Considerations on COM(2025)6 - EU position in the sixty-eighth 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(2025)6 - EU position in the sixty-eighth session of the Commission on Narcotic Drugs on the scheduling of substances under the Single ... |
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| document | COM(2025)6 |
| date | March 5, 2025 |
(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')13 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/JHA14 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 68th session scheduled for 10 to 14 March 2025 in Vienna, on the addition of six 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 2025.15 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 four new substances 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 Substances16.
(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 Union Drugs Agency (EUDA) as new psychoactive substances under the terms of Regulation (EU) 2023/1322 of the European Parliament and of the Council17.
(10) According to the assessment by the ECDD, protonitazepyne (IUPAC name: 5-nitro-2-[(4-propoxyphenyl)methyl]-1-(2-pyrrolidin-1-ylethyl)benzimidazole) is a synthetic opioid in the nitazene analogue family. Protonitazepyne has not previously been formally reviewed by WHO. Protonitazepyne has no known therapeutic uses or marketing authorizations. There is sufficient evidence that protonitazepyne 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 protonitazepyne be placed in Schedule I of the Convention on Narcotic Drugs.
(11) Protonitazepyne has been detected in six Member States and is controlled in at least two Member States. Protonitazepyne is under intensive monitoring by the EUDA. Seventy four acute poisonings with suspected exposure to protonitazepyne were reported by one Member State.
(12) Therefore, the position of the Union should be to add protonitazepyne to Schedule I of the Convention on Narcotic Drugs.
(13) According to the assessment by the ECDD, metonitazepyne (IUPAC name: 2-[(4-methoxyphenyl)methyl]-5-nitro-1-(2-pyrrolidin-1-ylethyl)-1H-benzoimidazole) is a synthetic opioid of the nitazene analogue family. Metonitazepyne has not previously been formally reviewed by WHO. Metonitazepyne has no known therapeutic uses or marketing authorizations. There is sufficient evidence that metonitazepyne 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 metonitazepyne be placed in Schedule I of the Convention on Narcotic Drugs.
(14) Metonitazepyne has been detected in four Member States and is controlled in at least two Member States. Metonitazepyne is under intensive monitoring by the EUDA.
(15) Therefore, the position of the Union should be to add metonitazepyne to Schedule I of the Convention on Narcotic Drugs.
(16) According to the assessment by the ECDD, etonitazepipne (IUPAC name: 2-[(4-Ethoxyphenyl)methyl]-5-nitro-1-(2-piperidin-1-ylethyl)-1H-benzoimidazole) is one of several synthetic 2-benzylbenzimidazoles opioids, collectively known as “nitazenes”. Etonitazepipne has not previously been formally reviewed by WHO. Etonitazepipne has no known therapeutic uses or marketing authorizations. There is sufficient evidence that etonitazepipne 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 etonitazepipne be placed in Schedule I of the Convention on Narcotic Drugs.
(17) Etonitazepipne has been detected in five Member States and is controlled in at least six Member States. Etonitazepipne is under monitoring by the EUDA. Two deaths and one acute poisoning with confirmed exposure to etonitazepipne have been reported by three Member States.
(18) Therefore, the position of the Union should be to add etonitazepipne to Schedule I of the Convention on Narcotic Drugs.
(19) According to the assessment by the ECDD, N-desethyl isotonitazene (IUPAC name: N-ethyl-2-[2-[(4-isopropoxyphenyl)methyl]-5-nitro-benzimidazol-1-yl]ethanamine) is a benzimidazole-derived synthetic opioid with a chemical structure and pharmacological similarities to drugs under Schedule I of the 1961 United Nations Conventions), such as isotonitazene, and is a metabolite of isotonitazene. N-desethyl isotonitazene has not previously been formally reviewed by WHO. N-desethyl isotonitazene has no known therapeutic uses or marketing authorizations. There is sufficient evidence that N-desethyl isotonitazene 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 N-desethyl isotonitazene be placed in Schedule I of the Convention on Narcotic Drugs.
(20) N-desethyl isotonitazene has been detected in two Member States and is controlled in at least two Member States. N-desethyl isotonitazene is under intensive monitoring by the EUDA. Two deaths with confirmed exposure to N-desethyl isotonitazene have been reported by one Member State.
(21) Therefore, the position of the Union should be to add N-desethyl isotonitazene to Schedule I of the Convention on Narcotic Drugs.
(22) According to the assessment by the ECDD, hexahydrocannabinol (HHC) (IUPAC name: 6a,7,8,9,10,10a-hexahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol) is a semi-synthetic cannabinoid that is most commonly synthesized from cannabidiol as a precursor. Hexahydrocannabinol has not previously been formally reviewed by WHO. Hexahydrocannabinol has no known therapeutic uses or marketing authorizations. There is sufficient evidence that hexahydrocannabinol 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 hexahydrocannabinol be placed in Schedule II of the Convention on Psychotropic Substances.
(23) Hexahydrocannabinol has been detected in twenty-five Member States and is controlled in at least twenty Member States. Hexahydrocannabinol is under intensive monitoring by the EUDA. Four cases of acute poisoings with confirmed exposure to hexahydrocannabinol have been reported by two Member States. Seven cases of acute poisoning with probable exposure to hexahydrocannabinol have been reported by two Member States. Six cases of acute poisoning with suspected exposure to hexahydrocannabinol have been reported by three Member States.
(24) Therefore, the position of the Union should be to add hexahydrocannabinol to Schedule II of the Convention on Psychotropic Substances.According to the assessment by the ECDD, carisoprodol (IUPAC name: (2RS)-2-[(carbamoyloxy)methyl]-2-methylpentyl(1-methylethyl)carbamate) is a centrally acting muscle relaxant used in the short term as an adjunct to symptomatic treatment of acute musculoskeletal disorders associated with painful muscle spasm. The potential for misuse of carisoprodol may be related to both its sedative effects and its capacity to enhance the effects of other substances. Thus, the sedative effects of carisoprodol can be potentiated when it is combined with benzodiazepines, opioids or alcohol. Prolonged or excessive use of carisoprodol can lead to dependence. Carisoprodol may be diverted from legitimate medical channels and enter the illicit market to be sold without proper medical supervision, increasing potential abuse and adverse consequences. Carisoprodol was pre-reviewed in 2001 at the 32nd ECDD meeting. The Committee did not recommend critical review of carisoprodol at that time. Carisoprodol was further presented, discussed and pre-reviewed in 2023 at the 46th ECDD meeting, where proceeding to critical review was recommended. Carisoprodol is a prescription medication and appears to be a licensed drug in several countries and territories. However, it is no longer used medically in Europe since the European Medicines Agency Committee for Medicinal Products for Human Use suspended all marketing authorizations for carisoprodol throughout Europe. Carisoprodol has no known industrial use. There is sufficient evidence that carisoprodol 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 carisoprodol be placed in Schedule IV of the Convention on Psychotropic Substances.
(25) Carisoprodol has been detected in two Member States. Carisoprodol is under monitoring by the EUDA. Two deaths with confirmed exposure to carisoprodol have been reported by one Member State.
(26) Therefore, the position of the Union should be to add carisoprodol to Schedule IV of the Convention on Psychotropic Substances.
(27) 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 six substances will be capable of decisively influencing the content of Union law, namely Framework Decision 2004/757/JHA.
(28) The Union's position is to be expressed by the Member States that are members of the CND, acting jointly.
(29) Denmark is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.
(30) Ireland is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.