52003DC0258(01)

REPORT FROM THE COMMISSION TO THE COUNCIL Called for by the Joint Action on New Synthetic Drugs (97/396/JAI) concerning TMA-2

1. On the 8th of April 2003, the European Commission received from the EMCDDA the report on the risk assessment of TMA-2 (2,4,5-trimethoxyamphetamine). The report is called: "Report on the Risk Assessment of TMA-2 in the Framework of the Joint Action on New Synthetic Drugs". The risk assessment report was established following a meeting from 31 March to 1 April of the Scientific Committee of the EMCDDA and experts nominated by the Member States, representatives of the Commission, Europol and the EMEA. The risk assessment was requested by the Horizontal Drugs Group of 12 December 2002, in the framework of the Joint Action on New Synthetic Drugs of 16 June 1997. TMA-2 was officially notified as a new synthetic drug under Article 3 of the Joint Action on New Synthetic Drugs on three occasions: August 2001, June 2002 and September 2002.

2. Article 5 of the Joint Action states that following the establishment of the report there can either be an initiative presented to the Council within a month to make the new synthetic drug subject to measures of control, or "if the Commission deems it not necessary to present an initiative it shall present a report to the Council explaining its views".

3. Article 1 of the Joint Action states that the Joint Action "aims at the creation of a mechanism for rapid exchange of information on new synthetic drugs and the assessment of their risks in order to permit the application of the measures of control on psychotropic substances, applicable in the Member States, equally to new synthetic drugs".

4. Art 4 (1) of the Joint Action states that "at the request of one of the Member States or the Commission, the EMCDDA shall convene a special meeting under the auspices of the Scientific Committee extended with experts nominated by the Member States and to which representatives of the Commission, the EDU and the European Agency for the Evaluation of Medicinal Products shall be invited. This committee shall assess the possible risks, including the health and social risks, caused by the use of, and traffic in, new synthetic drugs, and possible consequences of prohibition".

5. The Commission has considered the conclusions of the report and notes the following:

5.1. TMA-2 is a synthetic drug which synthesis protocol was described by the American chemist Shulgin. TMA-2 could also be produced from the active principle asarone, which is extracted from the rhizome of the plant Acorus calamus. Recipes for extracting asarone and making TMA-2 are available on the Internet together with warnings about contra-indications. At present TMA-2 has no medical or industrial use.

5.2. There have been no reported deaths or instances of non-fatal intoxication involving TMA-2.

5.3. No Member State has information that suggests large-scale production, distribution of, and/ or trafficking in TMA-2 or a role of organised crime in these activities. One Member State reported a case of the production of a limited quantity of TMA-2 in a small kitchen-type laboratory in 1999. Another Member State reported one case of international trafficking involving one Member State.

5.4. One Member States reported on a small seizure of TMA-2. This seizure related to the seized kitchen-type facility mentioned in 5.3. In addition TMA-2 has been identified in four other Member States. The latest finding of TMA-2 was in 2002.

5.5. At present there are a few animal and no human data concerning general toxicity, reproductive toxicity, neurotoxicity or the mutagenicity and carcinogenic potential of TMA-2.

5.6. There is currently no evidence of negative social consequences nor is there specific evidence on the consequences of the use of TMA-2 that could be linked to disorderly conduct, acquisitive crime or violence.

6. Basing itself solely on the risk assessment report on TMA-2 and the principle of proportionality, the Commission concludes that it is not appropriate to present an initiative to the Council to propose that TMA-2 be submitted to control measures at the EU level, as provided for by Article 5(1) of the Joint Action on New Synthetic Drugs. But the Commission will encourage the EMCDDA and Europol to continue monitoring trends in recreational use of TMA-2 as part of the early warning system provided for in the Joint Action, and to inform the Horizontal Drugs Group should they find new elements, particularly evidence of a threat to public health or a social risk.