Commission Delegated Directive (EU) 2022/1326 of 18 March 2022 amending the Annex to Council Framework Decision 2004/757/JHA as regards the inclusion of new psychoactive substances in the definition of ‘drug’

(1)

Risk assessment reports on the new psychoactive substances 2-(methylamino)-1-(3-methylphenyl)propan-1-one (3-methylmethcathinone, 3-MMC) and 1-(3-chlorophenyl)-2-(methylamino)propan-1-one (3-chloromethcathinone, 3-CMC) were drawn up in compliance with Article 5c of Regulation (EC) No 1920/2006 of the European Parliament and of the Council (2) by the Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA; the Centre), extended following the procedure laid down in Article 5c(4) of the same Regulation, on 18 and 19 November 2021. The Centre submitted the risk assessment reports to the Commission and to the Member States on 25 November 2021.

(2)

3-MMC and 3-CMC are synthetic cathinones with psychostimulant effects. They are derivatives of cathinone, and closely related to and sharing similar psychostimulant effects with methcathinone (ephedrone) and mephedrone (4-methylmethcathinone; 4-MMC) and, respectively, with methcathinone and 4-chloromethcathinone (4-CMC; clephedrone). Cathinone, methcathinone, mephedrone, and 4-CMC are controlled under the 1971 United Nations Convention on Psychotropic Substances.

(3)

3-MMC has been available in the European Union since at least 2012 and has been detected in 23 Member States. After a decline in seizures in Europe between 2016 and 2018, 3-MMC appears to have re-emerged with approximately 740 kilograms of it in powder form seized in 2020 and with continued importation, distribution, and use in 2021, including a single large-scale seizure of just over 120 kilograms of powder at an external Union border.

(4)

Information provided from seizures and collected samples show that 3-MMC is typically available on the drug market as a powder. Other physical forms, such as tablets and capsules, have also been reported, but to a much smaller extent. Occasionally liquids, herbal material, and blotters containing 3-MMC have also been reported.

(5)

A total of 27 deaths with confirmed exposure to 3-MMC have been reported by five Member States. Fourteen acute non-fatal poisonings with confirmed exposeure to 3-MMC have also been reported by four Member States.

(6)

3-CMC has been available in the European Union since at least 2014 and has been detected in 23 Member States. During 2020 and 2021, approximately 2 500 kilograms of 3-CMC in powder form was seized, representing over 90 % of the total quantity of 3-CMC powders seized since monitoring of the substance began in Europe.

(7)

Information provided from seizures and collected samples show that 3-CMC is typically available on the drug market as a powder. Other physical forms, such as tablets and capsules, have also been reported, but to a much smaller extent. Occasionally liquids, herbal material, and blotters containing 3-CMC have also been reported.

(8)

A total of 10 deaths with confirmed exposure to 3-CMC have been reported by two Member States. One acute non-fatal poisoning with confirmed exposeure to 3-CMC has also been reported by one Member State.

(9)

The available information suggests that while 3-MMC and 3-CMC are typically sold and sought after as stimulant drugs in their own right, at least in part it appears that these substances are being manufactured, imported, distributed, sold, and used as a ‘legal’ replacement to controlled stimulants, including amphetamine, cocaine, and MDMA. In addition, it may also be missold as other drugs.

(10)

There is limited information on the involvement of organised crime in the manufacture, trafficking, and distribution of 3-MMC and of 3-CMC within the Union. However, there is information to suggest criminal acts, such as trafficking, illicit production, and supply offences, involving both substances.

(11)

The available information suggests that 3-MMC and 3-CMC are manufactured by chemical companies outside the Union and imported into it on an industrial-scale. In addition, limited information indicates that some production has taken place in illicit laboratories in Europe.

(12)

3-MMC and 3-CMC have no recognised human or veterinary medical use in the Union nor, it appears, elsewhere. There are no indications that the substances may be used for any other purpose aside from as an analytical reference standard and in scientific research.

(13)

The health and social risks associated with 3-MMC and 3-CMC are likely to share some similarities with other closely related synthetic cathinones and psychostimulants under international control. The available evidence and information on the health and social risks that the substances pose provide sufficient ground for including 3-MMC and 3-CMC in the definition of ‘drug’. Nevertheless, the risk assessment reports reveal also that many of the questions related to 3-MMC and 3-CMC that are posed by the lack of data on the risks to individual health, risks to public health and social risks could be answered through further research.

(14)

3-MMC and 3-CMC are not listed for control under the 1961 United Nations Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, or under the 1971 United Nations Convention on Psychotropic Substances. 3-CMC has not yet been assessed under the United Nations system whereas 3-MMC has been subject to a non-conclusive critical review by the WHO Expert Committee on Drug Dependence in November 2016. The Committee was unable to reach consensus, and instead it deferred an opinion, and requested the Secretariat to arrange another critical review of 3- MMC at a subsequent meeting of the Expert Committee. A further ECDD review of 3-MMC has not taken place yet. Since this critical review in 2016, significant new information has been reported by the Member States that suggests that 3-MMC might pose health and social threats at Union level and thus needs to be added in the definition of ‘drug’ in Union law.

(15)

Information from law enforcement seizures that took place in 2020 and 2021 indicates that its availability and potential for diffusion within the Union of both 3-MMC and of 3-CMC has recently increased and may be significant. The available information would suggest that the consumption of 3-MMC and of 3-CMC causes harm to health associated with their acute toxicity and, in the case of 3-MMC, its abuse liability or dependence producing potential. Due to lack of studies, there is uncertainty on the dependence potential and abuse liability of 3-CMC. This harm to health is considered life-threatening because it may cause death or lethal injury, severe disease, severe physical or mental impairment or a spread of diseases, including the transmission of blood-borne viruses, such as hepatitis C and HIV. These effects are comparable with other closely related synthetic cathinones and psychostimulants under international control, although this requires further study.

(16)

The available information would also suggest that the consumption of 3-MMC and of 3-CMC could cause social risks and may result in marginalisation and increased vulnerability. Moreover, it also has a potential for a wider risk to public safety, notably in case of driving under the influence of these substances.

(17)

Fifteen Member States control 3-MMC under national drug control legislation, six Member States control it under new psychoactive substances legislation and one Member State controls it under other legislation. Thirteen Member States control 3-CMC under national drug control legislation, seven Member States control it under new psychoactive substances legislation and one Member State controls it under other legislation. Given that these national control measures are already in place, including 3-MMC and 3-CMC in the definition of ‘drug’ and thereby covering them by provisions on the criminal offences and sanctions as defined in Framework Decision 2004/757/JHA would help avoiding the emergence of obstacles in cross-border law enforcement and judicial cooperation, and would help protecting from the risks that their availability and use can pose.

(18)

Article 1a of Framework Decision 2004/757/JHA confers the power to adopt delegated acts upon the Commission with a view to giving a quick and expertise-based response at Union level to the emergence of new psychoactive substances detected and reported by the Member States, by amending the Annex to that Framework Decision to include those substances in the definition of ‘drug’.

(19)

As the conditions and procedure for triggering the exercise of the powers to adopt a delegated act have been met, a delegated directive should be adopted in order to include 3-MMC and 3-CMC in the Annex to Framework Decision 2004/757/JHA.

(20)

Ireland is bound by Framework Decision 2004/757/JHA, as amended by Directive (EU) 2017/2103 of the European Parliament and of the Council (3), and is therefore taking part in the adoption and application of this Directive.

(21)

Denmark is bound by Framework Decision 2004/757/JHA as applicable until 21 November 2018, but is not bound by Directive (EU) 2017/2103. It is therefore not taking part in the adoption and application of this Directive and is not bound by it or subject to its application.

(22)

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (4), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

(23)

Framework Decision 2004/757/JHA should therefore be amended accordingly,

‘20.

2-(methylamino)-1-(3-methylphenyl)propan-1-one (3-MMC) (*1).

21.

1-(3-chlorophenyl)-2-(methylamino)propan-1-one (3-CMC) (*1).