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Parisse"/> <TLCRole currentId="poc" href="/ontology/roles/proofOfConcept" showAs="Proof of concept"/> </references> <proprietary currentId="proprietary_1" source="#parisse"> <!-- indicate the element that are, in the context of this xml file, globally numbered --> <ep:noIntraPrefix xmlns:ep="www.europarl.eu.int" currentId="proprietary_1__ep:noIntraPrefix_1" element="tblock;authorialNote"/> </proprietary> </meta> <coverPage currentId="coverPage"> <container currentId="coverPage__container_1" name="titlePage"> <p currentId="coverPage__container_1__p_1"><img currentId="coverPage__container_1__p_1__img_1" src="eu/europeanCommission/img/commission/logo/@logo-png"/></p> <p currentId="coverPage__container_1__p_2"><organization currentId="coverPage__container_1__p_2__organization_1" refersTo="#eu.europa.europarl.codict_institution-10">EUROPEAN COMMISSION</organization></p> <p currentId="coverPage__container_1__p_3"><legislature currentId="coverPage__container_1__p_3__legislature_1">2009-2014</legislature></p> </container> <container currentId="coverPage__container_2" name="repeatable"> <block currentId="coverPage__container_2__block_1" name="coverFooter"> <inline currentId="coverPage__container_2__block_1__inline_1" name="language" refersTo="#FRBRExpression__FRBRlanguage_1">EN</inline> </block> </container> </coverPage> <preface currentId="preface"> <container currentId="preface__container_1" name="mainDoc"> <p currentId="preface__container_1__p_1">Brussels, <docDate currentId="preface__container_1__p_1__docDate_1" date="2013-09-17">17.9.2013</docDate></p> <p currentId="preface__container_1__p_2"><docNumber currentId="preface__container_1__p_2__docNumber_1">COM(2013) 619 final</docNumber></p> <p currentId="preface__container_1__p_3"><docketNumber currentId="preface__container_1__p_3__docketNumber_1">2013/0305 (COD)</docketNumber></p> </container> <longTitle currentId="preface__ltti_1"> <p><docStage currentId="preface__ltti_1__p_1__docStage_1">Proposal for a</docStage> <docType currentId="preface__ltti_1__p_1__docType_1">REGULATION</docType><docAuthority currentId="preface__ltti_1__p_1__docAuthority_1"> OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL</docAuthority> <docPurpose currentId="preface__ltti_1__p_1__docPurpose_1">on new psychoactive substances</docPurpose></p> </longTitle> <container currentId="preface__container_2" name="relevance"> <p>(Text with EEA relevance)</p> </container> <container currentId="preface__container_3" name="docs"> <p currentId="preface__container_3__p_1">{SWD(2013) 319 final} </p> <p currentId="preface__container_3__p_2">{SWD(2013) 320 final}</p> </container> </preface> <collectionBody> <component currentId="collectionBody__component_1"> <documentRef currentId="collectionBody__component_1__documentRef" href="#component_1" showAs="Explanatory memorandum"/> </component> <component currentId="collectionBody__component_2"> <documentRef currentId="collectionBody__component_2__documentRef" href="#component_2" showAs="Proposal"/> </component> <component currentId="collectionBody__component_3"> <documentRef currentId="collectionBody__component_3__documentRef" href="#component_3" showAs="Financial statement"/> </component> </collectionBody> </documentCollection> <components> <component currentId="component_1"> <doc name="explanation" contains="originalVersion"> <meta> <identification source="
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http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/jha/126879.pdf" ;>
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/jha/126879.pdf </a></p> </authorialNote>, the Council requested the Commission to table a legislative proposal revising Council Decision 2005/387/JHA. A legislative proposal on new psychoactive substances is foreseen in the Commission's 2013 Work Programme<authorialNote currentId="doc_1__authorialNote_4" marker="4" placement="bottom"> <p>COM(2012) 629 final.</p> </authorialNote>.</p> <p currentId="doc_1__tblock_1.1__p_5">This proposal for a Regulation aims at improving the functioning of the internal market regarding licit uses of new psychoactive substances, by reducing obstacles to trade, preventing the emergence of such obstacles and increasing legal certainty for economic operators, while reducing the availability of substances that pose risks through swifter, more effective and more proportionate EU action. It is accompanied by a proposal for a Directive amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking<authorialNote currentId="doc_1__authorialNote_5" marker="5" placement="bottom"> <p>OJ L 335, 11.11.2004, p. 8.</p> </authorialNote>. This aims at expanding the scope of application of the Framework Decision to cover the most harmful new psychoactive substances, which pose <u currentId="doc_1__tblock_1.1__p_5__u_1">severe</u> risks. This means that substances that pose severe health, social and safety risks and are, therefore, submitted to permanent market restriction under this proposed Regulation, are also covered, through the proposed amended Framework Decision, by the criminal law provisions applying to controlled drugs.</p> <p currentId="doc_1__tblock_1.1__p_6">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. 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). Between 1997 and 2012 they reported around 290 substances. The number of notified substances tripled between 2009 and 2012 (from 24 to 73). Around 80% of these substances were reported by more than one Member State. The number of substances that can emerge may run into the thousands because many variations of existing or new, still unexploited substances, can be manufactured at relatively low cost. The issue has been further highlighted in the 2012<authorialNote currentId="doc_1__authorialNote_6" marker="6" placement="bottom"> <p>EMCDDA, 2012 <i currentId="doc_1__authorialNote_6__p_1__i_1">Annual report on the state of the drugs problem in Europe</i>; available at:
http://www.emcdda.europa.eu/publications/annual-report/2012 </p> </authorialNote>and 2013<authorialNote currentId="doc_1__authorialNote_7" marker="7" placement="bottom"> <p>EMCDDA, <i currentId="doc_1__authorialNote_7__p_1__i_1">European Drug Report 2013</i>; available at:
http://www.emcdda.europa.eu/edr2013 .</p> </authorialNote>EMCDDA annual reports, as well as in the EMCCDA-Europol "EU drug markets report: a strategic analysis"<authorialNote currentId="doc_1__authorialNote_8" marker="8" placement="bottom"> <p>Available at:
http://www.emcdda.europa.eu/publications/joint-publications/drug-markets </p> </authorialNote>, published in January 2013.</p> <p currentId="doc_1__tblock_1.1__p_7">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. According to the results of snapshot surveys conducted by the EMCDDA, the number of online shops selling new psychoactive substances increased four-fold between 2010 and 2012, to 690.</p> <p currentId="doc_1__tblock_1.1__p_8">The consumption of new psychoactive substances can cause harms to individuals' health and safety, resulting in deaths, injury or disease, and can pose risks to and burdens on society, as it may lead to violent behaviour and crime. These risks are amplified by the fact that many such substances are sold to consumers without appropriate labelling and instructions of use. In some cases they are sold on the black market alongside, or instead of, controlled drugs.</p> <p currentId="doc_1__tblock_1.1__p_9">The rapid emergence and spread of these substances, and the potential risks that they pose, have led national authorities to subject them to various restriction measures. Hundreds such substances or mixtures of substances have been subjected to different restriction measures in the Member States in the past years. Such national measures disrupt trade in licit uses of these substances. Around a fifth of the substances notified by the Member States have other uses (but information on such uses is not collected systematically across the EU).</p> <p currentId="doc_1__tblock_1.1__p_10">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. They have a chain-reaction impact on operators in different markets, because such substances are used in the production of other substances or mixtures, which in turn are used for manufacturing various goods. As the market for new psychoactive substances is likely to grow, so will these obstacles to licit trade.</p> <p currentId="doc_1__tblock_1.1__p_11">In order to facilitate the functioning of the internal market while protecting consumers from harmful new psychoactive substances, EU-level action shall ensure the free movement of new psychoactive substances for commercial and industrial use, and for scientific research and development, and provide for a graduated set of restriction measures for substances posing risks, proportionate to their level of risk.</p> <p currentId="doc_1__tblock_1.1__p_12">This proposal, therefore, sets up a robust system 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 for withdrawing from the market those substances that pose risks.</p> <p currentId="doc_1__tblock_1.1__p_13">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. While no restrictions will be introduced at the EU level on substances posing low health, social and safety risks, substances posing moderate risks will be subjected to consumer market restriction, which means that 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.</p> <p currentId="doc_1__tblock_1.1__p_14">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, as explained above, these substances will be subjected to EU criminal law provisions under the accompanying proposal for a Directive amending the Framework Decision on illicit drug trafficking.</p> <p currentId="doc_1__tblock_1.1__p_15">In relation to new psychoactive substances on which the EU has not acted, Member States may introduce national technical regulations, in full compliance with the EU provisions preventing the emergence of unjustified barriers to trade<authorialNote currentId="doc_1__authorialNote_9" marker="9" placement="bottom"> <p>Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society Services, OJ L 204, 21.7.1998, p. 37.</p> </authorialNote>.</p> </tblock> <tblock currentId="doc_1__tblock_1.2"> <num>1.2.</num> <heading currentId="doc_1__tblock_1.2__heading">Legal context</heading> <p currentId="doc_1__tblock_1.2__p_1">Soon after a borderless internal market was created, and following the emergence and rapid spread of synthetic drugs, such as amphetamines and ecstasy, it became clear that the effectiveness of national actions is limited and that EU action was necessary to contain the spread of harmful substances. The EU Joint Action 97/396/JHA concerning the information exchange, risk assessment and the control of new synthetic drugs<authorialNote currentId="doc_1__authorialNote_10" marker="10" placement="bottom"> <p>OJ L 167, 25.6.1997, p.1.</p> </authorialNote>was adopted in 1997 to address this problem.</p> <p currentId="doc_1__tblock_1.2__p_2">Council Decision 2005/387/JHA, which repealed Joint Action 97/396/JHA, established an EU-wide system for tackling new psychoactive substances (synthetic and natural) that raise concern at EU level. It lays down rules on the exchange of information on these substances between Member States, coordinated by the EMCDDA and Europol, on the assessment of their risks and the submission to control and criminal penalties across the EU of those substances that pose risks.</p> <p currentId="doc_1__tblock_1.2__p_3">The Commission's assessment report<authorialNote currentId="doc_1__authorialNote_11" marker="11" placement="bottom"> <p>COM(2011) 430 final and SEC(2011) 912 final.</p> </authorialNote>of July 2011, concluded that, while Council Decision 2005/387/JHA is a useful instrument, it is inadequate, considering the scale and complexity of the problem, and it, therefore, requires revision. This is because it involves a lengthy process, it is reactive and it lacks options to the submission to control and criminal penalties.</p> <p currentId="doc_1__tblock_1.2__p_4">This Regulation replaces Council Decision 2005/387/JHA.</p> </tblock> </tblock> <tblock currentId="doc_1__tblock_2"> <num>2.</num> <heading currentId="doc_1__tblock_2__heading">RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENT</heading> <tblock currentId="doc_1__tblock_2.1"> <num>2.1.</num> <heading currentId="doc_1__tblock_2.1__heading">Consultations with interested parties</heading> <p currentId="doc_1__tblock_2.1__p_1">Broad stakeholder and expert consultations together with a web-based public consultation and an external study have informed the preparatory work for this proposal. The Commission involved all Member States in the assessment of the functioning of Council Decision 2005/387/JHA, through written consultation. In the context of the external study, the Commission collected and examined the views of a host of national authorities (responsible for drug legislation, justice and health ministries, health institutes and law enforcement agencies) and of EU agencies involved in the implementation of Council Decision 2005/387/JHA. It also collected and examined the views of international organisations (including the World Health Organisation), civil society organisations, economic operators in various markets, research institutes and academic experts.</p> <p currentId="doc_1__tblock_2.1__p_2">The survey conducted among Member States in the context of the assessment report showed that a large number of Member States view the lack of alternatives to control and criminal penalties in the current instrument as inadequate and suggest that a wider range of options should be considered, backed by administrative law. Moreover, all Member States agreed that swifter action is necessary to address new psychoactive substances (including temporary measures) and that the current decision-making process is too slow.</p> <p currentId="doc_1__tblock_2.1__p_3">During the two experts' meetings organised by the Commission on 15 December 2011 and 1 March 2012, academic experts and practitioners stressed that the Council Decision and product safety legislation are inadequate to tackle the large number of new psychoactive substances emerging on the market, whose effects and risks are mostly unknown. They pointed out that new legislation on new psychoactive substances should be calibrated to the different levels of risks posed by these substances. Certain participants expressed concern that too rigorous policy responses (such as blanket restrictions on entire groups of substances or a wide recourse to criminal penalties) could have adverse effects. Such adverse effects include a displacement of substances from the licit to the illicit market, a replacement of the substances withdrawn from the market with other substances, possibly even more harmful, and rendering such substances inaccessible for research.</p> <p currentId="doc_1__tblock_2.1__p_4">Surveys and interviews were conducted with economic operators which manufacture such substances for various industrial uses, and with their trade associations, as well as with those who produce or distribute new psychoactive substances for recreational use. Recreational users of new psychoactive substances were also interviewed.</p> <p currentId="doc_1__tblock_2.1__p_5">The views of young people (15-24 years' old) were collected through the 2011 Eurobarometer "Youth attitudes on drugs". Almost half of respondents (47%) thought that only those substances which are proved to pose risks to health should be restricted, while 34% held that all substances which imitate the effects of controlled drugs should be restricted.</p> <p currentId="doc_1__tblock_2.1__p_6">The Commission run a public consultation on drugs policy from 28 October 2011 to 3 February 2012. It included a question on regulatory measures that the EU should develop to contain the spread of new psychoactive substances. Among the 134 replies, most stressed the need for more rapid action on new psychoactive substances and warned against imposing criminal sanctions indiscriminately. The European Economic and Social Committee has urged<authorialNote currentId="doc_1__authorialNote_12" marker="12" placement="bottom"> <p>OJ C 229, 31.7.2012, p. 85.</p> </authorialNote>the Commission to explore options that avoid making the personal use of such substances a criminal offence.</p> </tblock> <tblock currentId="doc_1__tblock_2.2"> <num>2.2.</num> <heading currentId="doc_1__tblock_2.2__heading">Impact Assessment</heading> <blockList currentId="doc_1__tblock_2.2__lst_1"> <listIntroduction currentId="doc_1__tblock_2.2__lst_1__intro">The Commission conducted an impact assessment of policy alternatives, taking into account the consultation of interested parties and the results of external studies. The impact assessment concluded that the following solution would be preferred:</listIntroduction> <item currentId="doc_1__tblock_2.2__lst_1__item_1"> <num> ??</num> <p>a more graduated and better targeted set of restriction measures on new psychoactive substances, which should not hinder the industrial use of substances.</p> </item> <item currentId="doc_1__tblock_2.2__lst_1__item_2"> <num> ??</num> <p>restriction measures should be introduced earlier and substances suspected to pose immediate public health risks should be subjected to temporary restrictions.</p> </item> <item currentId="doc_1__tblock_2.2__lst_1__item_3"> <num> ??</num> <p>restriction measures should be proportionate to a better determined level of risk of substances, with substances posing moderate risks subjected to restrictions on the consumer market (covered by administrative law), while substances posing severe risks should be subjected to a wider market restriction, as well as being covered by criminal law.</p> </item> <item currentId="doc_1__tblock_2.2__lst_1__item_4"> <num> ??</num> <p>restriction measures should be introduced through a quicker procedure.</p> </item> </blockList> <p>The impact assessment concluded that the most effective way to keep harmful new psychoactive substances out of the market is to apply the EU provisions on illicit drug trafficking to new psychoactive substances that pose severe risks. Applying the same criminal law provisions to controlled drugs and to equally harmful new psychoactive substances, posing severe risks, will help deter trafficking in such substances and the involvement of criminal groups, while streamlining and clarifying the EU legal framework on drugs.</p> </tblock> </tblock> <tblock currentId="doc_1__tblock_3"> <num>3.</num> <heading currentId="doc_1__tblock_3__heading">LEGAL ELEMENTS OF THE PROPOSAL</heading> <tblock currentId="doc_1__tblock_3.1"> <num>3.1.</num> <heading currentId="doc_1__tblock_3.1__heading">The legal base</heading> <p>The proposal 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.</p> <blockList currentId="doc_1__tblock_3.1__lst_1"> <listIntroduction currentId="doc_1__tblock_3.1__lst_1__intro">The proposal is based on Article 114 of the Treaty on the Functioning of the European Union (TFEU), which empowers the European Parliament and the Council to adopt measures for the approximation of the provisions laid down by law, regulation or administrative action in the Member States which have as their object the establishment and functioning of the internal market. Article 114(3) TFEU requires the Commission to ensure a high level of health, safety and consumer protection in its proposals envisaged in paragraph 1 of Article 114 TFEU. This proposal falls within the scope of action to improve the functioning of the internal market for the following reasons:</listIntroduction> <item currentId="doc_1__tblock_3.1__lst_1__item_1"> <num> ??</num> <p>it addresses obstacles to trade in new psychoactive substances having dual uses, while enabling the adoption of measures to restrict the availability to consumers of substances posing risks.</p> </item> <item currentId="doc_1__tblock_3.1__lst_1__item_2"> <num> ??</num> <p>it addresses the lack of legal certainty for economic operators by harmonising the response given to substances causing concern across the EU.</p> </item> <item currentId="doc_1__tblock_3.1__lst_1__item_3"> <num> ??</num> <p>it connects the market for industrial uses of new psychoactive substances to the wider internal market.</p> </item> </blockList> </tblock> <tblock currentId="doc_1__tblock_3.2"> <num>3.2.</num> <heading currentId="doc_1__tblock_3.2__heading">Subsidiarity, proportionality and the respect for fundamental rights</heading> <p currentId="doc_1__tblock_3.2__p_1">There is a clear need for EU action on new psychoactive substances. This is because Member States alone cannot reduce the problems caused by the spread in the internal market of harmful new psychoactive substances and by the proliferation of divergent national responses. Uncoordinated national action in this area can produce adverse knock-on effects, for instance hindrance to the operation of the internal market as far as licit trade in these substances is concerned or displacement of harmful substances from one Member State to another.</p> <p currentId="doc_1__tblock_3.2__p_2">Consequently, EU-level action is necessary to ensure that potentially harmful new psychoactive substances, which cause EU-wide concern, can be identified, assessed and, if they pose risks, withdrawn from the market rapidly in all Member States.</p> <p currentId="doc_1__tblock_3.2__p_3">The proposal is relevant for the following rights and principles enshrined in the EU Charter of Fundamental Rights: the right to health care (notably to a high level of human health protection, Article 35) and to consumer protection (Article 38), the respect of the freedom to conduct a business (Article 16), the right to property (Article 17), the right to an effective remedy and to a fair trial (Article 47), the presumption of innocence and right to defence (Article 48). These rights and freedoms can be subject to limitations, but only under the limits and requirements set by Article 52(1) of the EU Charter.</p> <p currentId="doc_1__tblock_3.2__p_4">The proposal is proportionate and does not go beyond what is necessary to achieve the objectives because it only addresses new psychoactive substances that are a concern at the EU level and because it sets out a calibrated, graduated approach, under which measures are proportionate to the actual risks of substances.</p> <p currentId="doc_1__tblock_3.2__p_5">Explicit safeguards laid down in the instrument itself guarantee that any person whose rights are affected by the implementation of any administrative measures or sanctions pursuant to the Regulation shall have the right to an effective remedy before a tribunal.</p> </tblock> <tblock currentId="doc_1__tblock_3.3"> <num>3.3.</num> <heading currentId="doc_1__tblock_3.3__heading">Choice of instrument</heading> <p>In order to establish uniform rules, ensure clarity of concepts and procedures, and provide legal certainty for market operators, while ensuring that restriction measures are directly applicable in all Member States, a Regulation is the appropriate instrument.</p> </tblock> <tblock currentId="doc_1__tblock_3.4"> <num>3.4</num> <heading currentId="doc_1__tblock_3.4__heading">Specific provisions</heading> <p currentId="doc_1__tblock_3.4__p_1"><i currentId="doc_1__tblock_3.4__p_1__i_1">Article 1: Subject matter and scope</i> ?? this provision sets out the purpose and scope of the proposal, and in particular that it establishes rules for restrictions to the free movement of new psychoactive substances in the internal market.</p> <p currentId="doc_1__tblock_3.4__p_2"><i currentId="doc_1__tblock_3.4__p_2__i_1">Article 2: Definitions</i> ?? this provision sets out definitions which apply throughout the instrument.</p> <p currentId="doc_1__tblock_3.4__p_3"><i currentId="doc_1__tblock_3.4__p_3__i_1">Article 3: Free movement</i> ?? this provision lays down the principle of free movement of new psychoactive substances for industrial and commercial uses, and for research and development.</p> <p currentId="doc_1__tblock_3.4__p_4"><i currentId="doc_1__tblock_3.4__p_4__i_1">Article 4: Prevention of barriers to free movement</i> ?? this provision clarifies under what conditions Member States may introduce restrictions on new psychoactive substances.</p> <p currentId="doc_1__tblock_3.4__p_5"><i currentId="doc_1__tblock_3.4__p_5__i_1">Article 5: Information exchange</i> ?? this provision establishes the respective roles of Member States, the EMCDDA and Europol in the process of exchange of information on new psychoactive substances.</p> <p currentId="doc_1__tblock_3.4__p_6"><i currentId="doc_1__tblock_3.4__p_6__i_1">Article 6: Joint report</i> ?? this provision lays down the contents and the procedures for the drawing up and the transmission by the EMCDDA and Europol of a joint report on a new psychoactive substance. The Commission, the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority are associated to the collection of information for a joint report.</p> <p currentId="doc_1__tblock_3.4__p_7"><i currentId="doc_1__tblock_3.4__p_7__i_1">Article 7: Risk assessment procedure and report</i> ?? this provision empowers the Commission to request the EMCDDA to assess the risks of a new psychoactive substance on which a joint report was drawn up. It lays down the procedures for the risk assessment, which is to be conducted by the Scientific Committee of the EMCDDA, and for the drawing up and the transmission of a risk assessment report.</p> <p currentId="doc_1__tblock_3.4__p_8"><i currentId="doc_1__tblock_3.4__p_8__i_1">Article 8: Exclusion from risk assessment</i> ?? this provision details such circumstances in which no risk assessment is to be conducted on a new psychoactive substance.</p> <p currentId="doc_1__tblock_3.4__p_9"><i currentId="doc_1__tblock_3.4__p_9__i_1">Article 9: Immediate risks to public health and temporary consumer market restriction</i> ?? this provision lays down the criteria on the basis of which the Commission determines whether a new psychoactive substance poses immediate risks to public health, and empowers the Commission to prohibit, temporarily, the making available of this substance on the consumer market, if it poses such immediate risks to public health.</p> <p currentId="doc_1__tblock_3.4__p_10"><i currentId="doc_1__tblock_3.4__p_10__i_1">Article 10: Determination of the level of health, social and safety risks following the risk assessment</i> ?? this provision lays down the criteria on the basis of which the Commission determines the level of health, social and safety risks posed by a new psychoactive substance.</p> <p currentId="doc_1__tblock_3.4__p_11"><i currentId="doc_1__tblock_3.4__p_11__i_1">Article 11: Low risks</i> ?? this provision sets out that the Commission shall introduce no restriction measures on new psychoactive substances posing low health, social and safety risks and provides a definition of low risks.</p> <p currentId="doc_1__tblock_3.4__p_12"><i currentId="doc_1__tblock_3.4__p_12__i_1">Article 12: Moderate risks and permanent consumer market restriction</i> ?? this provision empowers the Commission to prohibit the making available on the consumer market of new psychoactive substances which pose moderate health, social and safety risks, and provides a definition of moderate risks.</p> <p currentId="doc_1__tblock_3.4__p_13"><i currentId="doc_1__tblock_3.4__p_13__i_1">Article 13: Severe risks and permanent market restriction</i> ?? this provision 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.</p> <p currentId="doc_1__tblock_3.4__p_14"><i currentId="doc_1__tblock_3.4__p_14__i_1">Article 14: Authorised uses</i> ?? this provision sets out the exceptions to the market restrictions introduced under the Regulation.</p> <p currentId="doc_1__tblock_3.4__p_15"><i currentId="doc_1__tblock_3.4__p_15__i_1">Article 15: Monitoring</i> ?? this provision lays down monitoring obligations with regard to substances on which a joint report has been drawn up.</p> <p currentId="doc_1__tblock_3.4__p_16"><i currentId="doc_1__tblock_3.4__p_16__i_1">Article 16: Re-examination of the level of risks</i> ?? this provision sets out th