Explanatory Memorandum to COM(2014)716 - Subjecting 4-methyl-5-(4-methylphenyl)-4, 5-dihydrooxazol-2-amine (4, 4'-DMAR) and 1-cyclohexyl-4-(1, 2-diphenylethyl)piperazine (MT-45) to control measures - Main contents
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| dossier | COM(2014)716 - Subjecting 4-methyl-5-(4-methylphenyl)-4, 5-dihydrooxazol-2-amine (4, 4'-DMAR) and 1-cyclohexyl-4-(1, ... |
|---|---|
| source | COM(2014)716  |
| date | 01-12-2014 |
The Council Decision 2005/387/JHA on the information exchange, risk-assessment and control of new psychoactive substances[1] (hereby 'Council Decision') provides for a three-step procedure that may lead to the submission of a new psychoactive substance to control measures across the Union.
On 20 June 2014, pursuant to Article 6(1) of the Council Decision, the Council requested an assessment of the risks posed by the use, manufacture and trafficking of the new psychoactive substance 4-methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine (also known as 4,4'-DMAR or 4,4'-dimethylaminorex), the involvement of organised crime and the possible consequences of control measures introduced on this substance.
The risks of 4,4'-DMAR were assessed by the Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), acting in compliance with the provisions of Article 6(2), (3) and i of the Council Decision. The Chair of the Scientific Committee submitted the risk assessment report to the Commission and to the Council on 19 September 2014.
The main findings of the risk assessment are the following:
· The new psychoactive substance 4,4'-DMAR appears to have psychostimulant properties. 4,4'-DMAR is structurally related to two substances listed in the 1971 United Nations Convention on Psychotropic Substances (4-methylaminorex and aminorex).
· 4,4'-DMAR has been available on the drug market in the European Union since at least December 2012 and has been detected in nine Member States.
· Although the information available suggests that this substance has not been widely used, there have been 31 deaths associated with 4,4'-DMAR, registered in three Member States over a period of approximately one year, and one non-fatal intoxication.
On 25 September 2014, pursuant to Article 6(1) of the Council Decision, the Council decided to request the risk assessment of 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine (also known as MT-45).
The risks of MT-45 were assessed by the Scientific Committee of the EMCDDA, acting in compliance with the provisions of Article 6(2), (3) and i of the Council Decision. The Chair of the Scientific Committee submitted the risk assessment report to the Commission and to the Council on 6 October 2014.
The main findings of the risk assessment are the following:
· The new psychoactive substance MT-45 is a synthetic opioid, with a unique structure, which had been investigated for its analgesic properties in the 1970s.
· MT-45 has been available on the drug market in the European Union since October 2013 and has been detected in three Member States.
· A total of 28 deaths associated with MT-45 have been reported in one Member State, within a period of nine months, as well as 18 non-fatal intoxications.
Pursuant to Article 8(1) of Council Decision, within six weeks from the date of receipt of the risk assessment report, the Commission shall present to the Council either an initiative to subject the new psychoactive substances to control measures across the Union, or a report explaining its views on why such initiative is not deemed necessary.
Although the scientific evidence concerning the overall risks posed by the two substances is limited at this stage, the Commission considers that there are grounds for subjecting 4,4'-DMAR and MT-45 to control measures across the Union. The main reason is that, according to the information available from the risk assessment reports, the toxicity of these substances is such that it can cause severe harms to the health of individuals. Moreover, the risks are heightened by the fact that these substances have been reported, in some cases, to be consumed unknowingly by certain users together with or instead of other psychoactive substances.
2. OBJECTIVE OF THE PROPOSAL
The objective of this proposal for a Council Decision is to call upon the Member States to subject 4,4'-DMAR and MT-45 to control measures and criminal penalties as provided under their legislation by virtue of their obligations under the 1971 United Nations Convention on Psychotropic Substances.