Explanatory Memorandum to COM(2013)436 - Subjecting 5-(2-aminopropyl)indole to control measures - Main contents
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| dossier | COM(2013)436 - Subjecting 5-(2-aminopropyl)indole to control measures. |
|---|---|
| source | COM(2013)436  |
| date | 25-06-2013 |
The Council Decision 2005/387/JHA on the information exchange, risk-assessment and control of new psychoactive substances[1] provides for a three-step procedure that may lead to the submission of a new psychoactive substance to control measures across the Union.
On 22 January 2013, pursuant to Article 6(1) of the above-mentioned Council Decision, the Council requested[2] an assessment of the risks caused by the use, manufacture and trafficking of the new psychoactive substance 5-(2-aminopropyl)indole, the involvement of organised crime and the possible consequences of control measures introduced on this substance.
The risks of 5-(2-aminopropyl)indole 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 16 April 2013.
The main results of the risk assessment are the following:
5-(2-aminopropyl)indole is a synthetic derivative of indole substituted at the phenyl side of the indole ring system. It appears to be a stimulant substance that may also have hallucinogenic effects. Despite the structural similarities with better known compounds such as α-Methyltryptamine (AMT), 5-(2-aminopropyl)benzofuran (5-APB) and the internationally controlled drug 3,4-methylenedioxyamphetamine (MDA), the effects of 5-(2-aminopropyl)indole cannot be compared with the ones of these substances due to potential differences in mechanisms of action.
The acute toxicity of 5-(2-aminopropyl)indole appears to provoke adverse effects in humans such as tachycardia and hyperthermia, and may also cause mydriasis, agitation and tremor. In addition, 5-(2-aminopropyl)indole may interact with other substances, including medical products and stimulants that act on the monoaminergic system.
Since 2012, seven Member States, as well as Croatia and Norway, have detected 5-(2-aminopropyl)indole and reported information about it to the EMCDDA and Europol. Between April and August 2012, four Member States reported 24 fatalities where 5-(2-aminopropyl)indole alone or in combination with other substances has been detected post-mortem, and three Member States have reported 21 non-fatal intoxications associated with this new psychoactive substance. If this new psychoactive substance were to become more widely available and used, the implications for individual and public health could be significant.
5-(2-aminopropyl)indole has no known, established or acknowledged medical value or use and, apart from its use as an analytical reference standard and in scientific research, there is no indication that it is being used for other purposes.
Pursuant to Article 8 (1) of the Council Decision, within six week 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 substance to control measures across the Union, or a report explaining its views on why such an initiative is not deemed necessary.
Although the scientific evidence concerning the overall risks of 5-(2-aminopropyl)indole is limited at this stage, the Commission considers that there are grounds for subjecting the substance to control measures across the Union. The main reason is that, according to the information available from the risk assessment report, the acute toxicity of 5-(2-aminopropyl)indole is such that it can cause severe harms to the health of individuals. Moreover, the risks are heightened by the fact that 5-(2-aminopropyl)indole has been reported to be consumed unknowingly by some users together with or instead of other stimulant substances.
The objective of this proposal for a Council Decision is to call upon the Member States to subject 5-(2-aminopropyl)indole 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.