This is the implementation decision of the Council of the EU, based on a proposal from the European Commission, was adopted in the final stage of the three-step legal procedure designed to respond to new psychoactive substances (NPS) that may pose public health and social threats. The substance concerned is α-PVP is a potent psychostimulant, structurally related to cathinone, pyrovalerone and methylendioxypyrovaleron (MDPV).
COUNCIL IMPLEMENTING DECISION (EU) 2016/1070
of 27 June 2016
on subjecting 1-phenyl-2-(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 the information exchange, risk-assessment and control of new psychoactive substances (1), and in particular Article 8(3) thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Parliament (2),
A risk assessment report on the new psychoactive substance 1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (α-pyrrolidinovalerophenone, α-PVP) was drawn up in accordance with 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. α-PVP 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 in 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. Two illicit production sites have been seized in a Member State, indicating that the capacity to manufacture α-PVP also exists within the Union.
Eight Member States have reported a total of 115 deaths and 191 acute intoxications 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 prevalence of drug use, long-term consequences and on the social risks associated with the substance.
There is no available information or any published study assessing in a comprehensive way the health risks associated with α-PVP, namely chronic and acute toxicity, but observations in animals suggest similar effects to those observed in other stimulants. Adverse symptoms observed in humans include tachycardia, hyperthermia, diaphoresis, agitation, convulsions or seizures, confusion and aggression. Data from non-clinical studies suggest that α-PVP may have an abuse liability and possibly a dependence potential in humans.
α-PVP has no established or acknowledged human or veterinary medical use. 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.
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 grounds for subjecting α-PVP to control measures across the Union.
Given that 16 Member States control α-PVP under national legislation complying with the obligations of the 1971 United Nations Convention on Psychotropic Substances and that 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 could pose.
Decision 2005/387/JHA confers upon the Council implementing powers with a view to giving a quick and expertise-based response at Union level to the emergence of new psychoactive substances detected and reported by the Member States, by subjecting those substances to control measures across the Union. As the conditions and procedure for triggering the exercise of such implementing powers have been met, an implementing decision should be adopted in order to put α-PVP under control across the Union.
Denmark is bound by Decision 2005/387/JHA and is therefore taking part in the adoption and application of this Decision, which implements Decision 2005/387/JHA.
Ireland is bound by Decision 2005/387/JHA and is therefore taking part in the adoption and application of this Decision, which implements Decision 2005/387/JHA.
The United Kingdom is not bound by Decision 2005/387/JHA and is therefore not taking part in the adoption of this Decision, which implements Decision 2005/387/JHA, and is not bound by it or subject to its application,
HAS ADOPTED THIS DECISION:
The new psychoactive substance 1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (α-pyrrolidinovalerophenone, α-PVP) shall be subjected to control measures across the Union.
By 3 July 2017, Member States shall take the necessary measures, in accordance with their national law, to subject the new psychoactive substance referred to in Article 1 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.
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Decision shall apply in accordance with the Treaties.
Done at Luxembourg, 27 June 2016.
For the Council
M.H.P. VAN DAM
(1) OJ L 127, 20.5.2005, p. 32.
(2) Opinion of 8 June 2016 (not yet published in the Official Journal).