{"change_dates":[],"dossier":{"amendments":[{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-14","justification":"Title V (Area of Freedom, Security and Justice) is the more appropriate legal base\nparticularly in light of the huge levels of illicit trade of NPS.","location":[["Proposal for a regulation","Citation 1"]],"meps":[1318],"meta":{"created":"2019-07-03T05:25:24"},"new":["Having regard to the Treaty on the","Functioning of the European Union, and in","particular Title V thereof,"],"old":["Having regard to the Treaty on the","Functioning of the European Union, and in","particular Article 114 thereof,"],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"14","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-15","location":[["Proposal for a regulation","Recital 3"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:24"},"new":["(3) Member States' competent public","authorities introduce various restriction","measures on these new psychoactive","substances to address the risks that they","pose or may pose when consumed. As new","psychoactive substances are often used for","scientific research and development","purposes and in the production of various","goods or of other substances which are","used for manufacturing goods, such as","medicines, industrial solvents, cleaning","agents, goods in the hi-tech industry,","restricting their access for this use can have","an important impact on economic","operators, potentially disrupting their","business activities in the internal market","and can also impede sustainable scientific","research and development."],"old":["(3) Member States' competent public","authorities introduce various restriction","measures on these new psychoactive","substances to address the risks that they","pose or may pose when consumed. As new","psychoactive substances are often used in","the production of various goods or of other","substances which are used for","manufacturing goods, such as medicines,","industrial solvents, cleaning agents, goods","in the hi-tech industry, restricting their","access for this use can have an important","impact on economic operators, potentially","disrupting their business activities in the","internal market.","",""],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"15","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-16","location":[[" Proposal for a regulation","Recital 4"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:24"},"new":["(4) The increasing number of new","psychoactive substances available in the","internal market, their growing diversity, the","speed with which they emerge on the","market, the different risks that they may","pose when consumed by humans, the","growing number of individuals who","consume them and the lack of general","public knowledge and awareness about","the risks associated with their","consumption, challenge the capacity of","public authorities to provide effective","responses to protect public health and","safety without hampering the functioning","of the internal market."],"old":["(4) The increasing number of new","psychoactive substances available in the","internal market, their growing diversity, the","speed with which they emerge on the","market, the different risks that they may","pose when consumed by humans and the","growing number of individuals who","consume them, challenge the capacity of","public authorities to provide effective","responses to protect public health and","safety without hampering the functioning","of the internal market."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"16","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jacek Olgierd Kurski","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-17","location":[[" Proposal for a regulation","Recital 5"]],"meps":[96795],"meta":{"created":"2019-07-03T05:25:24"},"new":["(5) Restriction measures vary significantly","in different Member States, meaning that","economic operators that use them in the","production of various goods must comply,","in the case of the same new psychoactive","substance, with different requirements,","such as pre-export notification, export","authorisation, or import and export","licences. Consequently, the differences","between the Member States' laws,","regulations and administrative provisions","on new psychoactive substances hinder the","functioning of the internal market, by","causing obstacles to trade, market","fragmentation, lack of legal clarity and of","an even level playing field for economic","operators, making it difficult for companies","to operate across the internal market and","violating the principle of equality."],"old":["(5) Restriction measures vary significantly","in different Member States, meaning that","economic operators that use them in the","production of various goods must comply,","in the case of the same new psychoactive","substance, with different requirements,","","such as pre-export notification, export","authorisation, or import and export","licences. Consequently, the differences","between the Member States' laws,","regulations and administrative provisions","on new psychoactive substances hinder the","functioning of the internal market, by","causing obstacles to trade, market","fragmentation, lack of legal clarity and of","an even level playing field for economic","operators, making it difficult for companies","to operate across the internal market."],"orig_lang":"pl","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"17","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Zbigniew Ziobro","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-18","location":[["Proposal for a regulation","Recital 7"]],"meps":[96803],"meta":{"created":"2019-07-03T05:25:24"},"new":["(7) The disparities in the provisions","governing restrictions on the trade in","psychoactive substances significantly","increase the risk of illegal smuggling","channels arising for these substances and","lead to laws being circumvented in order","to obtain the necessary permits."],"old":["(7) The disparities between the various","restriction measures applied to new","psychoactive substances can also lead to","displacement of harmful new","psychoactive substances between the","Member States, hampering efforts to","restrict their availability to consumers and","undermining consumer protection across","the Union."],"orig_lang":"pl","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"18","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-19","location":[["Proposal for a regulation","Recital 7"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:24"},"new":["(7) The disparities between the various","restriction measures applied to new","psychoactive substances can also lead to","displacement of harmful new psychoactive","substances between the Member States,","hampering efforts to restrict their","availability to consumers, undermining","consumer protection across the Union and","the efforts to combat potential criminal","activities and organised crime activity","associated with their distribution."],"old":["(7) The disparities between the various","restriction measures applied to new","psychoactive substances can also lead to","displacement of harmful new psychoactive","substances between the Member States,","hampering efforts to restrict their","availability to consumers and undermining","consumer protection across the Union."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"19","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jacek Olgierd Kurski","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-20","location":[[" Proposal for a regulation","Recital 7"]],"meps":[96795],"meta":{"created":"2019-07-03T05:25:24"},"new":["(7) The disparities between the various","restriction measures applied to new","psychoactive substances can also lead to","displacement of harmful new psychoactive","substances between the Member States,","hampering efforts to restrict their","availability to consumers and undermining","consumer protection across the Union. The","disparities in the provisions governing","restrictions on the trade in psychoactive","substances significantly increase the risk","of illegal smuggling channels arising for","these substances and lead to laws being","circumvented in order to obtain the","necessary permits."],"old":["(7) The disparities between the various","restriction measures applied to new","psychoactive substances can also lead to","displacement of harmful new psychoactive","substances between the Member States,","hampering efforts to restrict their","availability to consumers and undermining","consumer protection across the Union."],"orig_lang":"pl","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"20","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-21","location":[["Proposal for a regulation","Recital 8"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:24"},"new":["(8) Such disparities are expected to","increase as Member States continue to","pursue divergent approaches to addressing","new psychoactive substances. Therefore,","the obstacles to trade and market","fragmentation, and the lack of legal clarity","and of a level playing field are expected to","increase, further hindering the functioning","of the internal market and the protection of","public health and safety."],"old":["(8) Such disparities are expected to","increase as Member States continue to","pursue divergent approaches to addressing","new psychoactive substances. Therefore,","the obstacles to trade and market","fragmentation, and the lack of legal clarity","and of a level playing field are expected to","increase, further hindering the functioning","of the internal market."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"21","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Zbigniew Ziobro","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-22","location":[["Proposal for a regulation","Recital 10"]],"meps":[96803],"meta":{"created":"2019-07-03T05:25:24"},"new":["deleted"],"old":["(10) New psychoactive substances and","mixtures should be able to move freely in","the Union when intended for commercial","and industrial use, as well as for scientific","research and development. This","Regulation should establish rules for","introducing restrictions to this free","movement."],"orig_lang":"pl","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"22","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Radvil\u00f7 Mork\u016bnait\u00f7-Mikul\u00f7nien\u00f7","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-23","location":[[" Proposal for a regulation","Recital 10"]],"meps":[96695],"meta":{"created":"2019-07-03T05:25:24"},"new":["(10) New psychoactive substances and","mixtures should be able to move freely in","the Union when intended for commercial","and industrial use, as well as for scientific","research and development. This Regulation","should establish rules for introducing","restrictions to this free movement. In","addition, however, illicit distribution of","these substances and mixtures should be","prevented."],"old":["(10) New psychoactive substances and","mixtures should be able to move freely in","the Union when intended for commercial","and industrial use, as well as for scientific","research and development. This Regulation","should establish rules for introducing","restrictions to this free movement."],"orig_lang":"lt","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"23","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Zbigniew Ziobro","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-24","location":[[" Proposal for a regulation","Recital 13"]],"meps":[96803],"meta":{"created":"2019-07-03T05:25:24"},"new":["(13) Any Union action on new","psychoactive substances should be based","on scientific evidence, as well as on","Member States\u2019 wide experience in this","area, and subject to a specific procedure.","Based on the information notified by","Member States, a report should be drawn","up on new psychoactive substances that","give rise to concerns across the Union. The","report shall include an assessment of the","dangers posed by the relevant","psychoactive substances. Following the","risk assessment, the Commission should","determine what restriction measures the","relevant substances should be subjected to.","In case of immediate public health","concerns, the Commission should subject","them to temporary consumer market","restriction before the conclusion of the risk","assessment. In case new information","emerges on a new psychoactive substance,","the Commission should re-assess the level","of risks that it poses and re-impose market","restrictions. Reports on new psychoactive","substances should be made publicly","available."],"old":["(13) Any Union action on new","psychoactive substances should be based","on scientific evidence and subject to a","specific procedure. Based on the","information notified by Member States, a","report should be drawn up on new","psychoactive substances that give rise to","concerns across the Union. The report","should indicate whether it is necessary to","carry out a risk assessment. Following the","risk assessment, the Commission should","determine whether the new psychoactive","substances should be subjected to any","restriction measures. In case of immediate","public health concerns, the Commission","should subject them to temporary","consumer market restriction before the","conclusion of the risk assessment. In case","new information emerges on a new","psychoactive substance, the Commission","","should re-assess the level of risks that it","poses. Reports on new psychoactive","substances should be made publicly","available."],"orig_lang":"pl","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"24","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nikos Chrysogelos","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-25","location":[["Proposal for a regulation","Recital 13 a (new)"]],"meps":[111823],"meta":{"created":"2019-07-03T05:25:24"},"new":["(13a) Taking into consideration","international developments regarding","drug policy reform and control of illicit","substances, an objective impact","assessment based upon scientific evidence","is required to evaluate the effectiveness of","different control and regulatory options,","including current restricting policies, in","order to safeguard public health,","consumer safety and human rights of","individual users."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"25","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-26","location":[["Proposal for a regulation","Recital 17"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:24"},"new":["(17) Certain new psychoactive substances","pose immediate public health risks,","requiring urgent action. Therefore, their","availability to consumers should be","restricted for a sufficient period of time,","pending their risk assessment."],"old":["(17) Certain new psychoactive substances","pose immediate public health risks,","requiring urgent action. Therefore, their","availability to consumers should be","restricted for a limited time, pending their","","risk assessment."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"26","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Zbigniew Ziobro","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-27","location":[[" Proposal for a regulation","Recital 18"]],"meps":[96803],"meta":{"created":"2019-07-03T05:25:24"},"new":["deleted"],"old":["(18) No restriction measures should be","introduced at Union level on new","psychoactive substances which pose low","health, social and safety risks."],"orig_lang":"pl","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"27","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-28","location":[[" Proposal for a regulation","Recital 24"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:24"},"new":["(24) The mechanism for rapid exchange of","information on new psychoactive","substances has proved to be a useful","channel for sharing information on new","psychoactive substances, on new trends in","the use of controlled psychoactive","substances and on related public health","warnings. That mechanism should be","further strengthened to enable a more","effective response to the rapid emergence","and spread of new psychoactive substances","across the Union, as well as to raise the","level of public awareness about the risks","associated with their use for any purposes,","other than commercial, industrial or","scientific."],"old":["(24) The mechanism for rapid exchange of","information on new psychoactive","substances has proved to be a useful","channel for sharing information on new","psychoactive substances, on new trends in","the use of controlled psychoactive","substances and on related public health","warnings. That mechanism should be","further strengthened to enable a more","effective response to the rapid emergence","and spread of new psychoactive substances","across the Union."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"28","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-29","location":[["Proposal for a regulation","Recital 29"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:25"},"new":["(29) Prevention, treatment and harm","reduction measures are important for","addressing the growing use of new","psychoactive substances and their potential","risks. The internet, which is one of the","important distribution channels through","which new psychoactive substances are","advertised and sold, should be used for","disseminating information on the health,","social and safety risks that they pose, and","for the prevention of misuse and abuse."],"old":["(29) Prevention, treatment and harm","reduction measures are important for","addressing the growing use of new","psychoactive substances and their potential","risks. The internet, which is one of the","important distribution channels through","which new psychoactive substances are","sold, should be used for disseminating","information on the health, social and safety","risks that they pose."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"29","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-30","location":[["Proposal for a regulation","Recital 29 a (new)"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:25"},"new":["(29a) The Commission and the Member","States should also promote educational","and awareness-rising activities, initiatives","and campaigns, targeting the health,","social and safety risks associated with the","misuse and abuse of new psychoactive","substances."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"30","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Zbigniew Ziobro","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-31","location":[[" Proposal for a regulation","Recital 32"]],"meps":[96803],"meta":{"created":"2019-07-03T05:25:25"},"new":["(32) The Commission should adopt","immediately applicable implementing acts","where, in duly justified cases relating to a","rapid increase in the number of reported","fatalities or incidents posing a grave","threat to health in several Member States","associated with the consumption of the","new psychoactive substance concerned,","imperative grounds of urgency so require."],"old":["(32) The Commission should adopt","immediately applicable implementing acts","where, in duly justified cases relating to a","rapid increase in the number of reported","fatalities in several Member States","associated with the consumption of the","new psychoactive substance concerned,","imperative grounds of urgency so require."],"orig_lang":"pl","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"31","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-32","location":[[" Proposal for a regulation","Recital 32"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:25"},"new":["(32) The Commission should adopt","immediately applicable implementing acts","where, in duly justified cases relating to a","rapid increase in the number of reported","fatalities and severe health consequences","in several Member States associated with","the consumption of the new psychoactive","substance concerned, imperative grounds","of urgency so require."],"old":["(32) The Commission should adopt","immediately applicable implementing acts","where, in duly justified cases relating to a","rapid increase in the number of reported","fatalities in several Member States","associated with the consumption of the","new psychoactive substance concerned,","imperative grounds of urgency so require."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"32","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Radvil\u00f7 Mork\u016bnait\u00f7-Mikul\u00f7nien\u00f7","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-33","location":[[" Proposal for a regulation","Article 3 \u2013 paragraph 1"]],"meps":[96695],"meta":{"created":"2019-07-03T05:25:25"},"new":["New psychoactive substances and mixtures","shall move freely in the Union for","commercial and industrial use only, as well","as for scientific research and development","purposes."],"old":["New psychoactive substances and mixtures","shall move freely in the Union for","commercial and industrial use, as well as","for scientific research and development","purposes."],"orig_lang":"lt","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"33","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-34","justification":"The Member States may call on the EMCDDA to draw up a report.","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 1"]],"meps":[1318],"meta":{"created":"2019-07-03T05:25:25"},"new":["1. Where the EMCDDA and Europol, the","Member States or the Commission,","consider that the information shared on a","new psychoactive substance notified by","several Member States gives rise to","concerns across the Union because of the","health, social and safety risks that the new","psychoactive substance may pose, the","EMCDDA and Europol shall draw up a","joint report on the new psychoactive","substance."],"old":["1. Where the EMCDDA and Europol, or","the Commission, consider that the","information shared on a new psychoactive","substance notified by several Member","States gives rise to concerns across the","Union because of the health, social and","safety risks that the new psychoactive","substance may pose, the EMCDDA and","Europol shall draw up a joint report on the","new psychoactive substance."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"34","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-35","justification":" The word 'several' is ambiguous. For clarity, the EU should act only when a substance has\n been identified in three or more Member States.","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 1"]],"meps":[112620],"meta":{"created":"2019-07-03T05:25:25"},"new":["1. Where the EMCDDA and Europol, or","the Commission, consider that the","information shared on a new psychoactive","substance notified by three or more","Member States gives rise to concerns","across the Union because of the health,","social and safety risks that the new","psychoactive substance may pose, the","EMCDDA and Europol shall draw up a","joint report on the new psychoactive","substance."],"old":["1. Where the EMCDDA and Europol, or","the Commission, consider that the","information shared on a new psychoactive","substance notified by several Member","States gives rise to concerns across the","Union because of the health, social and","safety risks that the new psychoactive","substance may pose, the EMCDDA and","Europol shall draw up a joint report on the","new psychoactive substance."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"35","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-36","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 2 \u2013 point b"]],"meps":[112620],"meta":{"created":"2019-07-03T05:25:25"},"new":["(b) the chemical and physical identity of","the new psychoactive substance, the","methods and, if known, the chemical","precursors used for its manufacture or","extraction, and any other new psychoactive","substance or groups of substances with a","similar chemical structure that have","emerged;"],"old":["(b) the chemical and physical identity of","the new psychoactive substance, the","methods and, if known, the chemical","precursors used for its manufacture or","extraction, and other new psychoactive","substances with a similar chemical","structure that have emerged;"],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"36","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" James Nicholson","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-37","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 2 \u2013 point c"]],"meps":[1318],"meta":{"created":"2019-07-03T05:25:25"},"new":["(c) the commercial and industrial use of the","new psychoactive substance, as well as its","use for scientific research and development","purposes or any other known use;"],"old":["(c) the commercial and industrial use of the","new psychoactive substance, as well as its","use for scientific research and development","purposes;"],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"37","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-38","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 2 \u2013 point d"]],"meps":[1318],"meta":{"created":"2019-07-03T05:25:25"},"new":["(d) the human and veterinary medical use","of the new psychoactive substance,","including as an active substance in a","medicinal, veterinary medicinal or similar","product;"],"old":["(d) the human and veterinary medical use","of the new psychoactive substance,","including as an active substance in a","medicinal product or veterinary medicinal","product;"],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"38","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-39","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 6 \u2013 subparagraph 1"]],"meps":[1318],"meta":{"created":"2019-07-03T05:25:25"},"new":["The EMCDDA and Europol shall submit","the joint report to the Commission within","eight weeks from the request for additional","information referred to in paragraph 3 and","4."],"old":["The EMCDDA and Europol shall submit","the joint report to the Commission within","eight weeks from the request for additional","information referred to in paragraph 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States,","related to the serious acute toxicity of the","new psychoactive substance;"],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"40","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-41","location":[[" Proposal for a regulation","Article 9 \u2013 paragraph 1 \u2013 point b"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:25"},"new":["(b) the prevalence and patterns of use of","the new psychoactive substance in the","general population and in specific groups,","in particular frequency, quantities and","modality of use, its availability to","consumers and the potential for diffusion,","which indicate that the scale of the risk is","moderate or considerable."],"old":["(b) the prevalence and patterns of use of","the new psychoactive substance in the","general population and in specific groups,","in particular frequency, quantities and","modality of use, its availability to","consumers and the potential for diffusion,","which indicate that the scale of the risk is","considerable."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"41","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"James Nicholson","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-42","justification":"The Member States should have the possibility to object the immediate ban on new\npsychoactive substances, therefore procedure in Article 19(2) should be used for all cases.","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[1318],"meta":{"created":"2019-07-03T05:25:25"},"new":["deleted"],"old":["On duly justified imperative grounds of","urgency relating to a rapid increase in the","number of reported fatalities in several","Member States associated with the","consumption of the new psychoactive","substance concerned, the Commission","shall adopt immediately applicable","implementing acts in accordance with the","procedure laid down in Article 19(3)."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"42","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marusya Lyubcheva","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-43","location":[["Proposal for a regulation","Article 10 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[37524],"meta":{"created":"2019-07-03T05:25:25"},"new":["(a) the harm to health caused by the","consumption of the new psychoactive","substance associated with its acute and","chronic toxicity, abuse liability and","dependence-producing potential, in","particular injury, disease, aggression, and","physical and mental impairment;"],"old":["(a) the harm to health caused by the","consumption of the new psychoactive","substance associated with its acute and","chronic toxicity, abuse liability and","dependence-producing potential, in","particular injury, disease, and physical and","mental impairment;"],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"43","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-44","location":[[" Proposal for a regulation","Article 10 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point c"]],"meps":[112620],"meta":{"created":"2019-07-03T05:25:26"},"new":["(c) the risks to public safety, in particular","the spread of diseases, including","transmission of blood borne viruses, the","consequences of physical and 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Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-46","location":[[" Proposal for a regulation","Article 11 \u2013 paragraph 1 \u2013 point c"]],"meps":[112620],"meta":{"created":"2019-07-03T05:25:26"},"new":["(c) the risks to public safety are limited, in","particular low risk of spread of diseases,","including transmission of blood borne","viruses, non-existent or low consequences","of physical and mental impairment on the","ability to drive, and the impact of the","manufacture, transport and disposal of the","new psychoactive substance and associated","waste materials on the environment is low."],"old":["(c) the risks to safety are limited, in","particular low risk of spread of diseases,","including transmission of blood borne","viruses, non-existent or low consequences","of physical and mental impairment on the","ability to drive, and the impact of the","manufacture, transport and disposal of the","new psychoactive substance and associated","waste materials on the environment is low."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"46","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-47","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 1 \u2013 point c"]],"meps":[112620],"meta":{"created":"2019-07-03T05:25:26"},"new":["(c) the risks to public safety are moderate,","in particular sporadic spread of diseases,","including transmission of blood borne","viruses, moderate consequences of physical","and mental impairment on the ability to","drive, and the manufacture, transport and","disposal of the new psychoactive substance","and associated waste materials results in","environmental nuisance."],"old":["(c) the risks to safety are moderate, in","particular sporadic spread of diseases,","including transmission of blood borne","viruses, moderate consequences of physical","and mental impairment on the ability to","drive, and the manufacture, transport and","disposal of the new psychoactive substance","and associated waste materials results in","environmental nuisance."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"47","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-48","justification":" Severe disease and severe physical or mental impairment are not necessarily life threatening,\n but substances having such consequences should be considered as high risk.","location":[["Proposal for a regulation","Article 13 \u2013 paragraph 1 \u2013 point a"]],"meps":[112620],"meta":{"created":"2019-07-03T05:25:26"},"new":["(a) the harm to health caused by the","consumption of the new psychoactive","substance associated with its acute and","chronic toxicity, abuse liability and","dependence-producing potential, is severe","and significant, as it generally provokes","death or lethal injury, severe disease, and","severe physical or mental impairment;"],"old":["(a) the harm to health caused by the","","consumption of the new psychoactive","substance associated with its acute and","chronic toxicity, abuse liability and","dependence-producing potential, is life","threatening, as it generally provokes death","or lethal injury, severe disease, and severe","physical or mental impairment;"],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"48","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-49","location":[[" Proposal for a 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harm."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"49","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jolanta Emilia Hibner","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-50","location":[[" Proposal for a regulation","Article 13 \u2013 paragraph 2 a (new)"]],"meps":[96753],"meta":{"created":"2019-07-03T05:25:26"},"new":["2a. The Commission shall not adopt the","draft implementing act where no opinion","is delivered by the committee referred to","in the Article 19(1)."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"50","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nikos Chrysogelos","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-51","justification":" Necessary in order to safeguard public health of users and consumer safety","location":[["Proposal for a regulation","Article 13 a (new)"]],"meps":[111823],"meta":{"created":"2019-07-03T05:25:26"},"new":["Article 13a","Information to individual consumers","(a) The Commission shall make readily","available to the public, especially youth,","science-based information on health,","social and safety risks of the new","psychoactive substances as referred to in","articles 11, 12.1 and 13.1.","(b) With regard to new psychoactive","substances of low risk as referred to in","article 11, the Commission shall also","make widely available to the public,","especially youth, information on usage","effects and safe usage, as well as, harm","reduction guidelines.","(c) With regard to new psychoactive","substances of moderate or severe risks as","referred to in articles 12.1 and 13.1, the","Commission shall also make widely","available to the public, especially youth,","information on identification and early","warning, prevention, treatment and harm","reduction measures.","(d) The Commission shall collaborate","with National Focal Points within the","European Information network on Drugs","and Drug Addiction (\"Reitox\") and other","harm reduction and addiction treatment","associations for providing accurate and","timely information to individual users."],"old":[""],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"51","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" James Nicholson","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-52","justification":" Member States should have the right to ask for re-examine the level of risk as well.","location":[[" Proposal for a regulation","Article 16 \u2013 paragraph 1"]],"meps":[1318],"meta":{"created":"2019-07-03T05:25:26"},"new":["Where new information and evidence is","available on the risks posed by a new","psychoactive substance the health, social","and safety risks of which have already been","determined in accordance with Article 10,","the Commission or the Member States","shall request the EMCDDA to update the","risk assessment report drafted on the new","psychoactive substance and shall re-","examine the level of risks that the new","psychoactive substance poses."],"old":["Where new information and evidence is","available on the risks posed by a new","psychoactive substance the health, social","and safety risks of which have already been","determined in accordance with Article 10,","the Commission shall request the","EMCDDA to update the risk assessment","report drafted on the new psychoactive","substance and shall re-examine the level of","risks that the new psychoactive substance","poses."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"52","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Radvil\u00f7 Mork\u016bnait\u00f7-Mikul\u00f7nien\u00f7","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-53","location":[[" Proposal for a regulation","Article 17 \u2013 paragraph 1"]],"meps":[96695],"meta":{"created":"2019-07-03T05:25:26"},"new":["Member States shall lay down the rules on","sanctions applicable to infringements of the","Decisions referred to in Article 9(1),","Article 12(1) and Article 13(1), and to","illicit distribution of new psychoactive","substances or mixtures, and shall take all","necessary measures to ensure that they are","implemented. 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Member","States shall notify those rules on sanctions","and any subsequent amendment affecting","those provisions to the Commission","without delay."],"orig_lang":"lt","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"53","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-54","justification":" As the effects of certain new psychoactive substances can be extremely localised, Member\n States should be free to introduce consumer bans on substances within their own territories\n where the EU has not acted, or has decided that a substance poses a low risk at European\n level and therefore requires no Union action. However, in respect to the principle of free\n movement of goods and the internal market, legitimate Union trade in such substances, where\n it exists, should not be compromised.","location":[["Proposal for a regulation","Article -20 (new)"]],"meps":[112620],"meta":{"created":"2019-07-03T05:25:26"},"new":["Article -20","National scope","Where the EU has not acted, or the","Commission has decided not to adopt any","restriction measures based on the","EMCDDA risk assessment of a new","psychoactive substance, individual","Member States may maintain or introduce","in their territory restrictions on the","making available of the new psychoactive","substance on the market to consumers,","without prejudice to legitimate trade in","industry, or to medicinal products or","veterinary medicinal products that have","obtained a marketing authorisation.","Member States shall ensure that such","restrictions are immediately","communicated to the Commission, the","EMCDDA and Europol."],"old":[""],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"54","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-55","justification":" The nature of new psychoactive substances can change rapidly, and therefore Union agencies\n and scientific and research centres need to be kept as up to date as possible in order to\n monitor any emerging threats to public health.","location":[[" Proposal for a regulation","Article 20 \u2013 paragraph 1"]],"meps":[112620],"meta":{"created":"2019-07-03T05:25:26"},"new":["The Commission and the Member States","shall support the development, sharing and","dissemination of information and","knowledge on new psychoactive","substances. They shall do so by facilitating","cooperation between the EMCDDA, other","Union agencies, and scientific and research","centres, and by regularly providing these","bodies with up to date information on","such substances wherever possible."],"old":["The Commission and the Member States","shall support the development, sharing and","dissemination of information and","knowledge on new psychoactive","substances. They shall do so by facilitating","cooperation between the EMCDDA, other","Union agencies, and scientific and research","centres."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"55","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2014-01-10T00:00:00","id":"PE526.242-56","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 1"]],"meps":[112620],"meta":{"created":"2019-07-03T05:25:26"},"new":["The EMCDDA and Europol shall report","annually to the Commission and Member","States on the implementation of this","Regulation, and such reports will be","published on a website and made public."],"old":["The EMCDDA and Europol shall report","annually on the implementation of this","Regulation."],"orig_lang":"en","peid":"PE526.242v01-00","reference":"2013/0305(COD)","seq":"56","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-526.242+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-21","location":[["Proposal for a regulation","Recital 5"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:49"},"new":["(5) As conditions and circumstances differ","in Member States with regard to","psychoactive substances, restriction","measures vary accordingly in different","Member States, meaning that economic","operators that use them in the production of","various goods must comply, in the case of","the same new psychoactive substance, with","different requirements, such as pre-export","notification, export authorisation, or import","and export licences. Consequently, the","differences between the Member States'","laws, regulations and administrative","provisions on new psychoactive substances","could potentially hinder to some extent the","functioning of the internal market, by","causing obstacles to trade, market","fragmentation, lack of legal clarity and of","an even level playing field for economic","operators, making it more difficult for","companies to operate across the internal","market."],"old":["(5) Restriction measures vary significantly","in different Member States, meaning that","economic operators that use them in the","production of various goods must comply,","in the case of the same new psychoactive","substance, with different requirements,","such as pre-export notification, export","authorisation, or import and export","licences. Consequently, the differences","between the Member States' laws,","regulations and administrative provisions","on new psychoactive substances hinder the","functioning of the internal market, by","causing obstacles to trade, market","fragmentation, lack of legal clarity and of","an even level playing field for economic","operators, making it difficult for companies","to operate across the internal market."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"21","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-22","location":[["Proposal for a regulation","Recital 6"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:49"},"new":["(6) Restriction measures could not only","cause barriers to trade in the case of new","psychoactive substances that already have","commercial, industrial or scientific uses,","but could also impede the development of","such uses, and are likely to cause obstacles","to trade for economic operators that seek to","develop such uses, by making access to","those new psychoactive substances more","difficult."],"old":["(6) Restriction measures not only cause","barriers to trade in the case of new","psychoactive substances that already have","commercial, industrial or scientific uses,","","but can also impede the development of","such uses, and are likely to cause obstacles","to trade for economic operators that seek to","develop such uses, by making access to","those new psychoactive substances more","difficult."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"22","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-23","location":[[" Proposal for a regulation","Recital 7"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:49"},"new":["(7) The disparities between the various","restriction measures applied to new","psychoactive substances, while they are","legitimate since they respond to each","Member State's particularities with regard","to psychoactive substances, could also","lead to displacement of harmful new","psychoactive substances between the","Member States, hampering efforts to","restrict their availability to consumers and","undermining consumer protection across","the Union, if efficient information","exchange and coordination among","Member States is not strengthened."],"old":["(7) The disparities between the various","restriction measures applied to new","psychoactive substances can also lead to","displacement of harmful new psychoactive","substances between the Member States,","hampering efforts to restrict their","availability to consumers and undermining","consumer protection across the Union."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"23","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" V\u00e9ronique Mathieu Houillon, Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-24","location":[[" Proposal for a regulation","Recital 7 a (new)"]],"meps":[4412,2307],"meta":{"created":"2019-07-03T05:50:49"},"new":["(7a) Such disparities facilitate illegal","trafficking of such substances by","criminals, in particular organised","criminal gangs."],"old":[""],"orig_lang":"fr","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"24","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-25","location":[["Proposal for a regulation","Recital 8"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:49"},"new":["(8) Such disparities are expected to","continue as Member States adopt","divergent approaches to addressing","challenges with regard to new","psychoactive substances. Therefore, the","obstacles to trade and market","fragmentation, and the lack of legal clarity","and of a level playing field are expected to","continue, further hindering the functioning","of the internal market if Member States do","not coordinate and cooperate more","efficiently."],"old":["(8) Such disparities are expected to","increase as Member States continue to","pursue divergent approaches to addressing","new psychoactive substances. Therefore,","the obstacles to trade and market","fragmentation, and the lack of legal clarity","and of a level playing field are expected to","increase, further hindering the functioning","of the internal market."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"25","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-26","location":[["Proposal for a regulation","Recital 9"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:49"},"new":["(9) Where distortions to the functioning of","the internal market are identified they","should be addressed and, to that end, the","rules relating to new psychoactive","substances that are of concern at Union","level should be approximated, while, at the","same time, ensuring a high level of health,","safety and consumer protection and a","flexibility for Member States to respond to","local situations."],"old":["(9) Those distortions to the functioning of","the internal market should be eliminated","and, to that end, the rules relating to new","psychoactive substances that are of concern","at Union level should be approximated,","while, at the same time, ensuring a high","level of health, safety and consumer","protection.",""],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"26","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-27","location":[[" Proposal for a regulation","Recital 10"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:50"},"new":["(10) New psychoactive substances and","mixtures should be able to move freely in","the Union when intended for commercial","and industrial use, as well as for scientific","research and development, by duly","authorised persons in establishments","which are directly under the control of","Member States' authorities or specifically","approved by them."],"old":["(10) New psychoactive substances and","mixtures should be able to move freely in","the Union when intended for commercial","and industrial use, as well as for scientific","research and development. This","Regulation should establish rules for","introducing restrictions to this free","movement."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"27","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Renate Weber","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-28","location":[[" Proposal for a regulation","Recital 14"]],"meps":[39713],"meta":{"created":"2019-07-03T05:50:50"},"new":["(14) No risk assessment should be","conducted under this Regulation on a new","psychoactive substance if it is subject to an","assessment under international law, or if it","is an active substance in a medicinal","product or in a veterinary medicinal","product, unless at Union level there is","sufficient data available to suggest the","need for a joint report of the European","Monitoring Centre for Drugs and Drug","Addiction (EMCDDA) and Europol."],"old":["(14) No risk assessment should be","conducted under this Regulation on a new","psychoactive substance if it is subject to an","assessment under international law, or if it","is an active substance in a medicinal","product or in a veterinary medicinal","product."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"28","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-29","justification":"This is linked with art.8 below. The Commission proposal reproduces the requirement\n(included also in the Council Decision 2005) that places the EU system under the authority of\nWHO. In fact the current text would prohibit the EU EWS to process a substance (Joint report\n\u2013 Risk Assessment) if \u201cthe new psychoactive substance is at an advanced stage of assessment\nwithin the United Nations system\u201d. Now this correspond to a political choice to place EU\ninterests below UN interest, while the EWS original idea was to create a EU system faster\nand more effective of the UN. Now that the WHO has under review at the same time dozen of\nsubstances, the EWS could be seriously impaired by mass analysis like this one. The\namendment restates the priority for the EU to act at its liberty.","location":[["Proposal for a regulation","Recital 14"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:50"},"new":["(14) No risk assessment should be","conducted under this Regulation on a new","psychoactive substance if it is an active","substance in a medicinal product or in a","veterinary medicinal product."],"old":["(14) No risk assessment should be","conducted under this Regulation on a new","psychoactive substance if it is subject to an","assessment under international law, or if","it is an active substance in a medicinal","product or in a veterinary medicinal","product."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"29","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-30","location":[["Proposal for a regulation","Recital 14"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:50"},"new":["(14) No risk assessment should be","conducted under this Regulation on a new","psychoactive substance if it is subject to an","assessment under international law, or if it","is an active substance in a medicinal","product or in a veterinary medicinal","product, provided that the substance used","is not liable to have ill effects and is","transformed in such a condition that it","cannot be abused or recovered."],"old":["(14) No risk assessment should be","conducted under this Regulation on a new","psychoactive substance if it is subject to an","assessment under international law, or if it","","is an active substance in a medicinal","product or in a veterinary medicinal","product."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"30","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-31","justification":" This is linked to Art 11 low risk which is requested to be substantially modified","location":[[" Proposal for a regulation","Recital 18"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:50"},"new":["deleted"],"old":["(18) No restriction measures should be","introduced at Union level on new","psychoactive substances which pose low","health, social and safety risks."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"31","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-32","location":[[" Proposal for a regulation","Recital 18"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:50"},"new":["(18) No restriction measures should be","introduced at Union level on new","psychoactive substances which pose low","health, social and safety risks, but Member","States may introduce further measures","that are deemed appropriate or necessary","depending on the specific risks that the","substance poses in their territories taking","into account national circumstances and","any social, economic, legal, administrative","or other factor they may consider","relevant."],"old":["(18) No restriction measures should be","introduced at Union level on new","psychoactive substances which pose low","health, social and safety risks.","",""],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"32","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Hedh","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-33","location":[["Proposal for a regulation","Recital 18"]],"meps":[28131],"meta":{"created":"2019-07-03T05:50:50"},"new":["(18) On the basis of existing evidence and","on predefined criteria, no restriction","measures should be introduced at Union","level on new psychoactive substances","which pose low health, social and safety","risks."],"old":["(18) No restriction measures should be","introduced at Union level on new","psychoactive substances which pose low","health, social and safety risks."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"33","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-34","justification":"No need to specify the degree of risk","location":[["Proposal for a regulation","Recital 19"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:50"},"new":["(19) Those new psychoactive substances","which pose health, social and safety risks","should not be made available to consumers."],"old":["(19) Those new psychoactive substances","which pose moderate health, social and","safety risks should not be made available to","consumers."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"34","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Hedh","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-35","location":[[" Proposal for a regulation","Recital 19"]],"meps":[28131],"meta":{"created":"2019-07-03T05:50:50"},"new":["(19) On the basis of the existing evidence","and on predefined criteria, those new","psychoactive substances which pose","moderate health, social and safety risks","should not be made available to consumers."],"old":["(19) Those new psychoactive substances","which pose moderate health, social and","safety risks should not be made available to","consumers."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"35","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Hedh","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-36","location":[[" Proposal for a regulation","Recital 20"]],"meps":[28131],"meta":{"created":"2019-07-03T05:50:50"},"new":["(20) On the basis of the existing evidence","and on predefined criteria, those new","psychoactive substances which pose severe","health, social and safety risks should not be","made available on the market."],"old":["(20) Those new psychoactive substances","which pose severe health, social and safety","risks should not be made available on the","market."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"36","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-37","location":[[" Proposal for a regulation","Recital 21"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:50"},"new":["(21) This Regulation should provide for","exceptions in order to ensure the protection","of human and animal health, to facilitate","scientific research and development, and to","allow the use of new psychoactive","substances in industry, provided that they","are not liable to have ill effects and that","they cannot be abused or recovered."],"old":["(21) This Regulation should provide for","exceptions in order to ensure the protection","","of human and animal health, to facilitate","scientific research and development, and to","allow the use of new psychoactive","substances in industry, provided that they","cannot be abused or recovered."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"37","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Renate Weber","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-38","location":[["Proposal for a regulation","Recital 23"]],"meps":[39713],"meta":{"created":"2019-07-03T05:50:50"},"new":["(23) The European Monitoring Centre for","Drugs and Drug Addiction (EMCDDA)","established by Regulation 1920/2006/EC","of the European Parliament and of the","Council of 12 December 200618 should","have a central role in the exchange and","coordination of information on new","psychoactive substances and in the","assessment of the health, social and safety","risks that they pose. Given that under the","scope of this Regulation there is an","increase in the amount of information","expected to be collected and managed by","the agency, specific support should be","envisaged and provided.","__________________","18","OJ L 376, 27.12.2006, p. 1."],"old":["(23) The European Monitoring Centre for","Drugs and Drug Addiction (EMCDDA)","established by Regulation 1920/2006/EC","of the European Parliament and of the","Council of 12 December 200618 should","have a central role in the exchange of","information on new psychoactive","substances and in the assessment of the","health, social and safety risks that they","pose.","__________________","18","OJ L 376, 27.12.2006, p. 1."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"38","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Carl Schlyter on behalf of the Verts/ALE Group","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-39","location":[["Proposal for a regulation","Recital 23 a (new)"]],"meps":[28139],"meta":{"created":"2019-07-03T05:50:50"},"new":["(23a) Since it is common practise to avoid","regulations by slightly modifying existing","substances the Commission should make","a proposal for delegated act in order to","classify groups of substances with the","same mode of action even if they are not","identical."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"39","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-40","justification":"In order to have a scientific monitoring and analysis of the risks that these substances may or\nmay not pose, it is essential to have a solid information system behind. The text proposed by\nthe Commission gives much attention to the regulatory system (at the end of the process) but\nneglects the information base on which the decision is based. This recital restates the balance\nin the text between need for solid evidence and decision making, and is linked with art.5\ninformation exchange, 20 research and analysis and 15 Monitoring","location":[[" Proposal for a regulation","Recital 24"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:50"},"new":["(24) The mechanism for rapid exchange of","information on new psychoactive","substances (the 'European Union Early","Warning System on New Psychoactive","Substances' (hereafter 'EWS')) has proved","to be a useful channel for sharing","information on new psychoactive","substances, on new trends in the use of","controlled psychoactive substances and on","related public health warnings. To enable a","more effective response to the rapid","emergence and spread of new psychoactive","substances across the Union, the","mechanism should be maintained and","further developed, in particular as regards","to the collection and management of data","on the detection and identification of new","psychoactive substances, adverse events","associated with their use, and the","involvement of criminal groups in the","market through the Union new","psychoactive substances database (the","'European Database on New Drugs'). The","media, particularly the scientific and","medical literature, can be an important","source of information on adverse event","case reports. In order to enhance the","efficiency of reporting, the EMCDDA","should monitor all new psychoactive","substances and enter this information into","the European Database on New Drugs.","Data sets essential to the functioning of","this Regulation include data on the","detection and identification of new","psychoactive substances, adverse events","associated with their use, and the","involvement of criminal groups in the","market. A core data set should be defined.","The core data set should be reviewed on a","regular basis to ensure it reflects the","information required in order for the","effective functioning of the Regulation.","Suspected serious adverse events,","including fatal adverse events, should be","subject to expedited reporting."],"old":["(24) The mechanism for rapid exchange of","information on new psychoactive","substances has proved to be a useful","channel for sharing information on new","psychoactive substances, on new trends in","the use of controlled psychoactive","substances and on related public health","warnings. That mechanism should be","further strengthened to enable a more","effective response to the rapid emergence","and spread of new psychoactive substances","across the Union.",""],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"40","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-41","justification":" It is essential for a quick spread of the information on new molecules and mixtures found out\n in the market, that authorities in MS and institution can access easily and simultaneously this\n information and that can share their knowledge. The European Database on New Drugs is an\n asset to the rapidity of the system","location":[["Proposal for a regulation","Recital 24 a (new)"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:50"},"new":["(24a) In order to allow Member States to","receive, access simultaneously and share","information on new psychoactive","substances in the Union, the European","Database on New Drugs should be fully","and permanently accessible to the","Member States, the EMCDDA, Europol","and the Commission"],"old":[""],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"41","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Elena Oana Antonescu","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-42","location":[[" Proposal for a regulation","Recital 24 a (new)"]],"meps":[96702],"meta":{"created":"2019-07-03T05:50:51"},"new":["(24a) The EMCDDA should issue health","alerts to all Member States, through the","system for rapid exchange of information","on new psychoactive substances, if, on the","basis of information received on a new","psychoactive substance, this seems to","cause public health concerns. These","health alerts should also contain","information regarding prevention,","treatment and harm reduction measures","that could be taken to address the risk of","the substance."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"42","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-43","justification":"The Commission proposal does not foresees support from the EU to cope with an expected\nincrease and complexity of work for the EMCDDA. This preambular paragraph states the\nprinciple that the activities of the European Union Early Warning System on New\nPsychoactive Substances must be adequately funded","location":[[" Proposal for a regulation","Recital 24 b (new)"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:51"},"new":["(24b) In order to protect public health the","EWS activities of EMCDDA and Europol","should be adequately funded."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"43","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-44","location":[["Proposal for a regulation","Recital 25"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:51"},"new":["(25) Information from Member States is","essential for the effective functioning of","this Regulation. Therefore, Member States","should collect, on a regular basis, data on","the use of new psychoactive substances,","related health, safety and social problems","and policy responses, in accordance with","the EMCDDA framework for data","collection. They should share this data"],"old":["(25) Information from Member States is","crucial for the effective functioning of the","procedures leading to decision on market","restriction of new psychoactive","substances. Therefore, Member States","should collect, on a regular basis, data on","the use of new psychoactive substances,","related health, safety and social problems","and policy responses, in accordance with","the EMCDDA framework for data","collection for the key epidemiological","indicators and other relevant data. They","should share this data."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"44","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Renate Weber","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-45","location":[[" Proposal for a regulation","Recital 25"]],"meps":[39713],"meta":{"created":"2019-07-03T05:50:51"},"new":["(25) Information from Member States is","crucial for the effective functioning of the","procedures leading to decision on market","restriction of new psychoactive substances.","Therefore, Member States should monitor","and collect, on a regular basis, data on the","use of any new psychoactive substances,","related health, safety and social problems","and policy responses, in accordance with","the EMCDDA framework for data","collection for the key epidemiological","indicators and other relevant data. They","should share this data notably with the","EMCDDA, Europol and the European","Commission."],"old":["(25) Information from Member States is","crucial for the effective functioning of the","procedures leading to decision on market","restriction of new psychoactive substances.","Therefore, Member States should collect,","on a regular basis, data on the use of new","psychoactive substances, related health,","safety and social problems and policy","responses, in accordance with the","EMCDDA framework for data collection","for the key epidemiological indicators and","other relevant data. They should share this","data."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"45","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-46","location":[[" Proposal for a regulation","Recital 25 a (new)"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:51"},"new":["(25a) Information on new psychoactive","substances provided by and exchanged","among Member States is crucial for their","national health policies, both in terms of","drug prevention and of the treatment for","psychoactive drug users in recovery","services. Member States should make use","of all the available information in an","effective manner and monitor the relevant","developments."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"46","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-47","justification":"It is clear the need to link existing forensic laboratories in a network capable of producing\nand sharing analyses in real time. This network should be lead/guided at European level by\nthe EMCDDA.","location":[["Proposal for a regulation","Recital 26"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:51"},"new":["(26) A lack of capacity to identify and","anticipate the emergence and spread of","new psychoactive substances and a lack of","evidence about their health, social and","safety risks hamper the provision of an","effective response. Therefore, support","should be provided, including at Union","level, in order for the EMCDDA to lead a","network of forensic laboratories and to","facilitate cooperation between the","EMCDDA, research institutes and forensic","laboratories with relevant expertise, in","order to increase the capacity to assess and","address effectively new psychoactive","substances."],"old":["(26) A lack of capacity to identify and","anticipate the emergence and spread of","new psychoactive substances and a lack of","evidence about their health, social and","safety risks hamper the provision of an","effective response. Therefore, support","should be provided, including at Union","level, to facilitate cooperation between the","EMCDDA, research institutes and forensic","laboratories with relevant expertise, in","order to increase the capacity to assess and","address effectively new psychoactive","substances."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"47","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"V\u00e9ronique Mathieu Houillon, Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-48","location":[["Proposal for a regulation","Recital 28 a (new)"]],"meps":[4412,2307],"meta":{"created":"2019-07-03T05:50:51"},"new":["(28a) Children and adolescents are","particularly vulnerable to the dangers","presented by such substances, the risks of","which are still largely unknown."],"orig_lang":"fr","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"48","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" V\u00e9ronique Mathieu Houillon, Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-49","location":[[" Proposal for a regulation","Recital 29"]],"meps":[4412,2307],"meta":{"created":"2019-07-03T05:50:51"},"new":["(29) Prevention, treatment and harm","reduction measures are important for","addressing the growing use of new","psychoactive substances and their potential","risks. The internet, which is one of the","important distribution channels through","which new psychoactive substances are","sold, should be used for disseminating","information on the health, social and safety","risks that they pose. It is essential for","children, adolescents and young adults to","be made aware of those risks, including","by means of information campaigns in","schools and other educational","environments."],"old":["(29) Prevention, treatment and harm","reduction measures are important for","addressing the growing use of new","psychoactive substances and their potential","risks. The internet, which is one of the","important distribution channels through","which new psychoactive substances are","sold, should be used for disseminating","information on the health, social and safety","risks that they pose."],"orig_lang":"fr","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"49","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-50","location":[[" Proposal for a regulation","Recital 31"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:51"},"new":["(31) In order to ensure uniform conditions","for the implementation of temporary and","permanent market restrictions, delegated","powers should be conferred on the","Commission. It is of particular","importance that the Commission carry out","appropriate consultations during its","preparatory work, including at expert","level. 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":["(31) In order to ensure uniform conditions","for the implementation of temporary and","permanent market restrictions,","implementing powers should be conferred","on the Commission. Those powers should","be exercised in accordance with","Regulation (EU) No 182/2011 of the","European Parliament and of the Council","","of 16 February 2011 laying down the","rules and general principles concerning","mechanisms for control by the Member","States of the Commission's exercise of","implementing powers23 .","__________________","23","OJ L 55, 28.02.2011, p.13."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"50","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-51","location":[["Proposal for a regulation","Recital 32"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:51"},"new":["(32) The Commission should adopt","immediately delegated acts where, in duly","justified cases relating to a rapid increase","in the number of reported fatalities in","several Member States associated with the","consumption of the new psychoactive","substance concerned, imperative grounds","of urgency so require."],"old":["(32) The Commission should adopt","immediately applicable implementing acts","where, in duly justified cases relating to a","rapid increase in the number of reported","fatalities in several Member States","associated with the consumption of the","new psychoactive substance concerned,","imperative grounds of urgency so require."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"51","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-52","location":[["Proposal for a regulation","Recital 33"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:51"},"new":["(33) In the application of this Regulation,","the Commission should consult Member","States' experts, relevant Union agencies, in","particular the EMCDDA, civil society and","economic operators."],"old":["(33) In the application of this Regulation,","the Commission should consult Member","States' experts, relevant Union agencies,","civil society and economic operators.","",""],"orig_lang":"it","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"52","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Renate Weber","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-53","location":[[" Proposal for a regulation","Recital 33"]],"meps":[39713],"meta":{"created":"2019-07-03T05:50:51"},"new":["(33) In the application of this Regulation,","the Commission should consult Member","States' experts, relevant Union agencies,","civil society, economic operators and any","other relevant stakeholder."],"old":["(33) In the application of this Regulation,","the Commission should consult Member","States' experts, relevant Union agencies,","civil society and economic operators."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"53","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Renate Weber","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-54","location":[[" Proposal for a regulation","Recital 36"]],"meps":[39713],"meta":{"created":"2019-07-03T05:50:52"},"new":["(36) This Regulation respects fundamental","rights and observes the principles","recognised by the Charter of Fundamental","Rights of the European Union and of the","European Convention of Human Rights,","including the freedom to conduct a","business, the right to property, the right of","access to preventive healthcare and the","right to benefit from medical treatment,"],"old":["(36) This Regulation respects fundamental","rights and observes the principles","recognised by the Charter of Fundamental","Rights of the European Union, including","the freedom to conduct a business, the right","to property and the right to an effective","remedy,"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"54","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-55","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 2 a (new)"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:52"},"new":["Each Member State shall set up an on-","line register of wholesalers and retailers","of such substances. The register shall be","kept by the health ministry of the Member","State or by delegated authorities. The sale","of such substances shall be subject to","inclusion in the register. Producers and","vendors shall be required to declare the","quantities bought, sold and produced,","whether for industrial, scientific or","commercial purposes."],"orig_lang":"it","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"55","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-56","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 2 b (new)"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:52"},"new":["Under no circumstances may such","substances be sold to children under 18","years of age."],"orig_lang":"it","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"56","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-57","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:52"},"new":["If a Member State has information","relating to what appears to be a new","psychoactive substance or mixture, its","National Focal Points within the European","Information Network on Drugs and Drug","Addiction (\u2018Reitox\u2019) and Europol National","Units shall provide to the EMCDDA and","Europol the available information on the","consumption, possible risks, manufacture,","extraction, importation, trade, distribution,","trafficking, commercial and scientific use","of that substance."],"old":["National Focal Points within the European","Information Network on Drugs and Drug","","Addiction (\u2018Reitox\u2019) and Europol National","Units shall provide to the EMCDDA and","Europol the available information on the","consumption, possible risks, manufacture,","extraction, importation, trade, distribution,","trafficking, commercial and scientific use","of substances that appear to be new","psychoactive substances or mixtures."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"57","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Renate Weber","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-58","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1"]],"meps":[39713],"meta":{"created":"2019-07-03T05:50:52"},"new":["National Focal Points within the European","Information Network on Drugs and Drug","Addiction (\u2018Reitox\u2019) and Europol National","Units shall gather continuously and","provide in a timely manner to the","EMCDDA and Europol the available","information on the detection,","identification, consumption, patterns of","use, dosage, use disorder, possible risks,","non-fatal intoxication, deaths, social","harms, manufacture, extraction,","importation, trade, distribution, trafficking,","commercial and scientific use of","substances that appear to be new","psychoactive substances or mixtures."],"old":["National Focal Points within the European","Information Network on Drugs and Drug","Addiction (\u2018Reitox\u2019) and Europol National","Units shall provide to the EMCDDA and","Europol the available information on the","consumption, possible risks, manufacture,","extraction, importation, trade, distribution,","trafficking, commercial and scientific use","of substances that appear to be new","psychoactive substances or mixtures."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"58","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-59","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 1"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:52"},"new":["National Focal Points within the European","Information Network on Drugs and Drug","Addiction (\u2018Reitox\u2019) and Europol National","Units shall provide to the EMCDDA and","Europol the information on the","consumption, possible risks, manufacture,","extraction, importation, trade, distribution,","trafficking, commercial and scientific use","of substances that appear to be new","psychoactive substances or mixtures."],"old":["National Focal Points within the European","Information Network on Drugs and Drug","Addiction (\u2018Reitox\u2019) and Europol National","Units shall provide to the EMCDDA and","Europol the available information on the","consumption, possible risks, manufacture,","extraction, importation, trade, distribution,","trafficking, commercial and scientific use","of substances that appear to be new","psychoactive substances or mixtures."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"59","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-60","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 1"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:52"},"new":["The national authorities which keep the","registers, National Focal Points within the","European Information Network on Drugs","and Drug Addiction (\"Reitox\") and","Europol National Units shall provide to the","EMCDDA and Europol the available","information on the consumption, possible","risks, manufacture, extraction, importation,","trade, distribution, trafficking, commercial","and scientific use of substances that appear","to be new psychoactive substances or","mixtures."],"old":["National Focal Points within the European","Information Network on Drugs and Drug","Addiction (\"Reitox\") and Europol National","Units shall provide to the EMCDDA and","Europol the available information on the","consumption, possible risks, manufacture,","extraction, importation, trade, distribution,","trafficking, commercial and scientific use","of substances that appear to be new","psychoactive substances or mixtures."],"orig_lang":"it","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"60","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-61","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 2"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:52"},"new":["The EMCDDA and Europol shall","communicate that information immediately","to Reitox, the Europol National Units and","the European Medicines Agency."],"old":["The EMCDDA and Europol shall","communicate that information immediately","to Reitox and the Europol National Units."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"61","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-62","justification":" This amendment states the need to reinforce the EWS as the system capable of monitoring the\n phenomenon and adequately prepare the ground for an informed decision making process.\n\nMoreover it states the principle that the EU should support the key actors involved in this\nsystem.","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 2 a (new)"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:52"},"new":["To enable a 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substances."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"62","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-63","location":[["Proposal for a regulation","Article 6 \u2013 title"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:52"},"new":["Report"],"old":["Joint report"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"63","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-64","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 1"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:52"},"new":["1. Where the EMCDDA or the","Commission considers, that the","information shared on a new psychoactive","substance notified by several Member","States gives rise to concerns across the","Union because of the health, social and","safety risks that the new psychoactive","substance may pose, the EMCDDA shall","draw up a report on the new psychoactive","substance."],"old":["1. Where the EMCDDA and Europol, or","the Commission, consider that the","information shared on a new psychoactive","substance notified by several Member","States gives rise to concerns across the","Union because of the health, social and","safety risks that the new psychoactive","substance may pose, the EMCDDA and","Europol shall draw up a joint report on the","new psychoactive substance."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"64","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"V\u00e9ronique Mathieu Houillon, Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-65","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 1"]],"meps":[4412,2307],"meta":{"created":"2019-07-03T05:50:52"},"new":["1. Where the EMCDDA and Europol, or","the Commission, consider that the","information shared on a new psychoactive","substance notified by several Member","States gives rise to concerns across the","Union because of the health, social and","safety risks that the new psychoactive","substance may pose, or in response to a","reasoned request from more than one","Member State, the EMCDDA and Europol","shall draw up a joint report on the new","psychoactive substance."],"old":["1. Where the EMCDDA and Europol, or","the Commission, consider that the","information shared on a new psychoactive","substance notified by several Member","States gives rise to concerns across the","Union because of the health, social and","safety risks that the new psychoactive","substance may pose, the EMCDDA and","Europol shall draw up a joint report on the","new psychoactive substance."],"orig_lang":"fr","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"65","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-66","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 2 \u2013 introductory part"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:52"},"new":["2. The report shall contain the following","information:"],"old":["2. The joint report shall contain the","following information:"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"66","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-67","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 2 \u2013 point e"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:52"},"new":["deleted"],"old":["(e) the involvement of criminal groups in","the manufacture, distribution or trade in","the new psychoactive substance, and any","use of the new psychoactive substance in","the manufacture of narcotic drugs or","","psychotropic substances;"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"67","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-68","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 3"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:53"},"new":["3. The EMCDDA shall request the","National Focal Points, the Europol","National Units and Europol to provide","information on the new psychoactive","substance and in particular on the","involvement of criminal groups in the","manufacture, distribution or trade in the","new psychoactive substance, and any use","of the new psychoactive substance in the","manufacture of narcotic drugs or","psychotropic substances. They shall","provide that information within four weeks","from receipt of the request."],"old":["3. The EMCDDA and Europol shall","request the National Focal Points and the","Europol National Units to provide","additional information on the new","psychoactive substance. They shall provide","that information within four weeks from","receipt of the request."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"68","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-69","location":[["Proposal for a regulation","Article 6 \u2013 paragraph 4 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:53"},"new":["4. The EMCDDA shall request the","European Medicines Agency and the","national competent authorities for","medicines of Member States to provide","information on whether, in the Union or in","any Member State, the new psychoactive","substance is:"],"old":["4. The EMCDDA and Europol shall","request the European Medicines Agency to","provide information on whether, in the","Union or in any Member State, the new","psychoactive substance is:"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"69","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-70","location":[[" Proposal for a regulation","Article 6 \u2013 paragraph 6 \u2013 subparagraph 1"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:53"},"new":["6. The EMCDDA shall submit the report to","the Commission within eight weeks from","the request for additional information","referred to in paragraph 3."],"old":["6. The EMCDDA and Europol shall","submit the joint report to the Commission","within eight weeks from the request for","additional information referred to in","paragraph 3."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"70","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-71","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 1"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:53"},"new":["1. Within four weeks from the receipt of","the report referred to in Article 6, the","Commission may request the EMCDDA to","assess the potential risks posed by the new","psychoactive substance and to draw up a","risk assessment report. The risk assessment","shall be conducted by the Scientific","Committee of the EMCDDA."],"old":["1. Within four weeks from the receipt of","the joint report referred to in Article 6, the","Commission may request the EMCDDA to","assess the potential risks posed by the new","psychoactive substance and to draw up a","risk assessment report. The risk assessment","shall be conducted by the Scientific","Committee of the EMCDDA."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"71","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" V\u00e9ronique Mathieu Houillon, Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-72","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 1"]],"meps":[4412,2307],"meta":{"created":"2019-07-03T05:50:53"},"new":["1. Within four weeks from the receipt of","the joint report referred to in Article 6, or","in response to a reasoned request from","more than one Member State, the","Commission may request the EMCDDA to","assess the potential risks posed by the new","psychoactive substance and to draw up a","risk assessment report. The risk assessment","shall be conducted by the Scientific","Committee of the EMCDDA."],"old":["1. Within four weeks from the receipt of","the joint report referred to in Article 6, the","Commission may request the EMCDDA to","assess the potential risks posed by the new","psychoactive substance and to draw up a","risk assessment report. The risk assessment","shall be conducted by the Scientific","Committee of the EMCDDA."],"orig_lang":"fr","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"72","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-73","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 3"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:53"},"new":["3. The Scientific Committee of the","EMCDDA shall assess the risks during a","special meeting. The Committee may be","extended by not more than five experts,","representing the scientific fields relevant","for ensuring a balanced assessment of the","risks of the new psychoactive substance.","The Director of the EMCDDA shall","designate them from a list of experts. The","Management Board of the EMCDDA shall","approve the list of experts every three","years. European Parliament, the Council,","the Commission, the EMCDDA, Europol","and the European Medicines Agency shall","each have the right to nominate two","observers."],"old":["3. The Scientific Committee of the","EMCDDA shall assess the risks during a","special meeting. The Committee may be","extended by not more than five experts,","representing the scientific fields relevant","for ensuring a balanced assessment of the","risks of the new psychoactive substance.","The Director of the EMCDDA shall","designate them from a list of experts. The","Management Board of the EMCDDA shall","approve the list of experts every three","years. The Commission, the EMCDDA,","Europol and the European Medicines","Agency shall each have the right to","nominate two observers."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"73","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-74","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 3"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:53"},"new":["3. The Scientific Committee of the","EMCDDA shall assess the risks during a","special meeting. The Committee may be","extended by not more than five experts,","including a psychologist specialising in","addiction and psychological disorders in","children and adolescents, representing the","scientific fields relevant for ensuring a","balanced assessment of the risks of the new","psychoactive substance. The Director of","the EMCDDA shall designate them from a","list of experts. The Management Board of","the EMCDDA shall approve the list of","experts every three years. The","Commission, the EMCDDA, Europol and","the European Medicines Agency shall each","have the right to nominate two observers."],"old":["3. The Scientific Committee of the","EMCDDA shall assess the risks during a","special meeting. The Committee may be","extended by not more than five experts,","representing the scientific fields relevant","for ensuring a balanced assessment of the","risks of the new psychoactive substance.","The Director of the EMCDDA shall","designate them from a list of experts. The","Management Board of the EMCDDA shall","approve the list of experts every three","years. The Commission, the EMCDDA,","Europol and the European Medicines","Agency shall each have the right to","nominate two observers."],"orig_lang":"it","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"74","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" V\u00e9ronique Mathieu Houillon, Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-75","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 3"]],"meps":[4412,2307],"meta":{"created":"2019-07-03T05:50:53"},"new":["3. The Scientific Committee of the","EMCDDA shall assess the risks during a","special meeting. The Committee may be","extended by not more than five experts,","representing the scientific fields relevant","for ensuring a balanced assessment of the","risks of the new psychoactive substance.","The Director of the EMCDDA shall","designate them from a list of experts. The","Management Board of the EMCDDA shall","approve the list of experts every three","years. The European Parliament, the","Council, the Commission, the EMCDDA,","Europol and the European Medicines","Agency shall each have the right to","nominate two observers."],"old":["3. The Scientific Committee of the","EMCDDA shall assess the risks during a","special meeting. The Committee may be","extended by not more than five experts,","representing the scientific fields relevant","for ensuring a balanced assessment of the","risks of the new psychoactive substance.","The Director of the EMCDDA shall","designate them from a list of experts. The","Management Board of the EMCDDA shall","","approve the list of experts every three","years. The Commission, the EMCDDA,","Europol and the European Medicines","Agency shall each have the right to","nominate two observers."],"orig_lang":"fr","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"75","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Renate Weber","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-76","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 4"]],"meps":[39713],"meta":{"created":"2019-07-03T05:50:54"},"new":["4. The Scientific Committee of the","EMCDDA shall carry out the risk","assessment on the basis of information on","the risks of the substance and on its uses,","like its patterns and dosage, including","commercial and industrial uses, provided","by the Member States, the Commission,","the EMCDDA, Europol, the European","Medicines Agency, the European","Chemicals Agency, the European Food","Safety Authority and on the basis of any","other relevant scientific evidence. It shall","take into consideration all opinions held by","its members. The EMCDDA shall support","the risk assessment and shall identify","information needs, including targeted","studies or tests."],"old":["4. The Scientific Committee of the","EMCDDA shall carry out the risk","assessment on the basis of information on","the risks of the substance and on its uses,","including commercial and industrial uses,","provided by the Member States, the","Commission, the EMCDDA, Europol, the","European Medicines Agency, the European","Chemicals Agency, the European Food","Safety Authority and on the basis of any","other relevant scientific evidence. It shall","take into consideration all opinions held by","its members. The EMCDDA shall support","the risk assessment and shall identify","information needs, including targeted","studies or tests."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"76","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Carl Schlyter on behalf of the Verts/ALE Group","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-77","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 6 \u2013 subparagraph 1 (new)"]],"meps":[28139],"meta":{"created":"2019-07-03T05:50:54"},"new":["The Commission shall within [18 months","after the adoption of this Regulation]","adopt delegated act concerning the","evaluation, classification and regulation","of substances in groups based on active","end-points."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"77","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-78","justification":" The Commission proposal reproduces the requirement (included also in the Council Decision\n 2005) that would place the EU system under the authority of WHO. In fact the current text\n would prohibit the EWS to process a substance (Joint report- RA) if \u201cthe new psychoactive\n substance is at an advanced stage of assessment within the United Nations system\u201d. Now this\n correspond to a political choice to place EU interests below UN interest, while the EWS\n original idea was to create a EU system faster and more effective of the UN. Now that the\n WHO has under review at the same time dozen of substances (many of which are under our\n radars), the EWS could be seriously impaired by mass analysis like this one.","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:54"},"new":["deleted"],"old":["1. No risk assessment shall be carried out","where the new psychoactive substance is","at an advanced stage of assessment within","the United Nations system, namely once","the World Health Organisation expert","committee on drug dependence has","published its critical review together with","a written recommendation, except where","there is significant information that is","new or of particular relevance for the","Union and that has not been taken into","account by the United Nations system."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"78","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-79","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 1"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:54"},"new":["1. No risk assessment shall be carried out","where the new psychoactive substance is at","an advanced stage of assessment within the","United Nations system, namely once the","World Health Organisation expert","committee on drug dependence has","published its critical review together with a","written recommendation, except where","there is significant and concrete","information that is new or of particular","relevance for the Union and that has not","been taken into account by the United","Nations system, which is to be mentioned","in the assessment report."],"old":["1. No risk assessment shall be carried out","where the new psychoactive substance is at","an advanced stage of assessment within the","United Nations system, namely once the","World Health Organisation expert","committee on drug dependence has","published its critical review together with a","written recommendation, except where","there is significant information that is new","or of particular relevance for the Union and","that has not been taken into account by the","United Nations system."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"79","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-80","justification":" The Commission proposal reproduces the requirement (included also in the Council Decision\n 2005) that would place the EU system under the authority of WHO. In fact the current text\n would prohibit the EWS to process a substance (Joint report- RA) if \u201cthe new psychoactive\n substance is at an advanced stage of assessment within the United Nations system\u201d. Now this\n correspond to a political choice to place EU interests below UN interest, while the EWS\n original idea was to create a EU system faster and more effective of the UN. Now that the\n WHO has under review at the same time dozen of substances (many of which are under our\n radars), the EWS could be seriously impaired by mass analysis like this one.","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 2"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:54"},"new":["deleted"],"old":["2. No risk assessment shall be carried out","where the new psychoactive substance has","been assessed within the United Nations","system, but it has been decided not to","schedule it under the 1961 Single","Convention on Narcotic Drugs, as","amended by the 1972 Protocol, or the","1971 Convention on Psychotropic","Substances, except where there is","significant information that is new or of","particular relevance for the Union."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"80","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-81","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 2"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:54"},"new":["2. No risk assessment shall be carried out","where the new psychoactive substance has","been assessed within the United Nations","system, but it has been decided not to","schedule it under the 1961 Single","Convention on Narcotic Drugs, as","amended by the 1972 Protocol, or the 1971","Convention on Psychotropic Substances,","except where there is significant and","concrete information that is new or of","particular relevance for the Union, the","reasons for which shall be indicated in the","assessment report."],"old":["2. No risk assessment shall be carried out","where the new psychoactive substance has","been assessed within the United Nations","system, but it has been decided not to","schedule it under the 1961 Single","Convention on Narcotic Drugs, as","amended by the 1972 Protocol, or the 1971","Convention on Psychotropic Substances,","except where there is significant","information that is new or of particular","relevance for the Union."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"81","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Renate Weber","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-82","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 4 (new)"]],"meps":[39713],"meta":{"created":"2019-07-03T05:50:54"},"new":["4. However, the risk assessment shall be","carried if at the Union level there is","sufficient data available to suggest the","need for a joint report of the European","Monitoring Centre for Drugs and Drug","Addiction (EMCDDA) and Europol."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"82","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-83","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:54"},"new":["The Commission shall adopt the Decision","referred to in paragraph 1 by means of","delegated acts. Those delegated acts shall","be adopted in accordance with the","procedure referred to in Article 19(1)."],"old":["The Commission shall adopt the Decision","referred to in paragraph 1 by means of","implementing acts. Those implementing","acts shall be adopted in accordance with","the examination procedure referred to in","Article 19(2)."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"83","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-84","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:54"},"new":["On duly justified imperative grounds of","urgency relating to a rapid increase in the","number of reported fatalities in several","Member States associated with the","consumption of the new psychoactive","substance concerned, the Commission shall","adopt delegated acts in accordance with the","urgency procedure laid down in Article","19(2)."],"old":["On duly justified imperative 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associated with","the new psychoactive substance, illicit","profits generated by the production, trade","and distribution of the new psychoactive","substance, and associated economic costs","of the social harm;"],"old":["(b) the social harm caused to individuals","and to society, in particular its impact on","social functioning, public order and","criminal activities, organised crime activity","associated with the new psychoactive","substance, illicit profits generated by the","production, trade and distribution of the","new psychoactive substance, and","associated economic costs of the social","harm;"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"85","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-86","location":[[" Proposal for a regulation","Article 10 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point c"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:54"},"new":["(c) the risks to safety, based on the spread","of diseases, including transmission of","blood borne viruses, the consequences of","physical and mental impairment on the","ability to drive, the impact of the","manufacture, transport and disposal of the","new psychoactive substance and associated","waste materials on the environment."],"old":["(c) the risks to safety, in particular the","spread of diseases, including transmission","of blood borne viruses, the consequences","of physical and mental impairment on the","ability to drive, the impact of the","manufacture, transport and disposal of the","new psychoactive substance and associated","waste materials on the environment."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"86","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-87","justification":"Such a definition cannot be based on scientific ground because the effects of the consumption\nof psychoactive substances on humans depend grossly by other factors besides the toxicity of\nthe substances, namely the dosage, the way of administrations, the interaction with other\nsubstances, individual characteristics of the person, etc. Those substances that have not been\nsubject to control should go on a sort of watch-list, within the EWS in order to monitor if new\ndata require reconsideration.","location":[["Proposal for a regulation","Article 11 \u2013 title"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:54"},"new":["Active Monitoring"],"old":["Low risks"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"87","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-88","location":[["Proposal for a regulation","Article 11 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:54"},"new":["The Commission shall not adopt restriction","measures on a new psychoactive substance","if, based on existing evidence, it :"],"old":["The Commission shall not adopt","restriction measures on a new psychoactive","substance if, based on existing evidence, it","poses, overall, low health, social and","safety risks, in particular:"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"88","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Hedh","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-89","justification":" The criteria proposed by the Commission for judging whether market restrictions are\n necessary or not under Articles 11, 12 and 13 are non-exhaustive. Such a non-exhaustive list\n is incompatible with the use of implementing acts, which presupposes that the Union\n legislature determines in a complete and exhaustive manner the criteria on the basis of which\n the Commission is empowered to act. This amendment renders the criteria exhaustive.","location":[["Proposal for a regulation","Article 11 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[28131],"meta":{"created":"2019-07-03T05:50:55"},"new":["The Commission shall not adopt restriction","measures on a new psychoactive substance","if, based on the existing evidence and on","the following criteria, it poses low health,","social and safety risks:"],"old":["The Commission shall not adopt","restriction measures on a new psychoactive","substance if, based on existing evidence, it","poses, overall, low health, social and safety","risks, in particular:"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"89","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Marco Scurria","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-90","location":[[" Proposal for a regulation","Article 11 \u2013 paragraph 1 \u2013 point a"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:55"},"new":["(a) does not represent imminent harm to","health;"],"old":["(a) the harm to health caused by the","consumption of the new psychoactive","substance associated with its acute and","chronic toxicity, abuse liability and","dependence-producing potential, is","limited, as it provokes minor injury and","disease, and minor physical or mental","impairment;"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"90","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Elena Oana Antonescu","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-91","location":[[" Proposal for a regulation","Article 11 \u2013 paragraph 1 \u2013 point a"]],"meps":[96702],"meta":{"created":"2019-07-03T05:50:55"},"new":["(a) the harm to health caused by the","consumption of the new 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regulation","Article 11 \u2013 paragraph 1 \u2013 point c"]],"meps":[96843],"meta":{"created":"2019-07-03T05:50:55"},"new":["(c) or risks to safety."],"old":["(c) the risks to safety are limited, in","particular low risk of spread of diseases,","including transmission of blood borne","viruses, non-existent or low consequences","of physical and mental impairment on the","ability to drive, and the impact of the","manufacture, transport and disposal of","the new psychoactive substance and","associated waste materials on the","environment is low."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"94","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-95","location":[[" Proposal for a regulation","Article 11 \u2013 paragraph 1 \u2013 point 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low."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"95","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-96","location":[["Proposal for a regulation","Article 11 \u2013 paragraph 1 \u2013 point c a (new)"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:55"},"new":["(ca) Member States may introduce further","measures that are deemed appropriate or","necessary with regard to a new","psychoactive substance, depending on the","specific risks that the substance poses in","their territories taking into account","national circumstances and any social,","economic, legal, administrative or other","factor they may consider relevant;"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"96","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-97","location":[["Proposal for a regulation","Article 11 \u2013 paragraph 1 \u2013 point c b (new)"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:55"},"new":["(cb) In case the decision to not adopt","restriction measures on a new","psychoactive substance that is considered","to pose overall low health, social and","safety risk was based on a partial or total","lack of evidence, it shall include an","appropriate mention in its 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The Commission shall, by means of a","Decision, without undue delay, prohibit the","making available on the market to","consumers of the new psychoactive","substance if, based on existing evidence, it","poses, overall, moderate health, social and","safety risks based on the following","criteria:"],"old":["1. The Commission shall, by means of a","Decision, without undue delay, prohibit the","making available on the market to","consumers of the new psychoactive","substance if, based on existing evidence, it","poses, overall, moderate health, social and","safety risks, in particular:"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"98","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Hedh","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-99","justification":" The criteria proposed by the Commission for judging whether market restrictions are\n\n\nnecessary or not under Articles 11, 12 and 13 are non-exhaustive. Such a non-exhaustive list\nis incompatible with the use of implementing acts, which presupposes that the Union\nlegislature determines in a complete and exhaustive manner the criteria on the basis of which\nthe Commission is empowered to act. This amendment renders the criteria exhaustive.","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[28131],"meta":{"created":"2019-07-03T05:50:55"},"new":["1. The Commission shall, by means of a","Decision, without undue delay, prohibit the","making available on the market to","consumers of the new psychoactive","substance if, based on the existing","evidence and on the following criteria, it","poses moderate health, social and safety","risks:"],"old":["1. The Commission shall, by means of a","Decision, without undue delay, prohibit the","making available on the market to","consumers of the new psychoactive","substance if, based on existing evidence, it","poses, overall, moderate health, social and","safety risks, in particular:"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"99","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-100","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 1 \u2013 point b"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:55"},"new":["(b) the social harm caused to individuals","and to society is moderate, based on its","impact on public order, producing public","nuisance; criminal activities and organised","crime activity associated with the","substance are sporadic, illicit profits and","economic costs are moderate;"],"old":["(b) the social harm caused to individuals","and to society is moderate, in particular","regarding its impact on social functioning","and public order, producing public","nuisance; criminal activities and organised","crime activity associated with the","substance are sporadic, illicit profits and","economic costs are moderate;"],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"100","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-101","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 1 \u2013 point c"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:55"},"new":["(c) the risks to safety are moderate, based","on a sporadic spread of diseases, including","transmission of blood borne viruses,","moderate consequences of physical and","mental impairment on the ability to drive,","and the manufacture, transport and disposal","of the new psychoactive substance and","associated waste materials results in","environmental nuisance."],"old":["(c) the risks to safety are moderate, in","particular sporadic spread of diseases,","including transmission of blood borne","viruses, moderate consequences of physical","and mental impairment on the ability to","drive, and the manufacture, transport and","disposal of the new psychoactive substance","and associated waste materials results in","environmental nuisance."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"101","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-102","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 2"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:55"},"new":["2. The Commission shall adopt the","Decision referred to in paragraph 1 by","means of delegated acts. Those delegated","acts shall be adopted in accordance with","the examination procedure referred to in","Article 19(1)."],"old":["2. The Commission shall adopt the","Decision referred to in paragraph 1 by","means of implementing acts. Those","implementing acts shall be adopted in","accordance with the examination procedure","referred to in Article 19(2)."],"orig_lang":"en","peid":"PE519.808v01-00","reference":"2013/0305(COD)","seq":"102","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-519.808+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2014-01-29T00:00:00","id":"PE519.808-103","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 2 a (new)"]],"meps":[28514],"meta":{"created":"2019-07-03T05:50:56"},"new":["2a. 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Such a non-exhaustive list\nis incompatible with the use of implementing acts, which presupposes that the Union\nlegislature determines in a complete and exhaustive manner the criteria on the basis of which\nthe Commission is empowered to act. This amendment renders the criteria exhaustive.","location":[[" Proposal for a regulation","Article 13 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[28131],"meta":{"created":"2019-07-03T05:50:56"},"new":["1. The Commission shall, by means of a","Decision, without undue delay, prohibit the","production, manufacture, making available","on the market including importation to the","Union, transport, and exportation from the","Union of the new psychoactive substance","if, based on the existing evidence and on","the following criteria, it poses severe","health, social and safety risks:"],"old":["1. 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PURPOSE: to approximate the rules relating to new\npsychoactive substances that are of concern at Union level whilst\nensuring a high level of health, safety and consumer\nprotection.
\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: new psychoactive substances, which may\nhave numerous commercial and industrial uses, as well as scientific\nuses, can pose health, social and safety risks when consumed\nby humans. Consumption of new psychoactive substances appears to be\nincreasing in Europe and use is predominant among young\npeople. According to the 2011 Eurobarometer \"Youth attitudes on\ndrugs\", 5% of young people in the EU have used such substances at\nleast once in their life, with a peak of 16% in Ireland, and close\nto 10% in Poland, Latvia and the UK.
\nDuring the past years, Member States have notified an\nincreasing number of new psychoactive substances to the European\nMonitoring Centre for Drugs and Drug Addiction (EMCDDA).\nNational restriction measures, which can vary depending on the\nMember State and on the substance, lead to obstacles to trade\nin licit uses, fragmentation, an uneven level playing field and\nlegal uncertainties for economic operators, and make it difficult\nfor companies to operate across the internal market. They make\nresearch more cumbersome, hampering the development of new uses for\nthese substances.
\nIn this context, the case\nfor swifter, more effective and more proportionate action on new\npsychoactive substances at EU level is compelling, considering the\nrapid changes in this market, which put national authorities under\npressure to act.
\nThe Commission Communication \"Towards a stronger European response to\ndrugs\", adopted in October 2011, identified the\nspread of new psychoactive substances as one of the most\nchallenging developments in drugs policy requiring a firmer EU\nresponse.
\nIMPACT ASSESSMENT: taking into account the results of\nimpact assessment, the following solutions are preferred: (i) a\nmore graduated and better targeted set of restriction measures on\nnew psychoactive substances, which should not hinder the industrial\nuse of substances; (ii) restriction measures should be introduced\nearlier; (iii) substances suspected to pose immediate public health\nrisks should be subjected to temporary restrictions; (iv)\nrestriction measures should be proportionate to a better determined\nlevel of risk of substances; (v) restriction measures should be\nintroduced through a quicker procedure.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union.
\nCONTENT: this proposed Regulation which is\nintended to replace Council Decision 2005/387/JHA\n- aims at ensuring that trade in new psychoactive substances\nhaving industrial and commercial uses is not hindered and\nthat the functioning of this market is improved, while the\nhealth and safety of individuals are protected from harmful\nsubstances, which cause concern at the EU level.
\nThe proposal is accompanied by a proposal for a Directive\namending Council Framework Decision 2004/757/JHA laying down\nminimum provisions on the constituent elements of criminal acts and\npenalties in the field of illicit drug trafficking.
\nThe main elements of the proposal are as\nfollows:
\nExchange of information and temporary consumer market\nrestrictions: this proposal sets up a\nrobust system: (i) for exchanging rapidly information on new\npsychoactive substances emerging on the market, including on their\ncommercial and industrial uses, for assessing the risks of\nsubstances that cause EU-wide concern and; (ii) for withdrawing\nfrom the market those substances that pose risks.
\nThe substances suspected to pose immediate public\nhealth risk will be withdrawn from the consumer market temporarily,\npending their risk assessment. Once the risk assessment is\ncompleted, measures will be taken proportionate to the risks of\nsubstances.
\nThe proposal establishes the respective roles of\nMember States, the EMCDDA and Europol in the process of exchange of\ninformation on new psychoactive substances.
\nLow and moderate risks:\naccording to the proposal, no restriction measures shall be\nintroduced on new psychoactive substances posing low health, social\nand safety risks and provides a definition of low risks.
\nFor substances posing moderate risks and permanent\nconsumer market restrictions, they cannot be sold to consumers\n(except for uses specifically authorised, for instance by medicines\nlegislation) but their trade is allowed for commercial and\nindustrial purposes as well as for scientific research and\ndevelopment.
\nSevere risks: the\nproposal empowers the Commission to prohibit the production,\nmanufacture, making available on the market, transport, importation\nor exportation of new psychoactive substances which pose severe\nhealth, social and safety risks, and provides a definition of\nsevere risks.
\nNew psychoactive substances posing severe risks will\nbe subjected to permanent market restriction, covering both\nthe consumer and commercial markets, and their use will only be\npossible for specifically authorised industrial and commercial\npurposes, as well as for scientific research and development. In\naddition, these substances will be subjected to EU criminal law\nprovisions.
\nSanctions: the proposal\nestablishes the obligation for the Member States to lay down the\nrules on administrative sanctions applicable to infringements to\nmarket restriction, and to ensure that they are effective,\nproportionate and dissuasive.
\nBUDGETARY IMPLICATION: the proposal has no direct\nimpact on the EU budget and does not create new tasks for the\nEMCDDA, Europol, the European Medicines Agencies, the European\nChemicals Agency (ECHA) and the European Food Safety Authority\n(EFSA).
\nThe Committee on Civil Liberties, Justice and Home\nAffairs adopted the report by Jacek PROTASIEWICZ (EPP, PL) on the\nproposal for a regulation of the European Parliament and of the\nCouncil on new psychoactive substances.
\nThe committee recommended that Parliaments\nposition in first reading following the ordinary legislative\nprocedure should amend the Commission position as\nfollows:
\nInformation exchange: to\nenable a more effective response to the rapid emergence and spread\nof new psychoactive substances across the Union, Members\nconsidered that the information exchange mechanism (the 'Early\nWarning System') should be maintained and further\ndeveloped, in particular as regards to the collection and\nmanagement of data on the detection and identification of new\npsychoactive substances.
\nThe European Monitoring Centre for Drugs and Drug\nAddiction (EMCDDA) should issue health alerts to all Member\nStates, through the system for rapid exchange of information on\nnew psychoactive substances if, on the basis of information\nreceived on a new psychoactive substances, this seemed to cause\npublic health concerns. Those health alerts should also\ncontain information regarding prevention, treatment and harm\nreduction measures that could be taken to address the risk of the\nsubstance.
\nImmediate risks to public health, and market\nrestrictions: the proposal provided\nthat the Commission should, by means of a Decision, prohibit the\nmaking available on the market to consumers of the new psychoactive\nsubstance if, based on existing information, it poses immediate\nrisks to public health. The market restriction should not exceed a\nperiod of twelve months.
\nMembers proposed that if the level of health, social\nand safety risks posed by the new psychoactive substance justified\nthe introduction of permanent restriction measures, the duration\nof the temporary market restriction may be extended by a\nfurther 12 months, in the absence of permanent market\nrestriction.
\nLow risks at Union level: the Commission should not adopt restriction measures\non a new psychoactive substance if, based on the existing\nevidence and on prescribed criteria, it posed, overall,\nlow health, social and safety risks at Union level.
\nHowever, where the decision to not adopt\nrestriction measures on a new psychoactive substance that was\nconsidered to pose overall low health, social and safety\nrisk at Union level was based on a partial or total lack\nof evidence, it should include an appropriate reference in the\njustification.
\nThe report also stressed that Members States should\nnot be prohibited from introducing or maintaining the more\nstringent measures regarding the specific risks the new\npsychoactive substance posed within their territory, independently\nof the classification of the substance by the Commission as posing\nlow or moderate risks on the EU level. The relevant laws,\nregulations or administrative provisions should be communicated to\nthe Commission and the other Member States should be\ninformed.
\nAuthorised use:\ndecisions prohibiting the marketing of new psychoactive\nsubstance presenting a serious risk should not impede the free\nmovement in the Union and the production, manufacture, making\navailable on the market of new psychoactive substances for\nscientific research and development purposes, by duly\nauthorised persons in establishments which were directly under the\ncontrol of Member States' authorities or specifically approved by\nthem.
\nFor all of authorised uses, new psychoactive\nsubstances and products containing new psychoactive substances\nshould include directions for use, including cautions,\nwarnings and contraindications with other substances, to be either\nindicated on the label or included in the accompanying leaflet for\nthe safety of the user.
\nFurthermore, Member States should take any appropriate\nmeasures to prevent the diversion to the illicit market of\nnew psychoactive substances used for research and development\npurposes or for any other authorised uses.
\nResearch, analysis, prevention and\nfunding: the amended text provided\nthat financial support and the necessary resources should\nbe provided at Union and national level for the development,\nsharing and dissemination of information and knowledge on new\npsychoactive substances.
\nMoreover, the Commission and the Member States should\npromote the research into new psychoactive substances and ensure\ncooperation and coordination between networks at national and\nUnion level in order to strengthen understanding of the\nphenomenon.
\nPrevention schemes as well as measures to raise\nawareness of the risks posed by psychoactive substances, such as\neducational information campaigns should be\npromoted.
\nEvaluation: five years\nafter the entry into force of the Regulation and every five years\nthereafter, the Commission should:
\nPURPOSE: to approximate the rules relating to new\npsychoactive substances that are of concern at Union level whilst\nensuring a high level of health, safety and consumer\nprotection.
\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: new psychoactive substances, which may\nhave numerous commercial and industrial uses, as well as scientific\nuses, can pose health, social and safety risks when consumed\nby humans. Consumption of new psychoactive substances appears to be\nincreasing in Europe and use is predominant among young\npeople. According to the 2011 Eurobarometer \"Youth attitudes on\ndrugs\", 5% of young people in the EU have used such substances at\nleast once in their life, with a peak of 16% in Ireland, and close\nto 10% in Poland, Latvia and the UK.
\nDuring the past years, Member States have notified an\nincreasing number of new psychoactive substances to the European\nMonitoring Centre for Drugs and Drug Addiction (EMCDDA).\nNational restriction measures, which can vary depending on the\nMember State and on the substance, lead to obstacles to trade\nin licit uses, fragmentation, an uneven level playing field and\nlegal uncertainties for economic operators, and make it difficult\nfor companies to operate across the internal market. They make\nresearch more cumbersome, hampering the development of new uses for\nthese substances.
\nIn this context, the case\nfor swifter, more effective and more proportionate action on new\npsychoactive substances at EU level is compelling, considering the\nrapid changes in this market, which put national authorities under\npressure to act.
\nThe Commission Communication \"Towards a stronger European response to\ndrugs\", adopted in October 2011, identified the\nspread of new psychoactive substances as one of the most\nchallenging developments in drugs policy requiring a firmer EU\nresponse.
\nIMPACT ASSESSMENT: taking into account the results of\nimpact assessment, the following solutions are preferred: (i) a\nmore graduated and better targeted set of restriction measures on\nnew psychoactive substances, which should not hinder the industrial\nuse of substances; (ii) restriction measures should be introduced\nearlier; (iii) substances suspected to pose immediate public health\nrisks should be subjected to temporary restrictions; (iv)\nrestriction measures should be proportionate to a better determined\nlevel of risk of substances; (v) restriction measures should be\nintroduced through a quicker procedure.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union.
\nCONTENT: this proposed Regulation which is\nintended to replace Council Decision 2005/387/JHA\n- aims at ensuring that trade in new psychoactive substances\nhaving industrial and commercial uses is not hindered and\nthat the functioning of this market is improved, while the\nhealth and safety of individuals are protected from harmful\nsubstances, which cause concern at the EU level.
\nThe proposal is accompanied by a proposal for a Directive\namending Council Framework Decision 2004/757/JHA laying down\nminimum provisions on the constituent elements of criminal acts and\npenalties in the field of illicit drug trafficking.
\nThe main elements of the proposal are as\nfollows:
\nExchange of information and temporary consumer market\nrestrictions: this proposal sets up a\nrobust system: (i) for exchanging rapidly information on new\npsychoactive substances emerging on the market, including on their\ncommercial and industrial uses, for assessing the risks of\nsubstances that cause EU-wide concern and; (ii) for withdrawing\nfrom the market those substances that pose risks.
\nThe substances suspected to pose immediate public\nhealth risk will be withdrawn from the consumer market temporarily,\npending their risk assessment. Once the risk assessment is\ncompleted, measures will be taken proportionate to the risks of\nsubstances.
\nThe proposal establishes the respective roles of\nMember States, the EMCDDA and Europol in the process of exchange of\ninformation on new psychoactive substances.
\nLow and moderate risks:\naccording to the proposal, no restriction measures shall be\nintroduced on new psychoactive substances posing low health, social\nand safety risks and provides a definition of low risks.
\nFor substances posing moderate risks and permanent\nconsumer market restrictions, they cannot be sold to consumers\n(except for uses specifically authorised, for instance by medicines\nlegislation) but their trade is allowed for commercial and\nindustrial purposes as well as for scientific research and\ndevelopment.
\nSevere risks: the\nproposal empowers the Commission to prohibit the production,\nmanufacture, making available on the market, transport, importation\nor exportation of new psychoactive substances which pose severe\nhealth, social and safety risks, and provides a definition of\nsevere risks.
\nNew psychoactive substances posing severe risks will\nbe subjected to permanent market restriction, covering both\nthe consumer and commercial markets, and their use will only be\npossible for specifically authorised industrial and commercial\npurposes, as well as for scientific research and development. In\naddition, these substances will be subjected to EU criminal law\nprovisions.
\nSanctions: the proposal\nestablishes the obligation for the Member States to lay down the\nrules on administrative sanctions applicable to infringements to\nmarket restriction, and to ensure that they are effective,\nproportionate and dissuasive.
\nBUDGETARY IMPLICATION: the proposal has no direct\nimpact on the EU budget and does not create new tasks for the\nEMCDDA, Europol, the European Medicines Agencies, the European\nChemicals Agency (ECHA) and the European Food Safety Authority\n(EFSA).
\nPURPOSE: to approximate the rules relating to new\npsychoactive substances that are of concern at Union level whilst\nensuring a high level of health, safety and consumer\nprotection.
\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: new psychoactive substances, which may\nhave numerous commercial and industrial uses, as well as scientific\nuses, can pose health, social and safety risks when consumed\nby humans. Consumption of new psychoactive substances appears to be\nincreasing in Europe and use is predominant among young\npeople. According to the 2011 Eurobarometer \"Youth attitudes on\ndrugs\", 5% of young people in the EU have used such substances at\nleast once in their life, with a peak of 16% in Ireland, and close\nto 10% in Poland, Latvia and the UK.
\nDuring the past years, Member States have notified an\nincreasing number of new psychoactive substances to the European\nMonitoring Centre for Drugs and Drug Addiction (EMCDDA).\nNational restriction measures, which can vary depending on the\nMember State and on the substance, lead to obstacles to trade\nin licit uses, fragmentation, an uneven level playing field and\nlegal uncertainties for economic operators, and make it difficult\nfor companies to operate across the internal market. They make\nresearch more cumbersome, hampering the development of new uses for\nthese substances.
\nIn this context, the case\nfor swifter, more effective and more proportionate action on new\npsychoactive substances at EU level is compelling, considering the\nrapid changes in this market, which put national authorities under\npressure to act.
\nThe Commission Communication \"Towards a stronger European response to\ndrugs\", adopted in October 2011, identified the\nspread of new psychoactive substances as one of the most\nchallenging developments in drugs policy requiring a firmer EU\nresponse.
\nIMPACT ASSESSMENT: taking into account the results of\nimpact assessment, the following solutions are preferred: (i) a\nmore graduated and better targeted set of restriction measures on\nnew psychoactive substances, which should not hinder the industrial\nuse of substances; (ii) restriction measures should be introduced\nearlier; (iii) substances suspected to pose immediate public health\nrisks should be subjected to temporary restrictions; (iv)\nrestriction measures should be proportionate to a better determined\nlevel of risk of substances; (v) restriction measures should be\nintroduced through a quicker procedure.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union.
\nCONTENT: this proposed Regulation which is\nintended to replace Council Decision 2005/387/JHA\n- aims at ensuring that trade in new psychoactive substances\nhaving industrial and commercial uses is not hindered and\nthat the functioning of this market is improved, while the\nhealth and safety of individuals are protected from harmful\nsubstances, which cause concern at the EU level.
\nThe proposal is accompanied by a proposal for a Directive\namending Council Framework Decision 2004/757/JHA laying down\nminimum provisions on the constituent elements of criminal acts and\npenalties in the field of illicit drug trafficking.
\nThe main elements of the proposal are as\nfollows:
\nExchange of information and temporary consumer market\nrestrictions: this proposal sets up a\nrobust system: (i) for exchanging rapidly information on new\npsychoactive substances emerging on the market, including on their\ncommercial and industrial uses, for assessing the risks of\nsubstances that cause EU-wide concern and; (ii) for withdrawing\nfrom the market those substances that pose risks.
\nThe substances suspected to pose immediate public\nhealth risk will be withdrawn from the consumer market temporarily,\npending their risk assessment. Once the risk assessment is\ncompleted, measures will be taken proportionate to the risks of\nsubstances.
\nThe proposal establishes the respective roles of\nMember States, the EMCDDA and Europol in the process of exchange of\ninformation on new psychoactive substances.
\nLow and moderate risks:\naccording to the proposal, no restriction measures shall be\nintroduced on new psychoactive substances posing low health, social\nand safety risks and provides a definition of low risks.
\nFor substances posing moderate risks and permanent\nconsumer market restrictions, they cannot be sold to consumers\n(except for uses specifically authorised, for instance by medicines\nlegislation) but their trade is allowed for commercial and\nindustrial purposes as well as for scientific research and\ndevelopment.
\nSevere risks: the\nproposal empowers the Commission to prohibit the production,\nmanufacture, making available on the market, transport, importation\nor exportation of new psychoactive substances which pose severe\nhealth, social and safety risks, and provides a definition of\nsevere risks.
\nNew psychoactive substances posing severe risks will\nbe subjected to permanent market restriction, covering both\nthe consumer and commercial markets, and their use will only be\npossible for specifically authorised industrial and commercial\npurposes, as well as for scientific research and development. In\naddition, these substances will be subjected to EU criminal law\nprovisions.
\nSanctions: the proposal\nestablishes the obligation for the Member States to lay down the\nrules on administrative sanctions applicable to infringements to\nmarket restriction, and to ensure that they are effective,\nproportionate and dissuasive.
\nBUDGETARY IMPLICATION: the proposal has no direct\nimpact on the EU budget and does not create new tasks for the\nEMCDDA, Europol, the European Medicines Agencies, the European\nChemicals Agency (ECHA) and the European Food Safety Authority\n(EFSA).
\nThe European Parliament adopted by 507 votes 37 with\n33 abstentions, a legislative resolution on the proposal for a\nregulation of the European Parliament and of the Council on new\npsychoactive substances.
\nParliaments position in first reading following\nthe ordinary legislative procedure amended the Commission position\nas follows:
\nInformation exchange: to\nenable a more effective response to the rapid emergence and spread\nof new psychoactive substances across the Union, Parliament\nconsidered that the information exchange mechanism (the 'Early\nWarning System') should be maintained and further\ndeveloped, in particular as regards to the collection and\nmanagement of data on the detection and identification of new\npsychoactive substances.
\nThe European Monitoring Centre for Drugs and Drug\nAddiction (EMCDDA) should issue health alerts to all Member\nStates, through the system for rapid exchange of\ninformation on new psychoactive substances if, on the\nbasis of information received on a new psychoactive substances,\nthis seemed to cause public health concerns. Those health\nalerts should also contain information regarding prevention,\ntreatment and harm reduction measures that could be taken to\naddress the risk of the substance. Information should include\nconsumption and its patterns, serious intoxication\nor deaths, possible risks as well as the toxicity\nlevel, and data concerning manufacture.
\nRisk assessment: a risk\nassessment should be conducted if there were sufficient data\navailable at Union level to suggest the need for a joint report of\nthe European Monitoring Centre for Drugs and Drug Addiction\n(EMCDDA) and Europol.
\nImmediate risks to public health, and market\nrestrictions: the proposal provided that the Commission should, by\nmeans of a Decision, prohibit the making available on the market to\nconsumers of the new psychoactive substance if, based on existing\ninformation, it poses immediate risks to public health. The market\nrestriction should not exceed a period of twelve months.
\nMembers proposed that if the level of health, social\nand safety risks posed by the new psychoactive substance justified\nthe introduction of permanent restriction measures,\nthe duration of the temporary market restriction may\nbe extended by a further 12 months, in the\nabsence of permanent market restriction.
\nLow risks at Union level: the Commission should not adopt restriction measures\non a new psychoactive substance if, based on the\nexisting evidence and on prescribed criteria, it posed,\noverall, low health, social and safety risks at Union\nlevel.
\nHowever, where the decision to not adopt\nrestriction measures on a new psychoactive substance that was\nconsidered to pose overall low health, social and safety\nrisk at Union level was based on a partial or total lack\nof evidence, it should include an appropriate reference in the\njustification.
\nParliament also stressed that Members States\nshould not be prohibited from introducing or maintaining the more\nstringent measures regarding the specific risks the new\npsychoactive substance posed within their territory, independently\nof the classification of the substance by the Commission as posing\nlow or moderate risks on the EU level.
\nA Member State willing to introduce a more stringent\nmeasure concerning the new psychoactive should immediately\ncommunicate the relevant draft laws, regulations or administrative\nprovisions to the Commission and shall inform the other Member\nStates.
\nAuthorised use:\ndecisions prohibiting the marketing of new psychoactive\nsubstance presenting a serious risk should not impede the free\nmovement in the Union and the production, manufacture, making\navailable on the market of new psychoactive substances\nfor scientific research and development purposes, by duly\nauthorised persons in establishments which were directly under the\ncontrol of Member States' authorities or specifically approved by\nthem.
\nFor all of authorised uses, new psychoactive\nsubstances and products containing new psychoactive substances\nshould include directions for use, including cautions,\nwarnings and contraindications with other substances, to be either\nindicated on the label or included in the accompanying leaflet for\nthe safety of the user.
\nFurthermore, Member States should take any appropriate\nmeasures to prevent the diversion to the illicit\nmarket of new psychoactive substances used for research\nand development purposes or for any other authorised\nuses.
\nResearch, analysis, prevention and\nfunding: the amended text provided\nthat financial support and the necessary resources should\nbe provided at Union and national level for the development,\nsharing and dissemination of information and knowledge on new\npsychoactive substances.
\nMoreover, the Commission and the Member States should\npromote the research into new psychoactive substances and ensure\ncooperation and coordination between networks at national and\nUnion level in order to strengthen understanding of the\nphenomenon.
\nPrevention schemes as well as measures to raise\nawareness of the risks posed by psychoactive substances, such\nas educational information campaigns should be\npromoted.
\nEvaluation: the\nEMCDDA and Europol should report annually to the European\nParliament, the Commission and Member States on the\nimplementation of the Regulation. Five years after the entry\ninto force of the Regulation and every five years thereafter, the\nCommission should:
\n\n· \nassess the implementation, application and\neffectiveness of this Regulation and publish a report. In this\nrespect, the Commission, the EMCDDA and Europol should conduct\npost-risk assessments of new psychoactive substances;
\n\n· \nevaluate and if appropriate present a proposal\nfor possible classification of groups of the new psychoactive\nsubstances in order to counteract the practise of bypassing the\nlegislation in force by slight modifications of the chemical\nstructure of the psychoactive substances.
\nThe implementation reports should be published on a\nwebsite and made publicly available.
\nPURPOSE: to approximate the rules relating to new\npsychoactive substances that are of concern at Union level whilst\nensuring a high level of health, safety and consumer\nprotection.
\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: new psychoactive substances, which may\nhave numerous commercial and industrial uses, as well as scientific\nuses, can pose health, social and safety risks when consumed\nby humans. Consumption of new psychoactive substances appears to be\nincreasing in Europe and use is predominant among young\npeople. According to the 2011 Eurobarometer \"Youth attitudes on\ndrugs\", 5% of young people in the EU have used such substances at\nleast once in their life, with a peak of 16% in Ireland, and close\nto 10% in Poland, Latvia and the UK.
\nDuring the past years, Member States have notified an\nincreasing number of new psychoactive substances to the European\nMonitoring Centre for Drugs and Drug Addiction (EMCDDA).\nNational restriction measures, which can vary depending on the\nMember State and on the substance, lead to obstacles to trade\nin licit uses, fragmentation, an uneven level playing field and\nlegal uncertainties for economic operators, and make it difficult\nfor companies to operate across the internal market. They make\nresearch more cumbersome, hampering the development of new uses for\nthese substances.
\nIn this context, the case\nfor swifter, more effective and more proportionate action on new\npsychoactive substances at EU level is compelling, considering the\nrapid changes in this market, which put national authorities under\npressure to act.
\nThe Commission Communication \"Towards a stronger European response to\ndrugs\", adopted in October 2011, identified the\nspread of new psychoactive substances as one of the most\nchallenging developments in drugs policy requiring a firmer EU\nresponse.
\nIMPACT ASSESSMENT: taking into account the results of\nimpact assessment, the following solutions are preferred: (i) a\nmore graduated and better targeted set of restriction measures on\nnew psychoactive substances, which should not hinder the industrial\nuse of substances; (ii) restriction measures should be introduced\nearlier; (iii) substances suspected to pose immediate public health\nrisks should be subjected to temporary restrictions; (iv)\nrestriction measures should be proportionate to a better determined\nlevel of risk of substances; (v) restriction measures should be\nintroduced through a quicker procedure.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union.
\nCONTENT: this proposed Regulation which is\nintended to replace Council Decision 2005/387/JHA\n- aims at ensuring that trade in new psychoactive substances\nhaving industrial and commercial uses is not hindered and\nthat the functioning of this market is improved, while the\nhealth and safety of individuals are protected from harmful\nsubstances, which cause concern at the EU level.
\nThe proposal is accompanied by a proposal for a Directive\namending Council Framework Decision 2004/757/JHA laying down\nminimum provisions on the constituent elements of criminal acts and\npenalties in the field of illicit drug trafficking.
\nThe main elements of the proposal are as\nfollows:
\nExchange of information and temporary consumer market\nrestrictions: this proposal sets up a\nrobust system: (i) for exchanging rapidly information on new\npsychoactive substances emerging on the market, including on their\ncommercial and industrial uses, for assessing the risks of\nsubstances that cause EU-wide concern and; (ii) for withdrawing\nfrom the market those substances that pose risks.
\nThe substances suspected to pose immediate public\nhealth risk will be withdrawn from the consumer market temporarily,\npending their risk assessment. Once the risk assessment is\ncompleted, measures will be taken proportionate to the risks of\nsubstances.
\nThe proposal establishes the respective roles of\nMember States, the EMCDDA and Europol in the process of exchange of\ninformation on new psychoactive substances.
\nLow and moderate risks:\naccording to the proposal, no restriction measures shall be\nintroduced on new psychoactive substances posing low health, social\nand safety risks and provides a definition of low risks.
\nFor substances posing moderate risks and permanent\nconsumer market restrictions, they cannot be sold to consumers\n(except for uses specifically authorised, for instance by medicines\nlegislation) but their trade is allowed for commercial and\nindustrial purposes as well as for scientific research and\ndevelopment.
\nSevere risks: the\nproposal empowers the Commission to prohibit the production,\nmanufacture, making available on the market, transport, importation\nor exportation of new psychoactive substances which pose severe\nhealth, social and safety risks, and provides a definition of\nsevere risks.
\nNew psychoactive substances posing severe risks will\nbe subjected to permanent market restriction, covering both\nthe consumer and commercial markets, and their use will only be\npossible for specifically authorised industrial and commercial\npurposes, as well as for scientific research and development. In\naddition, these substances will be subjected to EU criminal law\nprovisions.
\nSanctions: the proposal\nestablishes the obligation for the Member States to lay down the\nrules on administrative sanctions applicable to infringements to\nmarket restriction, and to ensure that they are effective,\nproportionate and dissuasive.
\nBUDGETARY IMPLICATION: the proposal has no direct\nimpact on the EU budget and does not create new tasks for the\nEMCDDA, Europol, the European Medicines Agencies, the European\nChemicals Agency (ECHA) and the European Food Safety Authority\n(EFSA).
\nThe Committee on Civil Liberties, Justice and Home\nAffairs adopted the report by Jacek PROTASIEWICZ (EPP, PL) on the\nproposal for a regulation of the European Parliament and of the\nCouncil on new psychoactive substances.
\nThe committee recommended that Parliaments\nposition in first reading following the ordinary legislative\nprocedure should amend the Commission position as\nfollows:
\nInformation exchange: to\nenable a more effective response to the rapid emergence and spread\nof new psychoactive substances across the Union, Members\nconsidered that the information exchange mechanism (the 'Early\nWarning System') should be maintained and further\ndeveloped, in particular as regards to the collection and\nmanagement of data on the detection and identification of new\npsychoactive substances.
\nThe European Monitoring Centre for Drugs and Drug\nAddiction (EMCDDA) should issue health alerts to all Member\nStates, through the system for rapid exchange of information on\nnew psychoactive substances if, on the basis of information\nreceived on a new psychoactive substances, this seemed to cause\npublic health concerns. Those health alerts should also\ncontain information regarding prevention, treatment and harm\nreduction measures that could be taken to address the risk of the\nsubstance.
\nImmediate risks to public health, and market\nrestrictions: the proposal provided\nthat the Commission should, by means of a Decision, prohibit the\nmaking available on the market to consumers of the new psychoactive\nsubstance if, based on existing information, it poses immediate\nrisks to public health. The market restriction should not exceed a\nperiod of twelve months.
\nMembers proposed that if the level of health, social\nand safety risks posed by the new psychoactive substance justified\nthe introduction of permanent restriction measures, the duration\nof the temporary market restriction may be extended by a\nfurther 12 months, in the absence of permanent market\nrestriction.
\nLow risks at Union level: the Commission should not adopt restriction measures\non a new psychoactive substance if, based on the existing\nevidence and on prescribed criteria, it posed, overall,\nlow health, social and safety risks at Union level.
\nHowever, where the decision to not adopt\nrestriction measures on a new psychoactive substance that was\nconsidered to pose overall low health, social and safety\nrisk at Union level was based on a partial or total lack\nof evidence, it should include an appropriate reference in the\njustification.
\nThe report also stressed that Members States should\nnot be prohibited from introducing or maintaining the more\nstringent measures regarding the specific risks the new\npsychoactive substance posed within their territory, independently\nof the classification of the substance by the Commission as posing\nlow or moderate risks on the EU level. The relevant laws,\nregulations or administrative provisions should be communicated to\nthe Commission and the other Member States should be\ninformed.
\nAuthorised use:\ndecisions prohibiting the marketing of new psychoactive\nsubstance presenting a serious risk should not impede the free\nmovement in the Union and the production, manufacture, making\navailable on the market of new psychoactive substances for\nscientific research and development purposes, by duly\nauthorised persons in establishments which were directly under the\ncontrol of Member States' authorities or specifically approved by\nthem.
\nFor all of authorised uses, new psychoactive\nsubstances and products containing new psychoactive substances\nshould include directions for use, including cautions,\nwarnings and contraindications with other substances, to be either\nindicated on the label or included in the accompanying leaflet for\nthe safety of the user.
\nFurthermore, Member States should take any appropriate\nmeasures to prevent the diversion to the illicit market of\nnew psychoactive substances used for research and development\npurposes or for any other authorised uses.
\nResearch, analysis, prevention and\nfunding: the amended text provided\nthat financial support and the necessary resources should\nbe provided at Union and national level for the development,\nsharing and dissemination of information and knowledge on new\npsychoactive substances.
\nMoreover, the Commission and the Member States should\npromote the research into new psychoactive substances and ensure\ncooperation and coordination between networks at national and\nUnion level in order to strengthen understanding of the\nphenomenon.
\nPrevention schemes as well as measures to raise\nawareness of the risks posed by psychoactive substances, such as\neducational information campaigns should be\npromoted.
\nEvaluation: five years\nafter the entry into force of the Regulation and every five years\nthereafter, the Commission should:
\nThe European Parliament adopted by 507 votes 37 with\n33 abstentions, a legislative resolution on the proposal for a\nregulation of the European Parliament and of the Council on new\npsychoactive substances.
\nParliaments position in first reading following\nthe ordinary legislative procedure amended the Commission position\nas follows:
\nInformation exchange: to\nenable a more effective response to the rapid emergence and spread\nof new psychoactive substances across the Union, Parliament\nconsidered that the information exchange mechanism (the 'Early\nWarning System') should be maintained and further\ndeveloped, in particular as regards to the collection and\nmanagement of data on the detection and identification of new\npsychoactive substances.
\nThe European Monitoring Centre for Drugs and Drug\nAddiction (EMCDDA) should issue health alerts to all Member\nStates, through the system for rapid exchange of\ninformation on new psychoactive substances if, on the\nbasis of information received on a new psychoactive substances,\nthis seemed to cause public health concerns. Those health\nalerts should also contain information regarding prevention,\ntreatment and harm reduction measures that could be taken to\naddress the risk of the substance. Information should include\nconsumption and its patterns, serious intoxication\nor deaths, possible risks as well as the toxicity\nlevel, and data concerning manufacture.
\nRisk assessment: a risk\nassessment should be conducted if there were sufficient data\navailable at Union level to suggest the need for a joint report of\nthe European Monitoring Centre for Drugs and Drug Addiction\n(EMCDDA) and Europol.
\nImmediate risks to public health, and market\nrestrictions: the proposal provided that the Commission should, by\nmeans of a Decision, prohibit the making available on the market to\nconsumers of the new psychoactive substance if, based on existing\ninformation, it poses immediate risks to public health. The market\nrestriction should not exceed a period of twelve months.
\nMembers proposed that if the level of health, social\nand safety risks posed by the new psychoactive substance justified\nthe introduction of permanent restriction measures,\nthe duration of the temporary market restriction may\nbe extended by a further 12 months, in the\nabsence of permanent market restriction.
\nLow risks at Union level: the Commission should not adopt restriction measures\non a new psychoactive substance if, based on the\nexisting evidence and on prescribed criteria, it posed,\noverall, low health, social and safety risks at Union\nlevel.
\nHowever, where the decision to not adopt\nrestriction measures on a new psychoactive substance that was\nconsidered to pose overall low health, social and safety\nrisk at Union level was based on a partial or total lack\nof evidence, it should include an appropriate reference in the\njustification.
\nParliament also stressed that Members States\nshould not be prohibited from introducing or maintaining the more\nstringent measures regarding the specific risks the new\npsychoactive substance posed within their territory, independently\nof the classification of the substance by the Commission as posing\nlow or moderate risks on the EU level.
\nA Member State willing to introduce a more stringent\nmeasure concerning the new psychoactive should immediately\ncommunicate the relevant draft laws, regulations or administrative\nprovisions to the Commission and shall inform the other Member\nStates.
\nAuthorised use:\ndecisions prohibiting the marketing of new psychoactive\nsubstance presenting a serious risk should not impede the free\nmovement in the Union and the production, manufacture, making\navailable on the market of new psychoactive substances\nfor scientific research and development purposes, by duly\nauthorised persons in establishments which were directly under the\ncontrol of Member States' authorities or specifically approved by\nthem.
\nFor all of authorised uses, new psychoactive\nsubstances and products containing new psychoactive substances\nshould include directions for use, including cautions,\nwarnings and contraindications with other substances, to be either\nindicated on the label or included in the accompanying leaflet for\nthe safety of the user.
\nFurthermore, Member States should take any appropriate\nmeasures to prevent the diversion to the illicit\nmarket of new psychoactive substances used for research\nand development purposes or for any other authorised\nuses.
\nResearch, analysis, prevention and\nfunding: the amended text provided\nthat financial support and the necessary resources should\nbe provided at Union and national level for the development,\nsharing and dissemination of information and knowledge on new\npsychoactive substances.
\nMoreover, the Commission and the Member States should\npromote the research into new psychoactive substances and ensure\ncooperation and coordination between networks at national and\nUnion level in order to strengthen understanding of the\nphenomenon.
\nPrevention schemes as well as measures to raise\nawareness of the risks posed by psychoactive substances, such\nas educational information campaigns should be\npromoted.
\nEvaluation: the\nEMCDDA and Europol should report annually to the European\nParliament, the Commission and Member States on the\nimplementation of the Regulation. Five years after the entry\ninto force of the Regulation and every five years thereafter, the\nCommission should:
\n\n· \nassess the implementation, application and\neffectiveness of this Regulation and publish a report. In this\nrespect, the Commission, the EMCDDA and Europol should conduct\npost-risk assessments of new psychoactive substances;
\n\n· \nevaluate and if appropriate present a proposal\nfor possible classification of groups of the new psychoactive\nsubstances in order to counteract the practise of bypassing the\nlegislation in force by slight modifications of the chemical\nstructure of the psychoactive substances.
\nThe implementation reports should be published on a\nwebsite and made publicly available.
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