Explanatory Memorandum to COM(2016)547 - Amendment of Regulation (EC) No 1920/2006 as regards information exchange, early warning system and risk assessment procedure on new psychoactive substances - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2016)547 - Amendment of Regulation (EC) No 1920/2006 as regards information exchange, early warning system and risk assessment ... |
|---|---|
| source | COM(2016)547  |
| date | 29-08-2016 |
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Over the past decade there has been a massive growth in new psychoactive substances (NPS), at global level and in Europe as well, and there are no signs of a slowdown. In 2015, 100 new substances were reported for the first time to the EU Early Warning System (EWS), bringing the total number of new substances monitored to more than 560 – with more than 380 (70%) of these detected in the last five years alone. 1
The United Nations General Assembly at the Special Session on the world drug problem (UNGASS, 19-21 April 2016) adopted the outcome document 'Our joint commitment to effectively addressing and countering the world drug problem' 2 . A specific section deals with addressing emerging and persistent challenges and threats including NPS. The joint commitment calls for strengthening action to address the challenge of NPS as well as for enhancing information-sharing and early warning networks.
On 17 September 2013, the Commission put forward a package of two legislative proposals on new psychoactive substances: a proposal for a Regulation on new psychoactive substances 3 and a Directive 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 4 . The objective was to reduce the availability of new psychoactive substances that pose risk through swifter, more effective action on Union level compared to the currently applicable system based on Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances 5 .
Inter-institutional negotiations of this legislative package have been ongoing for more than two years. The European Parliament adopted its legislative resolutions on 17 April 2014 6 . The Council did not adopt a general approach on the proposals; during the examination of the proposals Member States expressed doubts concerning the choice of Article 114 of the Treaty on the Functioning of the European Union (TFEU) as the legal basis for the proposed Regulation.
To achieve the same objective of a swifter, more effective EU action on NPS, the Permanent Representatives Committee (COREPER) on 6 April 2016 7 agreed to the approach proposed by the Netherlands Presidency in its discussion paper, including amendments of the draft Directive based on Article 83 TFEU that will in particular contain a definition of new psychoactive substances and provisions on swift Union level decision making in order to criminalise harmful new psychoactive substances in all Member States. COREPER also invited the Commission to present a proposal on amending the founding Regulation of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), Regulation 1920/2006. According to the Summary Record of the 2580th meeting of COREPER this decision triggers the start of the 3 months' opt-in deadline for the Member States concerned by Protocol 21 and has consequences under Protocol 22 annexed to the TEU. The European Parliament is informed about this change by a letter from the Council.
Given that the decision of COREPER aims to achieve the same objectives as proposed by the package of 2013, the Commission proposes targeted amendments of Regulation 1920/2006 integrating the draft provisions on early warning system and risk assessment procedure that were part of the 2013 Commission proposal for a Regulation on new psychoactive substances into the founding Regulation of the EMCDDA. The Commission will consider the withdrawal of the proposal on a Regulation on new psychoactive substances in preparing Commission's Work Programme for 2017.
The new proposal as the previous one aims at strengthening the EU early warning system and the risk assessment and at streamlining procedures to ensure more effective and fast action. Therefore, in order to speed up the process, deadlines are substantially shortened compared to the current system based on Council Decision 2005/387/JHA. For the purpose of swift and effective collection of information on NPS, the EMCDDA should conclude working arrangements with Europol, the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority without undue delay following the publication of the Regulation in the Official Journal.
This proposal also ensures a participation of EUROPOL in the early warning system and risk assessment procedure, in particular as input on the involvement of criminal groups in the manufacture and distribution of new psychoactive substances is concerned.
According to Article 23 of Regulation 1920/2006 the Commission may propose, if appropriate, and in the light of developments in respect of regulatory agencies on the basis of the next evaluation of the Centre further amendments to the EMCDDA founding Regulation.
• Consistency with existing policy provisions in the policy area
The proposal reflects the priorities set out by the European Agenda on Security 8 adopted on 28 April 2015. The European Agenda of Security stresses that the market for illicit drugs remains the most dynamic of criminal markets, with a recent trend being the proliferation of new psychoactive substances. It also states that the production of these substances is increasingly taking place in the Union thus pointing to the urgency of adopting a new legislative framework.
This proposal has to be read in conjunction with Directive (EU) …/ … [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 9 ]. Both instruments are designed to replace the mechanism established by Council Decision 2005/387/JHA.
• Legal basis
The proposal is based on Article 168(5) TFEU, which empowers the European Parliament and the Council to adopt measures concerning monitoring, early warning of and combating serious cross border threats to health whilst excluding any harmonisation of the laws and regulations of the Member States.
• Subsidiarity
There is a clear need for EU action on new psychoactive substances. Member States alone cannot reduce the problems caused by the spread of harmful new psychoactive substances. Uncoordinated national action in this area can produce adverse knock-on effects, for instance displacement of harmful substances from one Member State to another. Criminal groups may exploit this situation.
Consequently, EU-level action is necessary to ensure that potentially harmful new psychoactive substances, which cause EU-wide concern, can be identified, assessed and, if they pose risks, incriminated in all Member States. This Regulation has therefore to be read in conjunction with Directive (EU) …/ … [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] since both acts are designed to replace the mechanism established by Council Decision 2005/387/JHA.
• Proportionality
The proposal is proportionate and does not go beyond what is necessary to achieve the objectives because it only addresses new psychoactive substances that are a concern at the EU level.
• Choice of the instrument
The proposal concerns the amendment of a Regulation. There are no indications that a different instrument than a Regulation would be appropriate.
• Stakeholder consultations
This proposal follows an agreement by COREPER on 6 April 2016 on a compromise approach proposed by the Netherlands Presidency of the Council. In the meeting of the Committee on Civil Liberties, Justice and Home Affairs (LIBE) of the European Parliament of 15 June 2016, the Rapporteurs and the Shadow Rapporteurs announced that they have taken the decision to pursue this new approach as a package and work together with the Council and the Commissions to reach agreement. As the content reflects this agreement, this new proposal does not require further stakeholder consultations.
• Impact assessment
The Commission conducted an impact assessment of policy alternatives in the context of the package of two proposals put forward on 17 September of 2013. The impact assessment in particular concluded that the quality and quantity of information available at EU level and shared by Member States as well as the capacity to rapidly identify and assess new psychoactive substances needs to be improved. 10 Therefore, no new impact assessment is required for this proposal.
Contents
The EMCDDA is tasked with the exchange of information, the early warning system and the risk assessment procedure on new psychoactive substances. The subsidy for the Centre forms already part of the Union's budget.
However, for the Centre to adequately deal with the growing number of requests related to information exchange on new psychoactive substances as well as with the proposed streamlined procedures for the EU early warning system and risk assessment procedure, an amount of EUR 676.000 in total for the period 2017-2020 for the system development and an amount of EUR 100.000 per year to finance three additional contract agents will need to be added to the Centre's budget.
• Monitoring, evaluation and reporting arrangements
The EMCDDA is on a regular basis evaluated according to Article 23 of Regulation 1920/2006. According to this article, the Commission shall initiate an external evaluation of the EMCDDA every six years to coincide with the completion of two of the Centre's three-year programmes.
• Detailed explanation of the specific provisions of the proposal
Article 1 provides for the following amendments to Regulation 1920/2006:
New point (f) in Article 2 (Tasks) – this provision clarifies that tasks of the EMCDDA are information exchange and early warning on new psychoactive substances as well as risk assessment. The Centre also monitors all new psychoactive substances that have been reported by Member States.
New Article 5a (Exchange of information, early warning system and risk assessment on new psychoactive substances) – this provision establishes the respective roles of Member States, the EMCDDA and Europol in the process of exchange of information and early warning on new psychoactive substances.
New Article 5b (Initial report) – this provision lays down the contents and the procedures for the drawing up and the transmission by the EMCDDA of an initial report on a new psychoactive substance. Europol, the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority are associated to the collection of information for an initial report.
New Article 5c (Risk assessment procedure and report) – this provision empowers the Commission to request the EMCDDA to assess the risks of a new psychoactive substance on which an initial report has been drawn up. It lays down the procedures for the risk assessment, which is to be conducted by the Scientific Committee of the EMCDDA, and for the drawing up and the transmission of a risk assessment report.
New Article 5d (Exclusion from risk assessment) – this provision details such circumstances in which no risk assessment is to be conducted on a new psychoactive substance.
Article 2 establishes when the Regulation shall enter into force.