Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1920/2006 as regards information exchange, early warning system and risk assessment procedure on new psychoactive substances

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.

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 and a proposal for 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.

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.

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. The Council did not adopt a general approach on the proposals.

This proposal follows an agreement by COREPER on 6 April 2016 on a compromise approach proposed by the Netherlands Presidency of the Council. 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.

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 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.

EUR-Lex: COM(2016)547: Follow the progress of this proposal through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2016:547:FIN

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