Considerations on COM(2024)2 - EU position in the sixty-seventh session of the Commission on Narcotic Drugs on the scheduling of substances under the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances of 1971

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dossier COM(2024)2 - EU position in the sixty-seventh session of the Commission on Narcotic Drugs on the scheduling of substances under the Single ...
document COM(2024)2 EN
date March  4, 2024
 
(1)The United Nations (UN) Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol ('the Convention on Narcotic Drugs') 11 entered into force on 8 August 1975.

(2)Pursuant to Article 3 of the Convention on Narcotic Drugs, the Commission on Narcotic Drugs (CND) may decide to add substances to the Schedules of that Convention. It can make changes in the Schedules only in accordance with the recommendations of the World Health Organisation (WHO), but it can also decide not to make the changes recommended by the WHO.

(3)The UN Convention on Psychotropic Substances of 1971 ('the Convention on Psychotropic Substances') 12 entered into force on 16 August 1976.

(4)Pursuant to Article 2 of the Convention on Psychotropic Substances, the CND may decide to add substances to the Schedules of that Convention or to remove them, on the basis of recommendations of the WHO. It has broad discretionary powers to take into account economic, social, legal, administrative and other factors, but may not act arbitrarily.

(5)Changes to the Schedules of the Convention on Narcotic Drugs and the Convention on Psychotropic Substances have direct repercussions on the scope of application of Union law in the area of drug control. Council Framework Decision 2004/757/JHA 13 applies to substances listed in the Schedules of those Conventions. Thus, any change to the Schedules annexed to those Conventions directly affects common Union rules and alters their scope, in accordance with Article 3(2) of the TFEU.

(6)The CND is to decide, during its 67th session scheduled for 14 to 22 March 2024 in Vienna, on the addition of five new substances to the Schedules of the Convention on Narcotic Drugs and the Convention on Psychotropic Substances.

(7)The Union is neither a party to the Convention on Narcotic Drugs nor to the Convention on Psychotropic Substances. It has an observer status with no voting rights in the Commission on Narcotic Drugs, of which 13 Member States are members with the right to vote in March 2024. 14 It is necessary for the Council to authorise those Member States to express the position of the Union on the scheduling of substances under those Conventions since decisions on the addition of new substances to their Schedules fall under the exclusive competence of the Union.

(8)The WHO has recommended the addition of one new substance to Schedule I of the Convention on Narcotic Drugs, three new substances to Schedule II of the Convention on Psychotropic Substances, and one new substance to Schedule IV of the Convention on Psychotropic Substances 15 .

(9)All substances reviewed by the WHO Expert Committee on Drug Dependence (ECDD) and recommended for scheduling by the WHO are monitored by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) as new psychoactive substances under the terms of Regulation (EC) No 1920/2006 of the European Parliament and of the Council. 16

(10)According to the assessment by the ECDD, bromazolam (IUPAC name: 8-bromo-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine) is a benzodiazepine with a relatively high potency. Bromazolam was previously reviewed by the ECDD at its 45th meeting and placed under surveillance. Bromazolam has no known therapeutic uses or marketing authorizations. There is sufficient evidence that bromazolam is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that bromazolam be placed in Schedule IV of the Convention on Psychotropic Substances.

(11)Bromazolam has been detected in 19 Member States and is controlled in at least four Member States. Bromazolam is under monitoring by the EMCDDA. One acute poisoning with confirmed exposure to bromazolam has been reported by one Member State. An additional acute poisoning with suspected exposure to bromazolam has been reported by one Member State. A total of 15 deaths with confirmed exposure to bromazolam have been reported by five Member States.

(12)Therefore, the position of the Union should be to add bromazolam to Schedule IV of the Convention on Psychotropic Substances.

(13)According to the assessment by the ECDD, butonitazene (IUPAC name: 2-[(4-butoxyphenyl)methyl]-N,N-diethyl-5-nitro-1H-benzimidazole-1-ethanamine) is a benzimidazole-derived synthetic opioid (‘nitazene’) with a chemical structure and pharmacological action similar to those of drugs under Schedule I of the Convention on Narcotic Drugs. Butonitazene has not previously been reviewed by the ECDD. Butonitazene has no known therapeutic uses or marketing authorizations. There is sufficient evidence that butonitazene is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that butonitazene be placed in Schedule I of the Convention on Narcotic Drugs.

(14)Butonitazene has been detected in seven Member States and is controlled in at least three Member States. Butonitazene is under intensive monitoring by the EMCDDA. One death case with confirmed exposure to butonitazene has been reported by one Member State.

(15)Therefore, the position of the Union should be to add butonitazene to Schedule I of the Convention on Narcotic Drugs.

(16)According to the assessment by the ECDD, 3-chloromethcathinone (3-CMC; IUPAC name: 1-(3-chlorophenyl)-2-(methylamino)propan-1-one) is a synthetic stimulant of the cathinone family. 3-CMC is an analogue to the drug methcathinone which is controlled under Schedule I of the Convention on Psychotropic Substances. 3-CMC is not currently under international control, but its isomer 4-CMC was placed under international control in 2020. 3-CMC has not previously been reviewed by the WHO Expert Committee on Drug Dependence. 3-CMC has no known therapeutic uses or marketing authorizations. There is sufficient evidence that 3-CMC is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that 3-CMC be placed in Schedule II of the Convention on Psychotropic Substances.

(17)The risks of 3-CMC have been assessed by the scientific committee of the EMCDDA and 3-CMC has already been included in the definition of ‘drug’ under Framework Decision 2004/757/JHA by Commission Delegated Directive (EU) 2022/1326 17 . It is under monitoring by the EMCDDA. At the time of risk assessment, in November 2021, 3-CMC had been detected in 23 Member States. A total of 10 deaths with confirmed exposure to 3-CMC had been reported by two Member States and one acute poisoning with confirmed exposure to 3-CMC had been reported by one Member State. 

(18)Therefore, the position of the Union should be to add 3-CMC to Schedule II of the Convention on Psychotropic Substances.

(19)According to the assessment by the ECDD, dipentylone (IUPAC name: 1-(1,3-benzodioxol-5-yl)-2-(dimethylamino)pentan-1-one) is a synthetic stimulant of the cathinone family. It has a chemical structure and pharmacology similar to those of other synthetic cathinones of Schedule II of the Convention on Psychotropic Substances. Dipentylone has not previously been reviewed by the WHO Expert Committee on Drug Dependence. Dipentylone has no known therapeutic uses or marketing authorizations. There is sufficient evidence that dipentylone is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. No approved medical use has been reported. Thus, the WHO recommends that dipentylone be placed in Schedule II of the Convention on Psychotropic Substances.

(20)Dipentylone has been detected in 16 Member States and is controlled in at least four Member States. Dipentylone is under monitoring by the EMCDDA.

(21)Therefore, the position of the Union should be to add dipentylone to Schedule II of the Convention on Psychotropic Substances.

(22)According to the assessment by the ECDD, 2-fluorodeschloroketamine (2-FDCK; IUPAC name: 2-(2-fluorophenyl)-2-methylamino-cyclohexanone) is an arylcyclohexylamine that is chemically related to the dissociative anaesthetic ketamine. 2-FDCK has not previously been reviewed by the WHO Expert Committee on Drug Dependence. 2-FDCK has no known therapeutic uses or marketing authorizations. There is sufficient evidence that 2-FDCK is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that 2-FDCK be placed in Schedule II of the Convention on Psychotropic Substances.

(23)2-FDCK has been detected in 22 Member States and is controlled in at least five Member States. 2-FDCK is under intensive monitoring by the EMCDDA. Two deaths with confirmed exposure to 2-FDCK have been reported by two Member States. A total of 11 acute poisonings with confirmed exposure to 2-FDCK have been reported by three Member States. One additional case of acute poisoning with suspected exposure to 2-FDCK has been reported by one Member State.

(24)Therefore, the position of the Union should be to add 2-FDCK to Schedule II of the Convention on Psychotropic Substances.

(25)It is appropriate to establish the position to be taken on the Union’s behalf in the CND, as the decisions on scheduling as regards the five substances will be capable of decisively influencing the content of Union law, namely Framework Decision 2004/757/JHA.

(26)The Union's position is to be expressed by the Member States that are members of the CND, acting jointly.

(27)Denmark is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.

(28)Ireland is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.