{"change_dates":[],"dossier":{"amendments":[{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-22","location":[["Proposal for a regulation","Recital 10"]],"meps":[28514],"meta":{"created":"2019-07-03T05:51:56"},"new":["deleted"],"old":["(10) A European database on drug","precursors should be created to simplify","the reporting by Member States with","regard to seizures and stopped shipments,","to create a European register of operators","and users holding a license or a","registration which will facilitate","verification of the legitimacy of","commercial transactions involving","scheduled substances, and to enable","operators to provide the competent","authorities with information about their","legal transactions involving scheduled","substances."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"22","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sophia in 't Veld","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-23","location":[["Proposal for a regulation","Recital 10"]],"meps":[28266],"meta":{"created":"2019-07-03T05:51:56"},"new":["(10) A European database on drug","precursors should be created to simplify","the reporting by Member States with","regard to seizures and stopped shipments,","in the least intrusive way as regards the","processing of personal data, taking into","account the principle of data limitation","and the state of the art of privacy","enhancing technologies, to create a","European register of operators and users","holding a license or a registration which","will facilitate verification of the legitimacy","of commercial transactions involving","scheduled substances, and to enable","operators to provide the competent","authorities with information about their","legal transactions involving scheduled","substances."],"old":["(10) A European database on drug","precursors should be created to simplify","the reporting by Member States with","regard to seizures and stopped shipments,","to create a European register of operators","and users holding a license or a registration","which will facilitate verification of the","legitimacy of commercial transactions","involving scheduled substances, and to","enable operators to provide the competent","authorities with information about their","","legal transactions involving scheduled","substances."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"23","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Hedh","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-24","justification":"This amendment is a correction of AM 2 of the draft report, linked to the change proposed in\nArt 13b. It is important to specify more in detail the essential elements of the data processing\noperations that are included in this Regulation. While most data processing will apply to\ncompanies or legal persons, in many cases natural persons will be also identifiable. This\namendment takes into account recommendations made by the EDPS.","location":[[" Proposal for a regulation","Recital 11"]],"meps":[28131],"meta":{"created":"2019-07-03T05:51:56"},"new":["(11) Regulation (EC) No 273/2004","envisages the processing of information,","including the processing of personal data,","for the purposes of enabling the","competent authorities to monitor the","placing on the market of drug precursors","and preventing the diversion of scheduled","substances.","The processing of personal data should be","carried out in accordance with Union law","on data protection and, in particular, with","requirements relating to data quality,","proportionality, purpose limitation, and","with rights to information, access,","rectification of data, erasure and blocking,","organisational and technical measures","and international transfers of personal","data. Data should be adequate, accurate,","relevant and not excessive in relation to","the purpose for which it is collected. It","should not be processed for longer than","necessary in relation to the purpose for","which it is collected and its accuracy","should be regularly reviewed. Processing","of data should be carried out under the","supervision of the Member States'","competent authorities, in particular the","public independent authorities designated","by the Member States, as regards","processing of personal data carried out in","the Member States. It should also be","carried out under the supervision of the","European Data Protection Supervisor, as","regards the processing of personal data","carried out by the Commission within the","framework of this Regulation.","In order to enable law enforcement","authorities to detect, prevent, investigate","or prosecute drug trafficking criminal","offences, Member States may be allowed","to adopt legislative measures to grant","their competent authorities access to","personal data processed pursuant to this","Regulation for the above mentioned","purposes and in so far it is necessary,","proportionate and subject to adequate","safeguards. Since this processing","constitutes a restriction to the","fundamental right to the protection of","personal data, it should be interpreted","restrictively and in compliance with the","requirements set out by the Charter of","Fundamental Rights of the European","Union and by the European Convention","of Human Rights. This processing should","only take place on a case-by-case basis","and provided that the competent law","enforcement authorities have reasonable","grounds to believe that this processing","will substantially assist them in","preventing, detecting, or investigating","drug trafficking criminal offences."],"old":["(11) Regulation (EC) No 273/2004","envisages the processing of data. Such","processing of data may also cover personal","data which should be carried out in","accordance with Union Law.","",""],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"24","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-25","location":[[" Proposal for a regulation","Recital 15"]],"meps":[28514],"meta":{"created":"2019-07-03T05:51:57"},"new":["(15) In order to achieve the objectives of","Regulation (EC) No 273/2004, the power","to adopt acts in accordance with Article","290 of the Treaty on the Functioning of the","European Union should be delegated to the","Commission to specify the requirements","and conditions for the granting of the","licence and registration, for obtaining and","using customer declarations, for the","documentation and labelling of mixtures,","for provision of information by the","operators on transactions involving","scheduled substances and in order to","amend the Annexes. It is of particular","importance that the Commission carry out","appropriate consultations during its","preparatory work, including at expert level."],"old":["(15) In order to achieve the objectives of","Regulation (EC) No 273/2004, the power","to adopt acts in accordance with Article","290 of the Treaty on the Functioning of the","European Union should be delegated to the","Commission to specify the requirements","and conditions for the granting of the","licence and registration, for obtaining and","using customer declarations, for the","documentation and labelling of mixtures,","for provision of information by the","operators on transactions involving","scheduled substances, for listing operators","and users having obtained a licence or","registration in the European register and","in order to amend the Annexes. It is of","particular importance that the Commission","carry out appropriate consultations during","its preparatory work, including at expert","level."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"25","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-26","location":[[" Proposal for a regulation","Recital 18"]],"meps":[28514],"meta":{"created":"2019-07-03T05:51:57"},"new":["(18) The examination procedure should be","used for the adoption of the implementing","acts in order to set up details on how","customer declarations should be provided","in electronic form."],"old":["(18) The examination procedure should be","used for the adoption of the implementing","acts in order to set up details on how","customer declarations should be provided","in electronic form; to set up details on how","to provide the information about","transactions of operators with scheduled","","substances to a European database."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"26","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-27","justification":"From the opinion of the European Economic and Social Committee.","location":[["Proposal for a regulation","Article 1 \u2013 point 1 \u2013 point b"],["Regulation (EC) No 273/2004","Article 2 \u2013 point h"]],"meps":[2307],"meta":{"created":"2019-07-03T05:51:57"},"new":["(h) 'user' means any natural or legal person","who is not an operator and who possesses","a scheduled substance and is engaged in","the processing, formulation, consumption,","storage, keeping, treatment, filling into","containers, transfer from one container to","another, mixing, transformation or any","other utilisation of scheduled substances."],"old":["(h) 'user' means any natural or legal person","who possesses a scheduled substance and","is engaged in the processing, formulation,","consumption, storage, keeping, treatment,","filling into containers, transfer from one","container to another, mixing,","transformation or any other utilisation of","scheduled substances."],"orig_lang":"de","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"27","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-28","location":[["Proposal for a regulation","Article 1 \u2013 point 2 \u2013 point f"],["Regulation (EC) N) 273/2004","Article 3 \u2013 paragraph 8"]],"meps":[28514],"meta":{"created":"2019-07-03T05:51:57"},"new":["deleted"],"old":["8. The competent authorities shall enter","operators and users having obtained a","licence referred to in paragraph 2 or a","registration referred to in paragraph 6 in","","","a European Database on drug precursors","to be developed by the Commission as","provided for in Article 13a."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"28","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Sophia in 't Veld","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-29","location":[[" Proposal for a regulation","Article 1 \u2013 point 2 \u2013 point f"],[" Regulation No 273/2004","Article 3 \u2013 paragraph 9"]],"meps":[28266],"meta":{"created":"2019-07-03T05:51:57"},"new":["9. The Commission shall, after the","consultation of the EDPS, be empowered","to adopt delegated acts in accordance with","Article 15a concerning:"],"old":["9. The Commission shall be empowered to","adopt delegated acts in accordance with","Article 15a concerning:"],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"29","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Hedh","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-30","justification":"This amendment is a technical correction of AM 6 of the draft report.","location":[[" Proposal for a regulation","Article 1 \u2013 point 2 \u2013 point f"],[" Regulation (EC) No 273/2004","Article 3 \u2013 paragraph 9"]],"meps":[28131],"meta":{"created":"2019-07-03T05:51:57"},"new":["9. The Commission shall be empowered to","adopt delegated acts in accordance with","Article 15a concerning:","(a) the requirements and conditions for the","granting of the licence referred to in","paragraph 2, and the categories of data,","including of personal data, to be provided;","(b) the requirements and conditions for the","granting of the registration referred to in","paragraph 6 and the categories of data,","including of personal data, to be provided;","and","(c) the requirements and conditions for","listing operators and users having obtained","a licence or registration in a European","Database on drug precursors referred to in","paragraph 8.","(ca) The categories of personal data","referred to in points (a) and (b) of the first","subparagraph shall not include sensitive","data within the meaning of Article 8(1) of","Directive 95/46/EC."],"old":["9. The Commission shall be empowered to","adopt delegated acts in accordance with","Article 15a concerning:","(a) the requirements and conditions for the","granting of the licence referred to in","paragraph 2;","(b) the requirements and conditions for the","granting of the registration referred to in","paragraph 6.","","(c) the requirements and conditions for","listing operators and users having obtained","a licence or registration in a European","Database on drug precursors referred to in","paragraph 8."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"30","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-31","location":[["Proposal for a regulation","Article 1 \u2013 point 2 \u2013 point f"],["Regulation (EC) No 273/2004","Article 3 \u2013 paragraph 9 \u2013 point c"]],"meps":[28514],"meta":{"created":"2019-07-03T05:51:57"},"new":["deleted"],"old":["(c) the requirements and conditions for","listing operators and users having","obtained a licence or registration in a","European Database on drug precursors","referred to in paragraph 8."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"31","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sophia in 't Veld","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-32","justification":" The UN convention on which this obligation is based requires the documentation to be\n retained for a period of only two years. No clear reason is established for retaining all\n documentation in the EU for at least three or two years.","location":[["Proposal for a regulation","Article 1 \u2013 point 3 a (new) "]],"meps":[28266],"meta":{"created":"2019-07-03T05:51:57"},"new":["(3a) In article 5, paragraph 5 is replaced","by the following:","\"5. The documentation and records","referred to in paragraphs 1 to 4 shall be","kept for two years from the end of the","calendar year in which the transaction","referred to in paragraph 1 took place, and","must be readily available for inspection by","the competent authorities upon request\""],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"32","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Zbigniew Ziobro","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-33","location":[[" Proposal for a regulation","Article 1 \u2013 point 6"],[" Regulation No 273/2004","Article 8\u2013 paragraph 1"]],"meps":[96803],"meta":{"created":"2019-07-03T05:51:57"},"new":["Operators shall notify the competent","authorities immediately of any transactions","involving scheduled substances to be","placed on the market, which suggest that","such substances might be diverted for the","illicit manufacture of narcotic drugs or","psychotropic substances. To this end,","operators shall provide any available","information allowing the competent","authorities to verify the legitimacy of the","relevant order or transaction."],"old":["Operators shall notify the competent","authorities immediately of any","circumstances, such as unusual orders or","transactions involving scheduled","substances to be placed on the market,","which suggest that such substances might","be diverted for the illicit manufacture of","narcotic drugs or psychotropic substances.","To this end, operators shall provide any","available information allowing the","competent authorities to verify the","legitimacy of the relevant order or","","transaction."],"orig_lang":"pl","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"33","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sophia in 't Veld","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-34","location":[["Proposal for a regulation","Article 1 \u2013 point 6"],["Regulation No 273/2004","Article 8 \u2013 paragraph 3"]],"meps":[28266],"meta":{"created":"2019-07-03T05:51:57"},"new":["3. The Commission shall, after","consultation of the EDPS, be empowered","to adopt delegated acts in accordance with","Article 15a concerning the requirements","and conditions for operators to provide","information as referred to in paragraph 2."],"old":["3. The Commission shall be empowered to","adopt delegated acts in accordance with","Article 15a concerning the requirements","and conditions for operators to provide","information as referred to in paragraph 2."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"34","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sophia in 't Veld","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-35","justification":"\"pursuant to this Regulation\" rather than \"pursuant to this Article\"","location":[["Proposal for a regulation","Article 1 \u2013 point 6"],["Regulation No 273/2004","Article 8 \u2013 paragraph 3a (new)"]],"meps":[28266],"meta":{"created":"2019-07-03T05:51:57"},"new":["(3a) Operators shall not disclose personal","data processed pursuant to this","Regulation to recipients other than the","competent authorities."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"35","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-36","location":[[" Proposal for a regulation","Article 1 \u2013 point 9"],[" Regulation No 273/2004","Article 13a"]],"meps":[28514],"meta":{"created":"2019-07-03T05:51:57"},"new":["deleted"],"old":["(9) The following Article 13a is inserted:","\"Article 13a","Database","The Commission shall develop a","European Database on drug precursors","with the following functions:","(a) facilitating the communication of","information pursuant to Article 13(1), its","synthesis and analysis on the level of the","Union, and the reporting to the","International Narcotics Control Board","pursuant to Article 13(2);","(b) creating a European register of","operators and users, which have been","granted a licence pursuant to Article 3(2)","or registration pursuant to Article 3(6);","(c) enabling operators to provide the","competent authorities with information","about their transactions according to","Article 8(2) in electronic form, as","specified in implementing measures","adopted pursuant to Article 14.\""],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"36","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-37","location":[[" Proposal for a regulation","Article 1 \u2013 point 9 "]],"meps":[2307],"meta":{"created":"2019-07-03T05:51:57"},"new":["In accordance with the delegated acts","referred to in Article 3(9), the Commission","shall establish a European Database on","drug precursors with the following","functions:"],"old":["The Commission shall develop a European","Database on drug precursors with the","following functions:"],"orig_lang":"de","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"37","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Hedh","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-38","justification":" This amendment is a technical correction of AM 14 of the draft report.","location":[["Proposal for a regulation","Article 1 \u2013 point 9"],["Regulation (EC) No 273/2004","Article 13a \u2013 paragraphs 1b, 1c and 1d (new)"]],"meps":[28131],"meta":{"created":"2019-07-03T05:51:57"},"new":["1b. Information obtained pursuant to this","Regulation, including personal data, shall","be used in accordance with the applicable","legislation on personal data protection","and shall not be retained for longer than","necessary for its purpose. Processing of","the special categories of data referred to","in Article 8(1) of Directive 95/46/EC and","in Article 10(1) of Regulation (EC) No","45/2001 shall be prohibited.","Interconnection or correlation of personal","data contained in the European Database","with other databases for different","purposes shall be prohibited.","1c. A data subject shall be provided with","information concerning the purposes of","the processing and retention of data, the","categories of data processed and retained,","the identity of the controller of the data,","the identity of the recipients of the data,","information regarding the right of access,","rectification or erasure of the data","subject's personal data, the administrative","and judicial remedies available and the","contact details of the supervisory","authority referred to in Article 13b(1).","1d. The Commission shall make publicly","available a comprehensive privacy notice","concerning the European Database in","accordance with Articles 10 and 11 of","Regulation (EC) No 45/2201, in a clear","and understandable manner."],"old":[""],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"38","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-39","location":[[" Proposal for a regulation","Article 1 \u2013 point 9"],[" Regulation (EC) No 273/2004","Article 13\u0430 \u2013 paragraph 1 a (new)"]],"meps":[2307],"meta":{"created":"2019-07-03T05:51:57"},"new":["The information collected pursuant to this","Regulation may be used only for the","purposes of combating the illegal trade in","drugs and drug precursors and related","criminal activities and may not be","retained for any longer than is necessary","for those purposes. Processing of the","special categories of data referred to in","Article 8(1) of Directive 95/46/EC and in","Article 10(1) of Regulation (EC) No","45/2001 shall be prohibited."],"orig_lang":"de","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"39","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-40","location":[["Proposal for a regulation","Article 1 \u2013 point 9"],["Regulation (EC) No 273/2004","Article 13\u0430 \u2013 paragraph 1 b (new)"]],"meps":[2307],"meta":{"created":"2019-07-03T05:51:57"},"new":["A data subject shall be provided with","information concerning the purposes of","the processing and retention of data, the","categories of data processed and retained,","the identity of the controller of the data,","the identity of the recipients of the data,","information regarding the right of access","to and rectification or erasure of personal","data, the administrative and judicial","remedies available and the contact details","of the supervisory authority referred to in","Article 13b(1).","Some or all of this information may be","withheld if it would compromise","administrative or judicial investigations or","procedures, hamper the prevention,","investigation, detection or prosecution of","criminal offences or jeopardise public","safety or national security."],"orig_lang":"de","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"40","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Hedh","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-41","justification":" This amendment is a correction of AM 8 of the draft report. In order to ensure adequate data\n protection it is important to establish the purpose for which personal data under this\n Regulation will be processed (purpose limitation). At the same time, the possibility currently\n available under the Data Protection Directive for national competent authorities to use - in\n duly justified and under national data protection rules - the data provided for the prevention,\n investigation or prosecution of criminal offences (to discover and dismantle drug trafficking\n networks) should be preserved.","location":[["Proposal for a regulation","Article 1 \u2013 point 10"],["Regulation (EC) No 273/2004","Article 13b \u2013 paragraph 1a (new)"]],"meps":[28131],"meta":{"created":"2019-07-03T05:51:57"},"new":["1a. Without prejudice to Article 13 of","Directive 95/46/EC, personal data","obtained or processed pursuant to this","Regulation shall solely be used for the","purpose of preventing the diversion of","scheduled substances."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"41","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-42","location":[[" Proposal for a regulation","Article 1 \u2013 point 10"],[" Regulation (EC) No 273/2004","Article 13b \u2013paragraph 2"]],"meps":[28514],"meta":{"created":"2019-07-03T05:51:58"},"new":["deleted"],"old":["2. The processing of personal data by the","Commission, including for the purpose of","the European Database provided for in","Article 13a, shall be carried out in","accordance with Regulation (EC) No","45/2001 of the European Parliament and","of the Council and under the supervision","of the European Data Protection","Supervisor."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"42","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Sophia in 't Veld","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-43","location":[[" Proposal for a regulation","Article 1 \u2013 point 10 a (new)"],[" Regulation (EC) No 273/2004","Article 13 c (new)"]],"meps":[28266],"meta":{"created":"2019-07-03T05:51:58"},"new":["(10a) The following Article 13c is","inserted:","\"Article 13c","Delegated acts","The Commission shall, after consultation","of the EDPS, be empowered to adopt","delegated acts in accordance with Article","15a in respect of the categories of","personal data to be processed for the","European Database, the procedures by","which data subjects can exercise their","rights to access, rectify, erase and, where","appropriate, object and block data.\""],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"43","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Kyriacos Triantaphyllides","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-44","location":[["Proposal for a regulation","Article 1 \u2013 point 11"],["Regulation (EC) No 273/2004","Article 14 \u2013 paragraph 1 \u2013 point b"]],"meps":[28514],"meta":{"created":"2019-07-03T05:51:58"},"new":["deleted"],"old":["(b) rules on how to provide the","information referred to in Article 8(2) in","electronic form to a European database,","where appropriate."],"orig_lang":"en","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"44","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Hubert Pirker","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-45","location":[["Proposal for a regulation","Article 1 \u2013 point 12"],["Regulation (EC) No 273/2004","Article 16 \u2013 paragraph 3"]],"meps":[2307],"meta":{"created":"2019-07-03T05:51:58"},"new":["(3) The Commission shall evaluate the","implementation and functioning of this","Regulation by [60 months after of the date","of entry into force of this amending","Regulation].\""],"old":["(3) The Commission shall evaluate the","implementation and functioning of this","Regulation by [78 months after of the date","of entry into force of this amending","Regulation].\""],"orig_lang":"de","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"45","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jean-Pierre Audy","changes":{},"committee":["LIBE"],"date":"2013-03-04T00:00:00","id":"PE506.184-46","location":[[" Proposal for a regulation","Article 2"]],"meps":[33775],"meta":{"created":"2019-07-03T05:51:58"},"new":["This Regulation shall enter into force on","the twentieth day following that of its","publication in the Official Journal of the","European Union. 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This Regulation shall be","binding in its entirety and directly","applicable in all Member States."],"orig_lang":"fr","peid":"PE506.184v01-00","reference":"2012/0261(COD)","seq":"46","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.184+01+DOC+PDF+V0//EN&language=EN"}],"changes":{"2012-10-08T23:59:38":[{"data":[{"body":"EP","date":"2012-09-27T00:00:00","type":"EP officialisation"},{"body":"EC","commission":[{"Commissioner":"TAJANI Antonio","DG":{"title":"Enterprise and Industry","url":"http://ec.europa.eu/enterprise/"}}],"date":"2012-09-27T00:00:00","docs":[{"celexid":"CELEX:52012PC0548:EN","title":"COM(2012)0548","type":"Legislative proposal published","url":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=548"},{"title":"SWD(2012)0278","type":"Document attached to the procedure","url":"http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0278:FIN:EN:PDF"},{"title":"SWD(2012)0279","type":"Document attached to the procedure","url":"http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0279:FIN:EN:PDF"}],"type":"Legislative proposal"}],"path":["activities"],"type":"added"},{"data":[{"body":"EC","commissioner":"TAJANI Antonio","dg":{"title":"Enterprise and Industry","url":"http://ec.europa.eu/enterprise/"}}],"path":["other"],"type":"added"},{"data":[{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Food Safety","responsible":false},{"body":"EP","committee":"IMCO","committee_full":"Internal Market and Consumer Protection","responsible":false},{"body":"EP","committee":"INTA","committee_full":"International Trade","responsible":false},{"body":"EP","committee":"LIBE","committee_full":"Civil Liberties, Justice and Home Affairs","responsible":true}],"path":["committees"],"type":"added"},{"data":{"European Commission":{"title":"PreLex","url":"http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2012&DocNum=0261"},"National parliaments":{"title":"IPEX","url":"http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2012&number=0261&appLng=EN"}},"path":["links"],"type":"added"},{"data":{"instrument":"Regulation","legal_basis":["Treaty on the Functioning of the EU TFEU 114-p1"],"reference":"2012/0261(COD)","stage_reached":"Preparatory phase in Parliament","subject":["2.10.01 Customs Union, tax and duty-free, Community transit","2.80 Cooperation between administrations","4.20.04 Pharmaceutical products and industry","6.40.13 Relations with international organisations: UN, OSCE, OECD, Council of Europe, EBRD","7.30.30.04 Action to combat drugs and drug-trafficking"],"subtype":"Legislation","summary":["Amending Regulation (EC) No 273/2004"],"title":"Monitoring intra-EU trade in drug precursors","type":"COD - Ordinary legislative procedure (ex-codecision)"},"path":["procedure"],"type":"added"}],"2012-10-23T23:57:22":[{"data":{"body":"EP","committees":[{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Food Safety","responsible":false},{"body":"EP","committee":"IMCO","committee_full":"Internal Market and Consumer Protection","responsible":false},{"body":"EP","committee":"INTA","committee_full":"International Trade","responsible":false},{"body":"EP","committee":"LIBE","committee_full":"Civil Liberties, Justice and Home Affairs","responsible":true}],"date":"2012-10-22T00:00:00","type":"Committee referral announced in Parliament, 1st reading/single reading"},"path":["activities",2],"type":"added"},{"data":"LIBE/7/10801","path":["procedure","dossier_of_the_committee"],"type":"added"},{"data":["Preparatory phase in Parliament","Awaiting Parliament 1st reading / single reading / budget 1st stage"],"path":["procedure","stage_reached"],"type":"changed"}],"2012-10-31T22:10:27":[{"data":["
PURPOSE: to prevent the diversion from the EU-internal\ntrade of acetic anhydride, the main drug precursor for heroin, by\nextending the registration requirement to include users of the\nsubstance, and amending Regulation\n(EC) No 273/2004 on drug precursors
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: drug precursors are chemical substances\nhaving a wide variety of licit uses, such as in the synthesis of\nplastics, pharmaceuticals, cosmetics, perfumes, detergents, or\naromas. They are traded for legitimate purposes on global markets,\nbut some of them can also be diverted from the licit distribution\nchannels for the illicit manufacture of narcotic drugs. Taking into\naccount the wide legitimate uses of drug precursors, their trade\ncannot be prohibited. However, in order to prevent their diversion\nto illicit drug production, a specific regulatory framework has\nbeen set up on international level through Article 12 of the United\nNations Convention against the Illicit Traffic in Narcotic Drugs\nand Psychotropic Substances. The EU is a Party to the Convention\nand has implemented its obligations through Regulation (EC) No\n273/2004 governing the monitoring of the intra-EU trade in drug\nprecursors and Regulation\n(EC) No 111/2005 governing the external trade. The Union\nregulatory framework provides for the monitoring and control of the\nlegitimate trade in drug precursors. Operators, i.e. manufacturers,\ndistributors, brokers, importers, exporters and wholesalers of\nchemicals engaged in the legitimate trade of drug precursors are\nrequired to take measures against theft, check their customers,\ndetect suspicious transactions and notify the authorities\nthereof.
\nIn 2010, the European Commission adopted a Report\non the implementation and functioning of the existing EU\nlegislation on drug precursors, and recommended analysing ways to\nstrengthen the control of the trade of acetic anhydride\n(scheduled substance in Category 2) in order to better prevent the\ndiversion of acetic anhydride for the illicit production of\nheroin.
\nHeroin use accounts for the greatest share of\nmorbidity and mortality-related drug use in the EU. Even though the\nquantities of acetic anhydride seized in the EU have decreased very\nsubstantially since 2008, certain reports consider that the\nEuropean legislative control measures are not sufficiently strict\nto prevent the diversion of the main heroin precursor from the\nintra-EU trade.
\nIMPACT ASSESSMENT: the main problem driver being the\ninsufficient control by competent authorities over all economic\nplayers involved in the legitimate trade with drug precursors, all\npolicy options examined seek to improve control via enhanced\nreporting, notification or registration obligations imposed on the\neconomic players. The impacts of the following six policy options\nhave been analysed:
\nOption 5 is the preferred option. The overall conclusion of the impact assessment was\nthat both, Option 4 and Option 5 would be good choices, but Option\n5 would be less burdensome than Option 4 in terms of annual costs\nfor enterprises (provided authorities do not pass on all costs to\nregistrants by imposing fees), an argument which is particular\nrelevant for SMEs. All in all the strong political support which\nOption 5 has from most Member States, combined with views expressed\non international level that a more systematic control of (all)\nacetic anhydride end-users is lacking in the European\nlegislation, and the somewhat lower burden on SMEs tip the balance\nin favour of Option 5.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: this proposal aims to address a specific\nweakness which has been detected in the European Union, when large\nquantities of acetic anhydride (\"AA\"), the main drug precursor for\nheroin, were diverted from the EU- internal trade: in 2008, 75% of\nthe global seizures of Acetic anhydride happened in the EU. Until\nnow only EU companies producing or trading Acetic anhydride have to\nregister with their national authorities.
\nThe Commission proposes to:
\n\n· \nextend the registration\nrequirement, which so far applies\nonly to operators placing Acetic anhydride on the market, to\ninclude users of the substance;
\n\n· \nenhance the harmonised registration\nprovisions to achieve a more robust\nlevel playing field preserving the internal market and avoiding\nadoption of divergent national measures. More detailed rules on\nregistration are introduced to ensure uniform conditions of\nregistration in all Member States for scheduled substances in\ncategory 2 of Annex I. For substances scheduled in a new\nsubcategory 2A of Annex I, not only operators but also users will\nbe subject to a registration requirement.
\nBy ensuring that operators and users engaged in the\nlegal trade of drug precursors are subject to harmonised rules, the\nproposal will ensure a proper functioning of the Union market by\navoiding unnecessary barriers to such legitimate trade and by\nreducing administrative burdens for operators and competent\nauthorities.
\nAdditionally the Commission proposes to establish and\nmaintain a European Database on Drug Precursors in order to\nmodernize the collection of the information provided by Member\nStates on drug precursor seizures and stopped shipments, in\naccordance with current Article 13 of Regulation (EC) No 273/2004,\nand to maintain a list of EU licensed or registered operators and\nusers legally trading or using drug precursors, as well as to\nenable operators to provide competent authorities in summary form\nwith information about their transactions involving scheduled\nsubstances in accordance with current Article 8 (2) of Regulation\n(EC) No 273/2004.
\nIn addition, it should be noted that the proposal\nis:
\n\n· \nsubject to a notification to the WTO in the\nframework of the TBT Agreement;
\n\n· \nrelevant for the European Economic Area\n(EEA);
\n\n· \ncontains a transitional period for the coming\ninto force of the new registration obligations for end-users of\nAcetic anhydride;
\n\n· \nincludes a review clause to assess whether the\namended Regulation will have been effective to prevent the\ndiversion of Acetic anhydride.
\nAnnex: the proposal does\nnot extend the provisions for acetic anhydride to other scheduled\nsubstances in category 2. Acetic anhydride, currently scheduled in\ncategory 2 of Annex I, will be included in a new subcategory 2A of\nAnnex I to allow increased control of its trade. The remaining\nsubstances of category 2 will be listed as subcategory\n2B.
\nBUDGETARY IMPLICATIONS: the proposal has no impact on\nthe European Union budget because no additional resources are\nrequired to implement the action proposed. The necessary resources\nto implement the European database are already included in the\nallocations granted during the budget procedure and within the\nInternal Market line.
\nDELEGATED ACTS: the Commission shall have the power,\nin accordance with Article 290 of the Treaty on the Functioning of\nthe European Union, to adopt certain acts for which provision is\nmade in the proposal.
\nPURPOSE: to prevent the diversion from the EU-internal\ntrade of acetic anhydride, the main drug precursor for heroin, by\nextending the registration requirement to include users of the\nsubstance, and amending Regulation\n(EC) No 273/2004 on drug precursors
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: drug precursors are chemical substances\nhaving a wide variety of licit uses, such as in the synthesis of\nplastics, pharmaceuticals, cosmetics, perfumes, detergents, or\naromas. They are traded for legitimate purposes on global markets,\nbut some of them can also be diverted from the licit distribution\nchannels for the illicit manufacture of narcotic drugs. Taking into\naccount the wide legitimate uses of drug precursors, their trade\ncannot be prohibited. However, in order to prevent their diversion\nto illicit drug production, a specific regulatory framework has\nbeen set up on international level through Article 12 of the United\nNations Convention against the Illicit Traffic in Narcotic Drugs\nand Psychotropic Substances. The EU is a Party to the Convention\nand has implemented its obligations through Regulation (EC) No\n273/2004 governing the monitoring of the intra-EU trade in drug\nprecursors and Regulation\n(EC) No 111/2005 governing the external trade. The Union\nregulatory framework provides for the monitoring and control of the\nlegitimate trade in drug precursors. Operators, i.e. manufacturers,\ndistributors, brokers, importers, exporters and wholesalers of\nchemicals engaged in the legitimate trade of drug precursors are\nrequired to take measures against theft, check their customers,\ndetect suspicious transactions and notify the authorities\nthereof.
\nIn 2010, the European Commission adopted a Report\non the implementation and functioning of the existing EU\nlegislation on drug precursors, and recommended analysing ways to\nstrengthen the control of the trade of acetic anhydride\n(scheduled substance in Category 2) in order to better prevent the\ndiversion of acetic anhydride for the illicit production of\nheroin.
\nHeroin use accounts for the greatest share of\nmorbidity and mortality-related drug use in the EU. Even though the\nquantities of acetic anhydride seized in the EU have decreased very\nsubstantially since 2008, certain reports consider that the\nEuropean legislative control measures are not sufficiently strict\nto prevent the diversion of the main heroin precursor from the\nintra-EU trade.
\nIMPACT ASSESSMENT: the main problem driver being the\ninsufficient control by competent authorities over all economic\nplayers involved in the legitimate trade with drug precursors, all\npolicy options examined seek to improve control via enhanced\nreporting, notification or registration obligations imposed on the\neconomic players. The impacts of the following six policy options\nhave been analysed:
\nOption 5 is the preferred option. The overall conclusion of the impact assessment was\nthat both, Option 4 and Option 5 would be good choices, but Option\n5 would be less burdensome than Option 4 in terms of annual costs\nfor enterprises (provided authorities do not pass on all costs to\nregistrants by imposing fees), an argument which is particular\nrelevant for SMEs. All in all the strong political support which\nOption 5 has from most Member States, combined with views expressed\non international level that a more systematic control of (all)\nacetic anhydride end-users is lacking in the European\nlegislation, and the somewhat lower burden on SMEs tip the balance\nin favour of Option 5.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: this proposal aims to address a specific\nweakness which has been detected in the European Union, when large\nquantities of acetic anhydride (\"AA\"), the main drug precursor for\nheroin, were diverted from the EU- internal trade: in 2008, 75% of\nthe global seizures of Acetic anhydride happened in the EU. Until\nnow only EU companies producing or trading Acetic anhydride have to\nregister with their national authorities.
\nThe Commission proposes to:
\n\n· \nextend the registration\nrequirement, which so far applies\nonly to operators placing Acetic anhydride on the market, to\ninclude users of the substance;
\n\n· \nenhance the harmonised registration\nprovisions to achieve a more robust\nlevel playing field preserving the internal market and avoiding\nadoption of divergent national measures. More detailed rules on\nregistration are introduced to ensure uniform conditions of\nregistration in all Member States for scheduled substances in\ncategory 2 of Annex I. For substances scheduled in a new\nsubcategory 2A of Annex I, not only operators but also users will\nbe subject to a registration requirement.
\nBy ensuring that operators and users engaged in the\nlegal trade of drug precursors are subject to harmonised rules, the\nproposal will ensure a proper functioning of the Union market by\navoiding unnecessary barriers to such legitimate trade and by\nreducing administrative burdens for operators and competent\nauthorities.
\nAdditionally the Commission proposes to establish and\nmaintain a European Database on Drug Precursors in order to\nmodernize the collection of the information provided by Member\nStates on drug precursor seizures and stopped shipments, in\naccordance with current Article 13 of Regulation (EC) No 273/2004,\nand to maintain a list of EU licensed or registered operators and\nusers legally trading or using drug precursors, as well as to\nenable operators to provide competent authorities in summary form\nwith information about their transactions involving scheduled\nsubstances in accordance with current Article 8 (2) of Regulation\n(EC) No 273/2004.
\nIn addition, it should be noted that the proposal\nis:
\n\n· \nsubject to a notification to the WTO in the\nframework of the TBT Agreement;
\n\n· \nrelevant for the European Economic Area\n(EEA);
\n\n· \ncontains a transitional period for the coming\ninto force of the new registration obligations for end-users of\nAcetic anhydride;
\n\n· \nincludes a review clause to assess whether the\namended Regulation will have been effective to prevent the\ndiversion of Acetic anhydride.
\nAnnex: the proposal does\nnot extend the provisions for acetic anhydride to other scheduled\nsubstances in category 2. Acetic anhydride, currently scheduled in\ncategory 2 of Annex I, will be included in a new subcategory 2A of\nAnnex I to allow increased control of its trade. The remaining\nsubstances of category 2 will be listed as subcategory\n2B.
\nBUDGETARY IMPLICATIONS: the proposal has no impact on\nthe European Union budget because no additional resources are\nrequired to implement the action proposed. The necessary resources\nto implement the European database are already included in the\nallocations granted during the budget procedure and within the\nInternal Market line.
\nDELEGATED ACTS: the Commission shall have the power,\nin accordance with Article 290 of the Treaty on the Functioning of\nthe European Union, to adopt certain acts for which provision is\nmade in the proposal.
\nPURPOSE: to prevent the diversion from the EU-internal\ntrade of acetic anhydride, the main drug precursor for heroin, by\nextending the registration requirement to include users of the\nsubstance, and amending Regulation\n(EC) No 273/2004 on drug precursors
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: drug precursors are chemical substances\nhaving a wide variety of licit uses, such as in the synthesis of\nplastics, pharmaceuticals, cosmetics, perfumes, detergents, or\naromas. They are traded for legitimate purposes on global markets,\nbut some of them can also be diverted from the licit distribution\nchannels for the illicit manufacture of narcotic drugs. Taking into\naccount the wide legitimate uses of drug precursors, their trade\ncannot be prohibited. However, in order to prevent their diversion\nto illicit drug production, a specific regulatory framework has\nbeen set up on international level through Article 12 of the United\nNations Convention against the Illicit Traffic in Narcotic Drugs\nand Psychotropic Substances. The EU is a Party to the Convention\nand has implemented its obligations through Regulation (EC) No\n273/2004 governing the monitoring of the intra-EU trade in drug\nprecursors and Regulation\n(EC) No 111/2005 governing the external trade. The Union\nregulatory framework provides for the monitoring and control of the\nlegitimate trade in drug precursors. Operators, i.e. manufacturers,\ndistributors, brokers, importers, exporters and wholesalers of\nchemicals engaged in the legitimate trade of drug precursors are\nrequired to take measures against theft, check their customers,\ndetect suspicious transactions and notify the authorities\nthereof.
\nIn 2010, the European Commission adopted a Report\non the implementation and functioning of the existing EU\nlegislation on drug precursors, and recommended analysing ways to\nstrengthen the control of the trade of acetic anhydride\n(scheduled substance in Category 2) in order to better prevent the\ndiversion of acetic anhydride for the illicit production of\nheroin.
\nHeroin use accounts for the greatest share of\nmorbidity and mortality-related drug use in the EU. Even though the\nquantities of acetic anhydride seized in the EU have decreased very\nsubstantially since 2008, certain reports consider that the\nEuropean legislative control measures are not sufficiently strict\nto prevent the diversion of the main heroin precursor from the\nintra-EU trade.
\nIMPACT ASSESSMENT: the main problem driver being the\ninsufficient control by competent authorities over all economic\nplayers involved in the legitimate trade with drug precursors, all\npolicy options examined seek to improve control via enhanced\nreporting, notification or registration obligations imposed on the\neconomic players. The impacts of the following six policy options\nhave been analysed:
\nOption 5 is the preferred option. The overall conclusion of the impact assessment was\nthat both, Option 4 and Option 5 would be good choices, but Option\n5 would be less burdensome than Option 4 in terms of annual costs\nfor enterprises (provided authorities do not pass on all costs to\nregistrants by imposing fees), an argument which is particular\nrelevant for SMEs. All in all the strong political support which\nOption 5 has from most Member States, combined with views expressed\non international level that a more systematic control of (all)\nacetic anhydride end-users is lacking in the European\nlegislation, and the somewhat lower burden on SMEs tip the balance\nin favour of Option 5.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: this proposal aims to address a specific\nweakness which has been detected in the European Union, when large\nquantities of acetic anhydride (\"AA\"), the main drug precursor for\nheroin, were diverted from the EU- internal trade: in 2008, 75% of\nthe global seizures of Acetic anhydride happened in the EU. Until\nnow only EU companies producing or trading Acetic anhydride have to\nregister with their national authorities.
\nThe Commission proposes to:
\n\n· \nextend the registration\nrequirement, which so far applies\nonly to operators placing Acetic anhydride on the market, to\ninclude users of the substance;
\n\n· \nenhance the harmonised registration\nprovisions to achieve a more robust\nlevel playing field preserving the internal market and avoiding\nadoption of divergent national measures. More detailed rules on\nregistration are introduced to ensure uniform conditions of\nregistration in all Member States for scheduled substances in\ncategory 2 of Annex I. For substances scheduled in a new\nsubcategory 2A of Annex I, not only operators but also users will\nbe subject to a registration requirement.
\nBy ensuring that operators and users engaged in the\nlegal trade of drug precursors are subject to harmonised rules, the\nproposal will ensure a proper functioning of the Union market by\navoiding unnecessary barriers to such legitimate trade and by\nreducing administrative burdens for operators and competent\nauthorities.
\nAdditionally the Commission proposes to establish and\nmaintain a European Database on Drug Precursors in order to\nmodernize the collection of the information provided by Member\nStates on drug precursor seizures and stopped shipments, in\naccordance with current Article 13 of Regulation (EC) No 273/2004,\nand to maintain a list of EU licensed or registered operators and\nusers legally trading or using drug precursors, as well as to\nenable operators to provide competent authorities in summary form\nwith information about their transactions involving scheduled\nsubstances in accordance with current Article 8 (2) of Regulation\n(EC) No 273/2004.
\nIn addition, it should be noted that the proposal\nis:
\n\n· \nsubject to a notification to the WTO in the\nframework of the TBT Agreement;
\n\n· \nrelevant for the European Economic Area\n(EEA);
\n\n· \ncontains a transitional period for the coming\ninto force of the new registration obligations for end-users of\nAcetic anhydride;
\n\n· \nincludes a review clause to assess whether the\namended Regulation will have been effective to prevent the\ndiversion of Acetic anhydride.
\nAnnex: the proposal does\nnot extend the provisions for acetic anhydride to other scheduled\nsubstances in category 2. Acetic anhydride, currently scheduled in\ncategory 2 of Annex I, will be included in a new subcategory 2A of\nAnnex I to allow increased control of its trade. The remaining\nsubstances of category 2 will be listed as subcategory\n2B.
\nBUDGETARY IMPLICATIONS: the proposal has no impact on\nthe European Union budget because no additional resources are\nrequired to implement the action proposed. The necessary resources\nto implement the European database are already included in the\nallocations granted during the budget procedure and within the\nInternal Market line.
\nDELEGATED ACTS: the Commission shall have the power,\nin accordance with Article 290 of the Treaty on the Functioning of\nthe European Union, to adopt certain acts for which provision is\nmade in the proposal.
\nThe Committee on Civil Liberties, Justice and Home\nAffairs adopted the report by Anna HEDH (S&D, SE) on the\nproposal for a regulation of the European Parliament and of the\nCouncil amending Regulation (EC) No 273/2004 on drug\nprecursors.
\nThe committee recommends that the European\nParliaments position adopted at first reading, following the\nordinary legislative procedure, should amend the Commission\nproposal as follows:
\nDefinitions: Members\nredefine the term user so that it shall mean any\nnatural or legal person who is not an operator under the\nterms of the Regulation.
\nRegistration regime:\nMembers make a number of amendments to ensure that operators\nshould be discouraged from \"shopping around\" in the EU for the\ncompetent authorities with the lightest licensing/registration\nregime.
\nDatabase: the proposal\nseeks to establish a European Database on drug precursors to\nsimplify the reporting by Member States with regard to seizures and\nstopped shipments, where possible in an aggregated and\nanonymised manner and in the least intrusive way as regards the\nprocessing of personal data. The Commission and the competent\nauthorities shall take all necessary measures to ensure the\nsecurity, confidentiality and accuracy of the information contained\nin the European Database. The rights of data subjects are protected\nin accordance with that Directive 95/46/EC.
\nExchange and processing of personal\ndata: Regulation (EC) No 273/2004\nenvisages the processing of information, including the processing\nof personal data, for the purposes of enabling the competent\nauthorities to monitor the placing on the market of drug precursors\nand to prevent the diversion of scheduled substances. Members\nconsider that the processing of personal data should be carried out\nin accordance with Union law on data protection and, in particular,\nwith requirements relating to data quality, proportionality,\npurpose limitation, and rights to information, access,\nrectification of data, erasure and blocking, organisational and\ntechnical measures and international transfers of personal\ndata. Data should be adequate, accurate, relevant and not\nexcessive in relation to the purpose for which it is collected. It\nshould not be processed for longer than necessary in relation to\nthe purpose for which it is collected and its accuracy should be\nregularly reviewed.
\nOperators shall not disclose personal data processed\npursuant to this Regulation other than to the competent\nauthorities.
\nIt is stipulated that a data subject shall be provided\nwith information concerning the purposes of the processing and\nretention of data, the categories of data processed and retained,\nthe identity of the controller of the data, the identity of the\nrecipients of the data, information regarding the right of access,\nrectification or erasure of the data subject's personal data, the\nadministrative and judicial remedies available and the contact\ndetails of the supervisory authority. Some or all of that specific\ninformation may be withheld only in so far as it would compromise\nadministrative or judicial investigations or procedures, hamper the\nprevention, investigation, detection or prosecution of criminal\noffences or jeopardise public or national security.
\nData protection law, the various elements of\nprocessing personal data, including the exercise of rights by data\nsubjects, must be specified in delegated acts.
\nAs regards the processing of data, this should be\ncarried out under the supervision of the European Data\nProtection Supervisor, as regards the processing of personal\ndata carried out by the Commission within the framework of\nRegulation (EC) No 273/2004.
\nAccess by law enforcement agencies to personal\ndata: in order to enable law\nenforcement authorities to detect, prevent, investigate or\nprosecute drug trafficking criminal offences, Members call on\nMember States should to adopt legislative measures to grant their\ncompetent authorities access to personal data processed in so far\nas is necessary, proportionate and subject to adequate safeguards.\nSuch processing should only take place on a case-by-case basis and\nprovided that the competent law enforcement authorities have\nreasonable grounds for believing that it will substantially assist\nthem in preventing, detecting, or investigating drug trafficking\ncriminal offences.
\nDelegated acts: the\nCommission shall be empowered to adopt delegated acts in respect\nof :
\nBefore developing delegated acts, the Commission shall\nconsult the European Data Protection Supervisor.
\nReview: by 66 months\nafter the date of entry into force of this Regulation (and not 78\nas proposed by the commission), the Commission shall submit a\nreport to the European Parliament and to the Council on the\nimplementation and functioning of Regulation (EC) No 273/2004, and\nin particular on the possible need for additional action to\nmonitor and control suspicious transactions with non-scheduled\nsubstances.
\nThe European Parliament adopted by 575 votes to 34\nwith 54 abstentions, a legislative resolution on the proposal for a\nregulation of the European Parliament and of the Council amending\nRegulation (EC) No 273/2004 on drug precursors.
\nParliament adopted its position in first reading\nfollowing the ordinary legislative procedure. The amendments\nadopted in plenary are the result of a compromise negotiated\nbetween Parliament and Council.
\nScope and objectives: the Regulation established harmonised measures for the\nintra-Union control and monitoring of certain substances frequently\nused for the illicit manufacture of narcotic drugs or psychotropic\nsubstances with a view to preventing the diversion of such\nsubstances.
\nDefinitions: several\ndefinitions were clarified, including the definition of\nplacing on the market of scheduled substances within\nthe meaning of the Regulation.
\nThe meaning of user has also been\nclarified so that it cannot be confused with an operator within the\nmeaning of the Regulation.
\nRegistration: operators\nand users shall obtain a licence from the competent\nauthorities of the Member State in which they are\nestablished before they may possess or place on the market\nscheduled substances.
\nIt is also provided that competent authorities may\nrequire operators and users to pay a fee for the application for\na licence or for registration.
\nWhere a fee is levied, competent authorities must\nconsider adjusting the level of the fee depending on the size of\nthe enterprise. Such a fee must be levied in a non-discriminatory\nmanner and shall not exceed the cost of processing the\napplication.
\nDatabase: the proposal\nprovided for the creation of a European database to simplify the\nreporting by Member States with regard to seizures and stopped\nshipments. Data should, where possible, be in an aggregated and\nanonymised manner and in the least intrusive manner as regards the\nprocessing of personal data, taking into account the state of\nthe art of privacy-enhancing technologies and the principle of data\nlimitation.
\nThe kind of data which can be stored in the European\ndatabase would be established through delegated acts.
\nThe Commission must make publicly available, in a\nclear, comprehensive and understandable manner, information\nconcerning the European database.
\nExchange and processing of personal data:\nRegulation (EC) No 273/2004 envisages the\nprocessing of information, including the processing of\npersonal data, for the purposes of enabling the competent\nauthorities to monitor the placing on the market of drug precursors\nand to prevent the diversion of scheduled substances. However, the\namended text specified that the processing\nof personal data should be carried out in a manner\ncompatible with EU legislation on data protection and, in\nparticular, with requirements relating to data quality,\nproportionality, purpose limitation, and rights to information,\naccess, rectification of data, erasure and blocking, organisational\nand technical measures and international transfers of personal\ndata.
\nOperators must not disclose any personal data\ncollected pursuant to this Regulation other than to the competent\nauthorities.
\nSeizure of certain substances: competent authorities will have the power where\nnecessary, to detain and seize consignments to prevent the use of\nspecific non-scheduled substances for the illicit\nmanufacture of narcotic drugs or psychotropic\nsubstances.
\nCommunication from Member States: to permit any necessary adjustments to the\narrangements for monitoring trade in scheduled substances and\nnon-scheduled substances, the competent authorities in each\nMember State shall communicate to the Commission in electronic\nform via the European database all relevant information on the\nimplementation of the monitoring measures laid down in the\nRegulation, in particular as regards substances used for the\nillicit manufacture of narcotic drugs or psychotropic substances\nand methods of diversion and illicit manufacture, and their licit\ntrade.
\nThe Commission will be empowered to adopt delegated\nacts specifying the conditions and requirements concerning the\ninformation to be provided in this context. .
\nDelegated acts regarding the processing of personal\ndata: the scope of the delegation of\npower has been redefined so that the Commission would also be\nempowered to adopt delegated acts on:
\n\n· \nthe categories of personal data which can be\nprocessed by Member States and operators pursuant to Regulation\n(EC) No 273/2004;
\n\n· \nthe categories of personal data which can be\nstored in the European database, and
\n\n· \nthe safeguards for the processing of personal\ndata.
\nThe Commission should seek the opinion of the European\nData Protection Supervisor when preparing delegated acts relating\nto the processing of personal data.
\nThe power to adopt delegated acts will be conferred on\nthe Commission for a period of five years and\nshall be tacitly extended for periods of an identical duration,\nunless the European Parliament or the Council opposes such\nextension not later than three months before the end of each\nperiod.
\nReview: the Commission\nmust submit a report to the European Parliament and to the Council\non the implementation and functioning of the Regulation, and\nin particular on the possible need for additional action to monitor\nand control suspicious transactions with non-scheduled\nsubstances.
\nAnnex: the list of\nscheduled substances has been amended.
\nThe European Parliament adopted by 575 votes to 34\nwith 54 abstentions, a legislative resolution on the proposal for a\nregulation of the European Parliament and of the Council amending\nRegulation (EC) No 273/2004 on drug precursors.
\nParliament adopted its position in first reading\nfollowing the ordinary legislative procedure. The amendments\nadopted in plenary are the result of a compromise negotiated\nbetween Parliament and Council.
\nScope and objectives: the Regulation established harmonised measures for the\nintra-Union control and monitoring of certain substances frequently\nused for the illicit manufacture of narcotic drugs or psychotropic\nsubstances with a view to preventing the diversion of such\nsubstances.
\nDefinitions: several\ndefinitions were clarified, including the definition of\nplacing on the market of scheduled substances within\nthe meaning of the Regulation.
\nThe meaning of user has also been\nclarified so that it cannot be confused with an operator within the\nmeaning of the Regulation.
\nRegistration: operators\nand users shall obtain a licence from the competent\nauthorities of the Member State in which they are\nestablished before they may possess or place on the market\nscheduled substances.
\nIt is also provided that competent authorities may\nrequire operators and users to pay a fee for the application for\na licence or for registration.
\nWhere a fee is levied, competent authorities must\nconsider adjusting the level of the fee depending on the size of\nthe enterprise. Such a fee must be levied in a non-discriminatory\nmanner and shall not exceed the cost of processing the\napplication.
\nDatabase: the proposal\nprovided for the creation of a European database to simplify the\nreporting by Member States with regard to seizures and stopped\nshipments. Data should, where possible, be in an aggregated and\nanonymised manner and in the least intrusive manner as regards the\nprocessing of personal data, taking into account the state of\nthe art of privacy-enhancing technologies and the principle of data\nlimitation.
\nThe kind of data which can be stored in the European\ndatabase would be established through delegated acts.
\nThe Commission must make publicly available, in a\nclear, comprehensive and understandable manner, information\nconcerning the European database.
\nExchange and processing of personal data:\nRegulation (EC) No 273/2004 envisages the\nprocessing of information, including the processing of\npersonal data, for the purposes of enabling the competent\nauthorities to monitor the placing on the market of drug precursors\nand to prevent the diversion of scheduled substances. However, the\namended text specified that the processing\nof personal data should be carried out in a manner\ncompatible with EU legislation on data protection and, in\nparticular, with requirements relating to data quality,\nproportionality, purpose limitation, and rights to information,\naccess, rectification of data, erasure and blocking, organisational\nand technical measures and international transfers of personal\ndata.
\nOperators must not disclose any personal data\ncollected pursuant to this Regulation other than to the competent\nauthorities.
\nSeizure of certain substances: competent authorities will have the power where\nnecessary, to detain and seize consignments to prevent the use of\nspecific non-scheduled substances for the illicit\nmanufacture of narcotic drugs or psychotropic\nsubstances.
\nCommunication from Member States: to permit any necessary adjustments to the\narrangements for monitoring trade in scheduled substances and\nnon-scheduled substances, the competent authorities in each\nMember State shall communicate to the Commission in electronic\nform via the European database all relevant information on the\nimplementation of the monitoring measures laid down in the\nRegulation, in particular as regards substances used for the\nillicit manufacture of narcotic drugs or psychotropic substances\nand methods of diversion and illicit manufacture, and their licit\ntrade.
\nThe Commission will be empowered to adopt delegated\nacts specifying the conditions and requirements concerning the\ninformation to be provided in this context. .
\nDelegated acts regarding the processing of personal\ndata: the scope of the delegation of\npower has been redefined so that the Commission would also be\nempowered to adopt delegated acts on:
\n\n· \nthe categories of personal data which can be\nprocessed by Member States and operators pursuant to Regulation\n(EC) No 273/2004;
\n\n· \nthe categories of personal data which can be\nstored in the European database, and
\n\n· \nthe safeguards for the processing of personal\ndata.
\nThe Commission should seek the opinion of the European\nData Protection Supervisor when preparing delegated acts relating\nto the processing of personal data.
\nThe power to adopt delegated acts will be conferred on\nthe Commission for a period of five years and\nshall be tacitly extended for periods of an identical duration,\nunless the European Parliament or the Council opposes such\nextension not later than three months before the end of each\nperiod.
\nReview: the Commission\nmust submit a report to the European Parliament and to the Council\non the implementation and functioning of the Regulation, and\nin particular on the possible need for additional action to monitor\nand control suspicious transactions with non-scheduled\nsubstances.
\nAnnex: the list of\nscheduled substances has been amended.
\nPURPOSE: to prevent the diversion from the EU-internal\ntrade of acetic anhydride, the main drug precursor for\nheroin, by extending the registration requirement to include users\nof the substance, and amending Regulation (EC) No 273/2004 on drug\nprecursors.
\nLEGISLATIVE ACT: Regulation (EU) No 1258/2013 of the\nEuropean Parliament and of the Council amending Regulation (EC) No\n273/2004 on drug precursors.
\nCONTENT: this Regulation establishes harmonised\nmeasures for the intra-Union control and monitoring of certain\nsubstances frequently used for the illicit manufacture of narcotic\ndrugs or psychotropic substances with a view to preventing the\ndiversion of such substances.
\nDefinitions: several\ndefinitions have been amended such as:
\nRegistration: more\ndetailed rules on registration should be introduced to ensure\nuniform conditions of registration in all Member States for\nscheduled substances as laid down in the Regulation (EC) No\n273/2004. For acetic anhydride, in addition to operators\nusers should also be subject to a registration\nrequirement.
\nLicence: provisions as\nregards holding a licence for the placing on the market of a\nscheduled substance has been clarified. The competent authorities\nmay either limit the validity of the licence to a period not\nexceeding three years.
\nFor acetic anhydride,\noperators shall obtain registration from the competent authorities\nof the Member State in which they are established before placing\nthe substance on the market. From 1 July 2015, users\nshall obtain a registration from the competent authorities of the\nMember State in which they are established before possessing this\nsubstance.
\nWhen considering whether to grant registration, the\ncompetent authorities shall take into account, in particular, the\ncompetence and integrity of the applicant. They shall refuse\nregistration if there are reasonable grounds for doubting the\nsuitability and reliability of the applicant or of the officer\nresponsible for the trade in scheduled substances.
\nFees: operators and\nusers shall obtain a licence from the competent\nauthorities of the Member State in which they are\nestablished before they may possess or place on the market\nscheduled substances. It is also provided that competent\nauthorities may require operators and users to pay a fee for the\napplication for a licence or for registration.
\nWhere a fee is levied, competent authorities must\nconsider adjusting the level of the fee depending on the size of\nthe enterprise. Such a fee must be levied in a non-discriminatory\nmanner and shall not exceed the cost of processing the\napplication.
\nDatabase: a European\ndatabase on drug precursors shall be created to simplify the\nreporting by Member States with regard to seizures and stopped\nshipments, where possible in an aggregated and anonymised manner\nand in the least intrusive manner as regards the processing\nof personal data, taking into account the state of the art of\nprivacy-enhancing technologies and the principle of data\nlimitation. The European database should also serve as a European\nregister of operators and users holding a licence or registration\nwhich will facilitate verification of the legitimacy of commercial\ntransactions involving scheduled substances, and should enable\noperators to provide the competent authorities with information\nabout their transactions involving scheduled substances.
\nThe kind of data which can be stored in the European\ndatabase would be established through delegated acts.
\nExchange and processing of\npersonal data: Regulation (EC) No 273/2004 envisages the\nprocessing of information, including the processing of\npersonal data, for the purposes of enabling the competent\nauthorities to monitor the placing on the market of drug precursors\nand to prevent the diversion of scheduled substances. However, it\nis specified that the processing of personal data\nshould be carried out in a manner compatible with EU\nlegislation on data protection and, in particular, with\nrequirements relating to data quality, proportionality, purpose\nlimitation, and rights to information, access, rectification of\ndata, erasure and blocking, organisational and technical measures\nand international transfers of personal data.
\nOperators must not disclose any personal data\ncollected pursuant to this Regulation other than to the competent\nauthorities.
\nNotification of the competent\nauthorities:\noperators shall notify the competent authorities immediately of any\ncircumstances, such as unusual orders or transactions involving\nscheduled substances to be placed on the market, which suggest that\nsuch substances might be diverted for the illicit manufacture of\nnarcotic drugs or psychotropic substances. To that end, operators\nshall provide any available information allowing the competent\nauthorities to verify the legitimacy of the relevant order or\ntransaction.
\nCompetent authorities will have the power where\nnecessary, to detain and seize consignments to prevent the\nuse of specific non-scheduled substances for the illicit\nmanufacture of narcotic drugs or psychotropic\nsubstances.
\nCommunication from Member\nStates: to permit\nany necessary adjustments to the arrangements for monitoring trade\nin scheduled substances and non-scheduled substances, the competent\nauthorities in each Member State shall communicate to the\nCommission in electronic form via the European database all\nrelevant information on the implementation of the monitoring\nmeasures laid down in the Regulation, in particular as regards\nsubstances used for the illicit manufacture of narcotic drugs or\npsychotropic substances and methods of diversion and illicit\nmanufacture, and their licit trade.
\nThe Commission shall be empowered to adopt delegated\nacts concerning the requirements and conditions for operators to\nprovide information.
\nReport: the Commission\nshall, by 31 December 2019, submit a report to the European\nParliament and to the Council on the implementation and functioning\nof this Regulation, and in particular on the possible need for\nadditional action to monitor and control suspicious transactions\nwith non-scheduled substances.
\nAnnex: acetic anhydride,\ncurrently scheduled in category 2 of Annex I to Regulation (EC) No\n273/2004, should be included in a new subcategory 2A of\nAnnex I thereto to allow increased control of its trade. The\nremaining substances of category 2 of Annex I to Regulation (EC) No\n273/2004 should be listed as subcategory 2B of Annex I\nthereto.
\nENTRY INTO FORCE: 30.12.2013.
\nDELEGATED ACTS: the power to adopt delegated acts\nshall be conferred on the Commission for a period of five years\nfrom 30 December 2013. The delegation of power shall be tacitly\nextended for periods of an identical duration, unless the European\nParliament or the Council opposes such extension.
\nThe European Parliament or the Council may raise\nobjections to a delegated act within a period of two months from\nthe date of notification (this may be extended by two months.) If\nthe European Parliament or Council express objections, the\ndelegated act will not enter into force.
\nThe European Parliament adopted by 575 votes to 34\nwith 54 abstentions, a legislative resolution on the proposal for a\nregulation of the European Parliament and of the Council amending\nRegulation (EC) No 273/2004 on drug precursors.
\nParliament adopted its position in first reading\nfollowing the ordinary legislative procedure. The amendments\nadopted in plenary are the result of a compromise negotiated\nbetween Parliament and Council.
\nScope and objectives: the Regulation established harmonised measures for the\nintra-Union control and monitoring of certain substances frequently\nused for the illicit manufacture of narcotic drugs or psychotropic\nsubstances with a view to preventing the diversion of such\nsubstances.
\nDefinitions: several\ndefinitions were clarified, including the definition of\nplacing on the market of scheduled substances within\nthe meaning of the Regulation.
\nThe meaning of user has also been\nclarified so that it cannot be confused with an operator within the\nmeaning of the Regulation.
\nRegistration: operators\nand users shall obtain a licence from the competent\nauthorities of the Member State in which they are\nestablished before they may possess or place on the market\nscheduled substances.
\nIt is also provided that competent authorities may\nrequire operators and users to pay a fee for the application for\na licence or for registration.
\nWhere a fee is levied, competent authorities must\nconsider adjusting the level of the fee depending on the size of\nthe enterprise. Such a fee must be levied in a non-discriminatory\nmanner and shall not exceed the cost of processing the\napplication.
\nDatabase: the proposal\nprovided for the creation of a European database to simplify the\nreporting by Member States with regard to seizures and stopped\nshipments. Data should, where possible, be in an aggregated and\nanonymised manner and in the least intrusive manner as regards the\nprocessing of personal data, taking into account the state of\nthe art of privacy-enhancing technologies and the principle of data\nlimitation.
\nThe kind of data which can be stored in the European\ndatabase would be established through delegated acts.
\nThe Commission must make publicly available, in a\nclear, comprehensive and understandable manner, information\nconcerning the European database.
\nExchange and processing of personal data:\nRegulation (EC) No 273/2004 envisages the\nprocessing of information, including the processing of\npersonal data, for the purposes of enabling the competent\nauthorities to monitor the placing on the market of drug precursors\nand to prevent the diversion of scheduled substances. However, the\namended text specified that the processing\nof personal data should be carried out in a manner\ncompatible with EU legislation on data protection and, in\nparticular, with requirements relating to data quality,\nproportionality, purpose limitation, and rights to information,\naccess, rectification of data, erasure and blocking, organisational\nand technical measures and international transfers of personal\ndata.
\nOperators must not disclose any personal data\ncollected pursuant to this Regulation other than to the competent\nauthorities.
\nSeizure of certain substances: competent authorities will have the power where\nnecessary, to detain and seize consignments to prevent the use of\nspecific non-scheduled substances for the illicit\nmanufacture of narcotic drugs or psychotropic\nsubstances.
\nCommunication from Member States: to permit any necessary adjustments to the\narrangements for monitoring trade in scheduled substances and\nnon-scheduled substances, the competent authorities in each\nMember State shall communicate to the Commission in electronic\nform via the European database all relevant information on the\nimplementation of the monitoring measures laid down in the\nRegulation, in particular as regards substances used for the\nillicit manufacture of narcotic drugs or psychotropic substances\nand methods of diversion and illicit manufacture, and their licit\ntrade.
\nThe Commission will be empowered to adopt delegated\nacts specifying the conditions and requirements concerning the\ninformation to be provided in this context. .
\nDelegated acts regarding the processing of personal\ndata: the scope of the delegation of\npower has been redefined so that the Commission would also be\nempowered to adopt delegated acts on:
\n\n· \nthe categories of personal data which can be\nprocessed by Member States and operators pursuant to Regulation\n(EC) No 273/2004;
\n\n· \nthe categories of personal data which can be\nstored in the European database, and
\n\n· \nthe safeguards for the processing of personal\ndata.
\nThe Commission should seek the opinion of the European\nData Protection Supervisor when preparing delegated acts relating\nto the processing of personal data.
\nThe power to adopt delegated acts will be conferred on\nthe Commission for a period of five years and\nshall be tacitly extended for periods of an identical duration,\nunless the European Parliament or the Council opposes such\nextension not later than three months before the end of each\nperiod.
\nReview: the Commission\nmust submit a report to the European Parliament and to the Council\non the implementation and functioning of the Regulation, and\nin particular on the possible need for additional action to monitor\nand control suspicious transactions with non-scheduled\nsubstances.
\nAnnex: the list of\nscheduled substances has been amended.
\nPURPOSE: to prevent the diversion from the EU-internal\ntrade of acetic anhydride, the main drug precursor for heroin, by\nextending the registration requirement to include users of the\nsubstance, and amending Regulation\n(EC) No 273/2004 on drug precursors
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: drug precursors are chemical substances\nhaving a wide variety of licit uses, such as in the synthesis of\nplastics, pharmaceuticals, cosmetics, perfumes, detergents, or\naromas. They are traded for legitimate purposes on global markets,\nbut some of them can also be diverted from the licit distribution\nchannels for the illicit manufacture of narcotic drugs. Taking into\naccount the wide legitimate uses of drug precursors, their trade\ncannot be prohibited. However, in order to prevent their diversion\nto illicit drug production, a specific regulatory framework has\nbeen set up on international level through Article 12 of the United\nNations Convention against the Illicit Traffic in Narcotic Drugs\nand Psychotropic Substances. The EU is a Party to the Convention\nand has implemented its obligations through Regulation (EC) No\n273/2004 governing the monitoring of the intra-EU trade in drug\nprecursors and Regulation\n(EC) No 111/2005 governing the external trade. The Union\nregulatory framework provides for the monitoring and control of the\nlegitimate trade in drug precursors. Operators, i.e. manufacturers,\ndistributors, brokers, importers, exporters and wholesalers of\nchemicals engaged in the legitimate trade of drug precursors are\nrequired to take measures against theft, check their customers,\ndetect suspicious transactions and notify the authorities\nthereof.
\nIn 2010, the European Commission adopted a Report\non the implementation and functioning of the existing EU\nlegislation on drug precursors, and recommended analysing ways to\nstrengthen the control of the trade of acetic anhydride\n(scheduled substance in Category 2) in order to better prevent the\ndiversion of acetic anhydride for the illicit production of\nheroin.
\nHeroin use accounts for the greatest share of\nmorbidity and mortality-related drug use in the EU. Even though the\nquantities of acetic anhydride seized in the EU have decreased very\nsubstantially since 2008, certain reports consider that the\nEuropean legislative control measures are not sufficiently strict\nto prevent the diversion of the main heroin precursor from the\nintra-EU trade.
\nIMPACT ASSESSMENT: the main problem driver being the\ninsufficient control by competent authorities over all economic\nplayers involved in the legitimate trade with drug precursors, all\npolicy options examined seek to improve control via enhanced\nreporting, notification or registration obligations imposed on the\neconomic players. The impacts of the following six policy options\nhave been analysed:
\nOption 5 is the preferred option. The overall conclusion of the impact assessment was\nthat both, Option 4 and Option 5 would be good choices, but Option\n5 would be less burdensome than Option 4 in terms of annual costs\nfor enterprises (provided authorities do not pass on all costs to\nregistrants by imposing fees), an argument which is particular\nrelevant for SMEs. All in all the strong political support which\nOption 5 has from most Member States, combined with views expressed\non international level that a more systematic control of (all)\nacetic anhydride end-users is lacking in the European\nlegislation, and the somewhat lower burden on SMEs tip the balance\nin favour of Option 5.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: this proposal aims to address a specific\nweakness which has been detected in the European Union, when large\nquantities of acetic anhydride (\"AA\"), the main drug precursor for\nheroin, were diverted from the EU- internal trade: in 2008, 75% of\nthe global seizures of Acetic anhydride happened in the EU. Until\nnow only EU companies producing or trading Acetic anhydride have to\nregister with their national authorities.
\nThe Commission proposes to:
\n\n· \nextend the registration\nrequirement, which so far applies\nonly to operators placing Acetic anhydride on the market, to\ninclude users of the substance;
\n\n· \nenhance the harmonised registration\nprovisions to achieve a more robust\nlevel playing field preserving the internal market and avoiding\nadoption of divergent national measures. More detailed rules on\nregistration are introduced to ensure uniform conditions of\nregistration in all Member States for scheduled substances in\ncategory 2 of Annex I. For substances scheduled in a new\nsubcategory 2A of Annex I, not only operators but also users will\nbe subject to a registration requirement.
\nBy ensuring that operators and users engaged in the\nlegal trade of drug precursors are subject to harmonised rules, the\nproposal will ensure a proper functioning of the Union market by\navoiding unnecessary barriers to such legitimate trade and by\nreducing administrative burdens for operators and competent\nauthorities.
\nAdditionally the Commission proposes to establish and\nmaintain a European Database on Drug Precursors in order to\nmodernize the collection of the information provided by Member\nStates on drug precursor seizures and stopped shipments, in\naccordance with current Article 13 of Regulation (EC) No 273/2004,\nand to maintain a list of EU licensed or registered operators and\nusers legally trading or using drug precursors, as well as to\nenable operators to provide competent authorities in summary form\nwith information about their transactions involving scheduled\nsubstances in accordance with current Article 8 (2) of Regulation\n(EC) No 273/2004.
\nIn addition, it should be noted that the proposal\nis:
\n\n· \nsubject to a notification to the WTO in the\nframework of the TBT Agreement;
\n\n· \nrelevant for the European Economic Area\n(EEA);
\n\n· \ncontains a transitional period for the coming\ninto force of the new registration obligations for end-users of\nAcetic anhydride;
\n\n· \nincludes a review clause to assess whether the\namended Regulation will have been effective to prevent the\ndiversion of Acetic anhydride.
\nAnnex: the proposal does\nnot extend the provisions for acetic anhydride to other scheduled\nsubstances in category 2. Acetic anhydride, currently scheduled in\ncategory 2 of Annex I, will be included in a new subcategory 2A of\nAnnex I to allow increased control of its trade. The remaining\nsubstances of category 2 will be listed as subcategory\n2B.
\nBUDGETARY IMPLICATIONS: the proposal has no impact on\nthe European Union budget because no additional resources are\nrequired to implement the action proposed. The necessary resources\nto implement the European database are already included in the\nallocations granted during the budget procedure and within the\nInternal Market line.
\nDELEGATED ACTS: the Commission shall have the power,\nin accordance with Article 290 of the Treaty on the Functioning of\nthe European Union, to adopt certain acts for which provision is\nmade in the proposal.
\nThe Committee on Civil Liberties, Justice and Home\nAffairs adopted the report by Anna HEDH (S&D, SE) on the\nproposal for a regulation of the European Parliament and of the\nCouncil amending Regulation (EC) No 273/2004 on drug\nprecursors.
\nThe committee recommends that the European\nParliaments position adopted at first reading, following the\nordinary legislative procedure, should amend the Commission\nproposal as follows:
\nDefinitions: Members\nredefine the term user so that it shall mean any\nnatural or legal person who is not an operator under the\nterms of the Regulation.
\nRegistration regime:\nMembers make a number of amendments to ensure that operators\nshould be discouraged from \"shopping around\" in the EU for the\ncompetent authorities with the lightest licensing/registration\nregime.
\nDatabase: the proposal\nseeks to establish a European Database on drug precursors to\nsimplify the reporting by Member States with regard to seizures and\nstopped shipments, where possible in an aggregated and\nanonymised manner and in the least intrusive way as regards the\nprocessing of personal data. The Commission and the competent\nauthorities shall take all necessary measures to ensure the\nsecurity, confidentiality and accuracy of the information contained\nin the European Database. The rights of data subjects are protected\nin accordance with that Directive 95/46/EC.
\nExchange and processing of personal\ndata: Regulation (EC) No 273/2004\nenvisages the processing of information, including the processing\nof personal data, for the purposes of enabling the competent\nauthorities to monitor the placing on the market of drug precursors\nand to prevent the diversion of scheduled substances. Members\nconsider that the processing of personal data should be carried out\nin accordance with Union law on data protection and, in particular,\nwith requirements relating to data quality, proportionality,\npurpose limitation, and rights to information, access,\nrectification of data, erasure and blocking, organisational and\ntechnical measures and international transfers of personal\ndata. Data should be adequate, accurate, relevant and not\nexcessive in relation to the purpose for which it is collected. It\nshould not be processed for longer than necessary in relation to\nthe purpose for which it is collected and its accuracy should be\nregularly reviewed.
\nOperators shall not disclose personal data processed\npursuant to this Regulation other than to the competent\nauthorities.
\nIt is stipulated that a data subject shall be provided\nwith information concerning the purposes of the processing and\nretention of data, the categories of data processed and retained,\nthe identity of the controller of the data, the identity of the\nrecipients of the data, information regarding the right of access,\nrectification or erasure of the data subject's personal data, the\nadministrative and judicial remedies available and the contact\ndetails of the supervisory authority. Some or all of that specific\ninformation may be withheld only in so far as it would compromise\nadministrative or judicial investigations or procedures, hamper the\nprevention, investigation, detection or prosecution of criminal\noffences or jeopardise public or national security.
\nData protection law, the various elements of\nprocessing personal data, including the exercise of rights by data\nsubjects, must be specified in delegated acts.
\nAs regards the processing of data, this should be\ncarried out under the supervision of the European Data\nProtection Supervisor, as regards the processing of personal\ndata carried out by the Commission within the framework of\nRegulation (EC) No 273/2004.
\nAccess by law enforcement agencies to personal\ndata: in order to enable law\nenforcement authorities to detect, prevent, investigate or\nprosecute drug trafficking criminal offences, Members call on\nMember States should to adopt legislative measures to grant their\ncompetent authorities access to personal data processed in so far\nas is necessary, proportionate and subject to adequate safeguards.\nSuch processing should only take place on a case-by-case basis and\nprovided that the competent law enforcement authorities have\nreasonable grounds for believing that it will substantially assist\nthem in preventing, detecting, or investigating drug trafficking\ncriminal offences.
\nDelegated acts: the\nCommission shall be empowered to adopt delegated acts in respect\nof :
\nBefore developing delegated acts, the Commission shall\nconsult the European Data Protection Supervisor.
\nReview: by 66 months\nafter the date of entry into force of this Regulation (and not 78\nas proposed by the commission), the Commission shall submit a\nreport to the European Parliament and to the Council on the\nimplementation and functioning of Regulation (EC) No 273/2004, and\nin particular on the possible need for additional action to\nmonitor and control suspicious transactions with non-scheduled\nsubstances.
\nThe European Parliament adopted by 575 votes to 34\nwith 54 abstentions, a legislative resolution on the proposal for a\nregulation of the European Parliament and of the Council amending\nRegulation (EC) No 273/2004 on drug precursors.
\nParliament adopted its position in first reading\nfollowing the ordinary legislative procedure. The amendments\nadopted in plenary are the result of a compromise negotiated\nbetween Parliament and Council.
\nScope and objectives: the Regulation established harmonised measures for the\nintra-Union control and monitoring of certain substances frequently\nused for the illicit manufacture of narcotic drugs or psychotropic\nsubstances with a view to preventing the diversion of such\nsubstances.
\nDefinitions: several\ndefinitions were clarified, including the definition of\nplacing on the market of scheduled substances within\nthe meaning of the Regulation.
\nThe meaning of user has also been\nclarified so that it cannot be confused with an operator within the\nmeaning of the Regulation.
\nRegistration: operators\nand users shall obtain a licence from the competent\nauthorities of the Member State in which they are\nestablished before they may possess or place on the market\nscheduled substances.
\nIt is also provided that competent authorities may\nrequire operators and users to pay a fee for the application for\na licence or for registration.
\nWhere a fee is levied, competent authorities must\nconsider adjusting the level of the fee depending on the size of\nthe enterprise. Such a fee must be levied in a non-discriminatory\nmanner and shall not exceed the cost of processing the\napplication.
\nDatabase: the proposal\nprovided for the creation of a European database to simplify the\nreporting by Member States with regard to seizures and stopped\nshipments. Data should, where possible, be in an aggregated and\nanonymised manner and in the least intrusive manner as regards the\nprocessing of personal data, taking into account the state of\nthe art of privacy-enhancing technologies and the principle of data\nlimitation.
\nThe kind of data which can be stored in the European\ndatabase would be established through delegated acts.
\nThe Commission must make publicly available, in a\nclear, comprehensive and understandable manner, information\nconcerning the European database.
\nExchange and processing of personal data:\nRegulation (EC) No 273/2004 envisages the\nprocessing of information, including the processing of\npersonal data, for the purposes of enabling the competent\nauthorities to monitor the placing on the market of drug precursors\nand to prevent the diversion of scheduled substances. However, the\namended text specified that the processing\nof personal data should be carried out in a manner\ncompatible with EU legislation on data protection and, in\nparticular, with requirements relating to data quality,\nproportionality, purpose limitation, and rights to information,\naccess, rectification of data, erasure and blocking, organisational\nand technical measures and international transfers of personal\ndata.
\nOperators must not disclose any personal data\ncollected pursuant to this Regulation other than to the competent\nauthorities.
\nSeizure of certain substances: competent authorities will have the power where\nnecessary, to detain and seize consignments to prevent the use of\nspecific non-scheduled substances for the illicit\nmanufacture of narcotic drugs or psychotropic\nsubstances.
\nCommunication from Member States: to permit any necessary adjustments to the\narrangements for monitoring trade in scheduled substances and\nnon-scheduled substances, the competent authorities in each\nMember State shall communicate to the Commission in electronic\nform via the European database all relevant information on the\nimplementation of the monitoring measures laid down in the\nRegulation, in particular as regards substances used for the\nillicit manufacture of narcotic drugs or psychotropic substances\nand methods of diversion and illicit manufacture, and their licit\ntrade.
\nThe Commission will be empowered to adopt delegated\nacts specifying the conditions and requirements concerning the\ninformation to be provided in this context. .
\nDelegated acts regarding the processing of personal\ndata: the scope of the delegation of\npower has been redefined so that the Commission would also be\nempowered to adopt delegated acts on:
\n\n· \nthe categories of personal data which can be\nprocessed by Member States and operators pursuant to Regulation\n(EC) No 273/2004;
\n\n· \nthe categories of personal data which can be\nstored in the European database, and
\n\n· \nthe safeguards for the processing of personal\ndata.
\nThe Commission should seek the opinion of the European\nData Protection Supervisor when preparing delegated acts relating\nto the processing of personal data.
\nThe power to adopt delegated acts will be conferred on\nthe Commission for a period of five years and\nshall be tacitly extended for periods of an identical duration,\nunless the European Parliament or the Council opposes such\nextension not later than three months before the end of each\nperiod.
\nReview: the Commission\nmust submit a report to the European Parliament and to the Council\non the implementation and functioning of the Regulation, and\nin particular on the possible need for additional action to monitor\nand control suspicious transactions with non-scheduled\nsubstances.
\nAnnex: the list of\nscheduled substances has been amended.
\nPURPOSE: to prevent the diversion from the EU-internal\ntrade of acetic anhydride, the main drug precursor for\nheroin, by extending the registration requirement to include users\nof the substance, and amending Regulation (EC) No 273/2004 on drug\nprecursors.
\nLEGISLATIVE ACT: Regulation (EU) No 1258/2013 of the\nEuropean Parliament and of the Council amending Regulation (EC) No\n273/2004 on drug precursors.
\nCONTENT: this Regulation establishes harmonised\nmeasures for the intra-Union control and monitoring of certain\nsubstances frequently used for the illicit manufacture of narcotic\ndrugs or psychotropic substances with a view to preventing the\ndiversion of such substances.
\nDefinitions: several\ndefinitions have been amended such as:
\nRegistration: more\ndetailed rules on registration should be introduced to ensure\nuniform conditions of registration in all Member States for\nscheduled substances as laid down in the Regulation (EC) No\n273/2004. For acetic anhydride, in addition to operators\nusers should also be subject to a registration\nrequirement.
\nLicence: provisions as\nregards holding a licence for the placing on the market of a\nscheduled substance has been clarified. The competent authorities\nmay either limit the validity of the licence to a period not\nexceeding three years.
\nFor acetic anhydride,\noperators shall obtain registration from the competent authorities\nof the Member State in which they are established before placing\nthe substance on the market. From 1 July 2015, users\nshall obtain a registration from the competent authorities of the\nMember State in which they are established before possessing this\nsubstance.
\nWhen considering whether to grant registration, the\ncompetent authorities shall take into account, in particular, the\ncompetence and integrity of the applicant. They shall refuse\nregistration if there are reasonable grounds for doubting the\nsuitability and reliability of the applicant or of the officer\nresponsible for the trade in scheduled substances.
\nFees: operators and\nusers shall obtain a licence from the competent\nauthorities of the Member State in which they are\nestablished before they may possess or place on the market\nscheduled substances. It is also provided that competent\nauthorities may require operators and users to pay a fee for the\napplication for a licence or for registration.
\nWhere a fee is levied, competent authorities must\nconsider adjusting the level of the fee depending on the size of\nthe enterprise. Such a fee must be levied in a non-discriminatory\nmanner and shall not exceed the cost of processing the\napplication.
\nDatabase: a European\ndatabase on drug precursors shall be created to simplify the\nreporting by Member States with regard to seizures and stopped\nshipments, where possible in an aggregated and anonymised manner\nand in the least intrusive manner as regards the processing\nof personal data, taking into account the state of the art of\nprivacy-enhancing technologies and the principle of data\nlimitation. The European database should also serve as a European\nregister of operators and users holding a licence or registration\nwhich will facilitate verification of the legitimacy of commercial\ntransactions involving scheduled substances, and should enable\noperators to provide the competent authorities with information\nabout their transactions involving scheduled substances.
\nThe kind of data which can be stored in the European\ndatabase would be established through delegated acts.
\nExchange and processing of\npersonal data: Regulation (EC) No 273/2004 envisages the\nprocessing of information, including the processing of\npersonal data, for the purposes of enabling the competent\nauthorities to monitor the placing on the market of drug precursors\nand to prevent the diversion of scheduled substances. However, it\nis specified that the processing of personal data\nshould be carried out in a manner compatible with EU\nlegislation on data protection and, in particular, with\nrequirements relating to data quality, proportionality, purpose\nlimitation, and rights to information, access, rectification of\ndata, erasure and blocking, organisational and technical measures\nand international transfers of personal data.
\nOperators must not disclose any personal data\ncollected pursuant to this Regulation other than to the competent\nauthorities.
\nNotification of the competent\nauthorities:\noperators shall notify the competent authorities immediately of any\ncircumstances, such as unusual orders or transactions involving\nscheduled substances to be placed on the market, which suggest that\nsuch substances might be diverted for the illicit manufacture of\nnarcotic drugs or psychotropic substances. To that end, operators\nshall provide any available information allowing the competent\nauthorities to verify the legitimacy of the relevant order or\ntransaction.
\nCompetent authorities will have the power where\nnecessary, to detain and seize consignments to prevent the\nuse of specific non-scheduled substances for the illicit\nmanufacture of narcotic drugs or psychotropic\nsubstances.
\nCommunication from Member\nStates: to permit\nany necessary adjustments to the arrangements for monitoring trade\nin scheduled substances and non-scheduled substances, the competent\nauthorities in each Member State shall communicate to the\nCommission in electronic form via the European database all\nrelevant information on the implementation of the monitoring\nmeasures laid down in the Regulation, in particular as regards\nsubstances used for the illicit manufacture of narcotic drugs or\npsychotropic substances and methods of diversion and illicit\nmanufacture, and their licit trade.
\nThe Commission shall be empowered to adopt delegated\nacts concerning the requirements and conditions for operators to\nprovide information.
\nReport: the Commission\nshall, by 31 December 2019, submit a report to the European\nParliament and to the Council on the implementation and functioning\nof this Regulation, and in particular on the possible need for\nadditional action to monitor and control suspicious transactions\nwith non-scheduled substances.
\nAnnex: acetic anhydride,\ncurrently scheduled in category 2 of Annex I to Regulation (EC) No\n273/2004, should be included in a new subcategory 2A of\nAnnex I thereto to allow increased control of its trade. The\nremaining substances of category 2 of Annex I to Regulation (EC) No\n273/2004 should be listed as subcategory 2B of Annex I\nthereto.
\nENTRY INTO FORCE: 30.12.2013.
\nDELEGATED ACTS: the power to adopt delegated acts\nshall be conferred on the Commission for a period of five years\nfrom 30 December 2013. The delegation of power shall be tacitly\nextended for periods of an identical duration, unless the European\nParliament or the Council opposes such extension.
\nThe European Parliament or the Council may raise\nobjections to a delegated act within a period of two months from\nthe date of notification (this may be extended by two months.) If\nthe European Parliament or Council express objections, the\ndelegated act will not enter into force.
\n