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1. Within two weeks of receipt of an initial report as referred to in Article 9(10), the Commission may request the Agency to assess the potential risks posed by the new psychoactive substance and to draw up a risk assessment report, where there are indications in the initial report to believe that the new psychoactive substance might pose severe public health risks and, where applicable, severe social risks. The risk assessment shall be carried out by the Scientific Committee.

2. Within two weeks of receipt of individual initial reports or a combined initial report as referred to in Article 9(11), the Commission may request the Agency to assess the potential risks posed by several new psychoactive substances with a similar chemical structure and to draw up a combined risk assessment report, where there are indications in the combined initial report to believe that those new psychoactive substances might pose severe public health risks and, where applicable, severe social risks. The combined risk assessment shall be carried out by the Scientific Committee.

3. A risk assessment report or combined risk assessment report shall contain:

(a) available information on the chemical and physical properties of the new psychoactive substance or substances and the methods and the precursors used to manufacture or extract it or them;

(b) available information on the pharmacological and toxicological properties of the new psychoactive substance or substances;

(c) an analysis of the health risks associated with the new psychoactive substance or substances, in particular with respect to its or their acute and chronic toxicity, abuse liability, dependence-producing potential, and physical, mental and behavioural effects;

(d) an analysis of the social risks associated with the new psychoactive substance or substances, in particular its or their impact on social functioning, public order and criminal activities, and of the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance or substances;

(e) available information on the extent and patterns of use of the new psychoactive substance or substances and its or their availability and potential for diffusion within the Union;

(f) available information on the commercial and industrial use of the new psychoactive substance or substances, the extent of such use, as well as its or their use for scientific research and development purposes;

(g) other relevant information, where available.

4. The Scientific Committee shall carry out a risk assessment in order to assess the risks posed by the new psychoactive substance or group of new psychoactive substances. For each such risk assessment, the Commission, the Agency, Europol and the European Medicines Agency shall each have the right to appoint two observers.

5. The Scientific Committee shall carry out risk assessments as referred to in paragraph 4 on the basis of the available information and of any other relevant scientific evidence. It shall take into account all opinions held by its members. The Agency shall organise the risk assessment procedure, including identifying future information needs and relevant studies.

6. The Agency shall submit the risk assessment report or the combined risk assessment report to the Commission and the Member States within six weeks of receipt of the request from the Commission to draw up a risk assessment report pursuant to paragraph 1 or a combined risk assessment report pursuant to paragraph 2.

7. Upon receipt of a duly reasoned request of the Agency, the Commission may extend the period for completion of the risk assessment or combined risk assessment set out in paragraph 6 to allow for additional research and data collection to take place. Such a request shall contain information on the period of time needed to complete the risk assessment or combined risk assessment.

8. The Agency shall provide timely rapid risk assessments, in accordance with Article 20 of Regulation (EU) 2022/2371 of the European Parliament and of the Council , in the case of a threat as referred to in Article 2(1), point (b), of that Regulation, where the threat falls under the mandate of the Agency.