This Risk Assessment Report presents the summary findings and the conclusions of the risk assessment carried out by the EMCDDA’s extended Scientific Committee of the new psychoactive substance 4-methylmethcathinone (hereinafter ‘mephedrone’). The report has
been prepared and drafted in accordance with the conceptual framework and the procedure set out in the Operating guidelines for risk assessment of new psychoactive substances (EMCDDA, 2010). It is written as a stand-alone document which presents detailed information on and analysis of the scientific and law enforcement data available at this time. The conclusion section of the report summarises the main issues addressed and reflects all opinions held by the members of the Committee. A more detailed ‘Technical report on mephedrone’ is annexed to this report (Annex 1).

The risk assessment has been undertaken in compliance with Article 6 of Council Decision 2005/387/JHA of 10 May 2005 on information exchange, risk assessment and control of new psychoactive substances (1) (hereinafter the ‘Decision’). The Decision establishes a mechanism for the rapid exchange of information on new psychoactive substances that may pose publichealth and social threats, including the involvement of organised crime, thus allowing European Union institutions and Member States to act on all new narcotic and psychotropic substances (2) that appear on the European Union drug scene. The Decision also provides for an assessment of the risks associated with these new psychoactive substances so that, if applicable, measures in the Member States for the control of narcotic and psychotropic substances (3) can be applied to these new substances.

There is emerging evidence that the new psychoactive substance mephedrone is being used as a recreational drug in Europe. In response to this, in compliance with the provisions of Article 5 of the Decision, on 25 March 2010, the EMCDDA and Europol submitted to the Council, the Commission and the European Medicines Agency (EMA) a Joint Report on the new psychoactive substance 4-methylmethcathinone (mephedrone) (4). Taking into account the Joint Report's conclusion, and in accordance with Article 6 of the Decision, on 26 May 2010, the Council formally requested that ‘the risk assessment should be carried out by the extended Scientific Committee of the EMCDDA and be submitted to the Commission and the Council within twelve weeks of this notification’. I

n accordance with Article 6.2, the meeting to assess the risks of mephedrone was convened under the auspices of the EMCDDA’s Scientific Committee with the participation of five additional experts designated by the Director of the EMCDDA, acting on the advice of the Chairperson of the Scientific Committee, chosen from a panel proposed by Member States and approved by the Management Board of the EMCDDA. The additional experts are from scientific fields that are not represented, or not sufficiently represented, on the Scientific Committee, and whose contribution is necessary for a balanced and adequate assessment of the possible risks of mephedrone, including, health and social risks. Furthermore, one expert from the Commission, one expert from Europol and two experts from the European Medicines Agency (EMA) participated in the risk assessment. The meeting took place on 15 July 2010 at the EMCDDA in Lisbon. The risk assessment was carried out on the basis of information provided to the Scientific Committee by the Member States, the EMCDDA, Europol and the EMA. A full list of the extended Scientific Committee, as well as the list of participants, attending the risk assessment meeting, is annexed to this report (Annex 2).

For the risk assessment, the Scientific Committee considered the following:

(i) Technical report on mephedrone (July 2010) — Annex 1 to the Risk Assessment Report; Appendix 1 to the Technical report, ‘Mephedrone: assessment of health risks and harms’ (July 2010) (EMCDDA-commissioned cross-sectional survey of UK clubbers); and Appendix 2 to the Technical report, ‘Mephedrone: additional studies. Overview of prevalence, use patterns, effects’ (July 2010).

(ii) Europol–EMCDDA Joint Report on a new psychoactive substance: 4-methylmethcathinone (mephedrone) (5);

(iii) Scientific articles, official reports, media articles and grey literature;

(iv) Operating guidelines for risk assessment of new psychoactive substances, (EMCDDA, 2010) (6);

(v) Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances.

(1) OJ L 127, 20.5.2005, p. 32.

(2) According to the definition provided by the Council Decision, a ‘new psychoactive substance’ means a new narcotic drug or a new psychotropic drug in pure form or in a preparation; ‘new narcotic drug’ means a substance in pure form or in a preparation that has not been scheduled under the 1961 United Nations Single Convention on Narcotic Drugs, and that may pose a threat to public health comparable to the substances listed in Schedule I, II or IV; ‘new psychotropic drug’ means a substance in pure form or in a preparation that has not been scheduled under the 1971 United Nations Convention on Psychotropic Substances, and that may pose a threat to public health comparable to the substances listed in Schedule I, II, III or IV.

(3) In compliance with the provisions of the 1961 UN Single Convention on Narcotic Drugs and the 1971 UN Convention on Psychotropic Substances.

(4) 8145/10 CORDROGUE 36/SAN 68.