases in food-producing animals","or to enhance their performance"],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"203","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Iratxe Garc\u00eda P\u00e9rez","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-204","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[28298],"meta":{"created":"2019-07-03T06:28:25"},"new":["2. Medicated feed containing antibiotic","veterinary medicinal products shall not be","used for food-producing animals, except in","prophylactic uses where there is a high","risk of infection and they are allowed","under the conditions of use already","defined in the authorisation for the same","medicinal product."],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"204","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Fredrick Federley, Marit Paulsen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-205","justification":"Prophylactic use of medicated feed containing antimicrobial veterinary medicine contributes\nheavily to the risk of developing antimicrobial resistance.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[124989,4270],"meta":{"created":"2019-07-03T06:28:25"},"new":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall be used","in accordance with good animal","husbandry standards and not be used for","preventive treatment (prophylactic use)."],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"205","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-206","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:25"},"new":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used routinely to prevent diseases in food-","producing animals. It shall only be used in","limited and precise circumstances","prescribed by the veterinarian."],"old":["2. Medicated feed containing antimicrobial","","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"206","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-207","justification":" Preventive use is justified when there is a high risk of a group of animals contracting a\n disease. It should be allowed, but restricted to specific situations, and should also always be\n subject to a veterinary prescription based on clinical and epidemiological knowledge. Routine\n use for prevention purposes, or to compensate for poor hygiene or husbandry, must not be\n authorised under any circumstances.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:25"},"new":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to enhance performance."],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"207","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Lynn Boylan","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-208","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[124984],"meta":{"created":"2019-07-03T06:28:25"},"new":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance","and should be strictly restricted to","therapeutic use and individual treatment."],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","","animals or to enhance their performance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"208","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-209","justification":"A total ban on preventative use could have adverse implications on animal health and\nwelfare, particularly in cases where diseases emerge and spread rapidly. Preventative use\nshould only be allowed in precise and defined conditions, under the auspices of the\nepidemiological and clinical knowledge of the person who issued the prescription.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:25"},"new":["2. 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Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"209","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pavel Poc, Daciana Octavia S\u00e2rbu","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-210","justification":" A clarification based on the EPRUMA definitions was introduced. The ban on growth\n promotion was already mentioned in the recitals. It is important that preventive treatment is\n not used in neither food nor non-food producing animals.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[96715,33989],"meta":{"created":"2019-07-03T06:28:25"},"new":["2. 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Medicated feed containing antimicrobial","","","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"210","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Zolt\u00e1n Balcz\u00f3","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-211","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 3"]],"meps":[96877],"meta":{"created":"2019-07-03T06:28:25"},"new":["(3) When administering medicated feed,","the holder of food-producing animals must","ensure compliance with the withdrawal","period provided for in the veterinary","prescription."],"old":["(3) When administering medicated feed,","the holder of food-producing animals shall","ensure compliance with the withdrawal","period provided for in the veterinary","prescription."],"orig_lang":"hu","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"211","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Fredrick Federley, Jan Huitema, Marit Paulsen","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-212","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 4"]],"meps":[124989,58789,4270],"meta":{"created":"2019-07-03T06:28:25"},"new":["4. Feed business operators feeding food-","producing animals with medicated feed","shall keep records in accordance with","Article 69 of Directive 2001/82/EC. Those","records shall be kept for five years after the","date of administration of medicated feed,","including when the animal is slaughtered","during the five-year period. Member States","shall ensure that the data in those records","is collected and transferred to the Union","database on veterinary medicinal products","(referring to Article 51 and 54 in the","Regulation on veterinary medicinal","products 2014/0257 (COD))."],"old":["4. Feed business operators feeding food-","producing animals with medicated feed","shall keep records in accordance with","","","Article 69 of Directive 2001/82/EC. Those","records shall be kept for five years after the","date of administration of medicated feed,","including when the animal is slaughtered","during the five-year period."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"212","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-213","justification":"Both feed businesses as well as farmers should keep records.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 4"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:25"},"new":["4. 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Those","records shall be kept for five years after the","date of administration of medicated feed,","including when the animal is slaughtered","during the five-year period."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"213","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-214","location":[["Proposal for a regulation","Article 16 a (new)"]],"meps":[124851],"meta":{"created":"2019-07-03T06:28:25"},"new":["Article 16a","Use in non-food producing animals","The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific conditions in which medicated","feed may be used to treat non-food","producing animals. Such conditions shall","be based on scientific evidence and shall","define the species of non-food producing","animals as well as the specific health","conditions which may be treated with","medicated feed."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"214","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-215","location":[[" Proposal for a regulation","Article 16 a (new)"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:25"},"new":["Article 16a","Use in pet animals","The Commission shall be empowered to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific conditions in which medicated","feed may be used to treat pet animals."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"215","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Piernicola Pedicini, Marco Affronte, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-216","location":[[" Proposal for a regulation","Article 16 a (new)"]],"meps":[124844,124797,124779],"meta":{"created":"2019-07-03T06:28:26"},"new":["Article 16","Authorisation of the use of medicated feed","for pets","The Commission may adopt delegated acts","authorising the production and placing on","the market of medicated feed for pets","provided that there is sound scientific","evidence of the benefits of this method for","administering veterinary medicines and","the risks of over-administration and","under-administration are taken into","account. The Commission shall stipulate","the species of pet that may be treated with","medicated feed."],"orig_lang":"it","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"216","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Ivan Jakov\u010di\u0107","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-217","location":[["Proposal for a regulation","Article 17"]],"meps":[124754],"meta":{"created":"2019-07-03T06:28:26"},"new":["Member States, in cooperation with","regional and local authorities, shall ensure","that appropriate collection systems are in","place for medicated feed and intermediate","products that are expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription."],"old":["Member States shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that are expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription."],"orig_lang":"hr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"217","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Pilar Ayuso, Esther Herranz Garc\u00eda","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-218","justification":" It is up to the operators to establish procedures for the recall and disposal of the medicated\n feed referred to in Article 17: this echoes the obligation relating to non-medicated feed laid\n down in the section on complaints and product recall in Annex II to Regulation (EC)\n No 183/2005 laying down requirements for feed hygiene.","location":[["Proposal for a regulation","Article 17"]],"meps":[4319,22418],"meta":{"created":"2019-07-03T06:28:26"},"new":["Feed business operators shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that have expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription."],"old":["Member States shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that are expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription."],"orig_lang":"es","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"218","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-219","justification":"It is important to know how much medicated feed is returned.","location":[[" Proposal for a regulation","Article 17"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:26"},"new":["Member States shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that are expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription. Member","States shall ensure that manufacturers of","medicated feed and farmers are","informed where to find these collections","systems and how to get their unused","leftovers of medicated feed to these","collection points. Member States shall","ensure that operators of collection points","keep records of the medicated feed","collected. 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The delegation of power referred to in","Articles 7 and 18 shall be conferred on the","Commission for an indeterminate period of","time from the date of entry into force of","this Regulation."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"223","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-224","location":[["Proposal for a regulation","Article 19 \u2013 paragraph 2"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:26"},"new":["2. Member States shall communicate to","the Commission the text of the main","provisions of national law which they","adopt in the field covered by this","Directive."],"old":["2. 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The delegation of power referred to in","Articles 7 and 18 shall be conferred on the","Commission for an indeterminate period of","time from the date of entry into force of","this Regulation."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"225","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-226","location":[["Proposal for a regulation","Article 19 \u2013 paragraph 3"]],"meps":[124851],"meta":{"created":"2019-07-03T06:28:26"},"new":["3. The delegation of powers referred to in","Articles 7, 16a and 18 may be revoked at","any time by the European Parliament or by","the Council. A decision of revocation shall","put an end to the delegation of the power","specified in that decision. 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That period shall be extended","by two months at the initiative of the","European Parliament or the Council."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"228","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-229","location":[["Proposal for a regulation","Article 19 \u2013 paragraph 5"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:27"},"new":["5. A delegated act adopted pursuant to","Articles 7, 16a and 18 shall enter into force","only if no objection has been expressed","either by the European Parliament or the","Council within a period of two months of","notification of that act to the European","Parliament and the Council or if, before the","expiry of that period, the European","Parliament and the Council have both","informed the Commission that they will","not object. 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Exposure to\n them must be drastically reduced throughout their manufacturing and utilisation chain.","location":[[" Proposal for a regulation","Annex I \u2013 section 1 \u2013 point 5"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:27"},"new":["5. Drainage facilities shall be adequate for","the purpose intended; they shall be","designed and constructed to avoid the risk","of contamination of feed and of the","environment; in particular, they shall","prevent water contamination by","antimicrobials, especially antibiotics and","anti-parasites or substances classifiable as","endocrine disruptors in animals and","humans."],"old":["5. Drainage facilities shall be adequate for","the purpose intended; they shall be","designed and constructed to avoid the risk","of contamination of feed."],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"231","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-232","location":[[" Proposal for a regulation","Annex I \u2013 section 1 \u2013 point 6 a (new)"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:27"},"new":["6a. Feed used as the basis for medicated","feed shall not be derived from genetically","modified organisms."],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"232","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-233","justification":"Consistent with Article 7(1).","location":[["Proposal for a regulation","Annex I \u2013 section 3 \u2013 point 2"]],"meps":[1318],"meta":{"created":"2019-07-03T06:28:27"},"new":["2. Technical or organisational measures","shall be taken to avoid or minimise, any","cross-contamination and errors, to carry","out checks in the course of manufacture","and to ensure effective tracing of the","products used for the manufacture of","medicated feed and intermediate products."],"old":["2. Technical or organisational measures","shall be taken to avoid any cross-","contamination and errors, to carry out","checks in the course of manufacture and to","ensure effective tracing of the products","used for the manufacture of medicated feed","and intermediate products."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"233","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-234","location":[["Proposal for a regulation","Annex I \u2013 section 3 \u2013 point 2"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:27"},"new":["2. Technical or organisational measures","shall be taken to prevent any cross-","contamination and errors, to carry out","checks in the course of manufacture and to","ensure effective tracing of the products","used for the manufacture of medicated feed","and intermediate products."],"old":["2. Technical or organisational measures","shall be taken to avoid any cross-","contamination and errors, to carry out","checks in the course of manufacture and to","ensure effective tracing of the products","","used for the manufacture of medicated feed","and intermediate products."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"234","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-235","location":[[" Proposal for a regulation","Annex I \u2013 section 3 \u2013 point 3"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:27"},"new":["3. The presence of undesirable substances","within the meaning of Directive","2002/32/EC and of other contaminants in","relation to human and animal health shall","not be permitted, and appropriate measures","to prevent this presence shall be taken."],"old":["3. The presence of undesirable substances","within the meaning of Directive","2002/32/EC and of other contaminants in","relation to human and animal health shall","be monitored, and appropriate measures to","minimise this presence shall be taken."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"235","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-236","location":[[" Proposal for a regulation","Annex I \u2013 section 3 \u2013 point 4"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:27"},"new":["4. The products used for the manufacture","and unprocessed feed shall be stored","separately from medicated feed and","intermediate products in order to prevent","any cross-contamination."],"old":["4. The products used for the manufacture","and unprocessed feed shall be stored","separately from medicated feed and","intermediate products in order to avoid any","cross-contamination."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"236","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-237","location":[["Proposal for a regulation","Annex I \u2013 section 6 \u2013 point 2 \u2013 point i"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:27"},"new":["(i) information on the veterinarian who","has issued the prescription, including at","least his name and address."],"old":["(i) information on the person who has","issued the prescription, including at least","his name and address."],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"237","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Tibor Szanyi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-238","location":[["Proposal for a regulation","Annex I \u2013 section 6 \u2013 point 2 \u2013 point i"]],"meps":[124703],"meta":{"created":"2019-07-03T06:28:27"},"new":["(i) information on the veterinarian who","has issued the prescription, including at","least his name and address."],"old":["(i) information on the person who has","issued the prescription, including at least","his name and address."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"238","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-239","location":[["Proposal for a regulation","Annex I \u2013 section 6 \u2013 point 2 \u2013 point i"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:27"},"new":["(i) information on the veterinary agent","who has issued the prescription, including","at least his name and address."],"old":["(i) information on the person who has","issued the prescription, including at least","his name and address."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"239","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-240","location":[[" Proposal for a regulation","Annex I \u2013 section 6 \u2013 point 2 \u2013 subparagraph 2"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:27"},"new":["Apart from the documents that are","permanent in nature, the documents shall","be kept for six years in the register after","their date of issuance."],"old":["Apart from the documents that are","permanent in nature, the documents shall","be kept for three years in the register after","their date of issuance."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"240","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-241","location":[[" Proposal for a regulation","Annex II \u2013 point 1"]],"meps":[96882],"meta":{"created":"2019-07-03T06:28:28"},"new":["1. Mobile mixers or on-farm mixers shall","only use veterinary medicinal products at","inclusion rates above 2 kg/t of feed. By","way of derogation, smaller inclusion rates","may be specified in the veterinary","prescription:","- to adjust the quantity of medicated feed","produced to the size of the herd;","- if the prescription, production and use","take place under the supervision of the","veterinarian monitoring the herd; and","- if the farmer and the veterinarian","monitoring the herd are subject to an","external process control."],"old":["1. Mobile mixers or on-farm mixers shall","only use veterinary medicinal products at","inclusion rates above 2 kg/t of feed."],"orig_lang":"de","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"241","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-242","location":[[" Proposal for a regulation","Annex III \u2013 paragraph 1 \u2013 point 4"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:28"},"new":["4. the batch reference number of the","medicated feed or intermediate product","and the country of manufacture;"],"old":["4. the batch reference number of the","medicated feed or intermediate product;"],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"242","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-243","justification":"To make it easier for veterinarians to do their job and for farmers who make the effort to use\norganic production methods to do their work, authorised medicinal products must be clearly\nidentifiable.","location":[["Proposal for a regulation","Annex III \u2013 paragraph 1 \u2013 point 9"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:28"},"new":["9. a recommendation to read the package","leaflet of the veterinary medicinal","products, including a hyperlink where it","can be found, a warning that the product is","only for the treatment of animals, a","warning that the product must be kept out","of the sight and reach of children, and a","warning concerning authorisation to","administer the product to organically","farmed animals in accordance with the","regulations and directives in force and","with any special conditions of use;"],"old":["9. a recommendation to read the package","leaflet of the veterinary medicinal","products, including a hyperlink where it","can be found, a warning that the product is","only for the treatment of animals and a","warning that the product must be kept out","of the sight and reach of children;"],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"243","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-244","justification":" Information on where and how to appropriately dispose of unused material can be provided\n by a hyperlink.","location":[[" Proposal for a regulation","Annex III \u2013 paragraph 1 \u2013 point 16 a (new)"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:28"},"new":["(16a) Information that inappropriate","disposal of medicated feed poses serious","threats to the environment and may","contribute to antimicrobial resistance.","Information on where and how to","appropriately dispose of unused material."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"244","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-245","location":[[" Proposal for a regulation","Annex III \u2013 paragraph 1 \u2013 point 16 a (new)"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:28"},"new":["For medicated feed containing","antibiotics: the request to use antibiotics","only as a last resort and in a most prudent","and responsible manner"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"245","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-246","location":[[" Proposal for a regulation","Annex 4"]],"meps":[96743],"meta":{"created":"2019-07-03T06:28:28"},"new":["deleted","Tolerance","\u00b1 10%","\u00b1 20%","\u00b1 30%","\u00b1 40%"],"old":["Annex IV","","","Permitted tolerances for the","compositional labelling of medicated feed","or intermediate products as referred to in","Article 9(3)","1. The tolerances laid down in this point","shall include technical and analytical","deviations.","Where the composition of a medicated","feed or an intermediate product is found","to deviate from the amount of an","antimicrobial active substance indicated","on the label, a tolerance of 10% shall","apply. For the other active substances, the","following tolerances shall apply:","Active substance","per kg of","medicated feed","> 500 mg","> 10 mg and \u2264","500 mg","> 0,5 mg and \u2264","10 mg","\u2264 0,5 mg","2. For the labelling particulars referred to","in points 10 and 12 of Annex III to this","Regulation, the tolerances laid down in","Annex IV to Regulation (EC) No","767/2009 shall apply, as appropriate."],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"246","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Stefan Eck","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-247","location":[["Proposal for a regulation","Annex IV \u2013 heading 1"]],"meps":[124863],"meta":{"created":"2019-07-03T06:28:28"},"new":["Tolerances for the compositional labelling","of medicated feed or intermediate products","won't be permitted"],"old":["Permitted tolerances for the compositional","labelling of medicated feed or intermediate","products as referred to in Article 9(3)"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"247","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-248","justification":" Given the potency of antimicrobial active substances, a tolerance of 10% is far too high.","location":[[" Proposal for a regulation","Annex IV \u2013 point 1 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:28"},"new":["Where the composition of a medicated feed","or an intermediate product is found to","deviate from the amount of an","antimicrobial active substance indicated on","the label, a tolerance of 3% shall apply. For","the other active substances, the following","tolerances shall apply:"],"old":["Where the composition of a medicated","feed or an intermediate product is found to","deviate from the amount of an","antimicrobial active substance indicated on","the label, a tolerance of 10% shall apply.","For the other active substances, the","following tolerances shall apply:"],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"248","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe Loiseau","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-249","location":[[" Proposal for a regulation","Annex V \u2013 point 1"]],"meps":[21331,124770,124750,124767,125684],"meta":{"created":"2019-07-03T06:28:28"},"new":["1. Surname, forename, address and","professional membership number of the","veterinarian."],"old":["1. Surname, forename, address and","professional membership number of the","person allowed to prescribe a veterinary","medicinal product."],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"249","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":" Sylvie Goddyn, Jean-Fran\u00e7ois Jalkh, Mireille D'Ornano, Edouard Ferrand, Philippe","changes":{},"committee":["ENVI"],"compromise":["Loiseau"],"date":"2015-04-28T00:00:00","id":"PE554.992-250","location":[["Proposal for a regulation","Annex V \u2013 point 2"]],"meps":[21331,124770,124750,124767],"meta":{"created":"2019-07-03T06:28:28"},"new":["2. Issue date and signature or electronic","identification of the veterinarian."],"old":["2. Issue date and signature or electronic","identification of the person allowed to","prescribe a veterinary medicinal product."],"orig_lang":"fr","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"250","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Martin H\u00e4usling","changes":{},"committee":["ENVI"],"date":"2015-04-28T00:00:00","id":"PE554.992-251","justification":" These preventative measures include regularly checking the welfare of individual animals,\n which would not be possible in many mass rearing operations for chickens for example.","location":[["Proposal for a regulation","Annex V a (new)"]],"meps":[96752],"meta":{"created":"2019-07-03T06:28:28"},"new":["Annex Va","Preventive measures","Preventive measures to be used before","resorting to antimicrobial treatment of","entire groups (metaphylaxis):","- using good healthy breeding stock that","grows naturally, with suitable genetic","diversity","- conditions that respect the behavioural","needs of the species, including social","interactions/ hierarchies","- stocking densities that do not increase","risk of disease transmission","- isolation of sick animals away from the","rest of the group","- (for chickens and smaller animals)","subdivision of flocks into smaller,","physically separated groups","- Implementation of existing animal","welfare rules pursuant to Council","Directive 98/58/EC of 20 July 1998","concerning the protection of animals kept","for farming purposes (OJ L 221, 8.8.1998,","p. 23),","Council Directive 91/630/EEC of 19","November 1991 laying down minimum","standards for the protection of pigs (OJ L","340, 11.12.1991, p. 33), Council Directive","91/629/EEC of 19 November 1991 laying","down minimum standards for the","protection of calves (OJ L 340,","11.12.1991, p. 28)."],"old":[""],"orig_lang":"en","peid":"PE554.992v01-00","reference":"2014/0255(COD)","seq":"251","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-554992_EN.pdf"},{"authors":"Clara Eugenia Aguilera Garc\u00eda","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-41","justification":"The legal basis for this proposal is Article 43(2) whereby the ordinary legislative procedure is\nused for legislation necessary for the pursuit of the objectives of the common agricultural\npolicy.","location":[["Draft legislative resolution","Citation 1"]],"meta":{"created":"2019-07-03T06:47:30"},"new":["\u2013 having regard to Article 294(2) and","Article 43(2) and Article 168(4)(b) of the","Treaty on the Functioning of the European","Union, pursuant to which the Commission","submitted the proposal to Parliament (C8-","0143/2014),"],"old":["\u2013 having regard to Article 294(2) and","Article 43 and Article 168(4)(b) of the","Treaty on the Functioning of the European","Union, pursuant to which the Commission","submitted the proposal to Parliament (C8-","0143/2014),"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"41","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-42","location":[["Proposal for a regulation","Recital 2"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:30"},"new":["(2) Livestock production, animal health","and welfare occupy a very important place","in the agriculture of the Union. The rules","concerning medicated feed have significant","influence on the keeping and on the rearing","of animals, including non-food producing","animals, and on the production of products","of animal origin."],"old":["(2) Livestock production occupies a very","important place in the agriculture of the","Union. The rules concerning medicated","feed have significant influence on the","keeping and on the rearing of animals,","including non-food producing animals, and","on the production of products of animal","origin."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"42","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" John Stuart Agnew","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-43","justification":" Due to the diversity of farming systems, feed manufacturing facilities, pet ownership and\n veterinary services existing in Member States it is not possible to adequately coordinate fair\n rules governing the manufacturing, placing on the market and use of medicated feed at Union\n level and thus responsibility for this should rightly belong to the Member States.","location":[[" Proposal for a regulation","Recital 2 a (new)"]],"meps":[96897],"meta":{"created":"2019-07-03T06:47:30"},"new":["(2a) In accordance with the principle of","subsidiarity, Member States should be","free to set rules on the manufacture,","placing on the market and use of","medicated feed for all animals suitable to","their territory; accordingly Council","Directive 90/167/EEC should be repealed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"43","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-44","location":[[" Proposal for a regulation","Recital 3 a (new)"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:30"},"new":["(3a) Medicinal treatments, especially with","antimicrobials, should never replace good","husbandry, bio-security and management","practices."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"44","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-45","location":[["Proposal for a regulation","Recital 6"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:30"},"new":["(6) As types of feed, medicated feed and","intermediate products fall within the scope","of Regulation (EC) No 183/2005 of the","European Parliament and of the Council6,","of Regulation (EC) No 767/2009 of the","European Parliament and of the Council7,","of Regulation (EC) No 1831/2003 of the","European Parliament and of the Council8","and of Directive 2002/32/EC of the","European Parliament and of the Council9.","Specific provisions for medicated feed and","intermediate products should be","established concerning facilities and","equipment, personnel, manufacture quality","control, storage and transport, record-","keeping, complaints and product recalls,","the application of procedures based on the","hazard analysis and critical control points","(HACCP) principles and labelling.","__________________","6","Regulation (EC) No 183/2005 of the","European Parliament and of the Council of","12 January 2005 laying down requirements","for feed hygiene (OJ L 35, 8.2.2005, p. 1).","7","Regulation (EC) No 767/2009 of the","European Parliament and of the Council of","13 July 2009 on the placing on the market","and use of feed (OJ L 229, 1.9.2009, p. 1).","8","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition (OJ L 268, 18.10.2003, p.","29).","9","Directive 2002/32/EC of the European","Parliament and of the Council of 7 May","2002 on undesirable substances in animal","feed (OJ L 140, 30.5.2002, p. 10)."],"old":["(6) As a type of feed, medicated feed falls","within the scope of Regulation (EC) No","183/2005 of the European Parliament and","of the Council6, of Regulation (EC) No","767/2009 of the European Parliament and","of the Council7, of Regulation (EC) No","1831/2003 of the European Parliament and","of the Council8 and of Directive","2002/32/EC of the European Parliament","and of the Council9. Specific provisions for","medicated feed and intermediate products","should be established concerning facilities","and equipment, personnel, manufacture","quality control, storage and transport,","record-keeping, complaints and product","recalls, the application of procedures based","on the hazard analysis and critical control","points (HACCP) principles and labelling.","__________________","6","Regulation (EC) No 183/2005 of the","European Parliament and of the Council of","12 January 2005 laying down requirements","for feed hygiene (OJ L 35, 8.2.2005, p. 1).","7","Regulation (EC) No 767/2009 of the","European Parliament and of the Council of","13 July 2009 on the placing on the market","and use of feed (OJ L 229, 1.9.2009, p. 1).","8","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition (OJ L 268, 18.10.2003, p.","29).","9","Directive 2002/32/EC of the European","Parliament and of the Council of 7 May","2002 on undesirable substances in animal","feed (OJ L 140, 30.5.2002, p. 10)."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"45","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-46","location":[[" Proposal for a regulation","Recital 6"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:31"},"new":["(6) As a type of feed, medicated feed falls","within the scope of Regulation (EC) No","183/2005 of the European Parliament and","of the Council6, of Regulation (EC) No","767/2009 of the European Parliament and","of the Council7, of Regulation (EC) No","1831/2003 of the European Parliament and","of the Council8 and of Directive","2002/32/EC of the European Parliament","and of the Council9. Specific provisions for","medicated feed and intermediate products","should be established concerning facilities","and equipment, personnel, animal welfare,","manufacture quality control, storage and","transport, record-keeping, complaints and","product recalls, the application of","procedures based on the hazard analysis","and critical control points (HACCP)","principles and labelling.","__________________","6","Regulation (EC) No 183/2005 of the","European Parliament and of the Council of","12 January 2005 laying down requirements","for feed hygiene (OJ L 35, 8.2.2005, p. 1).","7","Regulation (EC) No 767/2009 of the","European Parliament and of the Council of","13 July 2009 on the placing on the market","and use of feed (OJ L 229, 1.9.2009, p. 1).","8","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition (OJ L 268, 18.10.2003, p.","29).","9","Directive 2002/32/EC of the European","Parliament and of the Council of 7 May","2002 on undesirable substances in animal","feed (OJ L 140, 30.5.2002, p. 10)."],"old":["(6) As a type of feed, medicated feed falls","within the scope of Regulation (EC) No","183/2005 of the European Parliament and","of the Council6, of Regulation (EC) No","767/2009 of the European Parliament and","of the Council7, of Regulation (EC) No","1831/2003 of the European Parliament and","of the Council8 and of Directive","2002/32/EC of the European Parliament","and of the Council9. Specific provisions for","medicated feed and intermediate products","should be established concerning facilities","and equipment, personnel, manufacture","quality control, storage and transport,","record-keeping, complaints and product","recalls, the application of procedures based","on the hazard analysis and critical control","points (HACCP) principles and labelling.","__________________","6","Regulation (EC) No 183/2005 of the","European Parliament and of the Council of","12 January 2005 laying down requirements","for feed hygiene (OJ L 35, 8.2.2005, p. 1).","7","Regulation (EC) No 767/2009 of the","European Parliament and of the Council of","13 July 2009 on the placing on the market","and use of feed (OJ L 229, 1.9.2009, p. 1).","8","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition (OJ L 268, 18.10.2003, p.","29).","9","Directive 2002/32/EC of the European","Parliament and of the Council of 7 May","2002 on undesirable substances in animal","feed (OJ L 140, 30.5.2002, p. 10)."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"46","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-47","justification":" At this point, it is important to specify that both medicated feed and intermediate products fall\n within the scope of Regulation (EC) No 183/2005 and of Regulation (EC) No 767/2009 and\n should therefore comply with the same rules (with particular regard to traceability, HACCP,\n etc.).","location":[["Proposal for a regulation","Recital 6"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:31"},"new":["(6) As a type of feed, medicated feed and","intermediate products fall within the scope","of Regulation (EC) No 183/2005 of the","European Parliament and of the Council6,","of Regulation (EC) No 767/2009 of the","European Parliament and of the Council7,","of Regulation (EC) No 1831/2003 of the","European Parliament and of the Council8","and of Directive 2002/32/EC of the","European Parliament and of the Council9.","Specific provisions for medicated feed and","intermediate products should be","established concerning facilities and","equipment, personnel, manufacture quality","control, storage and transport, record-","keeping, complaints and product recalls,","the application of procedures based on the","hazard analysis and critical control points","(HACCP) principles and labelling.","__________________","6","Regulation (EC) No 183/2005 of the","European Parliament and of the Council of","12 January 2005 laying down requirements","for feed hygiene (OJ L 35, 8.2.2005, p. 1).","7","Regulation (EC) No 767/2009 of the","European Parliament and of the Council of","13 July 2009 on the placing on the market","and use of feed (OJ L 229, 1.9.2009, p. 1).","8","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition (OJ L 268, 18.10.2003, p.","29).","9","Directive 2002/32/EC of the European","Parliament and of the Council of 7 May","2002 on undesirable substances in animal","feed (OJ L 140, 30.5.2002, p. 10)."],"old":["(6) As a type of feed, medicated feed falls","within the scope of Regulation (EC) No","183/2005 of the European Parliament and","of the Council6, of Regulation (EC) No","767/2009 of the European Parliament and","of the Council7, of Regulation (EC) No","1831/2003 of the European Parliament and","of the Council8 and of Directive","2002/32/EC of the European Parliament","and of the Council9. Specific provisions for","medicated feed and intermediate products","should be established concerning facilities","and equipment, personnel, manufacture","quality control, storage and transport,","record-keeping, complaints and product","recalls, the application of procedures based","on the hazard analysis and critical control","points (HACCP) principles and labelling.","__________________","6","Regulation (EC) No 183/2005 of the","European Parliament and of the Council of","12 January 2005 laying down requirements","for feed hygiene (OJ L 35, 8.2.2005, p. 1).","7","Regulation (EC) No 767/2009 of the","European Parliament and of the Council of","13 July 2009 on the placing on the market","and use of feed (OJ L 229, 1.9.2009, p. 1).","8","Regulation (EC) No 1831/2003 of the","European Parliament and of the Council of","22 September 2003 on additives for use in","animal nutrition (OJ L 268, 18.10.2003, p.","29).","9","Directive 2002/32/EC of the European","Parliament and of the Council of 7 May","","2002 on undesirable substances in animal","feed (OJ L 140, 30.5.2002, p. 10)."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"47","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-48","location":[[" Proposal for a regulation","Recital 9"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:31"},"new":["(9) Medicated feed should be manufactured","only with authorised veterinary medicinal","products and the compatibility of all","compounds used should be ensured for the","purpose of safety and efficacy of the","product. Additional specific requirements","or instructions for the inclusion of the","veterinary medicinal products into feed","should be foreseen to ensure a safe and","efficient treatment of the animals. The","inclusion rates set should as a matter of","principle be geared to a farm\u2019s average","needs. To take account of the specific","features of the small-scale farming sector,","and in particular to enable small or","remote farms to optimise livestock care, it","should be permissible to retain established","control systems provided it is ensured that","the prescription, production and use of","medicated feed take place under the","instructions and supervision of a","veterinarian and are subject to an","external process control."],"old":["(9) Medicated feed should be manufactured","only with authorised veterinary medicinal","products and the compatibility of all","compounds used should be ensured for the","purpose of safety and efficacy of the","product. Additional specific requirements","or instructions for the inclusion of the","veterinary medicinal products into feed","should be foreseen to ensure a safe and","efficient treatment of the animals."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"48","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Norbert Erd\u0151s","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-49","justification":"I find it unacceptable that the feed business operator is responsible for the compatibility\nassessment of veterinary medicinal products and feed. This responsibility shall be placed on\nthe holder of the authorisation of the veterinary medicinal products.","location":[["Proposal for a regulation","Recital 9"]],"meps":[124711],"meta":{"created":"2019-07-03T06:47:31"},"new":["(9) Medicated feed should be manufactured","only with authorised veterinary medicinal","products and the compatibility of all","compounds used should be ensured for the","purpose of safety and efficacy of the","product. The holder of the authorisation","of the veterinary medicinal products is","responsible for compatibility assessment.","Additional specific requirements or","instructions for the inclusion of the","veterinary medicinal products into feed","should be foreseen to ensure a safe and","efficient treatment of the animals."],"old":["(9) Medicated feed should be manufactured","only with authorised veterinary medicinal","products and the compatibility of all","compounds used should be ensured for the","purpose of safety and efficacy of the","product. Additional specific requirements","or instructions for the inclusion of the","veterinary medicinal products into feed","should be foreseen to ensure a safe and","efficient treatment of the animals."],"orig_lang":"hu","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"49","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-50","location":[["Proposal for a regulation","Recital 12"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:31"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over' is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination' is to be considered as","a contamination resulting from a carry-over","or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be prohibited in","order to protect animal health, human","health and the environment."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","","concept of \u2018carry-over' is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination' is to be considered as","a contamination resulting from a carry-over","or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing","practice and the ALARA (As Low As","Reasonably Achievable) principle.","General limits should be set out in this","Regulation, taking into account the","unavoidable carry-over and the risk","caused by the active substances","concerned."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"50","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-51","location":[[" Proposal for a regulation","Recital 12"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:31"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over\u2019 is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination\u2019 is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels for traces of","active substances in non-target feed should","be established, based on a scientific risk","assessment performed by the European","Food Safety Authority and taking into","account the application of good","manufacturing practice and the ALARA","(As Low As Reasonably Achievable)","principle. In the interim, general","maximum limits should be set out in this","Regulation according to a basic approach,","taking into account the unavoidable carry-","over and the risk caused by the active","substances concerned."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over\u2019 is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","","feed to a non-target feed, while the term","\u2018cross-contamination\u2019 is to be considered","as a contamination resulting from a carry-","over or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. General limits","should be set out in this Regulation, taking","into account the unavoidable carry-over","and the risk caused by the active","substances concerned."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"51","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-52","location":[["Proposal for a regulation","Recital 12"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:31"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of 'carry-over' is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","'cross-contamination' is to be considered as","a contamination resulting from a carry-over","or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum limits for levels of","carry-over for active substances contained","in non-target feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. In the interim, a","general maximum limit should be set out","in this Regulation, taking into account the","unavoidable carry-over and the risk caused","by the active substances concerned."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over' is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination' is to be considered as","a contamination resulting from a carry-over","","or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. General limits","should be set out in this Regulation, taking","into account the unavoidable carry-over","and the risk caused by the active","substances concerned."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"52","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-53","location":[[" Proposal for a regulation","Recital 12"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:31"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over' is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination' is to be considered as","a contamination resulting from a carry-over","or from the transfer in feed of any","unintended substance. Carry-over of active","substances in non-target feed should be","kept as low as possible. In order to protect","animal health, human health and the","environment, maximum limits for trace","levels of active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. General limits","should be set out in this Regulation, taking","into account the unavoidable carry-over","and the risk caused by the active","substances concerned."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over' is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination' is to be considered as","a contamination resulting from a carry-over","or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. General limits","should be set out in this Regulation, taking","into account the unavoidable carry-over","and the risk caused by the active","substances concerned."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"53","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-54","location":[["Proposal for a regulation","Recital 12"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:31"},"new":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over' is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination' is to be considered as","a contamination resulting from a carry-over","or from the transfer in feed of any","unintended substance. Carry-over should","be avoided or reduced to an absolute","minimum. In order to protect animal","health, human health and the environment,","maximum levels of carry-over for active","substances contained in medicated feed","should be established, based on a scientific","risk assessment performed by the European","Food Safety Authority and taking into","account the application of good","manufacturing practice and the ALARA","(As Low As Reasonably Achievable)","principle. General limits should be set out","in this Regulation, taking into account the","unavoidable carry-over and the risk caused","by the active substances concerned."],"old":["(12) Carry-over may occur during","production, processing, storage and","transport of feed where the same","production and processing equipment,","storage facilities or means of transport are","used for feed with different components.","For the purposes of this Regulation, the","concept of \u2018carry-over' is used specifically","to designate the transfer of traces of an","active substance contained in a medicated","feed to a non-target feed, while the term","\u2018cross-contamination' is to be considered as","a contamination resulting from a carry-over","or from the transfer in feed of any","unintended substance. Carry-over of active","substances contained in medicated feed to","non-target feed should be avoided or kept","as low as possible. In order to protect","animal health, human health and the","environment, maximum levels of carry-","","over for active substances contained in","medicated feed should be established,","based on a scientific risk assessment","performed by the European Food Safety","Authority and taking into account the","application of good manufacturing practice","and the ALARA (As Low As Reasonably","Achievable) principle. General limits","should be set out in this Regulation, taking","into account the unavoidable carry-over","and the risk caused by the active","substances concerned."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"54","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-55","location":[[" Proposal for a regulation","Recital 13"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:31"},"new":["(13) Labelling of medicated feed should","comply with the general principles laid","down in Regulation (EC) No 767/2009 and","be subject to specific labelling","requirements in order to provide the user","with the information necessary to correctly","administer the medicated feed. Deviations","of the labelled content of medicated feed","from the actual content should be","prohibited."],"old":["(13) Labelling of medicated feed should","comply with the general principles laid","down in Regulation (EC) No 767/2009 and","be subject to specific labelling","requirements in order to provide the user","with the information necessary to correctly","administer the medicated feed. Similarly,","limits for the deviations of the labelled","content of medicated feed from the actual","content should be established."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"55","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Daniel Buda, Viorica D\u0103ncil\u0103, Lauren\u0163iu Rebega","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-56","location":[[" Proposal for a regulation","Recital 13"]],"meps":[125012,95281,124792],"meta":{"created":"2019-07-03T06:47:32"},"new":["(13) Labelling of medicated feed should","comply with the general principles laid","down in Regulation (EC) No 767/2009 and","be subject to specific labelling","requirements, contain concise, clear and","easily understandable information in","order to provide the end user with the","information necessary to correctly","administer the medicated feed. Similarly,","limits for the deviations of the labelled","content of medicated feed from the actual","content should be established."],"old":["(13) Labelling of medicated feed should","","comply with the general principles laid","down in Regulation (EC) No 767/2009 and","be subject to specific labelling","requirements in order to provide the user","with the information necessary to correctly","administer the medicated feed. Similarly,","limits for the deviations of the labelled","content of medicated feed from the actual","content should be established."],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"56","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Norbert Erd\u0151s","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-57","justification":"As regards packaging there is contradiction between the recital and Article 10 of the draft for\na Regulation; therefore I recommend that the recital be deleted.","location":[["Proposal for a regulation","Recital 14"]],"meps":[124711],"meta":{"created":"2019-07-03T06:47:32"},"new":["deleted"],"old":["(14) Medicated feed should be marketed","in sealed containers for safety reasons","and to protect user's interest."],"orig_lang":"hu","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"57","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Julie Girling, James Nicholson, Mairead McGuinness","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-58","justification":" Existing derogations under Article 23 of Regulation (EC) No 767/2009 for the transport of\n feed should be included in this regulation to ensure consistency with current transport\n arrangements for medicated feed in certain Member States.","location":[["Proposal for a regulation","Recital 14"]],"meps":[96956,1318,28115],"meta":{"created":"2019-07-03T06:47:32"},"new":["(14) Medicated feed should be marketed in","sealed containers for safety reasons and to","protect user's interest. However,","appropriate derogations should be","provided for where the application of this","requirement is not necessary to protect","human or animal health or consumer","interests, and would represent an","excessive administrative and technical","burden."],"old":["(14) Medicated feed should be marketed in","sealed containers for safety reasons and to","protect user's interest.","",""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"58","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Ulrike M\u00fcller","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-59","justification":"The obligatory approval of farmers as feed business operators would be disproportionate and\nfurthermore unnecessary. In view of the time and expense that this would entail, the current\nsystem for registering primary producers should be kept in place.","location":[[" Proposal for a regulation","Recital 16"]],"meps":[124862],"meta":{"created":"2019-07-03T06:47:32"},"new":["(16) Feed business operators","manufacturing, whether they operate in a","feed mill, with a specially equipped lorry","or on-farm, storing, transporting or placing","on the market medicated feed and","intermediate products, should be approved","by the competent authority, in line with the","approval system laid down in Regulation","(EC) No 183/2005, in order to ensure both","feed safety and product traceability.","Provision should be made for a transition","procedure concerning establishments","already approved under Directive","90/167/EEC. Establishments which","administer medications to animals orally","in the form of medicated feed should not","be obliged to obtain an approval."],"old":["(16) Feed business operators","manufacturing, whether they operate in a","feed mill, with a specially equipped lorry","or on-farm, storing, transporting or placing","on the market medicated feed and","intermediate products, should be approved","by the competent authority, in line with the","approval system laid down in Regulation","(EC) No 183/2005, in order to ensure both","feed safety and product traceability.","Provision should be made for a transition","procedure concerning establishments","already approved under Directive","90/167/EEC."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"59","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-60","location":[["Proposal for a regulation","Recital 16"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:32"},"new":["(16) Feed business operators","manufacturing, whether they operate in a","feed mill, with a specially equipped lorry","or on-farm, storing, transporting or placing","on the market medicated feed and","intermediate products, should be approved","by the competent authority, in line with the","approval system laid down in Regulation","(EC) No 183/2005, in order to ensure both","feed safety and product traceability.","Provision should be made for a transition","procedure concerning establishments","already approved under Directive","90/167/EEC. The approval and","registration procedure under Regulation","(EC) No 183/2005 should take account of","the specific features of primary","production with a view to ensuring that in","particular small or remote farms can","optimise livestock care through the use of","medicated feed."],"old":["(16) Feed business operators","manufacturing, whether they operate in a","feed mill, with a specially equipped lorry","or on-farm, storing, transporting or placing","on the market medicated feed and","intermediate products, should be approved","by the competent authority, in line with the","approval system laid down in Regulation","(EC) No 183/2005, in order to ensure both","feed safety and product traceability.","Provision should be made for a transition","procedure concerning establishments","already approved under Directive","90/167/EEC."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"60","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Miguel Viegas, Lidia Senra Rodr\u00edguez","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-61","location":[["Proposal for a regulation","Recital 17"]],"meps":[125100],"meta":{"created":"2019-07-03T06:47:32"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"pt","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"61","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-62","location":[[" Proposal for a regulation","Recital 17"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:33"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"62","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-63","location":[[" Proposal for a regulation","Recital 17"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:33"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription. However, the","possibility to manufacture medicated feed","before a prescription is presented to the","manufacturer should not be excluded."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"63","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Daniel Buda","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-64","location":[["Proposal for a regulation","Recital 17"]],"meps":[125012],"meta":{"created":"2019-07-03T06:47:33"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination and after a","veterinary diagnosis has been established,","or following a regular visit for checking","the health of the animals to be treated.","However, the possibility to manufacture","medicated feed before a prescription is","presented to the manufacturer should not","be excluded."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"64","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Annie Schreijer-Pierik, Tom Vandenkendelaere","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-65","location":[["Proposal for a regulation","Recital 17"]],"meps":[125030,129164],"meta":{"created":"2019-07-03T06:47:33"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals","and when a diagnosis is made, or if the","veterinarian has personal knowledge of","the condition of the animal. A written or","electronic prescription is always required","when the medicine is dispensed by anyone","other than the veterinarian. However, the","possibility to manufacture medicated feed","before a prescription is presented to the","manufacturer should not be excluded."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"65","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Tibor Szanyi","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-66","location":[[" Proposal for a regulation","Recital 17"]],"meps":[124703],"meta":{"created":"2019-07-03T06:47:33"},"new":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid written","or electronic veterinary prescription which","has been issued, for a limited period of","time, by a veterinarian or another","professional person qualified to do so in","accordance with applicable national law","after examination and diagnosis of the","animals to be treated. However, the","possibility to manufacture medicated feed","before a prescription is presented to the","manufacturer should not be excluded."],"old":["(17) In order to ensure the safe use of","medicated feed, its supply and use should","be subject to presentation of a valid","veterinary prescription which has been","issued after examination of the animals to","be treated. However, the possibility to","manufacture medicated feed before a","prescription is presented to the","manufacturer should not be excluded."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"66","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Julie Girling, James Nicholson","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-67","justification":"The persons authorised to prescribe certain veterinary medicines should be determined by the\nrelevant national authorities. Those with suitable qualifications, recognised by the Member\nState in which they reside, shall not be prohibited from prescribing and supplying certain\nveterinary medicines.","location":[[" Proposal for a regulation","Recital 17 a (new)"]],"meps":[96956,1318],"meta":{"created":"2019-07-03T06:47:33"},"new":["(17a) In order to ensure that the lines of","distribution and the supply of veterinary","medicines are not restricted, where","Member States have a legally defined,","professionally qualified animal medicines","advisor, they shall continue to prescribe","and supply certain veterinary medicines."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"67","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Annie Schreijer-Pierik, Tom Vandenkendelaere","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-68","location":[["Proposal for a regulation","Recital 18"]],"meps":[125030,129164],"meta":{"created":"2019-07-03T06:47:33"},"new":["(18) In order to ensure a particularly","prudent use, by which is meant","appropriate use of medicines according to","prescription, of medicated feed for food-","producing and non-food producing","animals and therefore provide the basis for","the assurance of a high level of protection","of public health, specific conditions","concerning the use and the validity of the","prescription, compliance with the","withdrawal period and record-keeping by","the animal holder should be provided for."],"old":["(18) In order to ensure a particularly","prudent use of medicated feed for food-","producing animals and therefore provide","the basis for the assurance of a high level","of protection of public health, specific","conditions concerning the use and the","validity of the prescription, compliance","with the withdrawal period and record-","keeping by the animal holder should be","provided for."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"68","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-69","location":[[" Proposal for a regulation","Recital 18"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:33"},"new":["(18) In order to ensure a particularly","prudent use of medicated feed for food-","producing animals and therefore provide","the basis for the assurance of a high level","of protection of animal health and public","health, specific conditions concerning the","use and the validity of the prescription,","compliance with the withdrawal period and","record-keeping by the animal holder should","be provided for."],"old":["(18) In order to ensure a particularly","prudent use of medicated feed for food-","producing animals and therefore provide","the basis for the assurance of a high level","of protection of public health, specific","conditions concerning the use and the","validity of the prescription, compliance","with the withdrawal period and record-","keeping by the animal holder should be","provided for."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"69","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Daniel Buda","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-70","location":[[" Proposal for a regulation","Recital 18"]],"meps":[125012],"meta":{"created":"2019-07-03T06:47:33"},"new":["(18) In order to ensure a particularly","prudent use of medicated feed for animals","and therefore provide the basis for the","assurance of a high level of protection of","public health, specific conditions","concerning the use and the validity of the","prescription, compliance with the","withdrawal period and record-keeping by","the animal holder should be provided for."],"old":["(18) In order to ensure a particularly","prudent use of medicated feed for food-","producing animals and, therefore provide","the basis for the assurance of a high level","of protection of public health, specific","conditions concerning the use and the","validity of the prescription, compliance","with the withdrawal period and record-","keeping by the animal holder should be","provided for."],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"70","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-71","justification":"Medicated feed is only one method of administering veterinary medicinal products and\nrestricting medicated feed containing antimicrobials is an inappropriate response to the\noverall public health risk posed by resistance to antimicrobials across different methods of\nadministration. Performance enhancing use of antimicrobials is already prohibited, and\npreventive use may only be permitted in exceptional circumstances based on the advice from\nthe person issuing the prescription.","location":[["Proposal for a regulation","Recital 19"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:33"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to take","measures to reduce the overall use of","antimicrobials, specifically antibiotics, in","food-producing animals.","The use of antimicrobials in medicated","feed to enhance the performance of food-","producing animals should be prohibited.","The use of antimicrobials, specifically","antibiotics, in medicated feed before a","disease is diagnosed or clinical signs are","present should only be allowed in very","exceptional circumstances and under","prescription on the basis of the","epidemiological and clinical knowledge of","the person who issued the prescription. It","should never be applied routinely nor to","compensate for poor hygiene or for","inadequate husbandry conditions."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing","animals. Preventive use or use to enhance","the performance of food-producing animals","should in particular not be allowed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"71","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Daniel Buda, Viorica D\u0103ncil\u0103, Lauren\u0163iu Rebega","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-72","location":[["Proposal for a regulation","Recital 19"]],"meps":[125012,95281,124792],"meta":{"created":"2019-07-03T06:47:33"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use, with the exception of","situations when such medication is","required for preventing the outbreak of","epizootics, or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"72","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Matt Carthy, Miguel Viegas","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-73","location":[[" Proposal for a regulation","Recital 19"]],"meps":[124986,125100],"meta":{"created":"2019-07-03T06:47:33"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Medicated feed containing antimicrobials","should not be used to prevent diseases in","food-producing animals unless such use","is permitted under Regulation (EU)","2015/... (Veterinary Medicinal Products).","The ban on the use of antibiotics as","growth-promoting agents as provided by","Regulation (EC) No 1831/2003 should be","strictly complied with."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"73","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Fredrick Federley, Hannu Takkula, Marit Paulsen","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-74","justification":"Medicated feed is often used for treating groups of animals. Individual treatment should\nalways be considered before treatment with medicated feed containing antimicrobial\nveterinary medicine is conducted.","location":[["Proposal for a regulation","Recital 19"]],"meps":[124989,28316,4270],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for animals. Group","treatment with medicated feed containing","antimicrobial veterinary medicinal","products should only be used in justifiable","cases where individual treatment is not","appropriate. Preventive (prophylactic) use","of veterinary medicine products","containing antimicrobials or use to","enhance the performance of animals should","in particular not be allowed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing","animals. Preventive use or use to enhance","the performance of food-producing","animals should in particular not be","allowed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"74","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Tibor Szanyi","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-75","location":[["Proposal for a regulation","Recital 19"]],"meps":[124703],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials. Preventive use or use to","enhance the performance of animals should","in particular not be allowed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing","animals. Preventive use or use to enhance","the performance of food-producing","animals should in particular not be","allowed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"75","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Norbert Lins, Peter Jahr, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-76","justification":" Limiting the use of medicated feed containing antimicrobials is vital for all animals, not only\n for food-producing ones. The term \"preventive use\" was replaced by a more precise one.","location":[[" Proposal for a regulation","Recital 19"]],"meps":[124808,96772,125030],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials. Prophylactic use of","antibiotics should in particular not be","allowed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing","animals. Preventive use or use to enhance","the performance of food-producing","animals should in particular not be","allowed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"76","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-77","justification":"Antimicrobials crucial for human use should be reserved for humans; the WHO has\nestablished a list of these antimicrobials which are \"critically important\" for human health.\nSecondly, \"Preventive use\" is a vague term open to misinterpretation; we introduce in other\namendments the term \"preventive measures\" which decrease the need for antimicrobial use in\nthe first place, so we wish to distinguish between prophylactic treatment with antimicrobials\nand measures which would prevent their use.","location":[[" Proposal for a regulation","Recital 19"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Antimicrobials which are critically","important for human use should not be","used at all. So-called preventive use or use","of antimicrobials to enhance the","performance of food-producing animals","should in particular not be allowed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed.",""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"77","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-78","location":[["Proposal for a regulation","Recital 19"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of antimicrobials in animals.","Preventive use or use to enhance the","performance of food-producing animals","should not be allowed. The Commission","should encourage innovation in the","development of nutritional solutions to","preserve animals' welfare and thereby","contribute to reduce the need for","veterinary treatment, in particular via","antimicrobials."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"78","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-79","location":[["Proposal for a regulation","Recital 19"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for animals. Use of","antibiotics to enhance the performance of","food-producing animals was already","banned in 2006. In addition, routine","preventive use of medicated feed","containing antimicrobials should not be","allowed."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"79","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-80","location":[[" Proposal for a regulation","Recital 19"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should be prohibited."],"old":["(19) Taking into account the serious public","health risk posed by resistance to","antimicrobials, it is appropriate to limit the","use of medicated feed containing","antimicrobials for food-producing animals.","Preventive use or use to enhance the","performance of food-producing animals","should in particular not be allowed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"80","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-81","location":[[" Proposal for a regulation","Recital 19 a (new)"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19a) Metaphylaxis for large animals","such as pigs and cows should not be","allowed, as they should be treated","individually."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"81","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Norbert Lins, Daniel Buda, Peter Jahr, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-82","location":[["Proposal for a regulation","Recital 19 b (new)"]],"meps":[124808,125012,96772,125030],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19b) In accordance with Regulation (EC)","No 1831/2003, the ban on the use of","antibiotics as growth promoting agents as","of 1 January 2006 should be strictly","adhered to and properly enforced."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"82","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-83","location":[["Proposal for a regulation","Recital 19 c (new)"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:34"},"new":["(19c) Alternative measures to prevent","diseases diagnosed in individuals","spreading through whole groups of","animals should be prioritised before","resorting to treatment with antimicrobials,","such as physical separation from the","group or rearing in smaller groups of","animals."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"83","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-84","location":[[" Proposal for a regulation","Recital 20"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:34"},"new":["(20) A system for the collection of unused","or expired products should be put in place","in order to control any risk that such","products might raise with regard to the","protection of animal, human health or the","environment. Records should be kept at","collection points on the return of","unconsumed medicated feed containing","antimicrobial veterinary medicinal","products."],"old":["(20) A system for the collection of unused","or expired products should be put in place","in order to control any risk that such","products might raise with regard to the","protection of animal, human health or the","environment."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"84","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-85","location":[[" Proposal for a regulation","Recital 20 a (new)"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:34"},"new":["(20a) A register of the prescriptions of","active substances should be kept up to","date at the level of competent authorities","for water management, to enable the","traceability of the dispersion of chemicals","in ecosystems."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"85","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Annie Schreijer-Pierik, Tom Vandenkendelaere","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-86","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point a"]],"meps":[125030,129164],"meta":{"created":"2019-07-03T06:47:34"},"new":["(a) the manufacture, storage and transport","of medicated feed and intermediate","products intended for both non-food and","food-producing animals;"],"old":["(a) the manufacture, storage and transport","of medicated feed and intermediate","products;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"86","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-87","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point a"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:34"},"new":["(a) the manufacture, storage and transport","of medicated feed and intermediate","products for food-producing and non-food","producing animals;"],"old":["(a) the manufacture, storage and transport","of medicated feed and intermediate","products;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"87","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Annie Schreijer-Pierik, Tom Vandenkendelaere","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-88","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point b"]],"meps":[125030,129164],"meta":{"created":"2019-07-03T06:47:34"},"new":["(b) the placing on the market, including","import, and use of medicated feed and","intermediate products intended for both","non-food and food-producing animals;"],"old":["(b) the placing on the market, including","import, and use of medicated feed and","intermediate products;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"88","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-89","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point b"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:34"},"new":["(b) the placing on the market, including","import from third countries, and use of","medicated feed and intermediate products;"],"old":["(b) the placing on the market, including","import, and use of medicated feed and","intermediate products;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"89","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-90","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point b"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:34"},"new":["(b) the placing on the market, including","import from third countries, and use of","medicated feed and intermediate products;"],"old":["(b) the placing on the market, including","import, and use of medicated feed and","intermediate products;"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"90","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Ulrike M\u00fcller","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-91","justification":"The use of orally administered medications is adequately regulated elsewhere; this includes\nmixing with feedstuffs immediately prior to feeding.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1a (new)"]],"meps":[124862],"meta":{"created":"2019-07-03T06:47:35"},"new":["1a. This Regulation shall not apply to","ready-prepared medications for oral","administration which are approved for","use in feedstuffs or drinking water, or to","mixtures of such medications with","feedstuffs which are manufactured for","direct administration in livestock","holdings."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"91","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-92","justification":"It is important to distinguish explicitly the scope of the present proposal from the proposal on\nVeterinary Medicinal Products (VMP). It should be clearly defined that \u201coral powders\u201d\n(authorised/intended to be administered as top dressings or direct mixing on farm of small\nquantities of feed to be administered to small groups of animals) are excluded from the scope\nof this regulation. Similarly \u201coral powders for use in drinking water\u201d should be excluded\nfrom the scope of this regulation.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 a (new)"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:35"},"new":["1a. This Regulation shall not apply to","finished veterinary medicinal products to","be orally administered that have been","approved for use via feed as oral powders","intended for small group medication or","for use via drinking water."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"92","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Tom Vandenkendelaere, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-93","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point b"]],"meps":[129164,125030],"meta":{"created":"2019-07-03T06:47:35"},"new":["(b) the definitions of 'feed additive',","'antimicrobials', 'antibiotic' and 'daily","ration' as laid down in Article 2(2) of","Regulation (EC) No 1831/2003;"],"old":["(b) the definitions of 'feed additive' and","'daily ration' as laid down in Article 2(2) of","Regulation (EC) No 1831/2003;",""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"93","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-94","justification":" Non-food producing animals should be included because the same type feed is required in\n their treatment.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point c"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:35"},"new":["(c) the definitions of 'food-producing","animal', 'non-food producing animal', 'fur","animal', 'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","'labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"old":["(c) the definitions of 'food-producing","animal', 'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","'labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"94","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-95","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point c"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:35"},"new":["(c) the definitions of 'food-producing","animal' and 'non-food producing","animals', 'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","'labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"old":["(c) the definitions of 'food-producing","animal', 'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","'labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"95","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-96","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point c"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:35"},"new":["(c) the definitions of 'food-producing","animal', 'non-food producing animal',","'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","'labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"old":["(c) the definitions of 'food-producing","animal', 'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","'labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"96","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Annie Schreijer-Pierik, Tom Vandenkendelaere","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-97","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point c"]],"meps":[125030,129164],"meta":{"created":"2019-07-03T06:47:35"},"new":["(c) the definitions of 'food-producing","animal', 'non-food producing animals',","'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","'labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"old":["(c) the definitions of 'food-producing","animal', 'feed materials', 'compound feed',","'complementary feed', 'mineral feed',","'labelling', 'label', 'minimum storage life'","and 'batch' as laid down in Article 3(2) of","Regulation (EC) No 767/2009;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"97","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Tibor Szanyi","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-98","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point d"]],"meps":[124703],"meta":{"created":"2019-07-03T06:47:35"},"new":["(d) the definition of 'establishment' and","'feed business operator' as laid down in","Article 3 of Regulation (EC) No 183/2005;"],"old":["(d) the definition of 'establishment' as laid","down in Article 3 of Regulation (EC) No","183/2005;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"98","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-99","justification":" The definition of the \u00b4premix for medicated feedingstuffs\u00b4 should be amended, as the\n medicated premix is the veterinary medicinal product, which is an appropriate\n pharmaceutical form primarily authorised to be used incorporated in medicated feedingstuffs\n in conditions fully in compliance with the conditions of the marketing authorisation.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point f"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:35"},"new":["(f) the definitions of 'veterinary medicinal","product', 'withdrawal period', 'strength\u00b4,","'veterinary prescription' and \u00b4premix for","medicated feedingstuffs\u00b4 as laid down in","Article 1 of Directive 2001/82/EC."],"old":["(f) the definitions of 'veterinary medicinal","product', 'withdrawal period', 'strength' and","'veterinary prescription' as laid down in","Article 1 of Directive 2001/82/EC."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"99","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Tibor Szanyi","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-100","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 point f a (new)"]],"meps":[124703],"meta":{"created":"2019-07-03T06:47:35"},"new":["(fa) the definitions of 'antimicrobials' and","'antibiotics' as laid down in Regulation","(EU) 2015/... (Veterinary Medicinal","Products);"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"100","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-101","justification":"The aims of the medicated feed need to be given in its definition, drawing from those\nappearing in Directive 2001/82/EC, in order to make its properties for treating or preventing\ndisease and its properties for providing nutrition (brought by its feed part) perfectly clear.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point a"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:35"},"new":["(a) 'medicated feed': a mixture of one","veterinary medicinal product or one","intermediate product with one or more","feeds which is ready to be directly fed to","animals without further processing, owing","to the properties brought by the medicinal","part of the mixture for treating or","preventing disease and owing to the","properties brought by the feed part of the","mixture for providing nutrition;"],"old":["(a) 'medicated feed': a mixture of one or","more veterinary medicinal products or","intermediate products with one or more","feeds which is ready to be directly fed to","animals without further processing;"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"101","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-102","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point a"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:36"},"new":["(a) 'medicated feed': a mixture of one","veterinary medicinal product or one","intermediate product with one or more","feeds which is ready to be directly fed to","animals without further processing, owing","to the properties brought by the medicinal","part of the mixture for treating or","preventing disease and owing to the","properties brought by the feed part of the","mixture for providing nutrition;"],"old":["(a) 'medicated feed': a mixture of one or","more veterinary medicinal products or","intermediate products with one or more","feeds which is ready to be directly fed to","animals without further processing;",""],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"102","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-103","justification":" The definition of medicated feed should clarify the legal status of medicated 'feed' and should\n not be binding on the concept of 'a mixture', as this could be too much of a restriction. In\n particular, other emerging technologies exist that could help reduce the risk of carry-over.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point a"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:36"},"new":["(a) 'medicated feed': feed resulting from","the manufacture of one or more veterinary","medicinal products authorised for this","purpose or intermediate products with one","or more feeds which is ready to be directly","fed to animals without further processing;"],"old":["(a) 'medicated feed': a mixture of one or","more veterinary medicinal products or","intermediate products with one or more","feeds which is ready to be directly fed to","animals without further processing;"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"103","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-104","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point a"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:36"},"new":["(a) 'medicated feed': a result of the","manufacturing of one or more veterinary","medicinal products or intermediate","products authorised for this purpose with","one or more feeds which is ready to be","directly fed to animals without further","processing;"],"old":["(a) 'medicated feed': a mixture of one or","more veterinary medicinal products or","intermediate products with one or more","feeds which is ready to be directly fed to","animals without further processing;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"104","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-105","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point a"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:36"},"new":["(a) 'medicated feed': a mixture of one or","more veterinary medicinal products or","intermediate products with compound","feeds which is ready to be directly fed to","animals without further processing;"],"old":["(a) 'medicated feed': a mixture of one or","more veterinary medicinal products or","intermediate products with one or more","feeds which is ready to be directly fed to","animals without further processing;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"105","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Esther Herranz Garc\u00eda, Pilar Ayuso, Ram\u00f3n Luis Valc\u00e1rcel Siso","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-106","justification":"We consider it more appropriate to refer to a mixture of one or more veterinary medicinal\nproducts with one or more raw materials, not with one or more feeds, as it should be taken\ninto account that use of the word 'feed', without further specification, implies that any type of\nfeed, with additives, etc., may be included.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point b"]],"meps":[22418,4319,125032],"meta":{"created":"2019-07-03T06:47:36"},"new":["(b) 'intermediate medicated feed': a","mixture of one or more veterinary","medicinal products with one or more raw","materials, intended to be used for the","manufacture of medicated feed;"],"old":["(b) 'intermediate product': a mixture of one","or more veterinary medicinal products with","one or more feeds, intended to be used for","the manufacture of medicated feed;"],"orig_lang":"es","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"106","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-107","justification":" The definition contained in the Commission's proposal is ambiguous and needs to be\n clarified.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point b"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:36"},"new":["(b) 'intermediate medicated feed': feed","resulting from the mixture of one or more","veterinary medicinal products authorised","for this use with one or more feeds,","intended to be used for the manufacture of","medicated feed;"],"old":["(b) 'intermediate product': a mixture of one","or more veterinary medicinal products with","one or more feeds, intended to be used for","the manufacture of medicated feed;"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"107","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Tibor Szanyi","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-108","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point f"]],"meps":[124703],"meta":{"created":"2019-07-03T06:47:36"},"new":["deleted"],"old":["(f) 'feed business operator': any natural","or legal person responsible for ensuring","that the requirements of this Regulation","are met within the feed business under","their control;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"108","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-109","justification":"Two definitions should be added, namely that of medicated feed manufacturer and that of\nbroker.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point f"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:36"},"new":["(f) 'medicated feed business operator': any","natural or legal person responsible for","ensuring that the requirements of this","Regulation are met within the feed","business under their control, including","brokers and livestock farmers using","medicated feed intended for the animals","in their possession;"],"old":["(f) 'feed business operator': any natural or","","legal person responsible for ensuring that","the requirements of this Regulation are met","within the feed business under their","control;"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"109","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-110","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point f"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:36"},"new":["(f) 'medicated feed business operator': any","natural or legal person responsible for","ensuring that the requirements of this","Regulation are met within the feed","business under their control, including","brokers and livestock farmers using","medicated feed intended for the animals","in their possession;"],"old":["(f) 'feed business operator': any natural or","legal person responsible for ensuring that","the requirements of this Regulation are met","within the feed business under their","control;"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"110","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Annie Schreijer-Pierik, Tom Vandenkendelaere","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-111","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point g"]],"meps":[125030,129164],"meta":{"created":"2019-07-03T06:47:36"},"new":["(g) 'distributor': any feed business operator","that supplies medicated feed, packaged and","ready for use, to other distributors and","directly to the animal holder;"],"old":["(g) 'distributor': any feed business operator","that supplies medicated feed, packaged and","","","ready for use, to the animal holder;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"111","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Norbert Erd\u0151s","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-112","justification":" According to professionals, a specifically equipped lorry (which is subject to authorisation) is\n unable to ensure the same homogeneity and reliability at a site as a feed mill which has to be\n strict and meet special requirements. Therefore I do not support the manufacture of\n medicated feed in mobile mixers.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point h"]],"meps":[124711],"meta":{"created":"2019-07-03T06:47:36"},"new":["deleted"],"old":["(h) 'mobile mixer': a feed business","operator with a feed establishment","consisting of a specifically equipped lorry","for the manufacture of medicated feed;"],"orig_lang":"hu","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"112","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-113","justification":"Besides lorries there are equipment pulled by e.g. tractors.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point h"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:36"},"new":["(h) 'mobile mixer': a feed business operator","with one or more mobile mixing","equipments for the manufacture of","medicated feed on farms;"],"old":["(h) 'mobile mixer': a feed business operator","with a feed establishment consisting of a","specifically equipped lorry for the","manufacture of medicated feed;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"113","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-114","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:36"},"new":["(i) 'on-farm mixer': a feed business","operator manufacturing medicated feed on","farms for food-producing animals in his","or her possession;"],"old":["(i) 'on-farm mixer': a feed business","operator manufacturing medicated feed on","the farm of use."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"114","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-115","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i a (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:36"},"new":["(ia) 'antimicrobial': an active substance of","synthetic or natural origin which destroys","microorganisms, suppresses their growth","or their ability to reproduce in animals or","humans. Antimicrobials are inclusive of","anti-bacterials, anti-virals, anti-fungals","and antiprotozoals;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"115","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-116","justification":" The definition of the \u00b4antimicrobials\u00b4 should be amended to clearly express and clarify the\n extent and coverage of this important category (keeping also in mind the fact that resistance\n development is an issue not only for anti-bacterials, but also for other substances as listed in\n the above-mentioned definition). The introduced definition was adopted by HMA (Heads of\n Medicines Agencies) in October 2012.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i a (new)"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:36"},"new":["(ia) \"antimicrobials\" mean any","compound with a direct action on","microorganisms used for treatment or","prevention of infections. Antimicrobials","include anti-bacterials, anti-virals, anti-","fungals and anti-protozoals."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"116","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Daniel Buda, Viorica D\u0103ncil\u0103, Mihai \u0162urcanu, Lauren\u0163iu Rebega","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-117","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i a (new)"]],"meps":[125012,95281,131750,124792],"meta":{"created":"2019-07-03T06:47:37"},"new":["(ia) \u2018antimicrobials\u2019: a general term for","any compound with a direct action on","micro-organisms used for treatment or","prevention of infections;"],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"117","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-118","justification":"To be distinguished from the wider definition of 'antimicrobial' which also includes anti-\nvirals, anti-fungals and antiprotozoals.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i b (new)"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:37"},"new":["(ib) 'antibiotic': an anti-bacterial used to","treat bacterial infections;"],"old":["",""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"118","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Daniel Buda, Viorica D\u0103ncil\u0103, Lauren\u0163iu Rebega","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-119","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i c (new)"]],"meps":[125012,95281,124792],"meta":{"created":"2019-07-03T06:47:37"},"new":["(ic) \u2018anti-parasites\u2019: medicine substance","used in the treatment of parasitic diseases","of varied aetiology;"],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"119","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Tom Vandenkendelaere, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-120","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i d (new)"]],"meps":[129164,125030],"meta":{"created":"2019-07-03T06:47:37"},"new":["(id) 'cross-contamination': a","contamination resulting from a carry-over","or from the transfer in feed of any","unintended substance;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"120","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Norbert Lins, Daniel Buda, Peter Jahr, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-121","justification":" In order to clarify the term \"preventive use\", a precise distinction between the different forms\n of treatment was added. The introduced definition was adopted by EPRUMA (European\n Platform for the Responsible Use of Medicines in Animals) in May 2013.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i e (new)"]],"meps":[124808,125012,96772,125030],"meta":{"created":"2019-07-03T06:47:37"},"new":["(ie) 'preventive treatment (prophylaxis)':","treatment of an animal or a group of","animals before the emergence of clinical","signs of a disease, in order to prevent the","occurrence of a disease or an infection;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"121","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-122","justification":" In order to clarify the term \"preventive use\".","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i e (new)"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:37"},"new":["(ie) 'preventive treatment (prophylaxis)':","treatment of an animal or a group of","animals before the emergence of clinical","signs of a disease, in order to prevent the","occurrence of a disease or an infection;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"122","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-123","justification":"In order to clarify the term \"preventive use\", a precise distinction between the different forms\nof treatment was added. The introduced definition was adopted by EPRUMA (European\nPlatform for the Responsible Use of Medicines in Animals) in May 2013. (In the case that the\ndefinition will be introduced in the regulation related veterinary medicinal products, cross\nlink to this regulation might be appropriate to be introduced.)","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i e (new)"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:37"},"new":["(ie) 'preventive treatment (prophylaxis)':","treatment of an animal or a group of","animals before the emergence of clinical","signs of a disease, in order to prevent the","occurrence of a disease or an infection;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"123","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-124","justification":"In order to clarify the term \"preventive use\", a precise distinction between the different forms\nof treatment was added. The introduced definition was adopted by EPRUMA (European\nPlatform for the Responsible Use of Medicines in Animals) in May 2013.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i e (new)"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:37"},"new":["(ie) 'preventive treatment (prophylaxis)':","treatment of an animal or a group of","animals before the emergence of clinical","signs of a disease, in order to prevent the","occurrence of a disease or an infection;"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"124","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-125","justification":" AM made in order to distinguish between prophylaxis and metaphylaxis use.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i e (new)"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:37"},"new":["(ie) 'prevention of diseases': treatment of","the group of animals without clinical","signs of disease;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"125","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Norbert Lins, Daniel Buda, Peter Jahr, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-126","justification":" In order to clarify the term \"preventive use\", a precise distinction between the different forms\n of treatment was added. The introduced definition was adopted by EPRUMA (European\n Platform for the Responsible Use of Medicines in Animals) in May 2013.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i f (new)"]],"meps":[124808,125012,96772,125030],"meta":{"created":"2019-07-03T06:47:37"},"new":["(if) 'control treatment (metaphylaxis)':","treatment of a group of animals, after a","diagnosis of a clinical disease in part of","the group has been made, with the aim of","treating the clinically sick animals and","controlling the spread of disease to","animals in close contact and at risk which","may already be (sub-clinically) infected;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"126","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-127","justification":"In order to clarify the term \"preventive use\".","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i f (new)"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:37"},"new":["(if) 'control treatment (metaphylaxis)':","treatment of a group of animals, after a","diagnosis of a clinical disease in part of","the group has been made, with the aim of","treating the clinically sick animals and","controlling the spread of disease to","animals in close contact and at risk which","may already be infected;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"127","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-128","justification":"In order to clarify the term \"preventive use\", a precise distinction between the different forms\nof treatment was added. The introduced definition was adopted by EPRUMA (European\nPlatform for the Responsible Use of Medicines in Animals) in May 2013.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i f (new)"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:37"},"new":["(if) 'control treatment (metaphylaxis)':","treatment of a group of animals, after a","diagnosis of a clinical disease in part of","the group has been made, with the aim of","treating the clinically sick animals and","controlling the spread of disease to","animals in close contact and at risk which","may already be (sub-clinically) infected;"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"128","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-129","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i f (new)"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:37"},"new":["(if) 'group treatment (metaphylaxis)':","treatment of a group of animals including","clinically healthy individuals presumed to","be infected, after a diagnosis of a clinical","disease in part of the group has been","made, with the aim of treating the","clinically sick animals and controlling the","spread of disease to animals in close","contact and at risk which may already be","(sub-clinically) infected;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"129","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-130","justification":" In order to clarify the term \"preventive use\", a precise distinction between the different forms\n of treatment was added. The introduced definition was adopted by EPRUMA (European\n Platform for the Responsible Use of Medicines in Animals) in May 2013. (In the case that the\n\ndefinition will be introduced in the regulation on veterinary medicinal products, cross link to\nthis regulation might be appropriate to be introduced.)","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i f (new)"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:37"},"new":["(if) 'control treatment (metaphylaxis)':","treatment of a group of animals, after a","diagnosis of a clinical disease in part of","the group has been made, with the aim of","treating the clinically sick animals and","controlling the spread of disease to","animals in close contact and at risk which","may already be (sub-clinically) infected;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"130","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Norbert Lins, Daniel Buda, Peter Jahr, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-131","justification":"In order to clarify the term \"preventive use\", a precise distinction between the different forms\nof treatment was added. The introduced definition was adopted by EPRUMA (European\nPlatform for the Responsible Use of Medicines in Animals) in May 2013.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i g (new)"]],"meps":[124808,125012,96772,125030],"meta":{"created":"2019-07-03T06:47:37"},"new":["(ig) 'curative (therapeutic) treatment':","treatment of an ill animal or group of","animals, when a diagnosis of a disease or","an infection has been made;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"131","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-132","justification":"It should be clearly defined the claimed use of the medicated feed as \u00b4treatment\u00b4\n(curative/therapeutic use) or the \u00b4metaphylaxis\u00b4 (control treatment). Proposed definition was\nadopted by EPRUMA (European Platform for the Responsible Use of Medicines in Animals)\n\n in May 2013.(In the case that the definition will be introduced in the regulation related\n veterinary medicinal products, cross link to this regulation might be appropriate to be\n introduced.)","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i g (new)"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:38"},"new":["(ig) 'curative (therapeutic) treatment':","treatment of an ill animal or group of","animals, when a diagnosis of a disease or","an infection has been made;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"132","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-133","justification":" In order to clarify the term \"preventive use\", a precise distinction between the different forms\n of treatment was added. The introduced definition was adopted by EPRUMA (European\n Platform for the Responsible Use of Medicines in Animals) in May 2013.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i g (new)"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:38"},"new":["(ig) 'curative (therapeutic) treatment':","treatment of an ill animal or group of","animals, when a diagnosis of a disease or","an infection has been made;"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"133","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-134","justification":" Two definitions should be added, namely that of medicated feed manufacturer and that of\n broker.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i h (new)"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:38"},"new":["(ih) 'medicated feed manufacturer': any","medicated feed business operator that","manufactures medicated feed;"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"134","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-135","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i h (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:38"},"new":["(ih) 'medicated feed manufacturer': any","medicated feed business operator that","manufactures medicated feed;"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"135","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-136","justification":"Two definitions should be added, namely that of medicated feed manufacturer and that of\nbroker.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i i (new)"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:38"},"new":["(ii) 'broker': any person active in the","buying or selling of medicated feed","(excluding the distribution of medicated","feed), which operations do not involve the","physical handling thereof but rather the","trading thereof, independently and in the","name of a physical or legal person;"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"136","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-137","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 2 \u2013 point i i (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:38"},"new":["(ii) 'broker': any person active in the","buying or selling of medicated feed","(excluding the distribution of medicated","feed), which operations do not involve the","physical handling thereof but rather the","trading thereof, independently and in the","name of a physical or legal person;"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"137","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-138","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:38"},"new":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I. Holders of","food-producing animals shall not be","allowed to prepare their own medicated","feed containing antimicrobial veterinary","medicinal products."],"old":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"138","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-139","justification":"A distinction must be made between industrial producers and agricultural establishments\nwhen applying Annex I. The approval and registration procedure under Regulation (EC)\nNo 183/2005 must take account of the special features of primary production. The provisions\nof Article 16 on the use of medicated feed are sufficient for these establishments, which do not\nplace such feed on the market but merely manufacture it for their own animals in accordance\nwith veterinary prescriptions.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:38"},"new":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with the requirements of","Annex I. This shall not apply to","agricultural establishments which feed","on-farm-manufactured medicated feed to","their own animals pursuant to Article 16."],"old":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I.",""],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"139","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-140","justification":"The obligations set out in Chapter II are not proportionate and will be technically difficult to\napply to those livestock farmers who only administer medicated feed to their own animals.\nSpecific use stipulations should nevertheless be applied to them, in accordance with\nArticle 16.","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:38"},"new":["Medicated feed business operators shall","manufacture, store, transport and place on","the market medicated feed and","intermediate products in compliance with","Annex I."],"old":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"140","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-141","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:38"},"new":["Medicated feed business operators shall","manufacture, store, transport and place on","the market medicated feed and","intermediate products in compliance with","Annex I."],"old":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"141","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-142","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:38"},"new":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with the requirements of","Regulation (EC) No 183/2005 and","Regulation (EC) No 767/2009 and","additional requirements established in","Annex I and III to this Regulation."],"old":["Feed business operators shall manufacture,","store, transport and place on the market","medicated feed and intermediate products","in compliance with Annex I."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"142","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-143","justification":"As mobile mixers can pose potential risks from the perspective of the carry-over and also\nepidemiological risks (considering that medicated feedingstuffs are intended for the treatment\nof ill animals and therefore mobile mixers/vehicles could transmit the diseases from farm to\nfarm). Current experience with mobile mixers considers situation, where premixes are mainly\nused preventively and therefore does not represent the worst-case scenario.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 a (new)"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:38"},"new":["A Member State may introduce national","provisions prohibiting or regulating,","within its territory, mobile mixers."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"143","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-144","justification":"Performing checks on livestock farmers is a very complicated process, especially when they\nare operating in the territories of several Member States (cross-border operations).","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 a (new)"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:38"},"new":["1a. A Member State may impose","restrictions for prohibiting or regulating","the use of mobile mixers in its territory."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"144","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-145","location":[["Proposal for a regulation","Article 3 \u2013 paragraph 1 a (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:38"},"new":["1a. A Member State may impose","restrictions for prohibiting or regulating","the use of mobile mixers in its territory."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"145","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-146","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 b (new)"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:38"},"new":["1b. Care should be taken to ensure that","the medicated feed handling requirements","imposed by the Regulation and secondary","legislation on feed business operators, in","particular on-farm mixers, are feasible","and practical."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"146","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-147","justification":" Member States must be able to prohibit or regulate the use of mobile mixers, since this\n equipment cannot guarantee that the medical substance(s) is (are) distributed evenly\n throughout the entire batch of medicated feed produced. In actual fact, the homogeneity of\n each batch is a quality factor that is of paramount importance when treating animals.","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 c (new)"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:38"},"new":["1c. By way of derogation from","paragraph 1, the provisions of Chapter II","shall not apply to livestock farmers who","only use medicated feed for their own","animals."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"147","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-148","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1 c (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:38"},"new":["1c. By way of derogation from","paragraph 1, the provisions of Chapter II","shall not apply to livestock farmers who","only use medicated feed for their own","animals."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"148","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Ulrike M\u00fcller","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-149","justification":"HACCP-compliant documentation procedures would be unaffordable for farmers and thus\ndisproportionate.","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 1"]],"meps":[124862],"meta":{"created":"2019-07-03T06:47:39"},"new":["Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall put in place, implement and","maintain a permanent written procedure or","procedures based on the hazard analysis","and critical control points (hereinafter:","'HACCP' ) system as provided for in","Regulation (EC) No 183/2005. Mixtures","consisting of feedstuffs and medications","approved for oral use which are","manufactured for immediate on-farm","administration shall be exempt from the","written procedure."],"old":["Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall put in place, implement and","maintain a permanent written procedure or","procedures based on the hazard analysis","and critical control points (hereinafter:","'HACCP' ) system as provided for in","Regulation (EC) No 183/2005."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"149","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-150","justification":" In implementing Regulation (EC) No 183/2005, primary feed producers already comply with\n the principles of the HACCP in the records they keep. It should remain possible to use these\n records.","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 1"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:39"},"new":["Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall put in place, implement and","maintain a permanent written procedure or","procedures based on the hazard analysis","and critical control points (hereinafter:","'HACCP' ) system as provided for in","Regulation (EC) No 183/2005. Established","control systems for on-farm mixers may","be retained, provided it is ensured that the","principles of the HACCP are complied","with."],"old":["Feed business operators manufacturing,","storing, transporting and placing on the","market medicated feed and intermediate","products shall put in place, implement and","maintain a permanent written procedure or","procedures based on the hazard analysis","and critical control points (hereinafter:","'HACCP' ) system as provided for in","Regulation (EC) No 183/2005."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"150","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-151","justification":"The wording \u00b4medicated premixes\u00b4 is preferred to be used (please refer to justification in the\namendment 5 above).","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:39"},"new":["1. Medicated feed and intermediate","products shall only be manufactured from","medicated premixes authorised for the","purpose of the manufacture of medicated","feed in accordance with the conditions laid","down in Directive 2001/82/EC (or","adequate link to the new Regulation)."],"old":["1. Medicated feed and intermediate","products shall only be manufactured from","veterinary medicinal products authorised","for the purpose of the manufacture of","medicated feed in accordance with the","conditions laid down in Directive","2001/82/EC."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"151","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-152","justification":"It should be clearly specified, that the manufacturer should follow precisely what is\nprescribed by the attending veterinarian.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 2 \u2013 point a"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:39"},"new":["(a) the medicated premix or intermediate","product is incorporated into the feed in","accordance with the conditions as","established in prescription of the","attending veterinarian."],"old":["(a) the veterinary medicinal product is","incorporated into the feed in accordance","with Annex II;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"152","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-153","justification":" In addition to the point 2.(a) here, in the point 2.(b) should be highlighted that the\n prescription and summary of the product characteristic should be followed (this is important\n from the perspective of following the conditions of authorisation, under which the medicated\n premix was assessed and approved from the perspective of the safe and efficacious use.)","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 2 \u2013 point b"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:39"},"new":["(b) the medicated feed is manufactured in","compliance with the relevant conditions","laid down in the prescription of the","attending veterinarian and in the","summary of product characteristics","referred to in Articles ... of Regulation","(EU) 2015/... 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to","adopt delegated acts in accordance with","Article 19 concerning the establishment of","specific carry-over limits for active","substances."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"176","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-177","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 1 a (new)"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:41"},"new":["(1a) Carry-over limits for each specific","substance shall be determined by the","Commission on the basis of a scientific","risk assessment carried out by the","European Food Safety Authority (EFSA)."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"177","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-178","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph -2"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:41"},"new":["deleted"],"old":["Where no specific carry-over limits have","been set for an active substance, the","","following carry-over limits shall apply:","(a) for antimicrobial active substances,","1% of the active substance in the last","batch of medicated feed or of intermediate","product produced before the production of","non-target feed;","(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"178","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-179","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 introductory part"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:41"},"new":["Where no specific carry-over limits have","been set for an active substance, the carry-","over limit shall be set at 3% of the active","substance in the last batch of medicated","feed or of intermediate product produced","before the production of non-target feed."],"old":["Where no specific carry-over limits have","been set for an active substance, the","following carry-over limits shall apply:"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"179","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Matt Carthy, Miguel Viegas","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-180","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 1 a"]],"meps":[124986,125100],"meta":{"created":"2019-07-03T06:47:41"},"new":["Carry-over limits for specific active","substances shall be determined by a","scientific risk assessment carried out by","the European Food Safety Authority","(EFSA), where such limits have not been","already determined."],"old":[""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"180","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-181","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:41"},"new":["deleted"],"old":["(a) for antimicrobial active substances,","1% of the active substance in the last","batch of medicated feed or of intermediate","product produced before the production of","non-target feed;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"181","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-182","justification":" Unnecessary exposure to active substances should be reduced as far as possible. 1 part per\n 100 of active substance is a lot, considering the active substance makes up a tiny fraction of a\n drug's volume. Cleaning production lines, separating antimicrobial and non-antimicrobial\n production lines, pre-packaging doses and packs of doses can achieve this. Active substances\n can be detected in soil and water at the level of \u03bcg's per Kg, so detecting 1g per 1000g of feed\n\n(0.1%) should pose no problem.","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:41"},"new":["(a) for antimicrobial active substances,","0.1% of the active substance in the last","batch of medicated feed or of intermediate","product produced before the production of","non-target feed;"],"old":["(a) for antimicrobial active substances, 1%","of the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"182","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-183","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[125030],"meta":{"created":"2019-07-03T06:47:41"},"new":["(a) for antimicrobial active substances, 2%","of the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed;"],"old":["(a) for antimicrobial active substances, 1%","of the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"183","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-184","justification":"The term antimicrobial should be broadened to all substances with potential to select\nresistance (antimicrobials and also antiparasitics (exo and endo parasitics) have such\npotential and can be of concern for the both veterinary medicine and treatment of diseases of\nanimals and in selected zoonotic bacteria/parasites of the interest for human medicine also.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point a"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:42"},"new":["(a) for substances with potential for","resistance selection, 1% of the active","substance in the last batch of medicated","feed or of intermediate product produced","before the production of non-target feed;"],"old":["(a) for antimicrobial active substances,","1% of the active substance in the last batch","of medicated feed or of intermediate","product produced before the production of","non-target feed;"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"184","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-185","justification":" Text incorporated into amendment on paragraph 2 \u2013 subparagraph 2 \u2013 introductory part","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:42"},"new":["deleted"],"old":["(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"185","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-186","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:42"},"new":["(b) for the other active substances, 1% of","the authorised maximum content of the","active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed for withdrawal feed and for","'continuous food-producing animals'","feed."],"old":["(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"186","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-187","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[125030],"meta":{"created":"2019-07-03T06:47:42"},"new":["(b) for the other active substances, 4% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"old":["(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"187","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Norbert Erd\u0151s","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-188","justification":"I request the full harmonisation of the maximum limits of veterinary medicinal products\nregarding the non-target feed. The basis of calculation shall be the 3% of the maximum\npermitted dose rather than the 3% of the last batch.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 \u2013 subparagraph 2 \u2013 point b"]],"meps":[124711],"meta":{"created":"2019-07-03T06:47:42"},"new":["(b) for the other active substances, 3% of","the maximum permitted dose of the active","substance in medicated feed or in","intermediate product produced before the","production of non-target feed."],"old":["(b) for the other active substances, 3% of","the active substance in the last batch of","medicated feed or of intermediate product","produced before the production of non-","target feed."],"orig_lang":"hu","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"188","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Matt Carthy, Miguel Viegas","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-189","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 a (new)"]],"meps":[124986,125100],"meta":{"created":"2019-07-03T06:47:42"},"new":["2a. In Member States where reduction to","these levels will be burdensome, the","Commission and Member States shall","promote potential funding sources to","provide assistance to farmers to meet","these targets, from within the European","Agricultural Guarantee Fund or EU","Health Programme, for example."],"old":[""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"189","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-190","justification":" La d\u00e9finition du terme \u00ab lot \u00bb est tr\u00e8s importante pour assurer une application harmonis\u00e9e de\n cette disposition. En particulier, le fait, de pouvoir d\u00e9finir un lot comme l'ensemble des unit\u00e9s\n fabriqu\u00e9es dans un laps de temps donn\u00e9, pourrait en pratique conduire \u00e0 permettre une\n dilution de la pr\u00e9sence r\u00e9siduelle de substances m\u00e9dicamenteuses due \u00e0 la contamination\n crois\u00e9e.Il serait \u00e9galement n\u00e9cessaire de permettre \u00e0 la Commission de fixer les modalit\u00e9s de\n pr\u00e9l\u00e8vement et les analyses \u00e0 effectuer (lieux de pr\u00e9l\u00e8vement).La Commission doit pouvoir\n fixer ces modalit\u00e9s par acte d\u2019ex\u00e9cution.","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 b (new)"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:42"},"new":["2b. The Commission shall be empowered","to adopt implementing acts for","establishing criteria in respect of:","-the definition of the batch, pursuant to","this Article;","-the analytical methods that must be","employed by medicated feed business","operators;","-the sampling methods and analytical","methods that must be employed by","medicated feed business operators and the","competent authorities in order to check","that the specific carry-over limits have","been complied with.","Those implementing acts shall be adopted","in accordance with the examination","procedure referred to in Article 20(2)."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"190","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-191","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 b (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:42"},"new":["2b. The Commission shall be empowered","to adopt implementing acts for","establishing criteria in respect of:","- the definition of the batch, pursuant to","this Article;","- the analytical methods that must be","employed by medicated feed business","operators;","- the sampling methods and analytical","methods that must be employed by","medicated feed business operators and the","competent authorities in order to check","that the specific carry-over limits have","been complied with.","Those implementing acts shall be adopted","in accordance with the examination","procedure referred to in Article 20(2)."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"191","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-192","justification":" The establishment of a schedule for fixing an order of priority concerning the assessment of\n the different substances must be provided for, and the consultation procedures of the different\n assessment agencies (EFSA and EMA) must be clarified. The performance of these tasks\n should lead to the Commission submitting a report to the European Parliament and to the\n Council, within two years of this Regulation entering into force.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 2 c (new)"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:42"},"new":["2c. A detailed schedule listing, in order of","priority, the different active substances for","which specific carry-over limits must be","adopted shall be established by way of an","implementing act. The agencies (EFSA","and EMA) shall be consulted as the list is","being compiled.","On [Office of Publications: please insert","date counting [24] months from the date","of entry into force of this Regulation], the","Commission shall submit a report to the","European Parliament and to the Council,","indicating the specific carry-over limits","adopted."],"old":["",""],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"192","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-193","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 2 c (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:42"},"new":["2c. A detailed schedule listing, in order of","priority, the different active substances for","which specific carry-over limits must be","adopted shall be established by way of an","implementing act. The agencies (EFSA","and EMA) shall be consulted as the list is","being compiled.","24 months from the date of entry into","force of this Regulation, the Commission","shall submit a report to the European","Parliament and to the Council, indicating","the specific carry-over limits adopted."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"193","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Miguel Viegas, Lidia Senra Rodr\u00edguez","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-194","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[125100],"meta":{"created":"2019-07-03T06:47:42"},"new":["deleted"],"old":["Medicated feed and intermediate products","may be manufactured and stored before","the prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers or in case of manufacture","of medicated feed or intermediate","products from veterinary medicinal","products in accordance with Articles 10 or","11 of Directive 2001/82/EC."],"orig_lang":"pt","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"194","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-195","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:42"},"new":["Medicated feed and intermediate products","may not be manufactured and stored before","the prescription referred to in Article 15 is","issued."],"old":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers or in case of manufacture","of medicated feed or intermediate","products from veterinary medicinal","products in accordance with Articles 10 or","11 of Directive 2001/82/EC."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"195","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Esther Herranz Garc\u00eda, Pilar Ayuso, Ram\u00f3n Luis Valc\u00e1rcel Siso","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-196","justification":" It does not make sense for the provision not to apply to on-farm mixers that have adequate\n physical installations to perform this activity, and yet to be applicable to mobile mixers.","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[22418,4319,125032],"meta":{"created":"2019-07-03T06:47:42"},"new":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","mobile mixers."],"old":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers or in case of manufacture","of medicated feed or intermediate","products from veterinary medicinal","products in accordance with Articles 10 or","11 of Directive 2001/82/EC."],"orig_lang":"es","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"196","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-197","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:42"},"new":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers, mobile mixers or in case","of manufacture of medicated feed or","intermediate products from veterinary","medicinal products in accordance with","Articles 10 or 11 of Directive 2001/82/EC","unless justified on the basis of","epidemiological and clinical knowledge."],"old":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers or in case of manufacture","of medicated feed or intermediate products","from veterinary medicinal products in","accordance with Articles 10 or 11 of","Directive 2001/82/EC."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"197","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-198","justification":"The advance manufacture of medicated feed should not result in an exemption from the\nrequirement for a veterinary prescription laid down in Article 15; such exemptions should\nonly be granted for production-related reasons, e.g. to avoid delays or contamination. In\norder to avoid abuse, operators should be obliged to notify the nature and quantity of\nmedicated feed which has been manufactured in advance to the supervisory authority in\naccordance with Regulation (EC) No 882/2004.","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:42"},"new":["Medicated feed and intermediate products","may be manufactured and stored for","production-related reasons before the","prescription referred to in Article 15 is","issued. In such cases the nature and","quantity of the medicated feed which is","manufactured or stored must be notified","to the competent authority. This provision","shall not apply to on-farm mixers or","mobile mixers or in case of manufacture of","medicated feed or intermediate products","from veterinary medicinal products in","accordance with Articles 10 or 11 of","Directive 2001/82/EC."],"old":["Medicated feed and intermediate products","may be manufactured and stored before the","prescription referred to in Article 15 is","issued. This provision shall not apply to","on-farm mixers or in case of manufacture","of medicated feed or intermediate products","from veterinary medicinal products in","accordance with Articles 10 or 11 of","Directive 2001/82/EC."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"198","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-199","justification":" Medicated feed, and intermediate products containing feed, are subject to labelling\n requirements established not only by Articles 11(1), 12 and 14 of Regulation (EC) No\n 767/2009, but also Articles 11(4), 15 and 17 and Annex IV to that Regulation. Only those\n labelling requirements specific to medicated feed and intermediate products should be\n mentioned in Annex III to the European Commission's proposal.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 1"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:43"},"new":["1. In addition to Articles 11(1), 11(4), 12,","14, 15(b), 15(d), 15(e), 15(f), 17(1)(a),","17(1)(d), 17(1)(e), 17(1)(f), 17(2) and","17(3) of Regulation (EC) No 767/2009, the","labelling of medicated feed and","intermediate products should comply with","Annex III to this Regulation."],"old":["1. In addition to Article 11(1), Articles 12","and 14 of Regulation (EC) No 767/2009,","the labelling of medicated feed and","intermediate products shall comply with","Annex III to this Regulation.","",""],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"199","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-200","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:43"},"new":["1. In addition to Article 11(1), Articles","11(4), 12, 14, 15 and 17 of Regulation","(EC) No 767/2009, the labelling of","medicated feed and intermediate products","shall comply with Annex III to this","Regulation."],"old":["1. In addition to Article 11(1), Articles 12","and 14 of Regulation (EC) No 767/2009,","the labelling of medicated feed and","intermediate products shall comply with","Annex III to this Regulation."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"200","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-201","justification":"Medicated feed which is fed directly to the animals by an on-farm mixer does not need to be\nspecially and additionally labelled.","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:43"},"new":["1. In addition to Article 11(1), Articles 12","and 14 of Regulation (EC) No 767/2009,","the labelling of medicated feed and","intermediate products, where these are not","fed directly to livestock, shall comply with","Annex III to this Regulation."],"old":["1. In addition to Article 11(1), Articles 12","and 14 of Regulation (EC) No 767/2009,","the labelling of medicated feed and","intermediate products shall comply with","Annex III to this Regulation."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"201","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-202","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 3"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:43"},"new":["3. Discrepancies between the labelled","compositional values of a medicated feed","or an intermediate product and the values","analysed in official controls shall not be","permitted."],"old":["3. Permitted tolerances for discrepancies","between the labelled compositional values","of a medicated feed or an intermediate","product and the values analysed in official","controls performed in accordance with","Regulation (EC) No 882/2004 are as set","out in Annex IV."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"202","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-203","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 3"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:43"},"new":["3. In addition to the tolerances listed in","Annex IV to Regulation (EC) No","767/2009, the permitted tolerances for","discrepancies between the labelled active","ingredient content of a medicated feed or","an intermediate product and the values","analysed in official controls performed in","accordance with Regulation (EC) No","882/2004 are as set out in Annex IV."],"old":["3. Permitted tolerances for discrepancies","between the labelled compositional values","of a medicated feed or an intermediate","product and the values analysed in official","controls performed in accordance with","Regulation (EC) No 882/2004 are as set","out in Annex IV."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"203","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-204","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 3"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:43"},"new":["3. Permitted tolerances for discrepancies","between the labelled compositional values","and amount of active substances in a","medicated feed or an intermediate product","and the values analysed in official controls","performed in accordance with Regulation","(EC) No 882/2004 are as set out in Annex","IV."],"old":["3. Permitted tolerances for discrepancies","between the labelled compositional values","of a medicated feed or an intermediate","product and the values analysed in official","controls performed in accordance with","Regulation (EC) No 882/2004 are as set","out in Annex IV."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"204","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Julie Girling, James Nicholson, Mairead McGuinness","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-205","justification":"Existing derogations under Article 23 of Regulation (EC) No 767/2009 for the transport of\nfeed should be included in this regulation to ensure consistency with current transport\narrangements for medicated feed in certain Member States.","location":[[" Proposal for a regulation","Article 10 \u2013 paragraph 1"]],"meps":[96956,1318,28115],"meta":{"created":"2019-07-03T06:47:43"},"new":["Medicated feed and intermediate products","shall be placed on the market only in","sealed packages or containers. Packages or","containers shall be sealed in such a way","that, when the package or container is","opened, the seal is damaged and cannot be","reused. Appropriate derogations should be","provided for those instances where the","application of this requirement is not","necessary to protect human or animal","health or consumer interests, and would","represent an excessive administrative and","technical burden."],"old":["Medicated feed and intermediate products","shall be placed on the market only in","sealed packages or containers. Packages or","containers shall be sealed in such a way","that, when the package or container is","opened, the seal is damaged and cannot be","reused."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"205","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Norbert Erd\u0151s","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-206","location":[["Proposal for a regulation","Article 10 \u2013 paragraph 1"]],"meps":[124711],"meta":{"created":"2019-07-03T06:47:43"},"new":["Medicated feed and intermediate products","shall be placed on the market only in","sealed packages \u2013 including sack","packaging \u2013 or containers. Packages or","containers shall be sealed in such a way","that, when the package or container is","opened, the seal is damaged and cannot be","reused."],"old":["Medicated feed and intermediate products","shall be placed on the market only in","sealed packages or containers. Packages or","containers shall be sealed in such a way","that, when the package or container is","opened, the seal is damaged and cannot be","reused."],"orig_lang":"hu","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"206","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-207","location":[["Proposal for a regulation","Article 11 a (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:43"},"new":["Article 11a","Trading with non-EU countries","Imports, from non-EU countries, of food-","producing animals which have been","administered medicated feed containing","antimicrobial veterinary medicinal","products in order to prevent disease shall","be prohibited. Similarly, imports of","foodstuffs derived from those animals","shall be prohibited."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"207","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-208","justification":" In order to improve the efficiency of water management, the competent authorities need to\n know which active substances are disseminated into the environment, which end up in the\n water.","location":[[" Proposal for a regulation","Article 11 b (new)"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:43"},"new":["Article 11b","Traceability of the active substances","disseminated in ecosystems","The professionals giving a prescription","shall fill in a register of prescriptions of","active substances. The register will be kept","up to date at the level of competent","authorities for water management or the","environment, to enable traceability of the","dispersal of chemicals in ecosystems."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"208","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-209","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 1"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:43"},"new":["Medicated feed business operators","manufacturing, storing or placing on the","market medicated feed or intermediate","products shall ensure that establishments","under their control are approved by the","competent authority. Medicated feed","business operators transporting medicated","feed or intermediate products shall ensure","that establishments under their control","are registered with the competent","authority.","The first subparagraph shall not apply to","medicated feed business operators","authorised to deliver veterinary medicinal","products to be retailed, or to holders of","animals who store or use medicated feed","for their own animals."],"old":["Feed business operators manufacturing,","storing, transporting or placing on the","market medicated feed or intermediate","products shall ensure that establishments","under their control are approved by the","","competent authority."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"209","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-210","justification":"Approvals are unnecessary for agricultural establishments which only feed on-farm-\nmanufactured medicated feed to their own animals under the supervision of a veterinarian.","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 1"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:43"},"new":["Feed business operators manufacturing,","storing, transporting or placing on the","market medicated feed or intermediate","products shall ensure that establishments","under their control are approved by the","competent authority. This shall not apply","to agricultural establishments which feed","on-farm-manufactured medicated feed to","their own animals."],"old":["Feed business operators manufacturing,","storing, transporting or placing on the","market medicated feed or intermediate","products shall ensure that establishments","under their control are approved by the","competent authority."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"210","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-211","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 1"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:43"},"new":["Feed business operators manufacturing,","storing, transporting or placing on the","market medicated feed or intermediate","products shall ensure that establishments","under their control are approved by the","competent public authority."],"old":["Feed business operators manufacturing,","storing, transporting or placing on the","market medicated feed or intermediate","products shall ensure that establishments","under their control are approved by the","competent authority."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"211","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-212","justification":" Addition of the point, which will serve the rules for member states to establish competent\n authority for approval of the manufacturers and wholesalers of medicated feedingstuffs.","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 1 a (new)"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:43"},"new":["Member States should establish","competent authorities for approval of the","manufacturers and wholesalers of","medicated feedingstuffs."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"212","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Fredrick Federley, Hannu Takkula, Marit Paulsen","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-213","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 1"]],"meps":[124989,28316,4270],"meta":{"created":"2019-07-03T06:47:43"},"new":["1. The supply of medicated feed to animal","holders shall be subject to the presentation","and, in case of manufacturing by on-farm","mixers, the possession of a veterinary","prescription issued by a veterinarian and","to the conditions laid down in paragraphs 2","to 6."],"old":["1. The supply of medicated feed to animal","holders shall be subject to the presentation","and, in case of manufacturing by on-farm","mixers, the possession of a veterinary","prescription and to the conditions laid","","down in paragraphs 2 to 6."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"213","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Daniel Buda, Viorica D\u0103ncil\u0103, Lauren\u0163iu Rebega","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-214","location":[["Proposal for a regulation","Paragraph 15 \u2013 subparagraph 1"]],"meps":[125012,95281,124792],"meta":{"created":"2019-07-03T06:47:44"},"new":["1. The supply of medicated feed to animal","holders shall be subject to the presentation","and, in case of manufacturing by on-farm","mixers, the possession of a veterinary","prescription issued after the veterinary","examination and the establishment of a","veterinary diagnosis, or following a","regular animal health check visit, and to","the conditions laid down in paragraphs 2 to","6."],"old":["1. The supply of medicated feed to animal","holders shall be subject to the presentation","and, in case of manufacturing by on-farm","mixers, the possession of a veterinary","prescription and to the conditions laid","down in paragraphs 2 to 6."],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"214","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-215","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:44"},"new":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The veterinarian issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"old":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"215","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-216","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 2"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:44"},"new":["2. The prescription shall contain the","information set out in Article 110 of","Regulation EU 2015/... (Veterinary","Medicinal Products). The original","prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"old":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"216","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-217","justification":"The provisions on veterinary prescriptions should be aligned with the Commission\u2019s current\nproposal on veterinary medicinal products.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 2"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:44"},"new":["2. The prescription shall contain the","information set out in Annex V, based on","Article 110 of the Regulation on","Veterinary Medicinal Products1 a . The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance.","__________________","1a Commission Proposal COM (2014)558","final"],"old":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"217","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Norbert Lins, Jan Huitema, Daniel Buda, Peter Jahr, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-218","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 2"]],"meps":[124808,58789,125012,96772,125030],"meta":{"created":"2019-07-03T06:47:44"},"new":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The veterinarian or another","professional person qualified to do so in","accordance with applicable national law","issuing the prescription and the animal","holder shall keep a copy of the","prescription. The original and copies shall","be kept for three years from the date of","issuance.","(N.B. horizontal amendment to replace","relevant wording throughout the proposal)"],"old":["2. The prescription shall contain the","information set out in Annex V. The","original prescription shall be kept by the","manufacturer or, where appropriate, the","distributor. The person issuing the","prescription and the animal holder shall","keep a copy of the prescription. The","original and copies shall be kept for three","years from the date of issuance."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"218","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-219","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 3"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:44"},"new":["3. With the exception of medicated feed for","companion and hobby animals, medicated","feed shall not be used for more than one","treatment under the same prescription."],"old":["3. With the exception of medicated feed for","non-food producing animals, medicated","feed shall not be used for more than one","treatment under the same prescription."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"219","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-220","justification":" The use of medicated feed is driven by the prescription of the veterinarian, who should fix the\n duration of the treatment taking into account the summary of product characteristics (SPC).\n One should note that both the prolongation and shortening of a treatment can increase\n resistance selection. In the authorisation procedure of the veterinary medicinal product the\n correct period of treatment was approved. Currently there are no approved treatments with a\n duration superior to 3 weeks.","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 3 \u2013 subparagraph 1a (new)"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:44"},"new":["The duration of the treatment should","follow the valid SPC of the authorised","medicated premix incorporated into the","medicated feed and should not exceed","three weeks in case of medicated feed with","incorporated medicated premixes","containing active substances with the","potential to select resistance."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"220","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-221","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 3 a (new)"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:44"},"new":["3a. By way of derogation to paragraph 3","above, in case of the occurrence of a","diagnosed disease as set out in Article","15(5), if part of the medicated feed is left","unused, it may be re-used under","prescription, provided that it is properly","stored and clearly identified."],"old":["",""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"221","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-222","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 4"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:44"},"new":["deleted"],"old":["4. The prescription shall be valid for a","maximum period of six months for non-","food producing animals and three weeks","for food-producing animals."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"222","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-223","justification":"It is preferred period of two weeks (instead of three) for all substances, except antimicrobials\nand antiparasitics (i.e. substances with potential of resistance selection), where the one week\n\n validity is essential for proper dosing of the animals (considering significant changes of the\n weight due to the weight gains of the fattening animals e.g. pigs).","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 4"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:44"},"new":["4. The prescription shall be valid from the","date of issuance for a maximum period of","six months for non-food producing animals","and two weeks for food-producing animals.","In case of medicated feed containing","veterinary medicinal products containing","substances with potential to select","resistance, the prescription shall be valid","from the date of issuance for a maximum","period of one week."],"old":["4. The prescription shall be valid for a","maximum period of six months for non-","food producing animals and three weeks","for food-producing animals."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"223","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-224","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 4"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:44"},"new":["4. The prescription shall be valid for a","maximum period of six months for hobby","and companion animals and three weeks","for food-producing and fur animals."],"old":["4. The prescription shall be valid for a","maximum period of six months for non-","food producing animals and three weeks","for food-producing animals."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"224","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-225","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 4"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:44"},"new":["4. The prescription shall be valid for a","maximum period of six months for non-","food producing animals and three months","for food-producing animals."],"old":["4. The prescription shall be valid for a","maximum period of six months for non-","food producing animals and three weeks","for food-producing animals."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"225","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Matt Carthy, Miguel Viegas","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-226","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[124986,125100],"meta":{"created":"2019-07-03T06:47:44"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. Significant","and imminent health risks may be","grounds for the limited and non-routine","prophylactic use of vaccines and anti-","parasitical treatments. The person who","issued the prescription shall verify that this","medication is justified for the target","animals on veterinary grounds.","Furthermore that person shall ensure that","the administration of the veterinary","medicinal product concerned is not","incompatible with another treatment or use","and that there is no contra-indication or","interaction where several medicinal","products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","","","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"226","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-227","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:44"},"new":["5. The prescribed medicated feed may be","used only for animals under the care of the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"227","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-228","justification":" The attending veterinarian (i.e. those who is familiar with the anamnesis and status of the\n herd/flock of animals) by definition is the only one who can make a diagnosis and decide\n upon the adequate treatment. Therefore the role of veterinarians with relevant knowledge of\n diseases animals and health status of the herd/flock needs to be strengthened. The wording\n \u00b4medicated premixes\u00b4 is preferred to be used (please refer to justification in the amendment 5\n above).","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:44"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","attending veterinarian who issued the","prescription and only for a diagnosed","disease. The veterinarian who issued the","prescription shall verify that this","medication is justified for the target","animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicated premixes are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"228","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-229","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:45"},"new":["5. The prescribed medicated feed may be","used only for individual animals or a","group of animals examined by the","veterinarian who issued the prescription","and only for a diagnosed disease. The","veterinarian who issued the prescription","shall verify that this medication is justified","for the target animals on veterinary","grounds. Furthermore he shall ensure that","the administration of the veterinary","medicinal product concerned is not","incompatible with another treatment or use","and that there is no contra-indication or","interaction where several medicinal","products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","","","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"229","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-230","justification":"The veterinarian by definition is the only one who can make a diagnosis and decide upon\nsuitable treatment. Therefore his role needs to be strengthened.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:45"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","veterinarian who issued the prescription","and only for a diagnosed disease. The","veterinarian who issued the prescription","shall verify that this medication is justified","for the target animals on veterinary","grounds. Furthermore he shall ensure that","the administration of the veterinary","medicinal product concerned is not","incompatible with another treatment or use","and that there is no contra-indication or","interaction where several medicinal","products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"230","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-231","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:45"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","veterinarian who issued the prescription","and only for a diagnosed disease. The","veterinarian who issued the prescription","shall verify that this medication is justified","for the target animals on veterinary","grounds. Furthermore he shall ensure that","the administration of the veterinary","medicinal product concerned is not","incompatible with another treatment or use","and that there is no contra-indication or","interaction where several medicinal","products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"231","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Fredrick Federley, Hannu Takkula, Marit Paulsen","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-232","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[124989,28316,4270],"meta":{"created":"2019-07-03T06:47:45"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","veterinarian who issued the prescription","and only for a diagnosed disease. The","veterinarian who issued the prescription","shall verify that this medication is justified","for the target animals on veterinary","grounds. Furthermore he shall ensure that","the administration of the veterinary","medicinal product concerned is not","incompatible with another treatment or use","and that there is no contra-indication or","interaction where several medicinal","products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"232","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Annie Schreijer-Pierik, Tom Vandenkendelaere","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-233","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[125030,129164],"meta":{"created":"2019-07-03T06:47:45"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds and","after having knowledge of the feeding","systems, the possibilities of mixing and","other relevant farm specificities.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"233","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-234","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 5"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:45"},"new":["5. The prescribed medicated feed may be","used only for groups of animals examined","by the person who issued the prescription","and only for a diagnosed disease. The","person who issued the prescription shall","verify that this medication is justified for","the target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"234","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Daniel Buda, Viorica D\u0103ncil\u0103, Lauren\u0163iu Rebega","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-235","location":[[" Proposal for a regulation","Paragraph 15 \u2013 subparagraph 5"]],"meps":[125012,95281,124792],"meta":{"created":"2019-07-03T06:47:45"},"new":["5. The prescribed medicated feed may be","used only for animals examined by the","authorised person who issued the","prescription and only for a diagnosed","disease. The person who issued the","prescription shall verify that this","medication is justified for the target","animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"old":["5. The prescribed medicated feed may be","used only for animals examined by the","person who issued the prescription and","only for a diagnosed disease. The person","who issued the prescription shall verify","that this medication is justified for the","target animals on veterinary grounds.","Furthermore he shall ensure that the","administration of the veterinary medicinal","product concerned is not incompatible with","another treatment or use and that there is","no contra-indication or interaction where","several medicinal products are used."],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"235","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-236","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 6"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:45"},"new":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","the inclusion rate of the veterinary","medicinal product and the quantity of","medicated feed calculated on the basis of","the relevant parameters. The daily dose","shall be incorporated in a quantity of","medicated feed that ensures the uptake of","the daily dose by the target animal","considering that the feed uptake of","diseased animals might differ from a","normal daily ration"],"old":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","the inclusion rate of the veterinary","medicinal product calculated on the basis","of the relevant parameters.",""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"236","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-237","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 6"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:45"},"new":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","the inclusion rate of the veterinary","medicinal product and the quantity of","medicated feed calculated on the basis of","the relevant parameters. The daily dose of","the veterinary medicinal product shall be","incorporated in a quantity of feed that","ensures the uptake of the daily dose by the","target animal considering that the feed","uptake of diseased animals might differ","from a normal daily ration."],"old":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","the inclusion rate of the veterinary","medicinal product calculated on the basis","of the relevant parameters."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"237","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-238","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 6"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:45"},"new":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","the inclusion rate of the veterinary","medicinal product calculated on the basis","of the relevant parameters and the quantity","of medicated feed calculated on the basis","of the relevant parameters. The daily dose","of the veterinary medicinal product shall","be incorporated in a quantity of medicated","feed that ensures the uptake of the daily","dose by the target animal considering that","the feed uptake of diseased animals might","differ from a normal daily ration."],"old":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","","the inclusion rate of the veterinary","medicinal product calculated on the basis","of the relevant parameters."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"238","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Daniel Buda, Viorica D\u0103ncil\u0103, Lauren\u0163iu Rebega","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-239","location":[[" Proposal for a regulation","Paragraph 15 \u2013 subparagraph 6"]],"meps":[125012,95281,124792],"meta":{"created":"2019-07-03T06:47:45"},"new":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","the inclusion rate of the veterinary","medicinal product calculated on the basis","of the relevant parameters taking into","account the product characteristics and,","where appropriate, the geographical or","season-related circumstances."],"old":["6. The prescription shall, in line with the","summary of the product characteristics of","the veterinary medicinal product, indicate","the inclusion rate of the veterinary","medicinal product calculated on the basis","of the relevant parameters."],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"239","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-240","location":[[" Proposal for a regulation","Article 15 \u2013 paragraph 6 a (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:45"},"new":["6a. The prescribing party shall be","required, in accordance with","Article 5(2)(d), to satisfy himself that the","medicated feed and the feed commonly","used to feed treated animals do not","contain, as active substances, the same","coccidiostat."],"old":[""],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"240","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-241","justification":"For reasons of public health, the principle of preparing a medical feed from a single\nauthorised veterinary medicinal product must be maintained.","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 6 b (new)"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:45"},"new":["6b. Member States may authorise","qualified people to prescribe, in","accordance with the applicable national","laws and pursuant to the conditions set","out under Article 10 of Directive","2001/82/CE, medicated feed containing","several veterinary medicinal products.","However, the prescription of medicated","feed containing several veterinary","medicinal products comprising one or","more antibiotic substances shall not be","authorised."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"241","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-242","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 6 b (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:45"},"new":["6b. Member States may authorise","qualified people to prescribe, in","accordance with the applicable national","laws and pursuant to the conditions set","out under Article 10 of Directive","2001/82/CE, medicated feed containing","several veterinary medicinal products.","However, the prescription of medicated","feed containing several veterinary","medicinal products comprising one or","more antibiotic substances shall not be","authorised."],"old":["",""],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"242","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Norbert Lins, Peter Jahr, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-243","justification":" Connected to AM 8 whereby the preventive treatment with antibiotics is prohibited for all\n animals, not just the food-producing ones, the title should reflect that.","location":[[" Proposal for a regulation","Article 16 \u2013 title"]],"meps":[124808,96772,125030],"meta":{"created":"2019-07-03T06:47:45"},"new":["Use in food-producing and non-food","producing animals"],"old":["Use in food-producing animals"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"243","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-244","location":[[" Proposal for a regulation","Article 16 \u2013 title"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:45"},"new":["Use in animals"],"old":["Use in food-producing animals"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"244","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Fredrick Federley, Hannu Takkula, Marit Paulsen","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-245","location":[["Proposal for a regulation","Article 16 \u2013 title"]],"meps":[124989,28316,4270],"meta":{"created":"2019-07-03T06:47:45"},"new":["Use in animals"],"old":["Use in food-producing animals"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"245","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-246","location":[["Proposal for a regulation","Article 16 \u2013 title"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:46"},"new":["Use"],"old":["Use in food-producing animals"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"246","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-247","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:46"},"new":["1. Feed business operators supplying","medicated feed to the holder of animals, or","on-farm mixers of medicated feed for food-","producing animals shall ensure that the","quantities supplied or mixed do not exceed:"],"old":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed:"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"247","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-248","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:46"},"new":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed the quantities","prescribed by the person issuing the","prescription."],"old":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed:"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"248","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-249","justification":" There is a need to distinguish between feed containing antimicrobial veterinary medicinal\n products or not. There should be no on-farm mixing of medicated feed with antimicrobial\n veterinary medicinal products.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:46"},"new":["1. For medicated feed containing","antimicrobial veterinary medicinal","products, feed business operators","supplying such medicated feed to the","holder of food-producing animals shall","ensure that the quantities supplied or mixed","do not exceed:"],"old":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed:"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"249","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-250","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:46"},"new":["1. Medicated feed business operators","supplying medicated feed to the holder of","food-producing animals, or on-farm mixers","of medicated feed for food-producing","animals shall ensure that the quantities","supplied or mixed do not exceed:"],"old":["1. Feed business operators supplying","medicated feed to the holder of food-","producing animals, or on-farm mixers of","medicated feed for food-producing animals","shall ensure that the quantities supplied or","mixed do not exceed:"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"250","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-251","justification":"The use of medicated feedingstuffs is driven by the prescription of veterinarian, who should\ndecide considering the approved SPC on the final duration of the treatment. Originally there\nwas proposed to limit treatment/use of medicated feed containing antimicrobials by the period\nof max two weeks. It should be taken into consideration that both prolongation and\nshortening can provide pressure for resistance selection. Within the veterinary medicinal\nproduct (here premix) authorisation it was assessed and approved, what is the right period of\ntreatment, which should be finally followed in practice. Currently there are no longer\ndurations of treatments than 3 weeks approved.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point a"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:46"},"new":["deleted"],"old":["(a) the quantities provided in the","prescription and"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"251","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-252","justification":" Text incorporated into paragraph 1 - introductory part.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point a"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:46"},"new":["deleted"],"old":["(a) the quantities provided in the","prescription and"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"252","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-253","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:46"},"new":["deleted"],"old":["(b) the quantities required for one","month's treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"253","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-254","justification":"The only prescription that should be followed is the one issued by the veterinarian.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:46"},"new":["deleted"],"old":["(b) the quantities required for one","month's treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"254","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Elisabeth K\u00f6stinger","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-255","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[96882],"meta":{"created":"2019-07-03T06:47:46"},"new":["(b) the quantities required for one month's","treatment."],"old":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"de","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"255","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Matt Carthy, Miguel Viegas","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-256","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[124986,125100],"meta":{"created":"2019-07-03T06:47:46"},"new":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products, unless","prescribed for longer by a veterinarian in","exceptional cases with veterinarian","justification."],"old":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"256","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-257","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:46"},"new":["(b) the quantities required for one month's","treatment or ten days in case of medicated","feed containing antimicrobial veterinary","medicinal products, unless differently","provided for in the prescription in","accordance with the summary of product","characteristics (SPC)."],"old":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"257","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Annie Schreijer-Pierik, Tom Vandenkendelaere","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-258","justification":" The Regulation on Medicated Feed and Regulation on Veterinary Medicinal Products are\n linked. It is therefore important to reference the conditions for use and duration as indicated\n in the VMP Regulation in this proposal. There are instances in which a treatment with an\n antimicrobial takes longer than two weeks, the MF regulation needs to take that into account","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[125030,129164],"meta":{"created":"2019-07-03T06:47:46"},"new":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products or the","quantities required for a duration","mentioned in the summary of the product","characteristics, unless otherwise","specifically authorised under Regulation","(EU) 2015/... (Veterinary Medicinal","Products)."],"old":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"258","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Daniel Buda, Viorica D\u0103ncil\u0103, Lauren\u0163iu Rebega","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-259","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[125012,95281,124792],"meta":{"created":"2019-07-03T06:47:46"},"new":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products, unless the","summary of product characteristics of the","prescribed antimicrobial veterinary","medicinal product establishes a treatment","period of a duration longer than one","week."],"old":["(b) the quantities required for one month' s","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"ro","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"259","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-260","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 \u2013 point b"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:46"},"new":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products for food-","producing and fur animals."],"old":["(b) the quantities required for one month's","treatment or two weeks in case of","medicated feed containing antimicrobial","veterinary medicinal products."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"260","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-261","justification":" There is a need to introduce a separate paragraph for medicated feed not containing\n antimicrobial veterinary medicinal products (where on farm-mixing is permitted).","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 1 a (new)"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:46"},"new":["1a. For medicated feed not containing","antimicrobial veterinary medicinal","products, feed business operators","supplying medicated feed to the holder of","food-producing animals, or on-farm","mixers of medicated feed for food-","producing animals shall ensure that the","quantities supplied or mixed do not","exceed the quantities provided in the","prescription."],"old":[""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"261","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-262","justification":" Clear conditions should be set with regard to metaphylaxis.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1 b (new)"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:46"},"new":["1b. 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Before a repeated prescription, it is","necessary for the veterinarian to do a","sensitivity check and to evaluate if the","treatment can be stopped or needs to be","continued or changed."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"263","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-264","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:46"},"new":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used."],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"264","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Julie Girling","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-265","justification":" Medicated feed is only one method of administering veterinary medicinal products and\n restricting medicated feed containing antimicrobials is an inappropriate response to the\n overall public health risk posed by resistance to antimicrobials across different methods of\n administration. Performance enhancing use of antimicrobials is already prohibited, and\n preventive use may only be permitted in exceptional circumstances based on the advice from\n the person issuing the prescription.","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[96956],"meta":{"created":"2019-07-03T06:47:46"},"new":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to enhance the performance of food-","producing animals. Medicated feed","containing antimicrobial veterinary","medicinal products, specifically","antibiotics, may be permitted in","exceptional cases before a disease is","diagnosed or clinical signs are present","under prescription on the basis of the","epidemiological and clinical knowledge of","the person who issued the prescription."],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance.",""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"265","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Matt Carthy, Miguel Viegas","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-266","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[124986,125100],"meta":{"created":"2019-07-03T06:47:47"},"new":["2. Medicated feed containing antimicrobial","antibiotic veterinary medicinal products","shall not be used to prevent diseases in","food-producing animals unless such use is","permitted under Regulation (EU) 2015/...","(Veterinary Medicinal Products)."],"old":["2. 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Group treatment should only be","used in justifiable cases where individual","treatment is not appropriate."],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance.","",""],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"267","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Tom Vandenkendelaere, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-268","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[129164,125030],"meta":{"created":"2019-07-03T06:47:47"},"new":["2. Medicated feed containing antibiotic","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"268","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-269","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:47"},"new":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in animals or to","enhance their performance."],"old":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"269","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-270","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:47"},"new":["2. Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases or to enhance their","performance."],"old":["2. 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Medicated feed containing antimicrobial","veterinary medicinal products shall not be","used to prevent diseases in food-producing","animals or to enhance their performance."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"271","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Norbert Lins, Peter Jahr, Annie Schreijer-Pierik","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-272","justification":"A clarification based on the EPRUMA definitions was introduced. The ban on growth\npromotion was already mentioned in the recitals. It is important that preventive treatment is\nnot used in neither food nor non-food producing animals.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 2"]],"meps":[124808,96772,125030],"meta":{"created":"2019-07-03T06:47:47"},"new":["2. 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Those","records shall be kept for five years after the","date of administration of medicated feed,","including when the animal is slaughtered","during the five-year period."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"278","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Fredrick Federley, Marit Paulsen, Hannu Takkula, Jan Huitema","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-279","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 4"]],"meps":[124989,4270,28316,58789],"meta":{"created":"2019-07-03T06:47:48"},"new":["4. Feed business operators feeding food-","producing animals with medicated feed","shall keep records in accordance with","Article 69 of Directive 2001/82/EC. Those","records shall be kept for five years after the","date of administration of medicated feed,","including when the animal is slaughtered","during the five-year period. 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Silos that once contained","medicated feed must be emptied before","being loaded with other types of feed, and","cleaned regularly."],"old":[""],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"280","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-281","location":[["Proposal for a regulation","Article 16 \u2013 paragraph 4 b (new)"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:48"},"new":["4b. The prescribed medicated feed may be","used only for animals under the care of","the person who issued the prescription","and only in accordance with the","prescription."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"281","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-282","location":[["Proposal for a regulation","Article 17 \u2013 title"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:48"},"new":["Collection systems of expired products"],"old":["Collection systems of unused or expired","products"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"282","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-283","location":[["Proposal for a regulation","Article 17 \u2013 title"]],"meps":[124851],"meta":{"created":"2019-07-03T06:47:48"},"new":["Collection systems of expired products"],"old":["Collection systems of unused or expired","","products"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"283","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-284","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:48"},"new":["Member States shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that are expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription. Member States","shall also ensure that manufacturers of","medicated feed and farmers are informed","where to find collection points and how to","get their unused leftovers of medicated","feed to these collection points. Member","States shall ensure that operators of","collection points keep records of the","medicated feed collected. Those records","shall be kept for five years after","collection."],"old":["Member States shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that are expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"284","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Esther Herranz Garc\u00eda, Pilar Ayuso, Ram\u00f3n Luis Valc\u00e1rcel Siso","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-285","justification":"It is the responsibility of operators to establish processes for the recall and disposal of the\nmedicated feed referred to in Article 17, in the same way as is laid down for non-medicated\nfeed in the paragraph on complaints and product recall in Annex II of Regulation (EC)\nNo 183/2005.","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1"]],"meps":[22418,4319,125032],"meta":{"created":"2019-07-03T06:47:48"},"new":["Feed business operators shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that have expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription."],"old":["Member States shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","","products that are expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription."],"orig_lang":"es","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"285","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Miguel Viegas, Lidia Senra Rodr\u00edguez","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-286","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1"]],"meps":[125100],"meta":{"created":"2019-07-03T06:47:48"},"new":["Member States shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that are expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription. Under such","circumstances, the justification for such","surpluses shall be expressly recorded in","the veterinary record."],"old":["Member States shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that are expired or in case the","animal holder has received a bigger","quantity of medicated feed than he actually","uses for the treatment referred to in the","veterinary prescription."],"orig_lang":"pt","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"286","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-287","justification":" Collection systems should only be envisaged for products that are expired and cannot be\n used. Any surplus in medicated feed should be disposed of as waste in accordance with\n European waste regulations.","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:48"},"new":["Member States shall ensure that","appropriate collection systems are in place","for medicated feed and intermediate","products that are expired. 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It is therefore considered as\nbeneficial to define rules for such monitoring in the case of medicated feedingstuffs, which\ncontains antimicrobials creating huge part of the total consumption of veterinary\nantimicrobials.","location":[["Proposal for a regulation","Article 17 \u2013 paragraph 1 a (new)"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:49"},"new":["Business operators shall provide data","needed for calculation of the volume of","the sales of veterinary medicinal products","incorporated into the final medicated feed","to the competent national authority of the","Member State.","Member States shall collect relevant and","comparable data on the volume of sales of","medicated feed containing antimicrobial","active substances.","Member States shall send data on the","volume of sales of medicated feed","containing antimicrobial active","substances to the competent European","authority.","That European authority shall analyse the","data and publish an annual report."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"290","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Hannu Takkula","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-291","location":[[" Proposal for a regulation","Annex 1 \u2013 section 1 \u2013 point 2 \u2013 point c"]],"meps":[28316],"meta":{"created":"2019-07-03T06:47:49"},"new":["(c) allow the machinery coming into","contact with feed except of machinery for","moist feed to be dried following any wet","cleaning process."],"old":["(c) allow the machinery coming into","contact with feed to be dried following any","wet cleaning process."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"291","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-292","location":[[" Proposal for a regulation","Annex 1 \u2013 section 2 \u2013 point 1 \u2013 paragraph 1"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:49"},"new":["1. 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Operators must ensure","that their hands do not come into direct","contact with unprotected products or with","any machinery that has come into contact","with the products."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"295","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-296","location":[[" Proposal for a regulation","Annex 1 \u2013 section 3 \u2013 point 2"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:49"},"new":["2. Technical or organisational measures","shall be taken to prevent any cross-","contamination and errors, to carry out","checks in the course of manufacture and to","ensure effective tracing of the products","used for the manufacture of medicated feed","and intermediate products."],"old":["2. Technical or organisational measures","shall be taken to avoid any cross-","contamination and errors, to carry out","checks in the course of manufacture and to","ensure effective tracing of the products","used for the manufacture of medicated feed","and intermediate products."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"296","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-297","location":[["Proposal for a regulation","Annex 1 \u2013 section 3 \u2013 point 2"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:49"},"new":["2. Technical or organisational measures","shall be taken to minimise any cross-","contamination and errors, to carry out","checks in the course of manufacture and to","ensure effective tracing of the products","used for the manufacture of medicated feed","and intermediate products."],"old":["2. Technical or organisational measures","shall be taken to avoid any cross-","contamination and errors, to carry out","checks in the course of manufacture and to","ensure effective tracing of the products","used for the manufacture of medicated feed","and intermediate products."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"297","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Anja Hazekamp, Stefan Eck","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-298","location":[["Proposal for a regulation","Annex 1 \u2013 section 3 \u2013 point 3"]],"meps":[125023,124863],"meta":{"created":"2019-07-03T06:47:49"},"new":["3. The presence of undesirable substances","within the meaning of Directive","2002/32/EC and of other contaminants in","relation to human and animal health shall","not be permitted, and appropriate measures","to avoid this presence shall be taken."],"old":["3. The presence of undesirable substances","within the meaning of Directive","2002/32/EC and of other contaminants in","relation to human and animal health shall","be monitored, and appropriate measures to","minimise this presence shall be taken."],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"298","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-299","location":[["Proposal for a regulation","Annex 1 \u2013 section 4 \u2013 point 1"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:49"},"new":["1. The quality control plan shall lay down","rules concerning manufacturing","sequences or incompatibilities between","certain manufacturing operations. This","plan shall also define, if appropriate, the","manufacturing operations that need to be","carried out using dedicated equipment."],"old":["1. 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Medicated feed business operators,","with the exception of holders of animals,","shall report, to the competent authority","and to the holder of the marketing","authorisation of the veterinary medicinal","product included in the composition of the","medicated feed, any suspected adverse","reactions to the medicated feed. The","appropriate information collected from","these reports shall be entered in the","veterinary pharmacovigilance system","described under Title VII of Directive","2001/82/EC."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"304","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-305","location":[[" Proposal for a regulation","Annex 1 \u2013 section 7 a (new)"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:49"},"new":["Section 7a","OPERATIONS CARRIED OUT BY","THIRD PARTIES","Any subcontracted activity shall fall under","an appropriately defined, agreed upon","and monitored contract so as to avoid any","misunderstandings that could lead to","work or products of an insufficient","quality. 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\u2018medication\u2019;"],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"316","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Stanislav Pol\u010d\u00e1k","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-317","justification":"This information seems to be redundant from the perspective of the proper use by farmer.","location":[["Proposal for a regulation","Annex 3 \u2013 point 6"]],"meps":[124704],"meta":{"created":"2019-07-03T06:47:50"},"new":["(6) the veterinary medicinal products with","name, active substance, strength, added","amount preceded by the heading","'medication';"],"old":["(6) the veterinary medicinal products with","name, active substance, strength, added","amount, marketing authorisation holder","and marketing authorisation number,","preceded by the heading \u2018medication';"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"317","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-318","location":[["Proposal for a regulation","Annex 3 \u2013 point 6"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:50"},"new":["(6) the veterinary medicinal products with","name, active substance and its added","amount, strength, marketing authorisation","holder and marketing authorisation","number, preceded by the heading","\u2018medication';"],"old":["(6) the veterinary medicinal products with","name, active substance, strength, added","amount, marketing authorisation holder","and marketing authorisation number,","preceded by the heading 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The tolerances laid down in this point","shall include technical and analytical","deviations."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"335","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-336","justification":"Given the potency of antimicrobial active substances, a tolerance of 10% is far too high.","location":[[" Proposal for a regulation","Annex 4 \u2013 point 1 \u2013 paragraph 2"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:51"},"new":["Where the composition of a medicated feed","or an intermediate product is found to","deviate from the amount of an","antimicrobial active substance indicated on","the label, a tolerance of 3% shall apply. 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For the other active substances, the","following tolerances shall apply:"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"337","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-338","justification":" Respecting tolerances by taking account of both technical and analytical deviations does not\n appear to be applicable in practice, since none of the analytical methods have been validated.\n Consequently, only the technical deviations should be considered and a single tolerance limit\n of +/- 10% imposed, regardless of the content and the active substance in question.","location":[["Proposal for a regulation","Annex 4 \u2013 point 1 \u2013 paragraph 2"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:51"},"new":["Where the composition of a medicated feed","or an intermediate product is found to","deviate from the amount of an active","substance indicated on the label, a","tolerance of \u00b1 10% shall apply."],"old":["Where the composition of a medicated feed","or an intermediate product is found to","deviate from the amount of an","antimicrobial active substance indicated","on the label, a tolerance of 10% shall","apply. For the other active substances, the","following tolerances shall apply:"],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"338","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Marco Zullo, Rosa D'Amato","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-339","location":[[" Proposal for a regulation","Annex 4 \u2013 point 1 \u2013 paragraph 2"]],"meps":[125237,124835],"meta":{"created":"2019-07-03T06:47:51"},"new":["Where the composition of a medicated feed","or an intermediate product is found to","deviate from the amount of an active","substance indicated on the label the","following tolerances shall apply:"],"old":["Where the composition of a medicated feed","or an intermediate product is found to","deviate from the amount of an","antimicrobial active substance indicated","on the label, a tolerance of 10% shall","apply. For the other active substances, the","following tolerances shall apply:"],"orig_lang":"en","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"339","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Norbert Erd\u0151s","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-340","location":[[" Proposal for a regulation","Annex 4 \u2013 point 1 \u2013 paragraph 2"]],"meps":[124711],"meta":{"created":"2019-07-03T06:47:52"},"new":["Where the composition of a medicated feed","or an intermediate product is found to","deviate from the amount of an","antimicrobial active substance indicated on","the label, a tolerance of 10 % shall apply.","For the other active substances, the","following tolerances shall apply:","Active substance per kg of Tolerance","medicated feed","> 500 mg \u2022 \u00b1 20%","> 100 mg and \u2264 500 mg \u2022 \u00b1 25%","> 10 mg and \u2264 100 mg \u2022 \u00b1 30%","\u2264 10 mg \u2022\u00b1 35%"],"old":["Where the composition of a medicated feed","or an intermediate product is found to","deviate from the amount of an","antimicrobial active substance indicated on","the label, a tolerance of 10% shall apply.","For the other active substances, the","following tolerances shall apply:","",""],"orig_lang":"hu","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"340","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-341","location":[["Proposal for a regulation","Annex 4 \u2013 point 1 \u2013 paragraph 2 \u2013 table"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:52"},"new":["","deleted"],"old":["Active substance per kg of medicated feed Tolerance","> 500 mg \u00b1 10%","> 10 mg and \u2264 500 mg \u00b1 20%","> 0,5 mg and \u2264 10 mg \u00b1 30%","> 0,5 mg \u00b1 40%",""],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"341","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-342","justification":" Respecting tolerances by taking account of both technical and analytical deviations does not\n appear to be applicable in practice, since none of the analytical methods have been validated.\n Consequently, only the technical deviations should be considered and a single tolerance limit\n of +/- 10% imposed, regardless of the content and the active substance in question.","location":[["Proposal for a regulation","Annex 4 \u2013 point 1 \u2013 paragraph 2 \u2013 table"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:52"},"new":[""," deleted"],"old":["Active substance per kg of medicated feed Tolerance","> 500 mg \u00b1 10%","> 10 mg and \u2264 500 mg \u00b1 20%","> 0,5 mg and \u2264 10 mg \u00b1 30%","> 0,5 mg \u00b1 40%","","","",""],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"342","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Eric Andrieu, Jean-Paul Denanot","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-343","justification":" Respecting tolerances by taking account of both technical and analytical deviations does not\n appear to be applicable in practice, since none of the analytical methods have been validated.\n Consequently, only the technical deviations should be considered and a single tolerance limit\n of +/- 10% imposed, regardless of the content and the active substance in question.","location":[[" Proposal for a regulation","Annex 4 \u2013 point 2"]],"meps":[113892,94282],"meta":{"created":"2019-07-03T06:47:52"},"new":["deleted"],"old":["2. For the labelling particulars referred to","in points 10 and 12 of Annex III to this","Regulation, the tolerances laid down in","Annex IV to Regulation (EC)","No 767/2009 shall apply, as appropriate."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"343","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":" Michel Dantin","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-344","location":[[" Proposal for a regulation","Annex 4 \u2013 point 2"]],"meps":[97296],"meta":{"created":"2019-07-03T06:47:52"},"new":["deleted"],"old":["2. For the labelling particulars referred to","in points 10 and 12 of Annex III to this","Regulation, the tolerances laid down in","Annex IV to Regulation (EC)","No 767/2009 shall apply, as appropriate."],"orig_lang":"fr","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"344","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Paolo De Castro","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-345","location":[["Proposal for a regulation","Annex 4 \u2013 point 2"]],"meps":[96891],"meta":{"created":"2019-07-03T06:47:52"},"new":["deleted"],"old":["2. For the labelling particulars referred to","in points 10 and 12 of Annex III to this","Regulation, the tolerances laid down in","Annex IV to Regulation (EC) No","767/2009shall apply, as appropriate."],"orig_lang":"it","peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"345","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"},{"authors":"Peter Eriksson on behalf of the Verts/ALE Group","changes":{},"committee":["AGRI"],"date":"2015-07-02T00:00:00","id":"PE560.826-346","justification":" Preventative measures should come before so-called preventative treatments with antibiotics,\n in order to limit antimicrobial use without deteriorating animal health or welfare.","location":[["Proposal for a regulation","Annex 5 a (new)"]],"meps":[124937],"meta":{"created":"2019-07-03T06:47:52"},"new":["ANNEX Va","Preventive measures","Preventive measures to be used before","resorting to antimicrobial treatment of","entire groups (metaphylaxis):","- using good healthy breeding stock that is","able to grow naturally and healthily, with","suitable genetic diversity","- conditions that respect the behavioural","needs of the species, including social","interactions/ hierarchies","- stocking densities that do not increase","risk of disease transmission","- isolation of sick animals away from the","rest of the group","- subdivision of large groups of animals","into smaller, physically separated groups","- implementation of existing animal","welfare laws pursuant to:","Council Directive 98/58/EC of 20 July","1998 concerning the protection of animals","kept for farming purposes (OJ L 221,","8.8.1998, p. 23),","Council Directive 91/630/EEC of 19","November 1991 laying down minimum","standards for the protection of pigs (OJ L","340, 11.12.1991, p. 33), and","Council Directive 91/629/EEC of 19","November 1991 laying down minimum","standards for the protection of calves (OJ","L 340, 11.12.1991, p. 28).","Or. en"],"old":["","","","","","(Respect of existing animal welfare laws referred to in the last point have already been","followed by CAP beneficiaries since cross compliance came into force after the CAP reform","of 2003.)"],"peid":"PE560.826v01-00","reference":"2014/0255(COD)","seq":"346","src":"http://www.europarl.europa.eu/doceo/document/AGRI-AM-560826_EN.pdf"}],"changes":{"2014-10-22T01:59:03":[{"data":[{"body":"EC","commission":[],"date":"2014-09-10T00:00:00","docs":[{"celexid":"CELEX:52014PC0556:EN","title":"COM(2014)0556","type":"Legislative proposal published","url":"http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2014/0556/COM_COM(2014)0556_EN.pdf"}],"type":"Legislative proposal published"}],"path":["activities"],"type":"added"},{"data":[],"path":["other"],"type":"added"},{"data":[{"body":"EP","committee":"AGRI","committee_full":"Agriculture and Rural Development","responsible":true},{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Food Safety","responsible":false},{"body":"EP","committee":"IMCO","committee_full":"Internal Market and Consumer Protection","responsible":false}],"path":["committees"],"type":"added"},{"data":{"European Commission":{"title":"PreLex","url":"http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2014&DocNum=0255"}},"path":["links"],"type":"added"},{"data":{"Mandatory consultation of other institutions":"Economic and Social Committee Committee of the Regions","instrument":"Regulation","legal_basis":["Treaty on the Functioning of the EU TFEU 043","Treaty on the Functioning of the EU TFEU 168-p4"],"reference":"2014/0255(COD)","stage_reached":"Preparatory phase in Parliament","subject":["3.10.08 Animal health requirements, veterinary legislation and pharmacy","3.10.08.01 Feedingstuffs, animal nutrition"],"subtype":"Legislation","summary":["Repealing Directive 90/167/EEC"],"title":"Medicated feed: manufacture, placing on the market and use","type":"COD - Ordinary legislative procedure (ex-codecision procedure)"},"path":["procedure"],"type":"added"}],"2014-10-23T04:12:13":[{"data":{"body":"EP","committees":[{"body":"EP","committee":"AGRI","committee_full":"Agriculture and Rural Development","responsible":true},{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Food Safety","responsible":false},{"body":"EP","committee":"IMCO","committee_full":"Internal Market and Consumer Protection","responsible":false}],"date":"2014-10-20T00:00:00","type":"Committee referral announced in Parliament, 1st reading/single reading"},"path":["activities",1],"type":"added"},{"data":"AGRI/8/01705","path":["procedure","dossier_of_the_committee"],"type":"added"},{"data":["Preparatory phase in Parliament","Awaiting committee decision"],"path":["procedure","stage_reached"],"type":"changed"}],"2014-10-31T04:49:56":[{"data":["
PURPOSE: to ensure a high level of protection of human\nand animal health, providing adequate information for users and\nstrengthen the effective functioning of the internal\nmarket.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nROLE OF THE EUROPEAN PARLIAMENT: the European\nParliament decides in accordance with the ordinary legislative\nprocedure and on an equal footing with the Council.
\nBACKGROUND: livestock production occupies a very\nimportant place in the agriculture of the Union. There are 13.7\nmillion animal holdings in the EU. The value of livestock\nfarming output in the EU is EUR 157 billion.
\nIn addition, the protection of animal health\nconstitutes one of the general objectives of EU food\nlaw.
\nThe rules concerning medicated feed have significant\ninfluence on the keeping and on the rearing of animals, including\nnon-food producing animals, and on the production of products of\nanimal origin.
\nCouncil Directive 90/167/EEC constitutes the Unions regulatory framework for\nthe manufacture, placing on the market and use of medicated\nfeed.
\nExperience with the application of Directive\n90/167/EEC has shown that further measures should be taken\nto strengthen the effective functioning of the Internal Market and\nto explicitly give and improve the possibility to treat non-food\nproducing animals by medicated feed.
\nIMPACT ASSESSMENT: the impact assessment identified\nthe following main axes along which the system has to change in\norder to answer the stakeholders concerns: residues of veterinary\nmedicines in feed, imprecise dosage of veterinary medicines,\nimpossible market access to medicated feed for pets and barriers to\nintra EU trade of medicated feed. The impact assessment concluded\nthat an EU Regulation with detailed rules would have the most\npositive impacts and would provide for the best way forward to\nachieve the objectives for the EU.
\nThe impact assessment concluded that an EU\nRegulation with detailed rules would have the most positive\nimpacts and would provide for the best way forward to achieve the\nobjectives for the EU.
\nCONTENT: the proposed Regulation seeks to update\nthe current legislation on medicated feed by repealing\nDirective 90/167/EEC which sets out the conditions under which\nmedicated animal feed may be manufactured, placed on the market and\nused within the EU.
\nThe main elements of the proposed Regulation\ninclude:
\nScope: the scope of the\nproposed Regulation covers the manufacture, placing on the market\nand use of medicated feed for use in pets and in food-producing\nanimals within the Union. It does not apply to veterinary medicinal\nproducts used as the medicinal component of medicated feed\n(previously called \"medicated premixes\"), which are dealt with\nunder the veterinary medicinal products legislation.
\nManufacture, composition, placing on the market and\nuse of medicated feed: the\nproposal:
\nLabelling: the proposal\nprovides that as regards labelling, the general provisions laid\ndown in Regulation (EC) No 767/2009 on the placing on the market\nand use of feed should apply and that it be subject to specific\nlabelling requirements in order to provide the user with the\ninformation necessary to correctly administer the medicated feed.\nIt should also ensure that:
\nDELEGATED ACT: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion.
\nThe Committee on Agriculture and Rural Development\nadopted a report by Clara Eugenia AGUILERA GARCÍA (S&D,\nES) on the proposal for a regulation of the European Parliament and\nof the Council on the manufacture, placing on the market and use of\nmedicated feed and repealing Council Directive\n90/167/EEC.
\nThe committee recommended that the European\nParliaments position adopted at first reading following the\nordinary legislative procedure should amend the Commission proposal\nas follows:
\nLegal basis: the\nproposal should be based on Article 43(2) whereby the\nordinary legislative procedure is used for legislation necessary\nfor the pursuit of the objectives of the common agricultural\npolicy.
\nScope: this Regulation\nshall apply to:
\nThis Regulation shall not apply to finished veterinary\nmedicinal products to be orally administered that have been\napproved for use via feed as oral powders (via 'top dressing')\nor in drinking water. The Commission shall, by 12 months after\nthe date of entry into force of this Regulation, propose a specific\nlegislative proposal on the administration of veterinary medicinal\nproducts for use via feed or in drinking water.
\nDefinitions: the report\nproposes:
\nGeneral obligations:\nMembers added a provisions stipulating that distributors who supply\nmedicated feed solely for non-food producing animals, which\nis manufactured and distributed in sealed bags and supplied under\nprescription directly to the animal holders, shall be exempt from\nthe obligations of feed business operators.
\nJustification
\nThe exemption proposed facilitates wholesale and\nretail (veterinary and pharmacist) distribution solely of medicated\nfeed for pets without imposing unnecessary administrative\nburdens.
\nComposition: the feed\nused for the production of medicated feed shall comply with all\nrelevant provisions of Union legislation concerning animal\nfeedingstuffs.
\nHomogeneous distribution: it is stated that feed business operators\nmanufacturing medicated feed shall ensure the homogeneous\ndistribution (instead of homogeneous incorporation) of the\nveterinary medicinal product or the intermediate product in the\nfeed.
\nCarry-over: according to\nthe amended text, feed business operators shall manufacture, store,\ntransport and place on the market medicated feed and intermediate\nproducts shall apply measures to avoid carry-over in\naccordance with the ALARA (As Low As Reasonably Achievable)\nprinciple, in order to avoid risk for animal health, human health\nor the environment.
\nThe Commission proposes to establish a general 1%\ncarry-over limit for all active substances containing\nantimicrobials, until such time as specific limits are set for each\nactive substance individually. Members proposed that a 3%\ngeneral limit for all active substances is more appropriate until\nspecific limits - established by the European Feed and Safety\nAuthority (EFSA) and based on scientific evidence - are fixed\nfor each active substance.
\nThe Commission shall, by means of implementing acts,\nestablish a detailed schedule listing, in order of priority, the\ndifferent active substances for which specific carry-over\nlimits must be adopted. EFSA and the European Medicines Agency\n(EMA) shall be consulted as the list is being compiled. By two\nyears after the date of entry into force of this Regulation, the\nCommission shall submit a report to the European Parliament\nand to the Council indicating the specific carry-over limits\nadopted.
\nPackaging: medicated\nfeed and intermediate products shall be placed on the market only\nin properly labelled and sealed packages, including sack packaging,\nor containers. Appropriate derogations should be provided for those\ninstances where the application of that requirement is not\nnecessary to protect human or animal health or consumer interests,\nand would represent an excessive administrative and technical\nburden.
\nTrade with third countries: Members proposed that imports, from third countries,\nof food producing animals which have been administered medicated\nfeed containing antimicrobial veterinary medicinal products in\norder to prevent disease shall be prohibited. Similarly, imports of\nfoodstuffs derived from those animals shall be\nprohibited.
\nPrescriptions: the\nsupply of medicated feed to animal holders shall be subject to the\npresentation and, in case of manufacturing by on-farm mixers, the\npossession of a veterinary prescription issued by a veterinarian\nor another professional person qualified to do so in accordance\nwith applicable national law, following a proper assessment of the\nhealth status of the animals concerned.
\nMembers called for prescriptions for medicated feed\ncontaining veterinary medicinal products which have anabolic,\nanti-inflammatory, anti-infectious (other than anthelmintic),\nanti-cancer, hormonal or psychotropic properties or substances only\nto be issued by a veterinarian after a clinical examination and\ndiagnosis.
\nFor medicated feed containing antibiotics, a\nphysical examination and diagnosis shall be carried out for every\nprescription issued.
\nThe duration of the treatment shall follow the valid summary of product\ncharacteristics (SPC) of the authorised veterinary medicinal\nproduct incorporated into the medicated feed and should not\nexceed three weeks in the case of medicated feed with\nincorporated veterinary medicinal products containing active\nsubstances with the potential to select resistance.
\nSignificant and imminent health risks may be grounds\nfor the limited and non-routine prophylactic use of vaccines and\nanti-parasitical treatments.
\nUse in food-producing animals: the Commission proposal sets limits for the\nquantities of medicated feed that suppliers are allowed to provide\nto farmers (one months supply or 2 weeks for\nantimicrobials).
\nMembers considered that setting time limits of this\ntype in an EU regulation is inappropriate. They suggested the\nquantities required for a treatment shall be determined in\naccordance with the summary of product characteristics included\nin the marketing authorisation of the veterinary medicinal product\nincluded in the prescription.
\nUse of medicated feed containing\nantimicrobials: Members stated that\nthe prophylactic use of medicated feed containing antibiotics\nshall not be allowed unless such use is permitted under the\nveterinary medicinal products. The use of antibiotics to enhance\nthe performance of food-producing animals shall be\nprohibited.
\nProphylaxis with antibiotics shall not be applied\nroutinely nor to compensate for poor hygiene or for inadequate\nhusbandry conditions. However, such prophylaxis may be permitted in\nvery exceptional cases before a disease is diagnosed or clinical\nsigns of disease are present on the basis of the epidemiological\nand clinical knowledge of the veterinarian.
\nAnnexes: in annex IV,\nthe report proposes changes to the permitted tolerances of\ndeviations from the amount of an active substance indicated on the\nlabel, in order to adapt them to the proportions used in the\nmanufacture of medicated feed.
\nPURPOSE: to ensure a high level of protection of human\nand animal health, providing adequate information for users and\nstrengthen the effective functioning of the internal\nmarket.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nROLE OF THE EUROPEAN PARLIAMENT: the European\nParliament decides in accordance with the ordinary legislative\nprocedure and on an equal footing with the Council.
\nBACKGROUND: livestock production occupies a very\nimportant place in the agriculture of the Union. There are 13.7\nmillion animal holdings in the EU. The value of livestock\nfarming output in the EU is EUR 157 billion.
\nIn addition, the protection of animal health\nconstitutes one of the general objectives of EU food\nlaw.
\nThe rules concerning medicated feed have significant\ninfluence on the keeping and on the rearing of animals, including\nnon-food producing animals, and on the production of products of\nanimal origin.
\nCouncil Directive 90/167/EEC constitutes the Unions regulatory framework for\nthe manufacture, placing on the market and use of medicated\nfeed.
\nExperience with the application of Directive\n90/167/EEC has shown that further measures should be taken\nto strengthen the effective functioning of the Internal Market and\nto explicitly give and improve the possibility to treat non-food\nproducing animals by medicated feed.
\nIMPACT ASSESSMENT: the impact assessment identified\nthe following main axes along which the system has to change in\norder to answer the stakeholders concerns: residues of veterinary\nmedicines in feed, imprecise dosage of veterinary medicines,\nimpossible market access to medicated feed for pets and barriers to\nintra EU trade of medicated feed. The impact assessment concluded\nthat an EU Regulation with detailed rules would have the most\npositive impacts and would provide for the best way forward to\nachieve the objectives for the EU.
\nThe impact assessment concluded that an EU\nRegulation with detailed rules would have the most positive\nimpacts and would provide for the best way forward to achieve the\nobjectives for the EU.
\nCONTENT: the proposed Regulation seeks to update\nthe current legislation on medicated feed by repealing\nDirective 90/167/EEC which sets out the conditions under which\nmedicated animal feed may be manufactured, placed on the market and\nused within the EU.
\nThe main elements of the proposed Regulation\ninclude:
\nScope: the scope of the\nproposed Regulation covers the manufacture, placing on the market\nand use of medicated feed for use in pets and in food-producing\nanimals within the Union. It does not apply to veterinary medicinal\nproducts used as the medicinal component of medicated feed\n(previously called \"medicated premixes\"), which are dealt with\nunder the veterinary medicinal products legislation.
\nManufacture, composition, placing on the market and\nuse of medicated feed: the\nproposal:
\nLabelling: the proposal\nprovides that as regards labelling, the general provisions laid\ndown in Regulation (EC) No 767/2009 on the placing on the market\nand use of feed should apply and that it be subject to specific\nlabelling requirements in order to provide the user with the\ninformation necessary to correctly administer the medicated feed.\nIt should also ensure that:
\nDELEGATED ACT: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion.
\nThe Committee on Agriculture and Rural Development\nadopted a report by Clara Eugenia AGUILERA GARCÍA (S&D,\nES) on the proposal for a regulation of the European Parliament and\nof the Council on the manufacture, placing on the market and use of\nmedicated feed and repealing Council Directive\n90/167/EEC.
\nThe committee recommended that the European\nParliaments position adopted at first reading following the\nordinary legislative procedure should amend the Commission proposal\nas follows:
\nLegal basis: the\nproposal should be based on Article 43(2) whereby the\nordinary legislative procedure is used for legislation necessary\nfor the pursuit of the objectives of the common agricultural\npolicy.
\nScope: this Regulation\nshall apply to:
\nThis Regulation shall not apply to finished veterinary\nmedicinal products to be orally administered that have been\napproved for use via feed as oral powders (via 'top dressing')\nor in drinking water. The Commission shall, by 12 months after\nthe date of entry into force of this Regulation, propose a specific\nlegislative proposal on the administration of veterinary medicinal\nproducts for use via feed or in drinking water.
\nDefinitions: the report\nproposes:
\nGeneral obligations:\nMembers added a provisions stipulating that distributors who supply\nmedicated feed solely for non-food producing animals, which\nis manufactured and distributed in sealed bags and supplied under\nprescription directly to the animal holders, shall be exempt from\nthe obligations of feed business operators.
\nJustification
\nThe exemption proposed facilitates wholesale and\nretail (veterinary and pharmacist) distribution solely of medicated\nfeed for pets without imposing unnecessary administrative\nburdens.
\nComposition: the feed\nused for the production of medicated feed shall comply with all\nrelevant provisions of Union legislation concerning animal\nfeedingstuffs.
\nHomogeneous distribution: it is stated that feed business operators\nmanufacturing medicated feed shall ensure the homogeneous\ndistribution (instead of homogeneous incorporation) of the\nveterinary medicinal product or the intermediate product in the\nfeed.
\nCarry-over: according to\nthe amended text, feed business operators shall manufacture, store,\ntransport and place on the market medicated feed and intermediate\nproducts shall apply measures to avoid carry-over in\naccordance with the ALARA (As Low As Reasonably Achievable)\nprinciple, in order to avoid risk for animal health, human health\nor the environment.
\nThe Commission proposes to establish a general 1%\ncarry-over limit for all active substances containing\nantimicrobials, until such time as specific limits are set for each\nactive substance individually. Members proposed that a 3%\ngeneral limit for all active substances is more appropriate until\nspecific limits - established by the European Feed and Safety\nAuthority (EFSA) and based on scientific evidence - are fixed\nfor each active substance.
\nThe Commission shall, by means of implementing acts,\nestablish a detailed schedule listing, in order of priority, the\ndifferent active substances for which specific carry-over\nlimits must be adopted. EFSA and the European Medicines Agency\n(EMA) shall be consulted as the list is being compiled. By two\nyears after the date of entry into force of this Regulation, the\nCommission shall submit a report to the European Parliament\nand to the Council indicating the specific carry-over limits\nadopted.
\nPackaging: medicated\nfeed and intermediate products shall be placed on the market only\nin properly labelled and sealed packages, including sack packaging,\nor containers. Appropriate derogations should be provided for those\ninstances where the application of that requirement is not\nnecessary to protect human or animal health or consumer interests,\nand would represent an excessive administrative and technical\nburden.
\nTrade with third countries: Members proposed that imports, from third countries,\nof food producing animals which have been administered medicated\nfeed containing antimicrobial veterinary medicinal products in\norder to prevent disease shall be prohibited. Similarly, imports of\nfoodstuffs derived from those animals shall be\nprohibited.
\nPrescriptions: the\nsupply of medicated feed to animal holders shall be subject to the\npresentation and, in case of manufacturing by on-farm mixers, the\npossession of a veterinary prescription issued by a veterinarian\nor another professional person qualified to do so in accordance\nwith applicable national law, following a proper assessment of the\nhealth status of the animals concerned.
\nMembers called for prescriptions for medicated feed\ncontaining veterinary medicinal products which have anabolic,\nanti-inflammatory, anti-infectious (other than anthelmintic),\nanti-cancer, hormonal or psychotropic properties or substances only\nto be issued by a veterinarian after a clinical examination and\ndiagnosis.
\nFor medicated feed containing antibiotics, a\nphysical examination and diagnosis shall be carried out for every\nprescription issued.
\nThe duration of the treatment shall follow the valid summary of product\ncharacteristics (SPC) of the authorised veterinary medicinal\nproduct incorporated into the medicated feed and should not\nexceed three weeks in the case of medicated feed with\nincorporated veterinary medicinal products containing active\nsubstances with the potential to select resistance.
\nSignificant and imminent health risks may be grounds\nfor the limited and non-routine prophylactic use of vaccines and\nanti-parasitical treatments.
\nUse in food-producing animals: the Commission proposal sets limits for the\nquantities of medicated feed that suppliers are allowed to provide\nto farmers (one months supply or 2 weeks for\nantimicrobials).
\nMembers considered that setting time limits of this\ntype in an EU regulation is inappropriate. They suggested the\nquantities required for a treatment shall be determined in\naccordance with the summary of product characteristics included\nin the marketing authorisation of the veterinary medicinal product\nincluded in the prescription.
\nUse of medicated feed containing\nantimicrobials: Members stated that\nthe prophylactic use of medicated feed containing antibiotics\nshall not be allowed unless such use is permitted under the\nveterinary medicinal products. The use of antibiotics to enhance\nthe performance of food-producing animals shall be\nprohibited.
\nProphylaxis with antibiotics shall not be applied\nroutinely nor to compensate for poor hygiene or for inadequate\nhusbandry conditions. However, such prophylaxis may be permitted in\nvery exceptional cases before a disease is diagnosed or clinical\nsigns of disease are present on the basis of the epidemiological\nand clinical knowledge of the veterinarian.
\nAnnexes: in annex IV,\nthe report proposes changes to the permitted tolerances of\ndeviations from the amount of an active substance indicated on the\nlabel, in order to adapt them to the proportions used in the\nmanufacture of medicated feed.
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