Proposal for a COUNCIL DECISION defining PMMA as a new synthetic drug which is to be made subject to control measures and criminal provisions

(presented by the Commission)

EXPLANATORY MEMORANDUM

I. INTRODUCTION

The European Commission has carefully considered the risk assessment report on PMMA (paramethoxymethylamphetamine or N-methyl-1-4-(methoxyphenyl)-2-aminopropane), prepared on 29 October 2001 at a meeting convened by the EMCDDA under the auspices of its Scientific Committee. The risk assessment was carried out in the framework of the Joint Action of 16 June 1997 (97/396/JHA) on new synthetic drugs (OJ No L 167, 25.6.1997, p. 1) as agreed at the Horizontal Drugs Group in the Council on 28 May 2001. Four risk assessments have been carried out in the past, as a result of which one synthetic drug (4-MTA) was made subject to control measures and criminal provisions on 13 September 1999 (1999/615/JHA).

At present, PMMA is controlled under the national drugs legislation in four Member States (Germany, Ireland, Sweden and the UK).

The attached proposal is based exclusively on the information to be found in the risk assessment report and its annexes.

II. SCOPE OF THE JOINT ACTION

The Joint Action "concerns new synthetic drugs which are not currently listed in any of the Schedules to the 1971 United Nations Convention on Psychotropic Substances, and which pose a comparable serious threat to public health as the substances listed in Schedules I or II thereto and which have limited therapeutic value." PMMA was first synthesised in 1938, but it has recently been sold as 'ecstasy' (MDMA) and used recreationally. It is not currently listed in any of the Schedules to the 1971 United Nations Convention on Psychotropic Substances. Given the health risks for individuals identified below PMMA could pose a threat to public health. PMMA is an amphetamine analogue very close to PMA, which was included in Schedule I to the 1971 UN Convention in 1986. PMMA has no therapeutic value. It would therefore seem that PMMA falls within the scope of the Joint Action.

III. RISKS POSED BY PMMA

Within the EU, PMMA has always been consumed with PMA, and occasionally additional drugs, in tablets taken as 'ecstasy'. There is no explicit consumer market for either PMMA or PMA.

PMMA has been associated in combination with PMA with three deaths within the EU (all in Denmark). Experiments in animals indicate there is a narrow margin between the behaviourally active and lethal dose of PMMA and therefore a high risk of acute toxicity. PMMA and PMA have a similar toxicity in mice. Blood concentrations of PMMA in the human cases of fatalities were within the same range as the blood concentrations of PMA or MDMA which are found in the case of deaths. PMMA's poor MDMA-like effects might be perceived as a weakness or failure of the pill, which may lead to the consumption of more pills and subsequent overdose.

Trafficking and distribution of PMMA has taken place in four Member States (Austria, Denmark, Germany and Sweden). Three Member States (Austria, Denmark and Sweden) have information on the role of organised crime in the trafficking of PMMA/PMA. 18,870 tablets containing PMMA have been seized in 29 incidents. All the tablets also contained PMA and some of them additional synthetic drugs (MDMA, ephedrine, MDA, etc.). This should be compared to seizures of more than 17 million 'ecstasy' tablets. Large scale production of PMMA does not take place in the EU. Most seizures are believed to come from Poland where two laboratories producing PMMA and PMA have beenseized. According to the Polish authorities, production of PMA and/or PMMA continues to take place in Poland and the Ukraine.

IV. PROPOSED DECISION BY THE COUNCIL

Taking these elements into consideration, the Commission concludes that it is necessary to present an initiative to the Council to propose that PMMA should be made subject to necessary measures of control, as provided for in Article 5(1) of the Joint Action of 16 June 1997 (97/396/JHA) on new synthetic drugs. According to the proposed Decision, the Member States should undertake to take the necessary measures in accordance with their national law to submit PMMA to control measures and criminal penalties as provided under their legislation complying with their obligations under the 1971 UN Convention with respect to substances listed in Schedules I or II thereto.

Proposal for a COUNCIL DECISION defining PMMA as a new synthetic drug which is to be made subject to control measures and criminal provisions

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union,

Having regard to Joint Action 97/396/JHA of 16 June 1997 adopted by the Council on the basis of Article K.3 of the Treaty on European Union concerning the information exchange, risk assessment and the control of new synthetic drugs [1], and in particular Article 5(1) thereof,

[1] OJ L 167, 25.6.1997, p. 1.

Having regard to the initiative of the Commission,

Whereas:

(1) A risk assessment report on PMMA (paramethoxymethylamphetamine or N-methyl-1-4-(methoxyphenyl)-2-aminopropane) was drawn up, on the basis of Article 4(3) of Joint Action 97/396/JHA, at a meeting convened under the auspices of the Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).

(2) At present, PMMA is controlled under the national drugs legislation in four Member States.

(3) PMMA is not currently listed in any of the Schedules to the 1971 United Nations Convention on Psychotropic Substances. PMMA poses health risks for individuals and could pose a threat to public health. PMMA is an amphetamine analogue very close to PMA, which is included in Schedule I to the 1971 UN Convention. PMMA has no therapeutic value.

(4) Within the EU, PMMA has always been consumed with PMA in tablets taken as 'ecstasy' (MDMA). There is no explicit consumer market for either PMMA or PMA.

(5) PMMA has been associated in combination with PMA with three deaths within the EU. Experiments in animals indicate there is a narrow margin between the behaviourally active and lethal dose of PMMA and therefore a high risk of acute toxicity. PMMA seems to have a similar toxicity to PMA and MDMA.

(6) Trafficking and distribution of PMMA has taken place in four Member States and three of these have information on the role of organised crime in the trafficking of PMMA/PMA. 18,870 tablets containing PMMA have been seized in 29 incidents. Large scale production of PMMA does not take place in the EU. Two laboratories have been seized in Eastern Europe and production is believed to continue there.

(7) PMMA should be subjected by the Member States to control measures and criminal penalties, as provided for under their legislation complying with their obligations under the 1971 United Nations Convention on Psychotropic Substances with respect to substances listed in Schedules I or II thereto,

HAS DECIDED AS FOLLOWS:

Article 1

Member States shall take the necessary measures, in accordance with their national law, to submit PMMA (paramethoxymethylamphetamine or N-methyl-1-4-(methoxyphenyl)-2-aminopropane), to control measures and criminal penalties, as provided for under their legislation complying with their obligations under the 1971 United Nations Convention on Psychotropic Substances with respect to substances listed in Schedules I or II thereto.

Article 2

Member States shall, in accordance with the third subparagraph of Article 5(1) of Joint Action 97/396/JHA, take the measures referred to in Article 1 within three months of the date on which this Decision takes effect. Within six months of the date on which this Decision takes effect Member States shall inform the Secretariat General of the Council and the Commission of the measures they have taken.

Article 3

This decision shall take effect on the day following that of its publication.

Done at Brussels,

For the Council

The President