Today, the European Commission has proposed to control two harmful new psychoactive substances (NPS) across the European Union. The substances in question — MDMB-4en-PINACA and 4F-MDMB-BICA — are both synthetic cannabinoids, which have been raising health concerns in Europe (1). The proposal to control the substances is based on risk assessments conducted by the EU drugs agency (EMCDDA) in December 2020.

MDMB-4en-PINACA and 4F-MDMB-BICA are sold as ‘legal’ replacements for cannabis (or already controlled synthetic cannabinoids) and can pose a high risk of severe poisoning. The substances have been detected in smoking mixtures, powders, liquids (including e-liquids) and paper impregnated with the substance (including blotters). Harmful effects linked to the use of the substances were reported by the EU Member States to the EMCDDA through the EU Early Warning System (EWS).

The two risk assessments were conducted by the EMCDDA Scientific Committee on 7 December 2020, with additional experts from the EU Member States, European Commission, Europol, the European Medicines Agency and the EMCDDA. These examined the health and social risks of the substances, as well as international trafficking and the involvement of organised crime (2).

At the time of the risk assessments, 12 and 21 deaths with confirmed exposure to MDMB-4en-PINACA and 4F-MDMB-BICA respectively had been reported in the EU.

Today’s proposal from the Commission (the adoption of a delegated directive) is based on the latest legislation designed to bring a stronger and faster response to NPS in Europe (3). The delegated directive includes the two substances in the definition of ‘drug’ under EU law (4). The European Parliament and the Council will have two months to analyse the act before it enters into force. Once in force, the Member States will have six months to introduce the relevant national legislation.

Of the 35 risk assessments carried out by the EMCDDA, seven have been related to synthetic cannabinoids (5). Products containing synthetic cannabinoids have been available in Europe since around 2006. MDMB-4en-PINACA has been available on the EU drug market since at least 2017 and 4F-MDMB-BICA since March 2020.