COMMISSION STAFF WORKING PAPER on the assessment of the functioning of Council Decision 2005/387/JHA on the information exchange, risk assessment and control of new psychoactive substances
Date: 2011-07-11
Institutions: European Commission
Subjects: EU Member State, European Monitoring Centre for Drugs and Drug Addiction, Europol, benchmarking, drug traffic, exchange of information, project evaluation, psychotropic substance

EUROPEAN COMMISSION 

Brussels, 11.7.2011 
SEC(2011) 912 final 

COMMISSION STAFF WORKING PAPER 

on the assessment of the functioning of Council Decision 2005/387/JHA on the 
information exchange, risk assessment and control of new psychoactive substances 

Accompanying the document 

REPORT FROM THE COMMISSION 

on the assessment of the functioning of Council Decision 2005/387/JHA on the 
information exchange, risk assessment and control of new psychoactive substances 

{COM(2011) 430 final} 

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TABLE OF CONTENTS 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

7.1. 

7.2. 

7.3. 

Introduction...................................................................................................................3 

Methodology.................................................................................................................4 

Key findings from the 2002 evaluation of the Joint Action on synthetic drugs ...........5 

Overview of notifications, types of substances and trends at EU level 2005-2010......7 

Other EU legislation relevant for the regulation of new psychoactive substances.....12 

Functioning of the Council Decision on new psychoactive substances .....................16 

Findings of the survey among Member States............................................................17 

Assessment of the Council Decision ..........................................................................17 

Stages in the functioning of the Council Decision .....................................................18 

National responses to new psychoactive substances ..................................................20 

7.3.1.  List of new psychoactive substances first notified by year ........................................22 

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1. 

INTRODUCTION 

Council Decision 2005/387/JHA on the information exchange, risk assessment and control of new 
psychoactive  substances1  ('the  Council  Decision')  enables  the  exchange  of  information  and 
assessment  of  new  psychoactive  substances  and,  if  necessary,  may  make  them  subject  to  control 
measures  and  criminal  penalties  across  the  EU.  This  Decision  has  replaced  Joint  Action 
97/396/JHA2 ('the Joint Action') and broadened its scope.  

The  Joint  Action  defined  new  synthetic  drugs  as  being  psychoactive  substances  with  limited 
therapeutic value not listed under the 1971 United Nations Convention on Psychotropic Substances3 
('UN  1971  Convention'),  but  which  posed  a  comparably  serious  threat  to  public  health  as  those 
substances  listed  in  Schedules  I  and  II  to  that  Convention.  The  term  ‘new’  referred  not  only  to  a 
newly  invented  substance,  but  also  to  a  ‘newly  available’  or  a  ‘newly  misused’  substance.  In 
practice, most such substances were created a long time ago, but had not been widely available or 
used before.  

The  Council  Decision  defines  a  new  psychoactive  substance  as  a  ‘new  narcotic  or  psychotropic 
drug,  in  pure  form  or  in  preparation,  that  is  not  controlled  by  the  1961  United  Nations  Single 
Convention  on  Narcotic  Drugs4  ('UN  1961  Convention')  or  the  UN  1971  Convention,  but  which 
may pose a public health threat comparable to that posed by substances listed in Schedule I or II or 
IV of the former and in Schedule I or II or III or IV of the latter Convention’5. This means that the 
Council  Decision  covers  not  only  synthetic  substances  but  also  those  based  on  herbs.  Substances 
notified through the information exchange mechanism set up by the Council Decision, namely the 
Early Warning System (EWS), may include medicines or substances used to manufacture medicinal 
products6, but such substances cannot be subjected to a risk assessment7, because they are covered 
by  other  types  of  legislation.  Furthermore,  chemicals  used  to  manufacture  illicit  drugs  (drugs 
precursors) are also excluded from the scope of the Council Decision, since they are governed by 
different regulations8.  

The  Council  Decision  provides  an  official  definition  of  new  psychoactive  substances,  but  several 
terms  are  used  in  common  language  to  designate  such  substances.  Although  the  Joint  Action 
referred  to  new  psychoactive  substances  as  ‘designer  drugs’,  nowadays  the  term  ‘legal  highs’  is 
more often used.  

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3 
4 

5 
6 
7 
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OJ L 127, 20.5.2005, p. 32-37. 
Joint  Action  97/396/JHA  of  16  June  1997  concerning  the  information  exchange,  risk  assessment  and  the 
control of new synthetic drugs, OJ L 167, 25.6.1997, p. 1-3. 
UN 1971 Convention on Psychotropic Substances. 
UN  1961  Single  Convention  on  Narcotic  Drugs  as  amended  by  the  1972  Protocol  amending  the  Single 
Convention on Narcotic Drugs. 
Article 3 of the Council Decision. 
Recital 5 of the Council Decision. 
Article 7(3). 
Regulation  (EC)  No  273/2004  of  the  European  Parliament  and  of  the  Council  of  11  February  2004  on  drug 
precursors (OJ L 47, 18.2.2004); Regulation (EC) No 111/2005 of the European Parliament and of the Council 
of  22  December  2004  laying  down  rules  for  the  monitoring  of  trade  between  the  Community  and  third 
countries  in  drug  precursors  (OJ  L  22,  26.1.2005);  Commission  Regulation  (EC)  No  1277/2005  of  27  July 
2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the 
Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring 
of trade between the Community and third countries in drug precursors (OJ L 202, 3.8.2005). 

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A  ‘designer  drug’  is  a  psychoactive  substance  produced  from  chemical  precursors  in  a 
(clandestine)  laboratory,  which  is  designed  to  mimic  the  properties  of  known  psychoactive 
substances,  has  a  limited  therapeutic  value  and  is  not  internationally  controlled.  The  term  ‘legal 
highs’  covers  all  unregulated  psychoactive  substances  or  products  containing  them,  specifically 
designed to mimic the effects of known illicit drugs in order to circumvent existing drug controls. 
The term encompasses a fairly wide range of synthetic and plant-derived substances and products, 
including ‘research chemicals’, ‘party pills’ and ‘herbal highs’, which are usually sold over the 
internet or in specialised shops (head shops). These are often advertised with aggressive marketing 
strategies  and  sometimes  intentionally  mislabelled  with  purported  ingredients  differing  from  the 
actual composition. Suppliers easily circumvent drug controls by rapidly offering new alternatives 
to products that are subjected to control.  

The Council Decision was developed taking into account the findings of an independent evaluation 
of the Joint Action, conducted in 20029 (see section 3). The final evaluation of the EU Drugs Action 
Plan 2005-200810 highlighted the fact that the Council Decision may need to be amended, in order 
to  improve  the  exchange  of  information  and  cover  gaps  between  the  Decision  and  other  EU 
legislation, including that setting up the pharmacovigilance system11. Subsequently, the EU Drugs 
Action  Plan  2009-201212  requested  the  Commission  to  "assess  the  functioning”  of  the  Council 
Decision and "amend, if necessary".  

2. 

METHODOLOGY 

The  European  Commission  has  conducted  this  assessment  with  the  support  of  the  European 
Monitoring  Centre  for  Drugs  and  Drug  Addiction  (EMCDDA)  and  Europol.  The  purpose  of  the 
assessment is to determine whether the objectives, scope and instruments of the Council Decision 
are adequate to efficiently tackle the rapidly evolving market for new psychoactive substances. The 
report  and  this  annexed  document  explore  the  main  developments  in  this  market  since  2005,  the 
functioning of the Council Decision, and its strengths and weaknesses. Lastly, it seeks to determine 
to what extent the Council Decision has added value. 

The assessment included: 

(a) 

(b) 

An evaluation of the main challenges posed by developments in the market for new 
psychoactive  substances, 
including  an  EMCDDA  overview  report  of  key 
developments  related  to  the  implementation  of  the  Council  Decision  (see  section  4 
for an overview of trends and developments). 

A  mapping  of  existing  EU  directives  and  regulations  that  are  relevant  for  tackling 
new  psychoactive  substances,  including  those  on  food  safety,  consumer  protection, 
dangerous  substances  and  products,  and  the  pharmacovigilance  system.  It  also 
involved  a  brief  screening  of  the  use  of  the  provisions  of  Directive  98/34/EC  by 

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The  Evaluation  Partnership  Ltd.,  Assessment  of  the  Joint  Action  on  new  Synthetic  Drugs,  contract 
JAI/B5831/200/C2. 
SEC (2008) 2456, 18.9.2008. 
The  process  of  monitoring  the  safety  of  medicines  and  taking  action  to  reduce  their  risks  and  increase  their 
benefits.  Regulation  (EC)  No  726/2004  of  the  European  Parliament  and  of  the  Council  of  31  March  2004 
laying  down  Community  procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human 
and veterinary use and establishing a European Medicines Agency. OJ L 136, 30.4.2004, 28.11.2001, p. 1-32. 
OJ C 326, 20.12.2008, p. 7–25. Action 69. 

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Member  States  to  limit  the  free  movement  of  goods  that  may  pose  a  public  health 
risk (see section 5 for an overview).  

An  assessment  of  the  functioning  of  the  Council  Decision,  identifying  its  strengths 
and weaknesses in terms of procedures, as well as its practical impact. 

A survey among Member States on the functioning of the Council Decision and their 
responses  to  the  emergence  of  new  psychoactive  substances  (see  section  7  for  a 
summary).  

(c) 

(d) 

Specific documents and reports were reviewed, including annual reports on the implementation of 
the  Council  Decision13,  the  Joint  Reports  on  mCPP,  BZP  and  mephedrone  produced  by  the 
EMCDDA and Europol, and the Risk Assessment reports on BZP and mephedrone, the information 
report on Spice, the evaluation report of the 2002 Joint Action and various media reports.  

3. 

KEY  FINDINGS  FROM  THE  2002  EVALUATION  OF  THE  JOINT  ACTION  ON  SYNTHETIC 
DRUGS 

In 2002 the predecessor of the Council Decision was evaluated. The evaluation identified a number 
of important strengths and weaknesses, as well as policy relevant questions, some of which continue 
to  be  relevant  today  as  well.  The  evaluation  of  the  Joint  Action  had  three  main  objectives:  a)  to 
assess the effectiveness of the Joint Action in meeting the requirements of the EU Action Plan on 
Drugs 2000-2004, b) to examine the operation of all aspects of the Joint Action since its adoption in 
1997,  including  strengths  and  weaknesses,  and  c)  to  provide  conclusions  to  help  the  Commission 
draft a revised instrument (the current Council Decision). 

The report concluded that, during its implementation, the Joint Action had changed from being a 
control instrument, as reflected in its legal basis, to a less clearly defined policy instrument where 
the different actors involved had different, and not fully compatible, objectives. These included the 
monitoring of new substances appearing in the market and public health campaigns.  

The report revealed that the Joint Action was undermined by fundamental disagreements among 
Member  States  on  how  to  assess  risks  of  new  psychoactive  substances,  the  evidence  needed  to 
submit them to control and the timing of the control process. There was no consensus among the 
Member States on the risk threshold that should trigger the procedure leading to control. For some 
Member  States,  simply  the  appearance  of  a  psychoactive  substance  seemed  to  justify  introducing 
control measures. In most cases these countries decided to take measures independently of the risk 
assessments conducted under the Joint Action. However, the Joint Action was seen as providing a 
framework for debating different positions and achieving balanced positions.  

The  evaluation  highlighted  the  fact  that  the  information-exchange  mechanism  introduced  by  the 
Joint  Action,  namely  the  EWS,  had  not  functioned  properly.  There  were  no  clear  criteria  for 
requesting a risk assessment and for introducing control measures, which resulted in Member States 
developing  different  approaches.  Member  States  were  hesitant  to  exchange  information,  as  they 
were concerned about confidentiality of data and potential public anxiety if information was made 
public. Certain Member States did not prioritise or properly resource their participation in the EWS.  

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Article 10. 

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The  assessment  also  revealed  problems  of  representation  in  the  Scientific  Committee  of  the 
EMCDDA, which conducts the risk assessment of substances. The committee's composition was 
not  sufficiently  balanced  to  provide  the  expertise  necessary  to  properly  assess  new  psychoactive 
substances  and  was  not  extended  to  include  external  experts,  although  this  would  have  been 
possible. The risk assessment lacked EU-wide analysis of societal and market aspects of substance 
use.  

On decision making, the report concluded that the tight deadlines for the Commission to issue its 
opinion  on  the  basis  of  the  risk  assessment  report  left  little  room  for  proper  evaluation  of  the 
conclusions. It pointed out that several Member States were in favour of modifying procedures for 
introducing  control  measures  and  wanted  alternative  options  for  tackling  new  psychoactive 
substances, not just the option of criminal control.  

The  relevance  of  the  Joint  Action  was  considered  to  be  limited,  because  new  psychoactive 
substances  had  not  become  as  big  a  problem  as  had  been  feared  when  it  was  adopted  in  1997. 
However,  Member  States  found  the  Joint  Action  broadly  useful  and  wanted  its  scope  to  be 
extended. The practical impact of the Joint Action was hard to assess as no proof could be found 
that it had contributed to coordinating law enforcement operations across Member States in the way 
it was originally meant to  do. The  evaluators concluded that the effectiveness of the Joint Action 
was limited and they identified two potential reform strategies to tackle this. A radical strategy 
was to split the Joint Action into two instruments, one aimed at combating designer drugs and one 
focusing  on  monitoring  new  trends  in  drug  consumption  covering  all  substances.  The  evaluators 
pointed out that, while this would address some of the tensions, it might affect cooperation between 
the  law  enforcement  and  public  health  sectors.  The  second  strategy  proposed  was  incremental 
change, through smaller operational improvements, including:  

•  Strengthening the National Focal Point primary data collection networks (on new drugs); 

•  Defining clear criteria and responsibilities for initiating the EWS progress report (in the Council 

Decision this is called the Joint Report); 

•  Improving the transparency of the Joint Action process; 

•  Complementing  existing  resources  with  centralised  monitoring  of  the  internet  and  'outbreak' 

investigations; 

•  Establishing exchanges among forensic laboratories; 

•  Introducing framework contracts to shorten tendering for risk assessment and for contracting out 

of work on sociological/criminological aspects to external experts; 

•  Reviewing the mechanism for appointment to the Scientific Committee; 

•  Strengthening existing databases within EMCDDA and the European Medicines Agency (EMA) 

on the legal status of substances; 

•  Establishing  procedures  to  request  further  scientific  information  during  the  risk  assessment,  if 

necessary, and; 

•  Providing funding for additional research in support of scientific information. 

The drafting of the Council Decision took many of these recommendations on board.  

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4. 

OVERVIEW OF NOTIFICATIONS, TYPES OF SUBSTANCES AND TRENDS AT EU LEVEL 2005-
2010 

New  psychoactive  substances  can  be  classified  in  chemical  families,  based  on  their  chemical 
structure  (see  Table  4.1).  Synthetic  cannabinoids  are  an  exception:  they  are  placed  in  a  category 
based on their mode of action rather than on their chemical composition, which varies considerably.  

Since the entry into force of the Council Decision in 2005, 115 new psychoactive substances14 have 
been  notified  for  the  first  time  through  the  EWS.  A  record  number  of  new  substances  (41)  were 
reported in 2010, i.e. more than a third of all substances notified since 2005. This increase in the 
number of substances notified may reflect not only the rise in the number of substances available in 
the EU, but also improved reporting capacities due to increased awareness about new substances.  

Table 4.1. – New psychoactive substances notified in 2005-2010 

Year 

Nr. 

2005 

14 

2006 

7 

2007 

16 

2008 

13 

Types of substances first notified 

substances  belonged 

All  newly-notified 
three  major  chemical  groups  – 
phenethylamines, tryptamines and piperazines. Of these 14 substances, methylone, DPIA 
and  mCPP  exhibited  characteristics  which  suggested  that  they  were  particularly 
appropriate for targeted monitoring and further vigilance15. 

to 

In  2006  the  chemical  make-up  of  the  reported  substances  was  more  diverse  –  some  of 
them  belonged  to  chemical  groups  never  previously  reported  through  the  EWS,  such  as 
indanes  and  benzodifuranyls.  Two  of  the  seven  reported  substances  had  pronounced 
hallucinogenic effects, whereas all of the others exhibited predominantly stimulant effects. 
Three of the seven new substances belonged to the piperazine family.  

The  group  of  notified  substances  was  varied  and,  in  addition  to  new  synthetic  drugs, 
included medicinal products, a metabolite/derivative of a medicinal product and naturally 
occurring  substances.  These  included  phenethylamines,  tryptamines  and  piperazines,  as 
well  as  substances  with  a  less  common  chemical  make-up.  The  group  was  evenly  split 
between  substances  that  had  pronounced  hallucinogenic  effects  and  those  that  exhibited 
predominantly stimulant properties. 

In 2008, the group of notified substances included two plants, but no medicinal products. 
Altogether,  the  group  consisted  predominantly  of  compounds  with  stimulant  properties, 
whilst  two  substances  presented  pronounced  hallucinogenic  effects.  In  particular,  fewer 
new  substances  than  in  previous  years  were  reported  from  the  better  known  chemical 
groups:  phenethylamines  (one);  tryptamines  (two)  and  piperazines  (none).  Six  of  the 
notified substances belonged to the group of cathinone derivatives. Furthermore, pFBT, a 
‘designer  drug’  based  on  cocaine,  is  one  chemically  interesting  compound  that  is  worth 
noting. 

2009 

24 

All new compounds were synthetic, including two substances with medicinal properties. 
Nine of the reported substances were synthetic cannabinoids from four distinct chemical 
groups  (naphthoylindoles,  phenylacetylindoles,  cyclohexylphenols  and  dibenzopyrans). 
Apart from these, there was a mix of substances belonging to more established chemical 
families – five phenethylamines, two tryptamines and four synthetic cathinones. No new 

14 
15 

A full list of the substances notified can be found in section 8 of this report. 
Six of these substances were notified under the terms of 1997 Joint action (period January – May 2005). 

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piperazines or psychoactive plants were reported in 2009. 

2010 

41 

Of the 41 compounds, 15 were synthetic cathinones and 11 were synthetic cannabinoids. 
Substances belonging to more established chemical families – five phenethylamines, one 
tryptamine and one piperazine – were also reported. The list of newly notified substances 
was  diverse  and  included  a  plant-based  substance,  a  synthetic  cocaine,  a  ketamine 
derivative, a phencyclidine derivative, an indane and a benzofuran, as well as a designer 
medicine which belongs to a group that can be denominated diphenyl-R-amine.  

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Table 4.2.  Main families of new psychoactive substances 

Family 

Parent compound 

Chemical  structure  of  the 
parent compound 

Effects 

Representatives 

No  of 
notified (2005-10) 

substances 

EMCDDA Publications 

Phenethylamines 

phenethylamine (N) 

Tryptamines  

tryptamine (N) 

stimulant 
hallucinogenic 

and/or 

amphetamine, 

methamphetamine,  MDMA, 
mescaline (N) 

hallucinogenic 

psilocin  and  psilocybin  (N), 
dimethyltryptamine 
/  DMT, 
lysergide / LSD (S) 

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12 

Piperazines 

piperazine  

stimulant 
hallucinogenic 

and/or 

mCPP, BZP, TFMPP 

8 

Cathinones 

cathinone (N) 

stimulant 

cathinone (N),  

26 

mephedrone, 
methcathinone (S) 

methylone, 

Synthetic 
cannabinoids 

the  category 

N/A  – 
includes  a 
number  of  chemically  unrelated  but 
functionally 
families  of 
similar 
cannabinoid  receptor  agonists  that 
mimic the effects of ∆9 – THC 

hallucinogenic, 
sedative, 
depressant 

(HU-210) 

JWH-018, CP 47,497,  

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HU-210, etc. 

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assessment 
Risk 
publications: 4-MTA (2002), 
(2003),  TMA-2 
PMMA 
(2004),  and  2C-I,  2C-T-2, 
2C-T-7 (2004) 

Thematic 
paper 
Hallucinogenic  mushrooms 
(2006) 

Drug  profile  Hallucinogenic 
mushrooms 

Risk  assessment  publication: 
BZP (2009); 

Active  monitoring 
mCPP 

report: 

Drug  profile  BZP  and  other 
piperazines 

Risk  assessment  publication: 
Mephedrone (2010); 

Drug 
cathinones  

profile 

Synthetic 

Thematic 
Understanding 
the 
phenomenon (2009); 

paper 
'Spice' 

Drug 

profile 

Synthetic 

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cannabinoids and 'Spice' 

Miscellaneous 
substances 

N/A  –  the  category  includes  new 
psychoactive  plants  as  well  as 
synthetic  psychoactive  substances, 
derivatives  of  well-established  drugs 
not  belonging  to  any  of  the  families 
listed  above,  designer  medicines, 
narcotic analgesics, etc. 

N/A 

N/A 

stimulant, 
hallucinogenic, 
narcotic analgesic / 
opiate,  depressant, 
etc. 

27 

Risk  assessment  publication: 
GHB  (2002)  and  Ketamine 
(2002) Thematic paper GHB 
and  its  precursor  GBL:  an 
emerging  trend  case  study 
(2008) 

(N) 

naturally occurring 

Thematic papers: http://www.emcdda.europa.eu/publications/searchresults?action=list&type=PUBLICATIONS&SERIES_PUB=w205 

(S) 

semi-synthetic 

Risk assessments: http://www.emcdda.europa.eu/publications/searchresults?action=list&type=PUBLICATIONS&SERIES_PUB=w12 

(N/A) 

non applicable 

Drug profiles: http://www.emcdda.europa.eu/publications/drug-profiles 

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As Table 4.3 shows, five countries accounted for 75% of all first notifications, with the UK 
reporting one third of new substances. More than half of these notifications had been filed in 
the past two years. Authorities in certain countries have actively sought after many of these 
substances through test-purchases on the internet and from specialised shops. This proactive 
searching  may  partially  explain  the  increased  number  of  notifications  in  previous  years. 
However,  as  not  all  Member  States  follow  a  proactive  approach,  the  number  of  new 
substances present in the market may be underreported. 

Table 4.3. – Number of new psychoactive substances first notified by a Member State 

Country 

2005 

2006 

2007 

2008 

2009 

2010 

Total 

United Kingdom 

Finland 

Sweden 

Germany 

Denmark 

Austria 

France 

Ireland 

Belgium 

Latvia 

Bulgaria 

Hungary 

Lithuania 

Malta 

Netherlands 

Poland 

Norway 

Total 

5 

- 

5 

- 

- 

- 

2 

- 

- 

- 

- 

- 

- 

1 

1 

- 

- 

14 

2 

2 

2 

- 

- 

- 

1 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

7 

3 

4 

1 

- 

2 

2 

- 

- 

- 

- 

1 

- 

- 

- 

- 

- 

- 

13 

2 

6 

1 

6 

6 

- 

- 

- 

2 

- 

- 

- 

1 

- 

- 

- 

16 

4 

2 

3 

- 

2 

- 

4 

- 

3 

1 

2 

- 

- 

- 

- 

- 

24 

4 

41 

35 

21 

11 

9 

8 

5 

4 

4 

3 

3 

2 

2 

1 

1 

1 

1 

4 

115 

7 

5 

- 

- 

- 

1 

1 

- 

1 

- 

- 

- 

- 

- 

- 

1 

- 

16 

11 

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EN 

 
 
 
 
 
 
 
 
 
 
Most  of  the  substances  notified  since  the  Council  Decision  came  into  effect  were  new 
psychotropic substances (synthetic drugs) similar to those listed in Schedules I and II of the 
1971  UN  Convention.  The  emergence  of  a  large  number  of  synthetic  compounds  illustrates 
the  speed  and  sophistication  with  which  the  market  reacts  to  control  measures.  The 
complexity and volatility of the EU drugs market largely explains the diversity of new drug 
‘families’. With rapid technological advances, such as cheap organic synthesis, coupled with 
the increased use of the internet for marketing and selling new drugs, it is likely that synthetic 
analogues of other major drug groups will continue to appear. The emergence of synthetic 
cannabinoids,  synthetic  cocaine  derivatives,  ketamine  and  phencyclidine  derivatives  marks 
the latest stage in this development.  

‘Designing’  a  drug  to  replace  a  controlled  substance  is  not  a  new  concept.  In  the  past, 
however,  designer  drugs  were  produced  illicitly  and  marketed  directly  on  the  illicit  market 
(from  those  based  on  fentanyl  in  the  1980s,  to  tryptamines  in  the  1990s  or  piperazines  and 
cathinone derivatives  in the 2000s). An  important difference today is that the chemicals are 
legally sourced but then sold as replacements for illicit drugs. One example is ‘Spice’, which 
was only sold over the internet or in specialised shops, rather than illicit networks. A relevant 
question  asked  in  many  Member  States  concerns  the  issue  of  which  mechanisms  are  most 
effective  for  monitoring  the  emergence  of  such  products  and  for  assessing  their  possible 
impact.  The  limited  knowledge  about  the  chemical  composition  and  effects  of  new 
compounds has, in practice, facilitated the emergence of a regulatory ‘grey area’ as authorities 
in charge of public health or medicinal products have often failed to assume responsibility for 
these substances.  

Information on these substances is scarce, and therefore the availability of reference materials 
(substances)  is  important  in  order  to  enable  forensic  and  toxicology  laboratories  to  identify 
them.  However,  there  is  no  EU  system  for  sharing  reference  substances,  as  there  is  for  the 
exchange of samples of seized illicit drugs, for which a procedure was created at EU level by 
a  Council  Decision16.  Improving  access  to  reference  materials  would  help  provide  a 
comprehensive solution to new psychoactive substances. 

5. 

OTHER  EU  LEGISLATION  RELEVANT  FOR  THE  REGULATION  OF  NEW 
PSYCHOACTIVE SUBSTANCES 

Member States use different approaches to regulate or control new psychoactive substances, 
the most frequent being legislation on drug control and medicines. The Council Decision does 
not  prevent  Member  States  from  maintaining  or  introducing  measures  to  control  new 
psychoactive  substances  on  their  territory  17.  However,  in  accordance  with  internal  market 
rules, Member States are obliged to notify the Commission of any draft technical regulation 
(i.e. a decision to control or limit availability through medicines legislation). A number of EU 
directives  and  regulations  enable  Member  States  to  adopt  such  decisions.  They  include  the 
following: 

16 

17 

Council Decision 2001/419/JHA of 28 May on the transmission of samples of controlled substances. OJ 
L 150, 6.6.2001.0 
Article 9(3). 

EN 

12 

   EN 

 
                                                 
•  Directive 98/34/EC18 of the European Parliament and of the Council of 22 June 1998 
1aying  down  a  procedure  for  the  provision  of  information  in  the  field  of  technical 
standards and regulations and of rules on Information Society services. 

This  Directive  requires  Member  States  to  report  immediately  to  the  Commission  technical 
regulations19  that  may  impede  the  internal  market  for  goods.  When  Member  States  seek  to 
limit  the  marketing  or  use  of  a  chemical  substance  on  grounds  of  public  health,  or  the 
protection  of  consumers  or  the  environment,  they  "shall  also  communicate  the  anticipated 
effects  of  the  measure  on  public  health  and  the  protection  of  the  consumer  and  the 
environment, together with an analysis of the risk carried out as appropriate". 

Member States "shall postpone the adoption of a draft technical regulation for three months 
from  the  date  of  receipt  by  the  Commission"  unless  they  are  obliged  to  introduced  it 
immediately  "for  urgent  reasons,  occasioned  by  serious  and  unforeseeable  circumstances 
relating to the protection of public health or safety, (….) also for public policy, notably the 
protection of minors".  

Few Member States have notified control measures to the Commission since 2005, although 
there  has  been  a  rapid  increase  since  200920.  Member  States  increasingly  request  the 
application of the urgency procedure for reasons of protection of public health, even though 
the  evidence  justifying  theurgency  requests  is  sometimes  questionable  or  not  fully 
documented, or concerns wide ranging legislation covering a variety of individual substances.  

•  Regulation (EC) No 726/200421 of the European Parliament and of the Council of 31 
March  2004  laying  down  Community  procedures  for  the  authorisation  and 
supervision  of  medicinal  products  for  human  and  veterinary  use  and  establishing  a 
European Medicines Agency.  

Some Member States also use medicines legislation to limit the manufacture and trade of new 
psychoactive  substances,  while  not  criminalising  possession  for  personal  use  and  use  of  a 
substance.  In  this  case  the  substance  is  labelled  as  a  medicinal  product22,  which  means  a 
product that is either presented as a medicine (e.g. as a box of capsules) or claims to have a 
specific medical function (e.g. in treating a medical problem). Member States are free to make 
specific substances subject to medicines legislation, provided they fall under the definition of 

18 
19 

20 

21 
22 

OJ L 24, 21.7.1998, p. 37 
Art.  1(11):  Technical  specifications  and  other  requirements,  including  the  relevant  administrative 
provisions, the observance of which is compulsory, de jure or de facto, in the case of marketing or use 
in a Member State or a major part thereof, as well as laws, regulations or administrative provisions of 
Member  States,  except  those  provided  for  in  Article  10,  prohibiting  the  manufacture,  importation, 
marketing or use of a product. 
Most  notifications  received  by  the  Commission  concern  amendments  of  national  drug  control 
legislation. From 2005 to 2010, the Commission received 33 notifications, from Sweden (16), Ireland 
(5),  Austria  (2),  Germany  (2)  Poland  (2),  Romania  (2),  Finland,  Hungary,  Latvia  and  the  Czech 
Republic (all 1). The number of notifications increased since 2009: 2005 (2), 2006 (1), 2007 (5), 2008 
(2), 2009 (9), 2010 (14). 
OJ L 136, 30.4.2004, 28.11.2001, p. 1-32. 
The directive defines a medicinal product as "a) any substance or combination of substances presented 
as  having  properties  for  treating  or  preventing  disease  in  human  beings;  or,  b)  any  substance  or 
combination of substances which may be used in or administered to human beings either with a view to 
restoring,  correcting  or  modifying  physiological 
functions  by  exerting  a  pharmacological, 
immunological or metabolic action, or to make a medical diagnosis" (Article 1(1). 

EN 

13 

   EN 

 
                                                 
a  medicinal  product.  The  EU  pharmacovigilance  system  primarily  monitors  the  potential 
adverse effects of medicinal products as well as their proper use.  

•  Regulation  Regulation  (EC)  No  764/200823  of  the  European  Parliament  and  of  the 
Council of 9 July 2008 laying down procedures relating to the application of certain 
national technical rules to products lawfully marketed in another Member State and 
repealing Decision No 3052/95/EC. 

The  Mutual  Recognition  Regulation  lays  down  procedures  relating  to  the  application  of 
certain national technical rules on products lawfully marketed in another Member State. The 
main  aim  is  to  make  the  mutual  recognition  principle  fully  operational.  The  Regulation  it 
should applies to administrative decisions addressed to economic operators on the basis of a 
technical rules in respect of any product lawfully marketed in another Member State. 

As  regards  psychoactive  substances,  the  Mutual  Recognition  Regulation  should  apply  in 
particular  cases  and  on  a  case  by  case  basis.  In  particular,  when  competent  authorities  of  a 
Member State intend to adopt a decision that could prohibit the marketing of those substances 
lawfully  marketed  in  another  Member  State  on  other  than  safety  or  health  grounds24,  the 
Regulation  should  apply.  This  is  the  case,  for  example,  when  a  psychoactive  substance 
lawfully  marketed  in  another  Member  State  is  denied  for  reasons  based  on  technical  rules 
(denomination, size, composition, etc.). 

•  Directive 2001/95/EC25 of the European Parliament and of the Council of 3 December 

2001 on general product safety. 

The RAPEX system, coordinated by the Commission, enables national authorities competent 
for  product  safety  to  exchange  very  quickly  and  efficiently  information  on  risk  assessment, 
dangerous  products  and  national  restrictive  measures  taken  in  respect  of  these  products.  In 
cases of serious risk to the health and safety of consumers in the various Member States, the 
Commission may decide, subject to strict conditions, to withdraw the product from the market 
for one year, following a comitology procedure26 (Article 13) 

•  Regulation (EC) No 178/200227 of the European Parliament and of the Council of 28 
January  2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing  the  European  Food  Safety  Authority  and  laying  down  procedures  in 
matters of food safety. 

When it is clear that a food or feed may pose serious risks to human health, the Commission 
can  adopt  emergency  measures  following  a  comitology  procedure,  or  in  extreme  cases  can 
adopt  emergency  measures  on  its  own,  to  be  confirmed  by  the  Committee  within  ten  days. 
These  measures  include  withdrawal  from  the  market,  laying  down  of  special  conditions,  or 

23 
24 

25 
26 

27 

OJ L 218/21, 13.08.2008, p. 21-29. 
When  the  decision  to  prohibit  the  marketing  of  certain  psychoactive  substances  lawfully  marketed  in 
another Member State is on safety or health grounds, Directive 2001/35/EC on general product safety 
should apply. 
OJ L 11, 15.1.2002, p. 4–17.  
For example, DMF, a solvent used in the fabrication of plastics and which may cause cancer and other 
serious illnesses, was banned from all products under this procedure in December 2007. 
OJ L 31, 1.2.2002, p. 1–24. 

EN 

14 

   EN 

 
                                                 
any appropriate interim measures28. Member States exchange information and introduce alerts 
through the RAS (Rapid Alert System), which is managed by the Commission (Article 50). 

Some new psychoactive substances can be treated as food, since any substance meant to be 
ingested orally is considered as food and therefore subject to food safety legislation (Article 
2). 

•  Directive 2000/13/EC29 of the European Parliament and of the Council of 20 March 
2000 on the approximation of the laws of the Member States relating to the labelling, 
presentation and advertising of foodstuffs. 

The Directive sets out conditions for food labelling (name, ingredient, quantity) and defines 
and  prohibits  misleading  clauses.  Controls  are  implemented  by  national  authorities,  which 
also impose sanctions. 

•  Regulation (EC) No 1925/200630 of the European Parliament and of the Council of 20 
December  2006  on  the  addition  of  vitamins  and  minerals  and  of  certain  other 
substances to foods. 

The  Regulation  on  food  supplements  enables  the  Commission  to  ban,  limit  or  subject  to  a 
four-year monitoring process substances that pose or are likely to pose a risk to human health 
(Article 8). The relevant clause has never been applied. 

•  Regulation  (EC)  No  1907/200631  of  the  European  Parliament  and  of  the  Council  of 
18 December  2006  concerning  the  Registration,  Evaluation,  Authorisation  and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency. 

Within  the  framework  of  REACH,  the  most  relevant  provisions  for  the  purpose  of  this 
document  concern  the  restriction  process.  Under  REACH,  either  a  Member  State  or  the 
European  Chemicals  Agency  (the  latter  at  the  request  of  the  Commission)  carries  out  the 
assessment of the hazard and risk of substances on their own, in mixtures or articles, where it 
is  considered  that  they  pose  a  risk  to  human  health  or  environment  that  is  not  adequately 
controlled and which needs to be addressed on a EU-wide basis. On this basis, and also taking 
into account the socio-economic consequences, a restriction report is prepared and submitted 
for  review  to  the  Committee  for  Risk  Assessment  and  the  Committee  for  Socio-economic 
Analysis  in  the  European  Chemicals  Agency.  Following  the  receipt  of  the  Committees 
opinions,  the  Commission  decides  under  the  comitology  procedure  whether  it  restricts  the 
manufacture, use or placing on the market, either completely or under specific conditions. In 
implementing  REACH,  Member  States  have  to  lay  down  penalties  that  are  effective, 
proportionate  and  dissuasive,  as  well  as  to  maintain  a  system  of  official  controls  and  other 
activities as appropriate to the circumstances.  

28 
29 
30 
31 

Article 53 and following. 
OJ L 109, 6.5.2000, p. 29–42. 
OJ L 404, 30.12.2006, p. 26–38. 
OJ L 396, 30.12.2006, p. 1–849. 

EN 

15 

   EN 

 
                                                 
6. 

FUNCTIONING OF THE COUNCIL DECISION ON NEW PSYCHOACTIVE SUBSTANCES 

The  Council  Decision  has  three  main  stages,  namely:  information  exchange  covering  the 
Early Warning System and the Joint Report, risk assessment and decision-making. There are 
clear criteria for triggering these phases and timeframes for implementation.  

Table 6.1 

Overview of mechanisms and timeframe of the Council Decision 

Step 

What 

Who 

Timeframe 

Output 

Article 

1. 

Notification on new 
psychoactive 
substances; data on 
manufacture, trade, 
use 

Member States via 
Reitox National 
Focal Points and 
Eurpopol National 
Units 

Ongoing 

Assessment of 
information on a 
specific new 
psychoactive 
substance 

Joint Report: data 
collection 

EMCDDA and 
Europol 

Member States 

6 weeks  

EMCDDA/ 
Europol/ EMA 

Presentation of Joint 
Report 

EMCDDA/ Europol 

4 weeks  

Decision on need for 
and possibility of 
Risk Assessment  

Council (at request 
of Commission or at 
least 1/4th Member 
States) 

4 weeks after 
reception of Joint 
Report by 
Commission or 
Council 

4 

Information is 
transmitted through 
Early Warning System to 
Member States, 
Commission and EMA 

Decision to develop 
EMCDDA-Europol Joint 
Report32 

Data from all Member 
States and available data 
at EU level; preliminary 
scientific data 

5(1)  to 
5(4) 

Joint Report is presented 
to Council and European 
Commission 

5(5) 

Decision by Council  

6(1) 

2. 

Risk Assessment33 

Scientific 
Committee of the 
EMCDDA 
(extended with 
Commission, 
Europol, EMA and 
external experts) 

12 weeks after 
notification by 
Council Secretariat 
of Council 
Decision to 
conduct a Risk 
Assessment  

Risk Assessment Report 

6(2)-
6(3) 

7 

32 

33 

The criteria used to make this decision include: quantity of substance seized, evidence of international 
trafficking  and  organised  crime  involvement,  toxico-pharmacological  properties  of  the  substance, 
evidence for potential further (rapid) spread, of intoxications or fatalities. 
The risk assessment report shall include a physical and chemical description of the substance, including 
medical  value;  health  and  social  risks;  involvement  of  organised  crime,  information  on  seizures  and 
manufacture; information on any assessment of the substance in the UN system; a description of control 
measures  applicable  to  the  substance  in  the  Member  States;  options  for  control  and  possible 
consequences of control measures. 

EN 

16 

   EN 

 
 
 
 
 
 
 
 
                                                 
Proposal on making 
specific new 
psychoactive 
substance subject to 
control measures 

3. 

Decision on 
Commission's 
proposal 

European 
Commission 

6 weeks after 
receipt of Risk 
Assessment Report 

Council 

Unspecified 

Member States 

Implementation of 
possible Council 
Decision to control 
the new psychoactive 
substance 

52 weeks after 
publication of the 
Council Decision 
in the Official 
Journal 

8(1) 

8(2), 

8(3) 

9 

Proposal for a Council 
Decision OR report by 
the Commission why 
control is not deemed 
necessary 

Decision to control or 
not to control the 
specific new 
psychoactive substance 

Member States submit 
substance to control 
measures and criminal 
penalties as provided 
under their laws by 
virtue of their 
obligations under the UN 
Drug Conventions 

7. 

FINDINGS OF THE SURVEY AMONG MEMBER STATES 

In  October  2010,  the  European  Commission  invited  the  Member  States  to  answer  a 
questionnaire  on  the  functioning  of  the  Council  Decision  –  its  formulation,  scope  and 
instruments.  Member  States  were  also  asked,  more  broadly,  how  they  had  tackled  new 
psychoactive  substances  over  the  previous  five  years.  Twenty-five  Member  States  returned 
their answers to the Commission. A summary of these answers is presented in this section. 

7.1. 

Assessment of the Council Decision 

Of the Member States that responded, 1834 find that the overall formulation of the Council 
Decision is sufficiently clear. Greece comments that the text is not up to date. Fifteen Member 
States35 indicate that the provisions on information exchange are clearly formulated and the 
other 15 Member States36 believe that this is the case for the risk-assessment stage. Portugal 
comments  that  the  formulation  could  be  improved,  but  does  not  indicate  in  which  parts. 
Twelve  Member  States37  are  satisfied  with  the  formulation  of  the  Council  Decision  with 
regard  to  the  decision-making  stage.  Ireland  points  out  that  the  formulation  should  be 
improved  to  enable  better  adherence  to  timelines.  Portugal  comments  that  it  could  be 
improved. Sweden is unclear as to whether other national control options are acceptable.  

Fourteen  Member  States38  find  that  the  scope  of  the  Council  Decision,  defined  by  analogy 
with  the  UN  Drugs  Conventions,  is  appropriate  as  regards  the  substances  included.  Ireland 

34 

35 

36 

37 

38 

Belgium,  Bulgaria,  Czech  Republic,  Germany,  Greece,  Spain,  Estonia,  Hungary,  Ireland,  Italy, 
Lithuania, Latvia, Malta, Netherlands, Poland, Portugal, Sweden, Slovenia. 
Belgium,  Bulgaria,  Germany,  Estonia,  Hungary,  Ireland,  Italy,  Lithuania,  Latvia,  Malta,  the 
Netherlands, Poland, Portugal, Sweden, Slovenia. 
Belgium,  Bulgaria,  Germany,  Estonia,  France,  Hungary,  Ireland,  Italy,  Lithuania,  Latvia,  Malta,  the 
Netherlands, Poland, Sweden, Slovenia. 
Belgium,  Bulgaria,  Germany,  Estonia,  Hungary,  Italy,  Lithuania,  Latvia,  Malta,  the  Netherlands, 
Poland, Slovenia. 
Belgium,  Bulgaria,  Germany,  Greece,  Spain,  Estonia,  Hungary,  Italy,  Lithuania,  Malta,  the 
Netherlands, Poland, Romania, Slovenia. 

EN 

17 

   EN 

 
 
 
                                                 
suggests that the scope should be widened and notes that the Council Decision does not take 
into account the fact that some substances are both "drugs precursors" and "end products". It 
points out that substances used in medicinal products are exempted from control, but does not 
indicate why this is a problem. France suggests that the scope could be expanded to include 
substances used for the production of medicines. Portugal comments that the scope could be 
optimised.  Sweden  suggests  widening  the  scope  to  include  substances  used  for  doping  (not 
related  to  sports)  as  well  as  substances  used  in  smoking  mixtures  (such  as  Spice).  Latvia 
comments that Article 2 should include a reference to the legislation on drugs precursors39. 

Ten Member States40 take the view that the control option provided by the Council Decision 
is  appropriate.  Bulgaria  suggests  considering  the  possibility  of  a  generic  approach  (banning 
several  chemically  related  substances  simultaneously).  Lithuania,  the  Netherlands,  the  UK, 
Portugal,  Latvia  and  Ireland  point  out  that  alternative  risk  management  options  should  be 
available to deal with these substances. Ireland adds that particular attention should be paid to 
the supply of new psychoactive substances over the internet. 

7.2. 

Stages in the functioning of the Council Decision  

Information exchange (EWS and Joint Report) 

Most  Member  States  are  satisfied  with  the  rapidity  and  outputs  of  the  EWS.  However, 
certain Member States41 note that a long time elapses between the detection of substances and 
reporting on them via the EWS. Most Member States are satisfied with the way in which the 
EWS facilitates the sharing of information, although three42 would like more information to 
be provided in the early warning reports.  

Although most Member States find the effectiveness and efficiency of the EWS satisfactory, 
three43 point out that more information should be disseminated44. The Netherlands finds that 
too  much  information  is  provided,  and  Belgium  says  that  the  system  is  too  slow  and 
ineffective.  France  contends  that  the  information  exchanged  through  the  EWS  reflects  the 
capacity and efficiency of individual Member States. All Member States find the EWS useful 
not  only  as  an  EU-level  instrument,  but  also  at  national  level  because  it  alerts  national 
authorities to the emergence of new substances in neighbouring Member States. 

Most Member States are satisfied with the Joint Report, although some argue that it should 
be completed sooner. Nearly all Member States think that substances that have been subject to 
a Joint Report, but are not submitted to risk assessment, should be actively monitored. Poland 
suggests  that  substances  subjected  to  Joint  Reports  should  be  temporarily  controlled  until  a 
decision on conducting a risk assessment is taken and the assessment is completed.  

There is no consensus on the need to build EU research capacity to provide toxicological 
and forensic analysis. Sixteen Member States state that the EU's forensic capacity should be 

39 

40 
41 
42 
43 
44 

Council  Regulation  (EC)  No  111/2005  laying  down  rules  for  the  monitoring  of  trade  between  the 
Community and third countries in drug Precursors [OJ L22, 26.1.2005, p.1-10]. 
Belgium, Germany, Greece, Spain, Estonia, Hungary, Italy, Malta, Poland, Slovenia. 
Cyprus, Italy and to a lesser extent, Germany. 
Slovakia, Sweden, and the United Kingdom. 
Bulgaria, Italy, Lithuania. 
These three countries find that the EWS facilitates the information sharing in a satisfactory manner. 

EN 

18 

   EN 

 
                                                 
enhanced45, while three take the view that it is adequate46. Three Member States are in favour 
of  building  a  centralised  forensic  capacity47,  while  ten  believe  that  it  should  be  improved 
through  enhanced  cooperation  between  national  laboratories  or  by  subcontracting  national 
laboratories to conduct forensic analysis.  

Risk Assessment  

Most Member States consider that the time-frame in which the risk assessment is carried out 
is  satisfactory.  Five  Member  States48  consider  the  process  to  be  too  long  and  one  Member 
State  (the  Netherlands)  considers  it  to  be  too  short  to  reach  any  valid  conclusions.  The  UK 
considers the process too long for a quick response, but too short for a robust assessment. All 
Member States consider the information and criteria used to complete the risk assessment to 
be satisfactory.  

Most  Member  States  find  the  role  and  composition  of  the  EMCDDA's  Scientific 
Committee to be satisfactory49. Greece points out that the Balkan countries should be better 
represented in the Scientific Committee, while Ireland believes that experts from all Member 
States should be included, since decisions to ban substances across the EU will be taken on 
the basis of risk assessment. Bulgaria calls for the Scientific Committee to be given decision-
making  powers,  but  does  not  explain  how  these  powers  could  be  implemented  within  the 
current EU institutional framework.  

Most  Member  States  find  the  content  and  structure  of  the  risk  assessment  report 
satisfactory.  Portugal  points  out  that  the  report  should  include  toxicological  and  forensic 
analysis, as well as the results of questionnaires addressed to drug users, while Bulgaria has 
requested more scientific information. Ireland points out that the scope of the risk assessment 
is too limited.  

All Member States except France are in favour of increasing the EU research capacity on 
new  psychoactive  substances,  either  because  of  a  lack  of  national  research  capacity  in  this 
field or because they think that decisions to impose control measures on substances should be 
backed up by enhanced scientific evidence. France is planning to increase its own capacity to 
detect new psychoactive substances and to evaluate their availability, use and toxicity. 

Two  Member  States50  suggest  that  the  risk  assessment  report  should  be  translated  into  all 
official  EU  languages.  Spain  thinks  that  the  Council  Decision  should  enable  monitoring  of 
substances  that  are  not  subject  to  control.  Ireland,  Finland  and  France  suggest  that  several 
substances of the same chemical family should be submitted to a risk assessment at the same 
time. The Netherlands notes that the risk assessment reports have so far provided insufficient 
evidence to justify the control of substances (in particular in the case of BZP) and contends 
that this undermines the objectives of the Council Decision. All Member States consider that 

45 

46 
47 
48 
49 

50 

Belgium,  Bulgaria,  Cyprus,  France,  Germany,  Greece,  Ireland,  Italy,  Malta,  Lithuania,  Poland, 
Portugal, Romania, Spain, Sweden and UK. 
Latvia, Netherlands and Slovenia. 
Bulgaria, Romania and UK. 
Spain, Estonia, France, Poland, Slovenia. 
The  composition  of  the  Scientific  Committee  was  changed  in  2008.  From  a  body  representing  all 
Member  States,  it  became  an  independent  body  of  experts  nominated  on  the  basis  of  their  scientific 
background. 
Belgium and Cyprus. 

EN 

19 

   EN 

 
                                                 
the  risk  assessment  report  is  useful  at  national  level,  either  as  a  complementary  source  of 
information or when considering national control measures. 

Decision making  

Eight  Member  States51  find  the  decision-making  procedure  adequate,  whereas  17  Member 
States52 believe it is too slow. Belgium thinks that the Commission is too slow in deciding on 
its position. Denmark suggests that Member States should decide directly on the basis of the 
risk assessment, without awaiting the Commission's position. Four Member States53 point out 
that  several  countries  had  already  introduced  control  measures  by  the  time  a  decision  was 
made at EU level, but they do not elaborate on whether that is a problem and, if so, why. 

Eighteen  Member  States54  are  in  favour  of  fast-track/emergency  control  measures. 
Lithuania  mentions  that  it  has  no  experience  of  temporary  control  measures.  Bulgaria  notes 
that  temporary  control  measures  are  not  necessary  in  the  current  structure,  but  if  the  risk 
assessment includes more thorough research, which takes more time, such measures might be 
needed. Portugal suggests that the EWS should play a more proactive role in detecting new 
substances,  monitoring  the  market  and  identifying  new  trends.  Spain  suggests  a  Standing 
Committee, which will include the relevant EU institutions and agencies and all the Member 
States,  to  decide  on  temporary  control  measures.  France  is  cautious  about  emergency 
measures,  because  substances  that  do  not  pose  risks  would  also  be  controlled  under  such 
measures. 

Fourteen Member States55 agree that a wider range of control options should be considered, 
including temporary controls and regulation, in respect of substances that are found to pose 
little  or  no  risk  to  health.  Greece  notes  that  it  already  applies  other  control  measures  (e.g. 
consumer protection and food safety legislation) and suggests that such options should also be 
viable at EU level. Finland, Ireland and the UK are in favour of using a generic approach to 
new  psychoactive  substances  (simultaneous  assessment  and  control  of  several  related 
compounds),  to  avoid  the  emergence  of  similar  versions  of  the  same  substance.  The 
Netherlands  suggests  increasing  the  monitoring  of  substances  and  the  introduction  of 
education  and  prevention  programmes,  while  Malta  considers  that  control  options  should 
reflect the overall risks of a substance – on the basis of scientific evidence - to the individual 
and  society.  France  proposes  that  the  time  between  risk  assessment  and  decision  should  be 
shortened. 

7.3. 

National responses to new psychoactive substances 

Fourteen Member States report that the decision to subject BZP to control measures has had 
no  measurable  effect  –  either  because  the  situation  has  remained  unchanged56  or  because 
there is no information on the presence of the substance on the market after it was subjected 

51 
52 

53 
54 

55 

56 

Bulgaria, Lithuania, Italy, Germany, Cyprus, Greece, the Netherlands and the Czech Republic. 
Belgium,  Denmark,  Romania,  Portugal,  Poland,  Ireland,  Hungary,  Latvia,  Estonia,  Spain,  Slovakia, 
Finland, the United Kingdom, Sweden, Malta, Slovenia and France. 
Denmark, Lithuania, Sweden and United Kingdom. 
Bulgaria,  Cyprus,  Denmark,  Estonia,  Finland,  Germany,  Greece,  Hungary,  Ireland,  Latvia,  Lithuania, 
Malta, Poland, Romania, Spain, Slovakia, Sweden and UK. 
Belgium,  Cyprus,  Finland,  Greece,  Ireland,  Lithuania,  Malta,  Latvia,  Netherlands,  Portugal,  Poland, 
Romania, Sweden and UK. 
France, Germany, Hungary, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden and UK. 

EN 

20 

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to  control57.  Six  Member  States58  report  a  decrease  in  seizures  after  the  introduction  of  the 
ban. 

Six  Member  States59  report  that  they  have  specialised  shops  selling  drugs  on  their  territory 
and  that,  when  specific  substances  are  prohibited,  they  are  no  longer  found  in  these  shops. 
Eight  Member  States60  have  forbidden  headshops,  either  by  controlling  the  substances  they 
sold or by tightening health and food legislation. Seven Member States61 have no legislation 
on headshops. Six Member States62 have taken specific measures to tackle  the  sale  of  new 
psychoactive substances online. Six Member States63 have not taken any action, but do not 
indicate whether online sales are a problem. Eight Member States64 use existing legislation for 
illicit drugs control, health or food and consumer protection to regulate online shops, which 
sometimes means that no action is taken.  

Six Member States65 use medicines legislation to regulate these substances until they become 
prohibited  under  illicit  drug  legislation.  Three66  of  them  use  consumer  protection  or  public 
health  laws  to  control  new  psychoactive  substances.  Italy  confirms  that  it  has  implemented 
emergency  measures.  Six  Member  States67  have  enforced  measures  available  under  other 
types of legislation because they enable a faster and more flexible response. Four of these68 
believe  that  the  alternative  options  mentioned  have  a  deterrent  effect.  Three69  indicate  that 
they  use  such  alternative  options  as  temporary  measures,  until  drug  control  legislation  is  in 
place. 

57 
58 
59 
60 
61 
62 
63 
64 
65 
66 
67 
68 
69 

Belgium, Bulgaria, Latvia and Slovenia. 
Cyprus, Denmark, Estonia, Greece, Ireland and Malta. 
Italy, Netherlands, Portugal, Spain, Romania and UK. 
Bulgaria, Finland, Greece, Ireland, Latvia, Lithuania, Poland and Slovakia. 
Cyprus, Estonia, Germany, Hungary, Malta, Sweden and Slovenia. 
Ireland, Italy, Poland, Romania, Spain and the UK. 
Bulgaria, Cyprus, Greece, Hungary, Malta and the Netherlands. 
Estonia, Finland, France, Germany, Latvia, Lithuania, Portugal and Sweden. 
Estonia, Finland, Germany, Italy, Netherlands and Lithuania. 
France, Lithuania and Spain. 
Germany, Ireland, Italy, Lithuania, Malta and the Netherlands. 
Germany, Ireland, Lithuania and the Netherlands. 
Italy, Lithuania and Malta. 

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21 

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7.3.1.  List of new psychoactive substances first notified by year 

2005    

January – May (under the terms of the Joint Action 

Nr 

Common/code name  

Chemical Name 

First notification 

1-(3-chlorophenyl)piperazin/CPP (chlor-phenyl-piperazine)  

February, France 

mCPP  

4-HO-DIPT  

methylone  

4-HO-DET  

DIPT  

MeOPP  

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

2006 

4-hydroxy-N,N-diisopropyltryptamine 

3,4-methylenedioxymethcathinone 

4-hydroxy-N,N-diethyltryptamine 

Diisopropyltryptamine 

1-(4-methoxyphenyl)-piperazine  

May-December(under the terms of the Council Decision 

MDHOET  

2C-P  

5MeO-AMT 

MIPT  

2C-T-4 

4-AcO-DIPT  

DPIA  

3,4-methylenedioxy-N-(2-hydroxyethyl)amphetamine  

2,5-dimethoxy-4-(n)-propylphenethylamine 

5-Methoxy-α-methyltryptamine 

N-Methyl-N-isopropyltryptamine 

2,5-dimethoxy-4-isopropylthiophenethylamine 

4-acetoxy-N,N-diisopropyltryptamin 

Di-(β-phenylisopropyl)amine 

March 2005 

March, Netherlands; 

April, Sweden 

April, Sweden 

April, Sweden 

May, France 

August, UK 
August, UK70 

August, UK 

August, UK 

September, Sweden 

October, Malta 

Nr 

Common/code name  

Chemical Name 

First notification 

70 

Substance not included in the count – previously notified in 2004. 

EN 

22 

EN 

 
  
 
 
 
 
 
 
 
                                                 
pFPP  

pCPP  

DBZP  

2,4-DMA  

2-aminoindan  

Bromo-Dragonfly  

DOI  

1 

2 

3 

4 

5 

6 

7 

2007 

p-Fluorophenylpiperazine 

1-4 chloro phenyl piperazine 

1, 4-Dibenzylpiperazine 

19 April 2006, UK 

6 November 2006, France 

9 November 2006, UK 

2,4-dimethoxy-alpha-methylbenzeneethanamine 
(2,5-dimethoxy-alpha-methylbenzeneethanamine) 

(or  2,5-DMA 

20 November 2006, Finland 

1H-Inden-2-amine,  2,3-dihydro;  or  1-aminoindan  (1H-Inden-1-
amine, 2,3-dihydro 

21 November 2006, Finland 

Bromo-benzodifuranyl-isoprophylamine 

4-iodo-2,5-dimethoxyamphetamine 

21 November 2006, Sweden 

21 November 2006, Sweden 

Nr 

Common/code name  

Chemical Name 

First notification 

(8-bromo-2,3,6,7-benzo-dihydro-difuran-ethylamine)  

15 February 2007, Finland 

N,N-diallyl-5-methoxytryptamine 

15 February 2007, Finland 

N-ethyl- 4-Bromo-2,5-dimethoxybenzeneethanamine 

22 February 2007, Finland 

1-[2-[bis(4-fluorophenyl)methoxy]ethyl]-4-(3-
phenylpropyl)piperazine 

3 May 2007, Belgium 

11 May 2007, UK 

11 June 2007, UK 
1st half of 2007, UK 

D2PM (proposed code name) 

(S)-(-)-α,α-Diphenyl-2-pyrrolidinylmethanol 

N-Acetyl-DOB  

1-PEA  

N-Acetyl-4-bromo-2,5-dimethoxyamphetamine 

1-Phenylethylamine 

2C-B-Fly  

5-MeO-Dalt  

N-ethyl-2C-B  

Vanoxerine  

1 

2 

3 

4 

5 

6 

7 

8 

9 

Gelbes (working name)  

1-(3-chlorophenyl)-4-(3Chloropropyl)piperazine hydrochloride 

24 September 2007, Austria  

NMPEA (proposed code name) 

N methyl Phenylethylamine 

10 

Glaucine (International  

(6aS)-1,2,9,10-tetramethoxyaporphine) 

6 December 2007, France 

2 July 2007, UK 

non-proprietary name) 

11 

Fenazepam  

7-brom-5/o-chlorphenyl/1,2-dihydro-3H-1,4-benzodiazepin-2-on 

1st half of 2007, Finland 

EN 

23 

EN 

 
  
 
 
 
12 

Nimetazepam 

2-methyl-9-nitro-6-phenyl-2,5-diazabicyclo[5.4.0]undeca-
5,8,10,12-tetraen-3-one 

N-desmethylsibutramine 

14 December 2007, Poland  

Bufotenine 

Harmine 

Salvia Divinorum 

3-(2-dimethylaminoethyl)-1H-indol-5-ol 

7-Methoxy-1-methyl-9H-pyrido[3,4-b]indole 

13 

14 

15 

16 

2008 

1st half of 2007, UK 

14 December 2007, Poland 
1st half of 2007, UK 
1st half of 2007, Finland  
1st half of 2007, UK 

Nr 

Common/code name  

Chemical Name 

First notification 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

bk-MBDB 

Ethylcathinone/Subcoca I 

Mephedrone/Subcoca II 

Kratom  

4-HO-MET  

Kava  

Flephedrone  

3-Fluoromethcathinone  

LSA 

pFBT  

MDPV 

p-Fluoramphetamine 

JWH-018  

2009 

EN 

2-methylamino-1-(3,4-methylenedioxyphenyl)butan-1-one 

29 January 2008, UK 

2-Ethylamino-1-phenylpropan-1-one 

2-Methylamino-1-p-tolylpropan-1-one 

7 March 2008, Finland 

7 March 2008, Finland 

Mitragynin/7α-Hydroxy-7H-mitragynin/Paynanthein 

19 March 2008, Austria 

4-hydroxy-N-methyl-N-ethyltryptamin 

Piper methysticum 

p-fluormethcathinone 

4 June 2008, Sweden 

22 July 2008, UK 

30 September 2008, Denmark 

20 October 2008, UK  

(8β)-9,10-didehydro-6-methyl-ergoline-8-carboxamide 

29 October 2008, Bulgaria 

3-pseudotropyl-4-fluorobenzoate 

1 December 2008, Finland 

1-(3,4-methylenedioxyphenyl)-2-pyrrolidinyl-pentan-1-one 

5 December 2008, Finland 

1-(4-fluorophenyl)propan-2-amine 

Naphthalen-1-yl-(1-pentylindol-3-yl)methanon 

5 December 2008, Denmark 

19 December 2008, Áustria 

24 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
2- or 3-fluoroamphetamine 

α-pyrrolidinopropiophenone 

2-diphenylmethylpiperidine 

First notification 

8 January 2009, Belgium 

27 January 2009, Denmark 

2 February 2009, Finland 

5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 

23 February 2009, Germany 

5-(1,1-dimethylhexyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 

23 February 2009, Germany 

5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 

23 February 2009, Germany 

5-(1,1-dimethylnonyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 

23 February 2009, Germany 

1-butyl-3-(1-naphthoyl)indole 

4-acetoxy-N-methyl-N-ethyltryptamine 

2,4,6-trimethoxyamphetamine 

6 March 2009, Denmark 

24 April 2009, Finland 

3 June 2009, Denmark 

1,1-dimethylheptyl-11-hydroxytetrahydrocannabinol 

22 June 2009, UK 

o-desmethyltramadol 

4-acetoxy-N,N-dimethyltryptamine 

2-phenethylamine 

1-pentyl-3-(4-chloro-1-naphthoyl)indole 

1-pentyl-3-(2-methoxyphenylacetyl)indole 

26 June 2009, Germany 

17 August 2009, Finland 

2 October 2009, Finland 

6 October 2009, UK 

6 October 2009, Germany 

12 October 2009, Sweden 

Nr 

Common/code name  

Chemical Name 

- 

PPP 

2-DPMP  

CP 47,497 

CP 47,497-C6 homologue 

CP 47,497-C8 homologue  

CP 47,497-C9 homologue 

JWH-073  

4-AcO-MET 

TMA-6 

HU-210  

ODT 

4-AcO-DMT  

2-PEA  

JWH-398 

JWH-250 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

bk-PMMA / methedrone 

4-Methoxymethcathinone 

Etaqualone  

MDPPP  

Metamfepramone 

3-FMA 

JWH-200 

3-(2-ethylphenyl)-2-methyl-quinazolin-4-one 

12 November 2009, Denmark 

3',4'-methylenedioxy-α-pyrrolidinopropiophenone 

12 November 2009, Denmark 

N,N-dimethylcathinone 

3-fluoromethamphetamine 

1-[2-(4-morpholino)ethyl]-3-(1-naphthoyl)indole 

12 November 2009, Denmark 

17 November 2009, Finland 

3 December 2009, Lithuania 

EN 

25 

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4-MA 

Pregabalin 

23 

24 

2010 

4-methylamphetamine 

(S)-3-(aminomethyl)-5-methylhexanoic acid 

14 December 2009, Belgium 

16 December 2009, Finland 

Nr 

Common/code name  

Chemical Name 

1-(4-bromo-2,5-dimethoxybenzyl)piperazine 

5,6-methylenedioxy-2-aminoindane 

2-phenylpropan-1-amine 

N-benzyl-1-phenethylamine  

N,N-dimethylphenethylamine 

4-fluoromethamphetamine 

First notification 

18 January 2010, Germany 

26 February 2010, Sweden 

26 February 2010, Norway 

26 February 2010, Norway 

26 February 2010, Norway 

24 March 2010, Norway 

(4-methoxyphenyl)(1-pentyl-1H-indol-3-yl)methanone 

25 May 2010, Hungary  

1-pentyl-3-(4-methoxy-1-naphthoyl)indole 

naphthylpyrovalerone 

1-ethylamino-1-phenyl-propan-2-one 

1,3-dimethylamylamine 

2 June 2010, Latvia  

11 June 2010, Sweden  

18 June 2010, Ireland  

21 June 2010, Ireland 

(3-diethylamino-2,2-dimethylpropyl)-4-aminobenzoate 

21 June 2010, Ireland 

JWH-073 methyl derivative  

1-Butyl-3-(1-(4-methyl)naphthoyl)indole) 

Buphedrone 

4-methylethcathinone  

(2-(methylamino)-1-phenylbutan-1-one 

2-Ethylamino-1-(4-methylphenyl)-1-propanone 

30 June 2010, Germany  

5 July 2010, Finland 

July 2010, UK 

AM-694  

JWH-122  

MPBP  

JWH-015 

1-[(5-fluoropentyl)-1H-indol-3-yl]-(2-iodophenyl)methanone 

19 July 2010, Ireland  

1-pentyl-3-(4-methyl-1-naphthoyl)indole) 

4’-methyl-α-pyrrolidinobutyrophenone 

1-propyl-2-methyl-3-(1-naphthoyl)indole) 

23 July 2010, Latvia  

27 July 2010, Bulgaria  

27 July 2010, Austria  

EN 

26 

EN 

2C-B-BZP  

MDAI  

β-Me-PEA  

- 

- 

4-FMA  

JWH-081  

Naphyrone  

Iso-ethcathinone  

DMAA  

Dimethocaine  

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

 
  
 
 
 
 
20 

21 

22 

23 

24 

25 

26 

27 

28 

29 

30 

31 

32 

33 

34 

35 

36 

37 

38 

39 

40 

41 

4-MBC  

MPPP  

CP 47,497 (C8 + C2) variant  

- 

Pentylone  

M-ALPHA  

5-MeO-DPT  

4-methyl-N-benzylcathinone 

4'-Methyl-α-pyrrolidinopropiophenone 

1-naphthalen-1-yl-2-pyrrolidin-1-yl-pentan-1-one  

16 August 2010, UK 

16 August 2010, UK 

17 August 2010, UK 

18 August 2010, UK 

2-Methylamino-1-(3,4-methylenedioxyphenyl)pentan-1-one 

3 September 2010, UK 

1-methylamino-1-(3,4-methylenedioxy-phenyl)propane 

3 September 2010, UK 

β-Ethyl-Methcathinone  

2-methylamino-1-phenyl-1-pentanone 

5-methoxy-N,N-dipropyltryptamine 

13 September 2010, Finland  

17 September 2010, Austria  

JWH- 210  

4-ethylnaphthalen-1-yl-(1-pentylindol-3-yl)methanone 

22 September 2010, Germany 

3,4-Dimethylmethcathinone 

1-(3,4-dimethylphenyl)-2-(methylamino)propan-1-one 

13 October 2010, Hungary  

JWH-203  

JWH-019  

Methoxetamine  

- 

MDPBP  

3-MeO-PCE  

2-(2-chlorophenyl)-1-(1-pentylindol-3-yl)ethanone 

14 October 2010, Latvia  

1-hexyl-3-(1-naphthoyl)indole 

2-(3-methoxyphenyl)-2-(ethylamino)cyclohexanone 

3-(4-Hydroxymethylbenzoyl)-1-pentylindole  

3',4'-methylenedioxy-α-pyrrolidinobutyrophenone 

3-methoxyeticyclidine 

26 October 2010, Finland  

9 November 2010, UK 

9 November 2010, UK 

17 November 2010, UK 

17 November 2010, UK 

DiButylone or bk-MMBDB  

2-dimethylamino-1-(3,4-methylenedioxyphenyl)-butan-1-one 

18 November 2010, Finland  

Arecoline  

BMDP  

BMDB  

5-APB  

Desoxy-D2PM  

methyl methyl-1,2,5,6-tetrahydropyridine-3-carboxylate 

22 November 2010, UK 

2-benzylamino-1-(3,4-methylenedioxyphenyl)propan-1-one 

9 December 2010, UK 

2-benzylamino-1-(3,4-methylenedioxyphenyl)butan-1-one 

9 December 2010, UK 

5-(2-aminopropyl)benzofuran 

2-(diphenylmethyl)pyrrolidine 

14 December 2010, UK 

23 December 2010, UK 

EN 

27 

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