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Brussels, 17 September 2013
Frequently Asked Questions: tackling psychoactive substances across Europe
What are new psychoactive substances?
They are natural or synthetic substances that affect the central nervous system and induce a stimulating or depressant effect, just like illicit drugs, such as cocaine or ecstasy, do. They can cause hallucinations, alterations in thinking, behaviour, perception, awareness or mood. In fact, they are often marketed as legal alternatives to illicit drugs (hence the name ‘legal highs’). And, just like illicit drugs, they can cause great harm to the people who use them. They are often mislabelled and sold as plant food, bath salts, or research chemicals, to circumvent laws on the protection of consumers.
Many new psychoactive substances have or could have other uses, for example in the medical, chemical or high tech industry - as active substances for medicines, for instance. Around a fifth of the substances notified through the EU-level mechanism of exchange of information have some other, legitimate, uses. Vanoxerine, for instance, is being researched for use in the treatment of cocaine addiction; GBL (gamma-butyrolactone) is a widely used chemical with excellent solvent qualities, used as aroma compound, stain remover, superglue remover, paint stripper; CPCPP (1-(3-chloropropyl)piperazine) is being used in the manufacture of an anti-depressant.
What risks can new psychoactive substances pose?
Their consumption can pose severe risks to individuals’ health and safety. These risks include death and severe physical or psychological harm, such as significant agitation, psychosis, delirium, tachycardia, hypertension, chest pain, seizures, overdose, severe psychiatric problems, spread of blood-borne infections such as HIV or hepatitis C.
The risk of physical and psychological harm is higher when several new psychoactive substances are consumed together or with alcohol, which they often are.
In addition, the use of new psychoactive substances can pose risks to society, as it may lead to an increase in violent behaviour and crime. It can also pose burdens on health or emergency services, for instance, who often struggle to identify which substances people used and which treatment will help, or on law enforcement authorities.
How many new psychoactive substances are around?
More and more new psychoactive substances are emerging and spreading increasingly quickly in the European Union. More than 300 new substances have been detected in Europe since 1997 and the problem has worsened in recent years: the number of substances identified between 2009 and 2012 tripled (from 24 to 73 a year).
Source: European Monitoring Centre for Drugs and Drug Addiction 'European Drug Report' 2013: http://www.emcdda.europa.eu/edr2013 , p26.
These substances spread easily in the internal market: around 80% were detected in more than one EU country.
How many people are using them?
The rise in the availability and consumption of New Psychoactive Substances is one of the most topical and dangerous trends in Europe's drug market. A growing number of individuals consume such substances, despite the risks to health and safety that they may pose. Many users are young. A 2011 Eurobarometer survey "Youth attitudes on drugs" shows that 5% of young people (15-24 years' old) in the EU reported having used such substances at least once in their life. As many as 16% of young people in Ireland have used new psychoactive substances, and close to 10% in Poland, Latvia and the UK.
Experience with legal substances which imitate the effects of illicit drugs
Source: 2011 Eurobarometer survey "Youth attitudes on drugs"
Why do we need to take action at the EU level on new psychoactive substances?
With a borderless internal market, we need common EU rules to tackle this problem. 80% of new psychoactive substances are reported in more than one Member State. Member States, individually, cannot address this issue effectively and sustainably. Moreover, attempts to reduce the availability of new psychoactive substances in a country can produce knock-on effects on other countries (displacement of harmful substances from one country to another, for instance). New psychoactive substances harmful to consumers must be withdrawn quickly from the market in all Member States, which requires action at EU level.
What action has the EU taken so far to address new psychoactive substances?
Nine substances1 have been submitted to restriction measures and criminal sanctions across the EU since 1997, because of the risks that they pose. The latest substances submitted to such measures at the EU level were BZP in 2008, mephedrone in 2010 (IP/10/1355) and 4-methylamphetamine in 2013 (IP/13/75).
In June 2013, the Commission proposed to subject the substance 5-IT to control and criminal sanctions (IP/13/604). In a short span of five months in 2012, four Member States reported 24 fatalities in which 5-IT – together with other substances – played a role, and three Member States reported 21 cases of intoxication linked with this substance.
Why is the Commission proposing a new mechanism?
The current EU instrument, the Council Decision (2005/387/JHA) on the information exchange, risk-assessment and control of new psychoactive substances, is unable to provide an adequate response to this growing challenge. It does not enable harmful substances to be withdrawn from the market quickly enough. Nor does it provide for a response proportionate to the level of risk involved.
This is, in particular, because it is too slow (there is a lapse of at least 24 months between the wheels of the EU being set into motion and Member States adopting the necessary measures), and it lacks options for restriction measures (it only offers a choice between imposing criminal measures to address the substance or taking no action at all).
The Commission is thus proposing new legislation to strengthen the EU’s ability to respond to this challenge.
How does the new mechanism differ from the current rules?
The Council Decision 2005/387/JHA set up a mechanism for the information exchange, risk assessment and control of new psychoactive substances. The new proposals build on the strengths of this mechanism and address its shortcomings. They establish clear rules for restrictions to the free movement of new psychoactive substances. They will enable quicker and more proportionate measures to be taken on new psychoactive substances.
EU action to detect, assess and withdraw harmful new psychoactive substances from the market will be much quicker:
Unlike under the current system, these measures will be directly applicable in the Member States and will not need to be transposed into national law. This will speed up dramatically the EU's response to harmful substances. Under the current system, the entry into force of restriction measures takes up to 24 months.
In addition, under the new mechanism, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) will look for chemicals similar to the one formally under examination. The purpose is for the Union to be one step ahead when criminals try to circumvent restrictive measures by making small changes to the chemical structure of a banned substance.
Graphic: Decision-making under the old and new systems
How will the new rules protect legitimate uses of new psychoactive substances and economic operators?
The new instrument sets out the principle of free movement of new psychoactive substances for commercial and industrial uses as well as for scientific research and development purposes. It also introduces clear rules for the adoption of restriction measures, to improve legal certainty for economic operators. In addition, it introduces a graduated, proportionate and better calibrated set of options for addressing new psychoactive substances, which will ensure that legitimate uses of the substance and research are not unduly hindered.
EU action will be proportionate to the health, social and safety risks that psychoactive substances pose. The risks of each substance will be determined following a risk assessment. While no restriction measures will be introduced at EU level on substances posing low risks, substances posing moderate risks will be subjected to restrictions on the consumer market (industrial uses and research will not be impeded). In the case of substances posing severe risks, however, even industrial use will be restricted, and the measures will be backed by criminal penalties, like in the case of illicit drugs. This approach will also enhance the effectiveness of the Union's action: restrictive measures will be adopted as regards a greater number of substances. The Union will be able to tackle harmful new psychoactive substances to which criminal measures would not be the appropriate response.
How does the new mechanism work?
As under the current instrument, Member States that detect a new psychoactive substance on their territory share the information they have with other Member States through an Early Warning System. This is managed by the EMCDDA and Europol.
When a substance raises concerns across the Union because of the health, social and safety risks that it poses, the EMCDDA and Europol draft a joint report on the substance. On the basis of this joint report, the Commission decides whether there are grounds to request a fully-fledged risk assessment of the substance.
If the joint report shows that the substance poses immediate risks to public health, for example, that it is highly toxic and is causing fatalities across Europe, the Commission also subjects it to temporary market restriction. This will forbid the sale of the substance to consumers for one year, but legitimate uses of the substance will not be affected. In this way, consumers are protected during the risk assessment of the substance, while industrial, commercial or scientific uses of the substance are not impeded.
Once the risks of the substance have been assessed, action will be taken depending on its level of risk. The EU can:
All restrictions, temporary and permanent, are directly applicable, as they are adopted by the Commission as implementing acts.
What does each legislative proposal cover?
The proposal for a Regulation on new psychoactive substances sets up a mechanism for the information exchange on, risk assessment of and restriction measures (temporary or permanent) applied to harmful new psychoactive substances within the internal market.
The proposal for a Directive amending the Framework Decision 2004/757/JHA on illicit drug trafficking enables the submission of new psychoactive substances that pose severe risks to the criminal law provisions that apply to illicit drugs. It includes severe-risk new psychoactive substances in the definition of ‘drugs’ and requires Member States to take the necessary measures within one year to ensure that these substances are covered by criminal law provisions, just like illicit drugs are.
What will the criminal penalties be?
The rules regarding the definition of offences and the levels of sanctions foreseen by Framework Decision 2004/757/JHA on illicit drug trafficking will apply to new psychoactive substances posing severe risks.
Trafficking in severe-risk new psychoactive substances should be punished with imprisonment of a maximum of at least between one and three years. If the offence involves large quantities, or drugs that cause the most harm to health, or it resulted in significant damage to the health of a significant number of people, the offence should be punished with a penalty of a maximum of at least between five and ten years of imprisonment.
In addition, if the offence is committed within the framework of a criminal organisation, it should be punished with a penalty of at least ten years of imprisonment.
Why do the new rules not apply to drug precursors, medicinal products or veterinary medicinal products?
Press release: IP/13/837
European Commission – Drug control policy:
2011 Eurobarometer on "Youth attitudes on drugs”
European Monitoring Centre for Drugs and Drug Addiction 'European Drug Report' 2013:
Homepage of Viviane Reding, Vice-President of the European Commission and EU Justice Commissioner:
4-MTA (1999), PMMA (2002), 2C-I, 2C-T-2, 2C-T-7, TMA-2 (2003), BZP (2008), mephedrone (2010), 4-methylamphetamine (2013); MBDB (1998), GHB and ketamine (2000) were assessed but no measures were introduced; the risk assessment of 5-(2-aminopropyl)indole was finalised in April 2013 and the Commission has proposed to subject this substance to control measures.