Commission Delegated Regulation (EU) 2023/196 of 25 November 2022, published on 31 January 2023 in the Official Journal of the European Union, came into force.
The new Regulation amends Regulation (EC) no. 273/2004 of the European Parliament and of the Council and Regulation (EC) no. 111/2005 of the Council, regarding the inclusion of certain drug precursors in the list of classified substances.
The classified substances listed in Annex I of Regulation (EC) no. 273/2004 and in the annex of Regulation (EC) n. 111/2005 are divided into categories for which separate measures applyso as to strike a fair balance between the level of threat posed by each specific substance and the impact on licit trade.
Category 1 substances are subject to the most stringent control and monitoring measures.
Regulation 2023/196 includes in Category 1 of drug precursors the substances 4-AP, 1-boc-4-AP and norfentanil, which can be used for the synthesis of the narcotic drug fentanyl and its analogues, and the substances DEPAPD and PMK ethyl glycidate for the synthesis of methamphetamine, amphetamine and MDMA.
Amphetamine, methamphetamine and MDMA are some of the most common drugs produced illicitly in the Union. These substances have serious consequences for human health and are causing serious social and public health problems in some regions of the Union.
The substances 4-AP, 1-boc-4-AP, norfentanil, DEPAPD and PMK ethyl glycidate, developed by criminal organizations to avoid the rigorous controls of classified substances required by the Regulations (EC), have no production, trade or a known lawful use, other than for research purposes.
For these reasons, the Commission has deemed it appropriate to amend Regulations (EC) no. 273/2004 and (CE) n. 111/2005, with the inclusion of these substances in Category 1 of drug precursors.
Category 1 drug precursors
Regulation 2023/196 provides for the inclusion in Category 1 of drug precursors of the substances:
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diethyl (phenylacetetil) propandioato (DEPAPD)
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ethyl 3-(2H-1,3-benzodioxol-5-yl)- 2-methyloxirane-2-carboxylate (PMK ethyl glycidate)
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N-phenylpiperidin-4-ammina (4-AP)
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terz-butil 4-anilinopiperidin-carbossilato (1-boc-4-AP)
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N-fenil-N-(piperidin-4-yl) propanammide (norfentanil)
The use (storage, manufacture, production, transformation, trade, distribution, export, import or intermediation) for any reason of Category 1 precursors is subject to the issue of a three-year license by the Ministry of Health.
The movement of these precursors is regulated both for transactions within the EU and for transactions with non-EU countries.
Consultation