New psychoactive substances: information exchange, early warning system and risk assessment procedure

2016/0261(COD)

The Committee on Civil Liberties, Justice and Home Affairs adopted the report by Michal BONI (EPP, PL) on the 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.

The committee recommended that Parliament’s position adopted in first reading following the ordinary legislative procedure should amend the Commission proposal as follows:

Improve monitoring: bearing in mind the rapid growth of the market of those novel products, which continues to be challenging, the amended text stressed the need to enhance monitoring and early warning systems, to assess their health, safety and social risks in order to develop responses such as risk reduction measures in order to combat those threats.

The Regulation should take into account the fact that vulnerable groups, and especially young people, are particularly exposed to the public health, safety and social risks arising from new psychoactive substances.

Exchange of information, early warning system and risk assessment: Members proposed that provisions on new trends in the use of existing psychoactive substances should be maintained. Information provided to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and to Europol should also include distribution channels, trafficking and smuggling. The Centre, in cooperation with Europol, shall collect, analyse, assess, and communicate this information in a timely manner to Member States and to the Commission.

The initial report on the new psychoactive substance should also give a first indication of safety risks. As one of the reasons of this report is to make the procedures limiting the dangerous new psychoactive substances shorter and more efficient, the information should be provided without undue delay to the Centre by the European Medicines Agency.

Risk assessment report: this must contain:

  • an analysis of the health risks associated with the new psychoactive substance, including contraindications for use with other substances, where available;
  • an analysis of the social risks associated with the new psychoactive substance, in particular the involvement of criminal groups in the development, manufacture, distribution and distribution channels, trafficking and smuggling of the new psychoactive substance.

The Scientific Committee assessing the risks posed by the new psychoactive substance may include a psychologist specialising in addiction. 

Exclusion from risk assessment: a substance not assumed dangerous on the international level could pose serious threats in the EU. Accordingly, if the data indicates this is needed, Members consider that it should be possible to conduct a risk assessment at Union level.