The Council, taking into account the advice of Europol and the EMCDDA, and acting by a majority of its members, may request that the risks, including the health and social risks, caused by the use of, the manufacture of, and traffic in a new psychoactive substance, the involvement of organised crime and possible consequences of control measures, be assessed.
In order to carry out the risk assessment, the EMCDDA convenes a special meeting under the auspices of its Scientific Committee. In addition, for the purpose of this meeting the Scientific Committee may be extended by a further five Member States’ experts form scientific fields that are not represented, or not sufficiently represented, in the Scientific Committee, but whose contribution is necessary for the balanced and adequate assessment of the possible risks. Furthermore, the Commission, Europol and the EMA are invited to participate in the risk assessment meetings.
The risk assessment takes into account all factors that, according to the 1961 United Nations Single Convention on Narcotic Drugs or the 1971 United Nations Convention on Psychotropic Substances, would warrant the placing of a substance under international control. A practical guide 'Risk assessment of new psychoactive substances — operating guidelines' has been published by the EMCDDA in 2010. The risk assessment guidelines have been fully redrafted in order to reflect the new scope, experience and additional knowledge, thus replacing the earlier guidelines published by the EMCDDA in 1999. On completion of the risk assessment, a report is drawn up consisting of an analysis of the scientific and law enforcement information available, and reflecting all opinions held by the members of the Committee. The risk assessment report is then submitted to the Commission and Council.
So far 22 risk-assessments have been completed under the terms of the 1997 Joint Action on new synthetic drugs and 2005 Council Decision on new psychoactive substances, as follows: MBDB, 4-MTA, GHB, Ketamine, PMMA, 2C-I, 2C-T-2, 2C-T-7, TMA-2, BZP, mephedrone, 4-MA, 5-IT, 25I-NBOMe, AH-7921, MDPV, methoxetamine, 4,4’-DMAR, MT-45, α-PVP , MDMB-CHMICA and acryloylfentanyl.