Considerations on COM(2016)547 - Amendment of Regulation (EC) No 1920/2006 as regards information exchange, early warning system and risk assessment procedure on new psychoactive substances - Main contents
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| dossier | COM(2016)547 - Amendment of Regulation (EC) No 1920/2006 as regards information exchange, early warning system and risk assessment ... |
|---|---|
| document | COM(2016)547  |
| date | November 15, 2017 |
| (2) | Vulnerable groups, especially young people, are particularly exposed to the health and social risks associated with new psychoactive substances. |
| (3) | In recent years, Member States have notified an increasing number of new psychoactive substances via the mechanism for rapid exchange of information on such substances, which was established by Council Joint Action 97/396/JHA (3) and further strengthened by Council Decision 2005/387/JHA (4). |
| (4) | New psychoactive substances that pose public health and, where applicable, social risks across the Union should be addressed at Union level. This Regulation should therefore be read in conjunction with Directive (EU) 2017/2103 of the European Parliament and of the Council (5) because both acts are designed to replace the mechanism established by Decision 2005/387/JHA. |
| (5) | A small number of new psychoactive substances can have commercial and industrial uses and can be used for scientific research and development. |
| (6) | Provisions concerning information exchange on, and the early warning system and risk assessment procedure for, new psychoactive substances should be included in Regulation (EC) No 1920/2006 of the European Parliament and of the Council (6). Provisions concerning the early warning of new psychoactive substances should, in particular, be strengthened and the procedures for drawing up an initial report and organising the risk assessment should be made more efficient. Substantially shortened deadlines for all stages of those procedures should be set. |
| (7) | Any Union action on new psychoactive substances should be based on scientific evidence and be subject to a specific procedure. |
| (8) | An initial report should be drawn up on a new psychoactive substance where information provided by the Member States on that new psychoactive substance gives rise to concerns that it might pose health or social risks at Union level. The initial report should allow the Commission to make an informed decision regarding the launch of the risk assessment procedure. The risk assessment procedure at Union level should be undertaken rapidly. |
| (9) | Following the risk assessment procedure, the Commission should determine whether the new psychoactive substance in question should be included in the definition of ‘drug’ in accordance with the procedure provided for in Council Framework Decision 2004/757/JHA (7). With a view to ensuring the continuous functioning of the mechanism for information exchange and of the reporting and risk assessment procedures set out in Decision 2005/387/JHA and in this Regulation, this Regulation should apply from the same date as the deadline for transposition of Directive (EU) 2017/2103, which is also the date on which Decision 2005/387/JHA is to be repealed. |
| (10) | In principle, no risk assessment should be carried out on a new psychoactive substance if it is subject to an assessment under international law. No risk assessment should be carried out on a new psychoactive substance if it is an active substance in a medicinal product for human use or in a veterinary medicinal product. |
| (11) | Regulation (EC) No 1920/2006 should therefore be amended accordingly, |