Proposal for a COUNCIL DECISION on subjecting the new psychoactive substance 1-phenyl-2-(1-pyrrolidin-1-yl) pentan-1-one (α-pyrrolidinovalerophenone, α-PVP) to control measures
Date: 2015-12-18
Institutions: Directorate-General for Migration and Home Affairs, European Commission
Subjects: EU control, drug addiction, drug traffic, health control, health risk, judicial cooperation in criminal matters in the EU, stimulant, toxicology

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   EUROPEAN COMMISSION  Brussels, 18.12.2015  COM(2015) 674 final 2015/0309 (CNS)   Proposal for a COUNCIL DECISION on subjecting the new psychoactive substance 1-phenyl-2-(1-pyrrolidin-1-yl) pentan-1-one (α-pyrrolidinovalerophenone, α-PVP) to control measures  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Council Decision 2005/387/JHA on the information exchange, risk-assessment and control of 
new  psychoactive  substances1  provides  for  a  three-step  procedure  that  may  lead  to  the 
submission of a new psychoactive substance to control measures across the Union. 

On  3  August  2015,  a  joint  report  of  the  European  Monitoring  Centre  for  Drugs  and  Drug 
Addition  (EMCDAA)  and  Europol  drawn  up  in  accordance  with  Article  5  of  Council 
Decision 2005/387/JHA was issued. On 15 September 2015, following the request made by 
the  Commission  and  seventeen  Member  States  and  pursuant  to  Article  6(1)  of  the  above-
mentioned Council Decision, the Council requested an assessment of the risks caused by the 
use, manufacture and trafficking of the new psychoactive substance α-PVP, the involvement 
of  organised  crime  and  the  possible  consequences  of  control  measures  introduced  on  this 
substance. 

The  risks  of  α-PVP  were  assessed  by  the  Scientific  Committee  of  the  EMCDDA,  acting  in 
compliance with the provisions of Article 6(2), (3) and (4) of the Council Decision. The Chair 
of  the  Scientific  Committee  submitted  the  risk  assessment  report  to  the  Commission  and  to 
the Council on 27 November 2015. The main results of the risk assessment are the following: 

α-PVP is a potent psychostimulant. The substance detected in all 28 Member States as well as 
in  Turkey  and  Norway,  is  mainly  imported  into  the  EU  drug  market  from  China  and  then 
distributed across Europe. 

There have been a total of 115 deaths and 191 acute intoxications registered in eight Member 
States reported where α-PVP was detected. 

There are no available information or published studies assessing in a comprehensive way the 
health  risks  associated  with  α-PVP,  namely  chronic  and  acute  toxicity,  but  observations  in 
animals suggest similar effects with those observed with other stimulants.  

Pursuant to Article 8(1) of Council Decision 2005/387/JHA, 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 an initiative is not deemed necessary. According to 
the  judgement  of  the  Court  of  Justice  of  16  April  2015  in  Joined  Cases  C-317/13  and  C-
679/13  the  European  Parliament  must  be  consulted  before  an  act  based  on  Article  8(1)  of 
Council Decision 2005/387/JHA is adopted.  

Based on the findings of the risk assessment report the Commission considers that there are 
grounds for subjecting this substance to control measures across the Union. According to the 
risk assessment report, the acute toxicity of α-PVP is such that it can cause severe harms to 
the health of individuals.  

2. 

OBJECTIVE OF THE PROPOSAL  

The  objective  of  this  proposal  for  a  Council  Decision  is  to  call  upon  the  Member  States  to 
subject α-PVP 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. 

1 

OJ L 127, 20.5.2005, p. 32. 

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2015/0309 (CNS) 

Proposal for a 

COUNCIL DECISION 

on subjecting the new psychoactive substance 1-phenyl-2-(1-pyrrolidin-1-yl) pentan-1-
one (α-pyrrolidinovalerophenone, α-PVP) to control measures 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, 

Having regard to Council Decision 2005/387/JHA of 10 May 2005 on information exchange, 
risk-assessment  and  control  of  new  psychoactive  substances2,  and  in  particular  Article  8(3) 
thereof, 

Having regard to the initiative of the European Commission, 
Having regard to the opinion of the European Parliament3,  

Acting in accordance with a special legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

A risk assessment report on the new psychoactive substance α-PVP was drawn up in 
compliance  with  Article  6  of  Decision  2005/387/JHA  by  a  special  session  of  the 
extended  Scientific  Committee  of  the  European  Monitoring  Centre  for  Drugs  and 
Drug  Addiction,  and  was  subsequently  submitted  to  the  Commission  and  to  the 
Council on 27 November 2015. 

α-PVP  is  a  potent  psychostimulant,  structurally  related  to  cathinone,  pyrovalerone 
and Methylendioxypyrovaleron (MDPV) which are controlled under the 1971 United 
Nations Convention on Psychotropic Substances.The substance has been detected in 
all  28  Member  States,  as  well  as  Turkey  and  Norway  and  the  information  from 
seizures  and  collected  samples  indicate  that  it  is  mainly  present  under  powder  and 
tablet form. The available information suggests that multi-kilogram quantities of α-
PVP are imported into the Union drug market from China and then distributed across 
the Union. The capacity to manufacture α-PVP is also within the Union, as two illicit 
production sites have been seized within one Member State. 

There have been a total of 115 deaths and 191 acute intoxications registered in eight 
Member States reported where α-PVP was detected. In most cases, the use of α-PVP 
was combined with other pharmacologically active substances, either intentionally or 
unintentionally.  If  α-PVP  were  to  become  more  widely  available  and  used,  the 
implications for individual and public health could be significant. 

The  available  data  suggests  that  α-PVP  is  used  by  stimulant  users  in  recreational 
settings as well as by high risk drug users, including those injecting stimulants and 
opioids, and that polydrug use may be common among them. There is limited data on 

2 
3 

OJ L 127, 20.5.2005, p. 32. 
OJ C , , p. . 

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(5) 

(6) 

(7) 

(8) 

(9) 

prevalence of drug use, the long-term consequences and on the social risks associated 
with the substance.  

There are no available information or published studies assessing in a comprehensive 
way the health risks associated with α-PVP, namely chronic and acute toxicity, but 
observations  in  animals  suggest  similar  effects  with  those  observed  with  other 
stimulants.  Adverse  symptons  observed  in  humans  have  been  described  as 
tachycardia, hyperthermia, diaphoresis, agitation, convulsions or seizures, confusion, 
aggression.  Data  from  non-clinical  studies  suggest  that  α-PVP  may  have  an  abuse 
liability and possibily a dependence potential in humans.  

α-PVP has no established or acknowledged medical use (human or veterinary). Apart 
from its use in analytical reference materials and in scientific research investigating 
its chemistry, pharmacology and toxicology as a result of its emergence on the drug 
market, there is no indication that it is being used for other purposes. 

α-PVP  has  not  been  under  assessment  and  is  currently  not  under  assessment  at  the 
United Nations’ level, and no such assessment is planned. 

Despite  the  limited  scientific  evidence  available  on  α-PVP,  the  evidence  and 
information  on  the  health  risks  that  the  substance  poses,  as  documented  in  its 
detection  in  fatalities  and  acute  intoxications,  provides  sufficient  ground  for 
subjecting α-PVP to control measures across the Union. 

Since  sixteen  Member  States  control  α-PVP  under  national  legislation  complying 
with  the  obligations  of  the  1971  United  Nations  Convention  on  Psychotropic 
Substances  and  five  Member  States  use  other  legislative  measures  to  control  it, 
subjecting this substance to control measures across the Union would help avoid the 
emergence  of  obstacles  in  cross-border  law  enforcement  and  judicial  cooperation, 
and would help protect from the risks that its availability and use can pose, 

(10) 

HAS ADOPTED THIS DECISION:  

Article 1 

new 

The 
pyrrolidinovalerophenone, α-PVP) shall be subjected to control measures across the Union. 

1-phenyl-2-(1-pyrrolidin-1-yl)pentan-1-one 

psychoactive 

substance 

(α-

Article 2 

By  [one  year  from  the  date  this  Decision  is  published],  Member  States  shall  take  the 
necessary  measures,  in  accordance  with  their  national  law,  to  subject  α-PVP  to  control 
measures and criminal penalties, as provided for under their legislation complying with their 
obligations under the 1971 United Nations Convention on Psychotropic Substances. 

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Article 3 

This  Decision  shall  enter  into  force  on  the  […]  day  following  that  of  its  publication  in  the 
Official Journal of the European Union. 

Done at Brussels, 

For the Council 
The President 

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