Awaiting Parliament 1st reading / single reading / budget 1st stage
Next event: Vote in plenary scheduled 2014/04/17 more...
- Council Meeting 2014/01/28
- Vote in committee, 1st reading/single reading 2014/03/10
- Committee report tabled for plenary, 1st reading/single reading 2014/03/13
Role | Committee | Rapporteur | Shadows |
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Opinion | ENVI | ANTONESCU Elena Oana (EPP) | |
Lead | LIBE | PROTASIEWICZ Jacek (EPP) | HEDH Anna (S&D), WEBER Renate (ALDE), SCHLYTER Carl (Verts/ALE), KIRKHOPE Timothy (ECR), TRIANTAPHYLLIDES Kyriacos (GUE/NGL) |
Legal Basis TFEU 114
Activites
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2014/04/17
Vote in plenary scheduled
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2014/03/13
Committee report tabled for plenary, 1st reading/single reading
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A7-0172/2014
summary
The Committee on Civil Liberties, Justice and Home Affairs adopted the report by Jacek PROTASIEWICZ (EPP, PL) on the proposal for a regulation of the European Parliament and of the Council on new psychoactive substances. The committee recommended that Parliament’s position in first reading following the ordinary legislative procedure should amend the Commission position as follows: Information exchange: to enable a more effective response to the rapid emergence and spread of new psychoactive substances across the Union, Members considered that the information exchange mechanism (the 'Early Warning System') should be maintained and further developed, in particular as regards to the collection and management of data on the detection and identification of new psychoactive substances. The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) should issue health alerts to all Member States, through the system for rapid exchange of information on new psychoactive substances if, on the basis of information received on a new psychoactive substances, this seemed to cause public health concerns. Those health alerts should also contain information regarding prevention, treatment and harm reduction measures that could be taken to address the risk of the substance. Immediate risks to public health, and market restrictions: the proposal provided that the Commission should, by means of a Decision, prohibit the making available on the market to consumers of the new psychoactive substance if, based on existing information, it poses immediate risks to public health. The market restriction should not exceed a period of twelve months. Members proposed that if the level of health, social and safety risks posed by the new psychoactive substance justified the introduction of permanent restriction measures, the duration of the temporary market restriction may be extended by a further 12 months, in the absence of permanent market restriction. Low risks at Union level: the Commission should not adopt restriction measures on a new psychoactive substance if, based on the existing evidence and on prescribed criteria, it posed, overall, low health, social and safety risks at Union level. However, where the decision to not adopt restriction measures on a new psychoactive substance that was considered to pose overall low health, social and safety risk at Union level was based on a partial or total lack of evidence, it should include an appropriate reference in the justification. The report also stressed that Members States should not be prohibited from introducing or maintaining the more stringent measures regarding the specific risks the new psychoactive substance posed within their territory, independently of the classification of the substance by the Commission as posing low or moderate risks on the EU level. The relevant laws, regulations or administrative provisions should be communicated to the Commission and the other Member States should be informed. Authorised use: decisions prohibiting the marketing of new psychoactive substance presenting a serious risk should not impede the free movement in the Union and the production, manufacture, making available on the market of new psychoactive substances for scientific research and development purposes, by duly authorised persons in establishments which were directly under the control of Member States' authorities or specifically approved by them. For all of authorised uses, new psychoactive substances and products containing new psychoactive substances should include directions for use, including cautions, warnings and contraindications with other substances, to be either indicated on the label or included in the accompanying leaflet for the safety of the user. Furthermore, Member States should take any appropriate measures to prevent the diversion to the illicit market of new psychoactive substances used for research and development purposes or for any other authorised uses. Research, analysis, prevention and funding: the amended text provided that financial support and the necessary resources should be provided at Union and national level for the development, sharing and dissemination of information and knowledge on new psychoactive substances. Moreover, the Commission and the Member States should promote the research into new psychoactive substances and ensure cooperation and coordination between networks at national and Union level in order to strengthen understanding of the phenomenon. Prevention schemes as well as measures to raise awareness of the risks posed by psychoactive substances, such as educational information campaigns should be promoted. Evaluation: five years after the entry into force of the Regulation and every five years thereafter, the Commission should: assess the implementation, application and effectiveness of this Regulation and publish a report. In this respect, the Commission, the EMCDDA and Europol should conduct post-risk assessments of new psychoactive substances; evaluate and if appropriate present a proposal for possible classification of groups of the new psychoactive substances in order to counteract the practise of bypassing the legislation in force by slight modifications of the chemical structure of the psychoactive substances.
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A7-0172/2014
summary
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2014/03/10
Vote in committee, 1st reading/single reading
- #3290
- 2014/01/28 Council Meeting
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2013/10/08
Committee referral announced in Parliament, 1st reading/single reading
- #3260
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2013/10/07
Council Meeting
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2013/09/17
Legislative proposal published
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COM(2013)0619
summary
PURPOSE: to approximate the rules relating to new psychoactive substances that are of concern at Union level whilst ensuring a high level of health, safety and consumer protection. PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: new psychoactive substances, which may have numerous commercial and industrial uses, as well as scientific uses, can pose health, social and safety risks when consumed by humans. Consumption of new psychoactive substances appears to be increasing in Europe and use is predominant among young people. According to the 2011 Eurobarometer "Youth attitudes on drugs", 5% of young people in the EU have used such substances at least once in their life, with a peak of 16% in Ireland, and close to 10% in Poland, Latvia and the UK. During the past years, Member States have notified an increasing number of new psychoactive substances to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). National restriction measures, which can vary depending on the Member State and on the substance, lead to obstacles to trade in licit uses, fragmentation, an uneven level playing field and legal uncertainties for economic operators, and make it difficult for companies to operate across the internal market. They make research more cumbersome, hampering the development of new uses for these substances. In this context, the case for swifter, more effective and more proportionate action on new psychoactive substances at EU level is compelling, considering the rapid changes in this market, which put national authorities under pressure to act. The Commission Communication "Towards a stronger European response to drugs", adopted in October 2011, identified the spread of new psychoactive substances as one of the most challenging developments in drugs policy requiring a firmer EU response. IMPACT ASSESSMENT: taking into account the results of impact assessment, the following solutions are preferred: (i) a more graduated and better targeted set of restriction measures on new psychoactive substances, which should not hinder the industrial use of substances; (ii) restriction measures should be introduced earlier; (iii) substances suspected to pose immediate public health risks should be subjected to temporary restrictions; (iv) restriction measures should be proportionate to a better determined level of risk of substances; (v) restriction measures should be introduced through a quicker procedure. LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union. CONTENT: this proposed Regulation – which is intended to replace Council Decision 2005/387/JHA - aims at ensuring that trade in new psychoactive substances having industrial and commercial uses is not hindered and that the functioning of this market is improved, while the health and safety of individuals are protected from harmful substances, which cause concern at the EU level. The proposal is accompanied by a proposal for a Directive amending Council Framework Decision 2004/757/JHA laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking. The main elements of the proposal are as follows: Exchange of information and temporary consumer market restrictions: this proposal sets up a robust system: (i) for exchanging rapidly information on new psychoactive substances emerging on the market, including on their commercial and industrial uses, for assessing the risks of substances that cause EU-wide concern and; (ii) for withdrawing from the market those substances that pose risks. The substances suspected to pose immediate public health risk will be withdrawn from the consumer market temporarily, pending their risk assessment. Once the risk assessment is completed, measures will be taken proportionate to the risks of substances. The proposal establishes the respective roles of Member States, the EMCDDA and Europol in the process of exchange of information on new psychoactive substances. Low and moderate risks: according to the proposal, no restriction measures shall be introduced on new psychoactive substances posing low health, social and safety risks and provides a definition of low risks. For substances posing moderate risks and permanent consumer market restrictions, they cannot be sold to consumers (except for uses specifically authorised, for instance by medicines legislation) but their trade is allowed for commercial and industrial purposes as well as for scientific research and development. Severe risks: the proposal empowers the Commission to prohibit the production, manufacture, making available on the market, transport, importation or exportation of new psychoactive substances which pose severe health, social and safety risks, and provides a definition of severe risks. New psychoactive substances posing severe risks will be subjected to permanent market restriction, covering both the consumer and commercial markets, and their use will only be possible for specifically authorised industrial and commercial purposes, as well as for scientific research and development. In addition, these substances will be subjected to EU criminal law provisions. Sanctions: the proposal establishes the obligation for the Member States to lay down the rules on administrative sanctions applicable to infringements to market restriction, and to ensure that they are effective, proportionate and dissuasive. BUDGETARY IMPLICATION: the proposal has no direct impact on the EU budget and does not create new tasks for the EMCDDA, Europol, the European Medicines Agencies, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA).
- DG {'url': 'http://ec.europa.eu/justice/', 'title': 'Justice'}, REDING Viviane
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COM(2013)0619
summary
Documents
- Legislative proposal published: COM(2013)0619
- Debate in Council: 3290
- Committee report tabled for plenary, 1st reading/single reading: A7-0172/2014
Amendments | Dossier |
43 |
2013/0305(COD)
2014/01/10
ENVI
43 amendments...
Amendment 14 #
Proposal for a regulation Citation 1 Having regard to the Treaty on the Functioning of the European Union, and in particular
Amendment 15 #
Proposal for a regulation Recital 3 (3) Member States' competent public authorities introduce various restriction measures on these new psychoactive substances to address the risks that they pose or may pose when consumed. As new psychoactive substances are often used for scientific research and development purposes and in the production of various goods or of other substances which are used for manufacturing goods, such as medicines, industrial solvents, cleaning agents, goods in the hi-tech industry, restricting their access for this use can have an important impact on economic operators, potentially disrupting their business activities in the internal market
Amendment 16 #
Proposal for a regulation Recital 4 (4) The increasing number of new psychoactive substances available in the internal market, their growing diversity, the speed with which they emerge on the market, the different risks that they may pose when consumed by humans
Amendment 17 #
Proposal for a regulation Recital 5 (5) Restriction measures vary significantly in different Member States, meaning that economic operators that use them in the production of various goods must comply, in the case of the same new psychoactive substance, with different requirements,
Amendment 18 #
Proposal for a regulation Recital 7 (7) The disparities
Amendment 19 #
Proposal for a regulation Recital 7 (7) The disparities between the various restriction measures applied to new psychoactive substances can also lead to displacement of harmful new psychoactive substances between the Member States, hampering efforts to restrict their availability to consumers
Amendment 20 #
Proposal for a regulation Recital 7 (7) The disparities between the various restriction measures applied to new psychoactive substances can also lead to displacement of harmful new psychoactive substances between the Member States, hampering efforts to restrict their availability to consumers and undermining consumer protection across the Union. The disparities in the provisions governing restrictions on the trade in psychoactive substances significantly increase the risk of illegal smuggling channels arising for these substances and lead to laws being circumvented in order to obtain the necessary permits.
Amendment 21 #
Proposal for a regulation Recital 8 (8) Such disparities are expected to increase as Member States continue to pursue divergent approaches to addressing new psychoactive substances. Therefore, the obstacles to trade and market fragmentation, and the lack of legal clarity and of a level playing field are expected to increase, further hindering the functioning of the internal market and the protection of public health and safety.
Amendment 22 #
Proposal for a regulation Recital 10 Amendment 23 #
Proposal for a regulation Recital 10 (10) New psychoactive substances and mixtures should be able to move freely in the Union when intended for commercial and industrial use, as well as for scientific research and development. This Regulation should establish rules for introducing restrictions to this free movement. In addition, however, illicit distribution of these substances and mixtures should be prevented.
Amendment 24 #
Proposal for a regulation Recital 13 (13) Any Union action on new psychoactive substances should be based on scientific evidence, as well as on Member States’ wide experience in this area, and subject to a specific procedure. Based on the information notified by Member States, a report should be drawn up on new psychoactive substances that give rise to concerns across the Union. The report sh
Amendment 25 #
Proposal for a regulation Recital 13 a (new) (13a) Taking into consideration international developments regarding drug policy reform and control of illicit substances, an objective impact assessment based upon scientific evidence is required to evaluate the effectiveness of different control and regulatory options, including current restricting policies, in order to safeguard public health, consumer safety and human rights of individual users.
Amendment 26 #
Proposal for a regulation Recital 17 (17) Certain new psychoactive substances pose immediate public health risks, requiring urgent action. Therefore, their availability to consumers should be restricted for a
Amendment 27 #
Proposal for a regulation Recital 18 Amendment 28 #
Proposal for a regulation Recital 24 (24) The mechanism for rapid exchange of information on new psychoactive substances has proved to be a useful channel for sharing information on new psychoactive substances, on new trends in the use of controlled psychoactive substances and on related public health warnings. That mechanism should be further strengthened to enable a more effective response to the rapid emergence and spread of new psychoactive substances across the Union, as well as to raise the level of public awareness about the risks associated with their use for any purposes, other than commercial, industrial or scientific.
Amendment 29 #
Proposal for a regulation Recital 29 (29) Prevention, treatment and harm reduction measures are important for addressing the growing use of new psychoactive substances and their potential risks. The internet, which is one of the important distribution channels through which new psychoactive substances are advertised and sold, should be used for disseminating information on the health, social and safety risks that they pose, and for the prevention of misuse and abuse.
Amendment 30 #
Proposal for a regulation Recital 29 a (new) (29a) The Commission and the Member States should also promote educational and awareness-rising activities, initiatives and campaigns, targeting the health, social and safety risks associated with the misuse and abuse of new psychoactive substances.
Amendment 31 #
Proposal for a regulation Recital 32 (32) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to a rapid increase in the number of reported fatalities or incidents posing a grave threat to health in several Member States associated with the consumption of the new psychoactive substance concerned, imperative grounds of urgency so require.
Amendment 32 #
Proposal for a regulation Recital 32 (32) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to a rapid increase in the number of reported fatalities and severe health consequences in several Member States associated with the consumption of the new psychoactive substance concerned, imperative grounds of urgency so require.
Amendment 33 #
Proposal for a regulation Article 3 – paragraph 1 New psychoactive substances and mixtures shall move freely in the Union for commercial and industrial use only, as well as for scientific research and development purposes.
Amendment 34 #
Proposal for a regulation Article 6 – paragraph 1 1. Where the EMCDDA and Europol, the Member States or the Commission, consider that the information shared on a new psychoactive substance notified by several Member States gives rise to concerns across the Union because of the health, social and safety risks that the new psychoactive substance may pose, the EMCDDA and Europol shall draw up a joint report on the new psychoactive substance.
Amendment 35 #
Proposal for a regulation Article 6 – paragraph 1 1. Where the EMCDDA and Europol, or the Commission, consider that the information shared on a new psychoactive substance notified by
Amendment 36 #
Proposal for a regulation Article 6 – paragraph 2 – point b (b) the chemical and physical identity of the new psychoactive substance, the methods and, if known, the chemical precursors used for its manufacture or extraction, and any other new psychoactive substance or groups of substances with a similar chemical structure that have emerged;
Amendment 37 #
Proposal for a regulation Article 6 – paragraph 2 – point c (c) the commercial and industrial use of the new psychoactive substance, as well as its use for scientific research and development purposes or any other known use;
Amendment 38 #
Proposal for a regulation Article 6 – paragraph 2 – point d (d) the human and veterinary medical use of the new psychoactive substance, including as an active substance in a medicinal
Amendment 39 #
Proposal for a regulation Article 6 – paragraph 6 – subparagraph 1 The EMCDDA and Europol shall submit the joint report to the Commission within eight weeks from the request for additional information referred to in paragraph 3 and 4.
Amendment 40 #
Proposal for a regulation Article 9 – paragraph 1 – point a (a) reported fatalities and severe health consequences associated with the consumption of the new psychoactive substance in several Member States, related to the
Amendment 41 #
Proposal for a regulation Article 9 – paragraph 1 – point b (b) the prevalence and patterns of use of the new psychoactive substance in the general population and in specific groups, in particular frequency, quantities and modality of use, its availability to consumers and the potential for diffusion, which indicate that the scale of the risk is moderate or considerable.
Amendment 42 #
Proposal for a regulation Article 9 – paragraph 2 – subparagraph 2 Amendment 43 #
Proposal for a regulation Article 10 – paragraph 2 – subparagraph 1 – point a (a) the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity, abuse liability and dependence-producing potential, in particular injury, disease, aggression, and physical and mental impairment;
Amendment 44 #
Proposal for a regulation Article 10 – paragraph 2 – subparagraph 1 – point c (c) the risks to public safety, in particular the spread of diseases, including transmission of blood borne viruses, the consequences of physical and mental impairment on the ability to drive, the impact of the manufacture, transport and disposal of the new psychoactive substance and associated waste materials on the environment.
Amendment 45 #
Proposal for a regulation Article 11 – paragraph 1 – point a (a) the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity, abuse liability and dependence-producing potential, is
Amendment 46 #
Proposal for a regulation Article 11 – paragraph 1 – point c (c) the risks to public safety are limited, in particular low risk of spread of diseases, including transmission of blood borne viruses, non-existent or low consequences of physical and mental impairment on the ability to drive, and the impact of the manufacture, transport and disposal of the new psychoactive substance and associated waste materials on the environment is low.
Amendment 47 #
Proposal for a regulation Article 12 – paragraph 1 – point c (c) the risks to public safety are moderate, in particular sporadic spread of diseases, including transmission of blood borne viruses, moderate consequences of physical and mental impairment on the ability to drive, and the manufacture, transport and disposal of the new psychoactive substance and associated waste materials results in environmental nuisance.
Amendment 48 #
Proposal for a regulation Article 13 – paragraph 1 – point a (a) the harm to health caused by the
Amendment 49 #
Proposal for a regulation Article 13 – paragraph 1 – point c (c) the risks to public safety are severe, in particular significant spread of diseases, including transmission of blood borne viruses, severe consequences of physical and mental impairment on the ability to drive, and the manufacture, transport and disposal of the new psychoactive substance and associated waste materials result in environmental harm.
Amendment 50 #
Proposal for a regulation Article 13 – paragraph 2 a (new) 2a. The Commission shall not adopt the draft implementing act where no opinion is delivered by the committee referred to in the Article 19(1).
Amendment 51 #
Proposal for a regulation Article 13 a (new) Article 13a Information to individual consumers (a) The Commission shall make readily available to the public, especially youth, science-based information on health, social and safety risks of the new psychoactive substances as referred to in articles 11, 12.1 and 13.1. (b) With regard to new psychoactive substances of low risk as referred to in article 11, the Commission shall also make widely available to the public, especially youth, information on usage effects and safe usage, as well as, harm reduction guidelines. (c) With regard to new psychoactive substances of moderate or severe risks as referred to in articles 12.1 and 13.1, the Commission shall also make widely available to the public, especially youth, information on identification and early warning, prevention, treatment and harm reduction measures. (d) The Commission shall collaborate with National Focal Points within the European Information network on Drugs and Drug Addiction ("Reitox") and other harm reduction and addiction treatment associations for providing accurate and timely information to individual users.
Amendment 52 #
Proposal for a regulation Article 16 – paragraph 1 Where new information and evidence is available on the risks posed by a new psychoactive substance the health, social and safety risks of which have already been determined in accordance with Article 10, the Commission or the Member States shall request the EMCDDA to update the risk assessment report drafted on the new psychoactive substance and shall re- examine the level of risks that the new psychoactive substance poses.
Amendment 53 #
Proposal for a regulation Article 17 – paragraph 1 Member States shall lay down the rules on sanctions applicable to infringements of the Decisions referred to in Article 9(1), Article 12(1) and Article 13(1), and to illicit distribution of new psychoactive substances or mixtures, and shall take all necessary measures to ensure that they are implemented. The sanctions provided for shall be effective, proportionate and dissuasive. Member States shall notify those rules on sanctions and any subsequent amendment affecting those provisions to the Commission without delay.
Amendment 54 #
Proposal for a regulation Article -20 (new) Article -20 National scope Where the EU has not acted, or the Commission has decided not to adopt any restriction measures based on the EMCDDA risk assessment of a new psychoactive substance, individual Member States may maintain or introduce in their territory restrictions on the making available of the new psychoactive substance on the market to consumers, without prejudice to legitimate trade in industry, or to medicinal products or veterinary medicinal products that have obtained a marketing authorisation. Member States shall ensure that such restrictions are immediately communicated to the Commission, the EMCDDA and Europol.
Amendment 55 #
Proposal for a regulation Article 20 – paragraph 1 The Commission and the Member States shall support the development, sharing and dissemination of information and knowledge on new psychoactive substances. They shall do so by facilitating cooperation between the EMCDDA, other Union agencies, and scientific and research centres, and by regularly providing these bodies with up to date information on such substances wherever possible.
Amendment 56 #
Proposal for a regulation Article 21 – paragraph 1 The EMCDDA and Europol shall report annually to the Commission and Member States on the implementation of this Regulation, and such reports will be published on a website and made public.
source: PE-526.242
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