(1)

Risk assessment reports on the new psychoactive substances 2-methylmethcathinone (2-MMC), N-ethylnorpentedrone (NEP) and 4-bromomethcathinone (4-BMC) were drawn up in compliance with Article 10 of Regulation (EU) 2023/1322 of the European Parliament and of the Council (2) by the Scientific Committee of the European Union Drugs Agency (the Agency), extended following the procedure laid down in Article 10(4) of that Regulation, on 20 and 21 May 2025. The Agency submitted the risk assessment reports to the Commission and to the Member States on 27 May 2025.

(2)

2-MMC, NEP and 4-BMC are synthetic cathinones with psychostimulant effects. They are derivatives of cathinone and closely related to methcathinone (ephedrone), sharing similar psychostimulant effects. Both 2-MMC and 4-BMC share similar psychostimulant effects with 4-methylmethcathinone (mephedrone, 4-MMC). 2-MMC shares similar psychostimulant effects with 3-methylmethcathinone (3-MMC). NEP share similar psychostimulant effects with pentedrone. 4-BMC shares similar psychostimulant effects with 4-chloromethcathinone (4-CMC) and 3-bromomethcathinone (3-BMC). Cathinone, methcathinone, mephedrone (4-MMC), 3-MMC, 4-CMC and pentedrone are controlled under the 1971 United Nations Convention on Psychotropic Substances.

(3)

2-MMC has been available in the Union since at least 2013 and has been detected in twenty-three Member States. The available data suggest that the availability of 2-MMC has significantly increased since 2022. Of the 2 196 cases reported between 2013 and 2024, 1 902 occured between 2022 and 2024, amounting to 45,7 tonnes.

(4)

Information provided from seizures and collected samples show that 2-MMC is typically available on the drug market as a powder. Other physical forms, such as tablets, capsules, liquids and herbal material have also been reported, but to a much smaller extent.

(5)

A total of eight deaths with confirmed exposure to 2-MMC have been reported by five Member States. One acute non-fatal poisoning with confirmed exposure to 2-MMC has been reported by one Member State. Forty cases of acute poisoning with suspected or probable exposure to 2-MMC have been reported by three Member States.

(6)

NEP has been available in the Union since at least 2013 and has been detected in twenty-five Member States. Since 2022, approximately 11 tonnes of NEP in powder form was seized, representing 99 % of the total quantity of NEP powders seized since monitoring of the substance began in the Union.

(7)

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

(8)

A total of sixty-three deaths with confirmed exposure to NEP have been reported by six Member States. Five acute non-fatal poisonings with confirmed exposure to NEP have also been reported by two Member States.

(9)

4-BMC has been available in the Union since at least 2011 and has been detected in eighteen Member States. After a decline between 2017 and 2023, there are indications that 4-BMC has re-emerged as of 2024 with approximately 1 tonne seized, representing 97 % of the total quantity of 4-BMC seized since monitoring of the substance began in the Union.

(10)

Information provided from seizures and collected samples show that 4-BMC is mostly 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.

(11)

No cases of deaths involving 4-BMC have been reported. No cases of non-fatal acute poisoning with confirmed exposure to 4-BMC have been reported. Three cases of acute poisoning with suspected exposure to 4-BMC were reported by two Member States.

(12)

The available information suggests that while 2-MMC, NEP and 4-BMC 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, they may also be missold as other drugs.

(13)

There is limited information on the involvement of organised crime in the manufacture, trafficking, and distribution of 2-MMC, NEP and 4-BMC within the Union. However, there is information to suggest criminal acts, such as trafficking, illicit production, and supply offences, involving the three substances.

(14)

The available information suggests that 2-MMC, NEP and 4-BMC are manufactured by chemical companies outside the Union and imported into it in large quantities. In addition, limited information indicates that some production has taken place in illicit laboratories in the Union.

(15)

2-MMC, NEP and 4-BMC 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.

(16)

The health and social risks associated with 2-MMC, NEP and 4-BMC 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 2-MMC, NEP and 4-BMC in the definition of ‘drug’. Nevertheless, the risk assessment reports reveal also that many of the questions related to 2-MMC, NEP and 4-BMC 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.

(17)

2-MMC, NEP and 4-BMC 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. 2-MMC, NEP and 4-BMC have not yet been assessed under the United Nations system.

(18)

Information from law enforcement seizures that took place between 2022 and 2024 indicates that the availability and potential for diffusion within the Union of 2-MMC, NEP and 4-BMC has recently increased and may be significant. Information on the acute toxicity of 2-MMC, NEP and 4-BMC is limited. Nevertheless, the available data would suggest that the health risks of these three substances are comparable to those associated with the use of other synthetic cathinones under international control. Due to lack of studies, there is uncertainty on the dependence potential and abuse liability of 2-MMC, NEP and 4-BMC. 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.

(19)

The available information would also suggest that the consumption of 2-MMC, NEP and 4-BMC 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.

(20)

Sixteen Member States control 2-MMC under national drug control legislation, three Member States control it under new psychoactive substances legislation and two Member States control it under other legislation. Fifteen Member States control NEP under national drug control legislation, four Member States control it under new psychoactive substances legislation and two Member States control it under other legislation. Fourteen Member States control 4-BMC under national drug control legislation, four Member States control it under new psychoactive substances legislation and two Member States control it under other legislation. Given that these national control measures are already in place, including 2-MMC, NEP and 4-BMC 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.

(21)

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 2-MMC, NEP and 4-BMC in the Annex to Framework Decision 2004/757/JHA.

(22)

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.

(23)

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.

(24)

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.

(25)

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

‘22.

2-(Methylamino)-1-(2-methylphenyl)propan-1-one (2-methylmethcathinone, 2-MMC) (*1).

23.

2-(Ethylamino)-1-phenylpentan-1-one (N-Ethylnorpentedrone, NEP) (*1).

24.

1-(4-Bromophenyl)-2-(methylamino)propan-1-one (4-bromomethcathinone, 4-BMC) (*1).