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A growing number of new unregulated synthetic drugs ('legal highs') have emerged in recent years which are marketed on the Internet and often used on the recreational and night clubbing circuit.

The EU has set up a system to detect new substances on the market and a mechanism to assess their risks and ban across the EU those substances that pose risks.

The Council Decision on the information exchange, risk assessment and control of new psychoactive substances establishes an early warning system, enabling a rapid exchange of information on a new psychoactive substances emerging in the EU.

Early Warning System

When a new substance gives rise to concern, the EMCDDA and Europol can draw up a Joint Report, based on information on the substance collected from across the EU. On the basis of this Joint Report, the Commission or the individual of EU countries can request a risk assessment of the substance.

Since 2005, EU countries notified more than 300 new psychoactive substances through the Early Warning System, while Joint Reports have been drafted for eleven substances:

  • mCPP (1-(3-chlorophenyl) piperazine);
  • BZP (1-Benzylpiperazine);
  • Mephedrone (4-methylmethcathinone);
  • 4-MA (4-methylamphetamine);
  • 5-IT (5-(2-aminopropyl)indole);
  • Methoxetamine (2-(3-Methoxyphenyl)-2-(ethylamino)cyclohexanone);
  • AH-7921 (3,4-dichloro-N-[[1-(dimethylamino)cyclohexyl]methyl]benzamide);
  • 25I-NBOMe (4-iodo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine);
  • MDPV (3,4-methylenedioxypyrovalerone);
  • 4,4'-DMAR  (4-methyl-5-(4-methylphenyl)-4,5- dihydrooxazol-2-amine);
  • MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine).

Risk Assessment

The risk assessment is conducted by the Scientific Committee of the EMCDDA, which is composed of independent scientists, the European Commission, Europol and the European Medicines Agency. The risk assessment is based on a specific set of criteria and guidelines. Eight risk assessment reports have been carried out since 2005: on BZP, Mephedrone, 4-MA5-ITpdf(3 MB) Choose translations of the previous link , Methoxetaminepdf(4 MB) Choose translations of the previous link , AH-7921pdf(3 MB) Choose translations of the previous link , 25I-NBOMepdf(3 MB) Choose translations of the previous link  and MDPVpdf(4 MB) Choose translations of the previous link .

To control or not to control?

The Commission must decide whether the evidence provided by the risk assessment report, justifies banning the substance (submitting it to EU-wide control measures). The Commission can:

  • either report to the Council that no further action is needed, or
  • submits a proposal for a Council Decision to control the substance EU-wide.

Since 2005, four substances have been submitted to control measures across the EU: BZP pdf български (bg)czech (cs)dansk (da)Deutsch (de)eesti (et)ελληνικά (el)español (es)Français (fr)Gaeilge (ga)italiano (it)latviešu (lv)lietuvių (lt)magyar (hu)Malti (mt)Nederlands (nl)polski (pl)português (pt)română (ro)slovenčina (sk)slovenščina (sl)suomi (fi)svenska (sv) , Mephedrone pdf български (bg)czech (cs)dansk (da)Deutsch (de)eesti (et)ελληνικά (el)español (es)Français (fr)Gaeilge (ga)italiano (it)latviešu (lv)lietuvių (lt)magyar (hu)Malti (mt)Nederlands (nl)polski (pl)português (pt)română (ro)slovenčina (sk)slovenščina (sl)suomi (fi)svenska (sv) , 4-MA pdf български (bg)czech (cs)dansk (da)Deutsch (de)eesti (et)ελληνικά (el)español (es)Français (fr)Gaeilge (ga)italiano (it)latviešu (lv)lietuvių (lt)magyar (hu)Malti (mt)Nederlands (nl)polski (pl)português (pt)română (ro)slovenčina (sk)slovenščina (sl)suomi (fi)svenska (sv) and 5-IT pdf български (bg)czech (cs)dansk (da)Deutsch (de)eesti (et)ελληνικά (el)español (es)Français (fr)Gaeilge (ga)italiano (it)latviešu (lv)lietuvių (lt)magyar (hu)Malti (mt)Nederlands (nl)polski (pl)português (pt)română (ro)slovenčina (sk)slovenščina (sl)suomi (fi)svenska (sv).

Assessment of the Council Decision 

The Commission has conducted an assessment of the Council Decision to see if it is still able to tackle effectively the rapidly changing market for new psychoactive substances. The assessment (Report pdf български (bg)czech (cs)dansk (da)Deutsch (de)eesti (et)ελληνικά (el)español (es)Français (fr)Gaeilge (ga)italiano (it)latviešu (lv)lietuvių (lt)magyar (hu)Malti (mt)Nederlands (nl)polski (pl)português (pt)română (ro)slovenčina (sk)slovenščina (sl)suomi (fi)svenska (sv) and Annex pdf български (bg)czech (cs)dansk (da)Deutsch (de)eesti (et)ελληνικά (el)español (es)Français (fr)Gaeilge (ga)italiano (it)latviešu (lv)lietuvių (lt)magyar (hu)Malti (mt)Nederlands (nl)polski (pl)português (pt)română (ro)slovenčina (sk)slovenščina (sl)suomi (fi)svenska (sv)), presented in July 2011, concluded that the EU instrument is a useful instrument for tackling the new challenges posed by new psychoactive substances, but that it has several major shortcomings, and notably:

  • It is slow and reactive, therefore not able to address effectively the increase in the number of new substances;
  • Insufficient evidence is available to take appropriate and sustainable decisions;
  • It lacks options for restriction measures.

Many newly emerged substances are variations within a specific group of chemicals and are similar to substances controlled at national level. Some substances contain herbal and synthetic compounds that emerge in various mixtures in different EU countries. One example is Spice, a mixture containing herbs and synthetic components that mimic the effects of cannabis.

Their diversity and the speed with which new substances are developed to replace those that are controlled make them difficult to regulate.

Users could believe that these new uncontrolled drugs are safe. However, the effects of these drugs are often unclear as there is little information on their potential health and social harms.

The main source of information on the potential effects and risks are often messages posted on the internet by drug users' communities.

The Commission launched a studypdf(3 MB) Choose translations of the previous link  in 2011 to provide a thorough analysis of the emerging challenges linked to new psychoactive substances and to assess the possible actions that could be taken to strengthen the EU ability to respond to them. This study, concluded one year later, informed the impact assessment report pdfthat accompanied the Commission’s legislative proposals on new psychoactive substances. The impact assessment report explains the reasons why it is necessary to take fresh EU-level action on new psychoactive substances.

On 17 September 2013, the Commission adopted legislative proposals (Regulation pdf български (bg)czech (cs)dansk (da)Deutsch (de)eesti (et)ελληνικά (el)español (es)Français (fr)Gaeilge (ga)italiano (it)latviešu (lv)lietuvių (lt)magyar (hu)Malti (mt)Nederlands (nl)polski (pl)português (pt)română (ro)slovenčina (sk)slovenščina (sl)suomi (fi)svenska (sv) and Directive pdf български (bg)czech (cs)dansk (da)Deutsch (de)eesti (et)ελληνικά (el)español (es)Français (fr)Gaeilge (ga)italiano (it)latviešu (lv)lietuvių (lt)magyar (hu)Malti (mt)Nederlands (nl)polski (pl)português (pt)română (ro)slovenčina (sk)slovenščina (sl)suomi (fi)svenska (sv)), to enable the EU to act swifter and more effectively to address new psychoactive substances.