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Brussels, 17.9.2013 SWD(2013) 319 Final COMMISSION STAFF

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Brussels, 17.9.2013 SWD(2013) 319 Final COMMISSION STAFF EUROPEAN COMMISSION Brussels, 17.9.2013 SWD(2013) 319 final COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on new psychoactive substances and proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking, as regards the definition of drug {COM(2013) 619 final} {COM(2013) 618 final} {SWD(2013) 320 final} EN EN EN TABLE OF CONTENTS 1. Introduction.................................................................................................................. 6 2. Procedural issues and consultation of interested parties.............................................. 7 3. Problem definition...................................................................................................... 11 4. Objectives................................................................................................................... 40 5. Policy options and their impacts ................................................................................ 41 6. Comparison of options and identification of the preferred option............................. 69 7. Monitoring and evaluation......................................................................................... 78 Annexes.................................................................................................................................... 80 EN 2 EN COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on new psychoactive substances and proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking, as regards the definition of drug This report commits only the Commission's services involved in its preparation and does not prejudge the final form of any decision to be taken by the Commission. EN 3 EN Executive Summary Sheet Impact assessment on a proposal for a Regulation on new psychoactive substances A. Need for action Why? What is the problem being addressed? New psychoactive substances are increasingly available in the EU internal market and a growing number of individuals, in particular young people, consume such substances, which are also used for various other, legitimate purposes. The potential risks that certain new psychoactive substances pose when consumed by people (for instance they can cause disease, injury, death) have prompted national authorities to submit them to various restriction measures (e.g. market bans, underpinned by either administrative or criminal law). These uncoordinated measures have negative effects on the internal market because they can hamper the legitimate trade and hinder the development of existing and new industrial, commercial and research uses of these substances. The main causes are the divergent national approaches to new psychoactive substances, which can result in displacement of harmful substances between Member States and disruption of legitimate trade, and the ineffectiveness of the current EU instrument on new psychoactive substances. What is this initiative expected to achieve? The main objectives of the proposal are: to protect the health and safety of consumers from the risks posed by harmful new psychoactive substances; to reduce obstacles to legitimate trade in new psychoactive substances and prevent the emergence of such obstacles. These general objectives will be achieved by improving the EU's capacity to rapidly identify and assess the risks posed by new psychoactive substances, by reducing the availability on the market of substances that raise immediate concerns to public health and that are proven to pose considerable health, social and safety risks. By harmonising the approach towards substances posing EU-wide risks, it will provide legal clarity to economic operators in the legitimate trade for these substances, facilitating the functioning of the internal market. What is the value added of action at the EU level? EU-level action would increase legal certainty and reduce obstacles for economic operators in the market for legitimate uses of new psychoactive substances, helping avoid the loss of business and facilitating the operation of companies across the internal market. It would also improve consumer protection, as harmful substances would be withdrawn from the market rapidly across the EU, thus avoiding their displacement. Member States individually cannot solve the problem, since substances withdrawn from the market in one country can still be sold in neighbouring countries or over the internet, which renders national action ineffective. EU-level action would also have the benefit of alerting Member States to harmful substances that have emerged in other countries, helping them anticipate and address potential health threats. B. Solutions What legislative and non-legislative policy options have been considered? Is there a preferred choice or not? Why? The policy options assessed have been grouped in four thematic clusters to address the main problems identified (the preferred option for each cluster is in bold): (a) Improving knowledge of new psychoactive substances: status quo; facilitating structural cooperation between the EMCDDA, research institutes and forensic laboratories; establishment of an EU-level research infrastructure on new psychoactive substances. (b) Approach to address new psychoactive substances (individually or in groups): individual approach (status quo); approach by group of substances; individual approach supported by information on EN 4 EN an 'intelligently clustered' group of substances. (c) Temporary emergency measures: no temporary emergency measures (status quo); EU recommendation to introduce temporary emergency measures; EU decision to introduce temporary emergency measures. (d) Decision on a new psychoactive substance: EU decision to submit substances to restriction measures backed by criminal sanctions or no action (status quo); status quo plus EU recommendation to submit substances to market restriction measures backed by administrative sanctions; status quo plus EU decision to submit substances to market restriction measures backed by administrative sanctions. Who supports which option? Each preferred option enjoys the support of a broad majority of stakeholders. Consultation of Member States showed the need for improving the knowledge-base on new psychoactive substances, as well as the speed of reaction and range of options available to act on substances posing risks, including through administrative measures. The proposed measures address these requests. Economic operators in the market for legitimate uses of new psychoactive substances have stressed the need for an approach proportionate to the risks posed by substances, to avoid unjustified restrictions of economic activities. In general, stakeholders' opinions do not indicate different combinations of options. Practitioners and academic experts have also expressed wide support for the preferred options. EN 5 EN 1. INTRODUCTION This Impact Assessment covers measures aimed at reducing the availability in the EU internal market of new psychoactive substances that pose health, social and safety risks, while preventing the emergence of obstacles to legitimate trade and increasing legal certainty for economic operators. What are new psychoactive substances? New psychoactive substances (also known as "legal highs") are natural or synthetic substances that act on the central nervous system and modify mental functions by inducing a stimulating or depressant effect, causing hallucinations, alterations in motor function, thinking, behaviour, perception, awareness or mood (psychoactive effects). Individuals use them to experience such psychoactive effects. They are sold freely, unless evidence about the risks that they pose when consumed prompts authorities to submit them to restriction measures1. Many new psychoactive substances have or could have different other uses ('legitimate uses'), including in the industry, in research, as active substances for medicines. Around a fifth of the substances notified through the EU-level mechanism of exchange of information have some other, legitimate, uses. New psychoactive substances are not subjected to control measures under the UN Conventions on Drugs2, unlike other psychoactive substances such as cocaine, cannabis or amphetamines ('illicit drugs'), which were submitted to such measures because of their risks and potential for abuse. They could be considered for restriction measures under the UN Conventions on Drugs, if deemed necessary on the basis of a risk assessment conducted by the World Health Organisation (WHO) at the request of one or more UN Member States. The current EU instrument tackling new psychoactive substances, the Council Decision 2005/387/JHA on the information exchange, risk assessment and control of new psychoactive substances3 ("the Council Decision"), does not enable an effective response to the rapid emergence and spread in the internal market of a growing number of such substances. On the other hand, Member States cannot reduce the problem alone. In addition,
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