Go back to the Europarl portal

Choisissez la langue de votre document :

  • bg - български
  • es - español
  • cs - čeština
  • da - dansk
  • de - Deutsch
  • et - eesti keel
  • el - ελληνικά
  • en - English (Selected)
  • fr - français
  • ga - Gaeilge
  • hr - hrvatski
  • it - italiano
  • lv - latviešu valoda
  • lt - lietuvių kalba
  • hu - magyar
  • mt - Malti
  • nl - Nederlands
  • pl - polski
  • pt - português
  • ro - română
  • sk - slovenčina
  • sl - slovenščina
  • fi - suomi
  • sv - svenska
Parliamentary questions
PDF 0kWORD 0k
28 March 2018
E-000566/2018(ASW)
Answer given by Mr Avramopoulos on behalf of the Commission
Question reference: E-000566/2018

The Commission is well aware of the increasing abuse of fentanyl and its derivatives and is closely following the developments in the US, e.g. through regular dialogues with the US.

Fentanyl is a controlled substance(1) widely used for general anaesthesia and for pain management. In the EU, medicines containing fentanyl are authorised either centrally or nationally in accordance with EU legislation. Many of them have been on the market for a long time and are only obtained under strict conditions due to the well-known potential of abuse. The mandatory product information documents advise about the safe use of the product including potential risk of abuse. The misuse is monitored through pharmacovigilance processes to be followed by marketing authorisation holders(2), the Member States and the European Medicines Agency (EMA).

The following fentanyl derivatives have been or are in the process of being subjected to control measures on European and/or United Nations level: acryloylfentanyl(3), furanylfentanyl(4), 4-fluoroisobutyrylfentanyl(5), tetrahydrofuranylfentanyl(6) and carfentanil(7).

Further information on fentanyl and its derivatives is available from the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), e.g. in the European Drug Report 2017(8) or on its website in the section ‘Action on new drugs’(9).

The new legislative package on new psychoactive substances(10), which will become fully effective as of November 2018, will enable the EU to respond more effectively to new substances, including new synthetic opioids, coming on the market.

(1)Fentanyl has been subjected to control measures through the UN Convention on Narcotic Drugs of 1961, which means that it is also subject to control measures in Europe through the application of Council Framework Decision 2004/757/JHA, OJ L 335, 11.11.2004, p. 8.
(2)The company or other legal entity that has the authorisation to market a medicine in one, several or all EU Member States.
(3)Council Implementing Decision (EU) 2017/1774 of 25 September 2017 on subjecting N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryloylfentanyl) to control measures, OJ L 251, 29.9.2017, p. 21.
(4)Council Implementing Decision (EU) 2017/2170 of 15 November 2017 on subjecting N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]furan-2-carboxamide (furanylfentanyl) to control measures, OJ L 306, 22.11.2017, p. 19.
(5)Proposal for a Council Implementing Decision on subjecting the new psychoactive substance N-(4-fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl)propanamide (4-fluoroisobutyrylfentanyl) to control measures, COM(2017) 756; currently awaiting the EP opinion before being adopted.
(6)Proposal for a Council Implementing Decision on subjecting the new psychoactive substance N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]oxolane-2-carboxamide (tetrahydrofuranylfentanyl; THF-F) to control measures, COM(2017) 759; currently awaiting the EP opinion before being adopted.
(7)Proposal for a Council Implementing Decision on subjecting the new psychoactive substance methyl 1-(2-phenylethyl)-4-[phenyl(propanoyl)amino]piperidine-4-carboxylate (carfentanil) to control measures, COM(2017) 765; currently awaiting the EP opinion before being adopted.
(8)http://www.emcdda.europa.eu/publications/edr/trends-developments/2017
(9)http://www.emcdda.europa.eu/activities/action-on-new-drugs
(10)Regulation (EU) 2017/2101 of the European Parliament and of the Council of 15 November 2017 amending Regulation (EC) No 1920/2006 as regards information exchange on, and an early warning system and risk. assessment procedure for, new psychoactive substances, OJ L 305, 22.11.2017, p. 1; Directive (EU) 2017/2103 of the European Parliament and of the Council of 15 November 2017 amending Council Framework Decision 2004/757/JHA in order to include new psychoactive substances in the definition of ‘drug’ and repealing Council Decision 2005/387/JHA, OJ L 305, 22.11.2017, p. 12.

Last updated: 23 April 2018Legal notice