Commission Delegated Regulation (EU) 2025/1475 of 21 May 2025 amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of the drug precursors 4-piperidone and 1-boc-4-piperidone in the list of scheduled substances

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors [^ntr1-L_202501475EN.000101-E0001], and in particular Article 15 thereof,

Having regard to Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Union and third countries in drug precursors [^ntr2-L_202501475EN.000101-E0002], and in particular Article 30a thereof,

Whereas:

• (1) Regulation (EC) No 273/2004 lays down measures for monitoring trade in drug precursors within the Union, while Regulation (EC) No 111/2005 governs trade in drug precursors between the Union and third countries. Annex I to Regulation (EC) No 273/2004 and the Annex to Regulation (EC) No 111/2005 each contain a list of scheduled substances, which are subject to several harmonised control and monitoring measures provided for by those Regulations.

• (2) By Decisions 67/6 and 67/7 of the Commission on Narcotic Drugs of the United Nations, taken at its sixty-seventh session from 18 to 23 March 2024, the substances 4-piperidone and 1-boc-4-piperidone have been added to Table I of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, adopted in Vienna on 19 December 1988 (‘the 1988 UN Convention’) and approved on behalf of the Union by Council Decision 90/611/EEC [^ntr3-L_202501475EN.000101-E0003].

• (3) The substances 4-piperidone and 1-boc-4-piperidone should consequently be included in Annex I to Regulation (EC) No 273/2004 and in the Annex to Regulation (EC) No 111/2005.

• (4) The substance 4-piperidone is an early-stage precursor involved in most synthetic routes to fentanyl and some fentanyl analogues. It can be used to make N-Phenethyl-4-piperidone (NPP), 4-Anilino-N-phenethylpiperidine (ANPP), N-Phenylpiperidin-4-amine (4-AP) and norfentanyl, which are all substances listed in Table I of the 1988 UN Convention.

• (5) The substance 1-boc-4-piperidone is a chemically protected derivative of 4-piperidone and can be used to make tert-butyl 4-anilinopiperidine-1-carboxylate (1-boc-4-AP) and subsequently norfentanyl, which are both substances listed in Table I of the 1988 UN Convention. The substance 1-boc-4-piperidone may also be converted back into 4-piperidone.

• (6) Both 4-piperidone and 1-boc-4-piperidone are very suitable precursors for the illicit manufacture of fentanyl and its analogues.

• (7) Fentanyl and fentanyl analogues are very potent narcotic drugs, typically 10-100 times stronger than heroin. Consequently, small amounts of 4-piperidone and 1-boc-4-piperidone (kg range) are sufficient to manufacture millions of doses of end products (fentanyls).

• (8) Therefore, 4-piperidone and 1-boc-4-piperidone should be included in the list of scheduled substances at Union level to reinforce their control and monitoring.

• (9) The scheduled substances listed in Annex I to Regulation (EC) No 273/2004 and in the Annex to Regulation (EC) No 111/2005 are divided into categories for which different measures apply, so as to achieve a proportionate balance between the level of threat posed by each specific substance and the burden on licit trade. The strictest control and monitoring measures apply to substances of Category 1.

• (10) There is limited known legitimate manufacture of and trade in 4-piperidone and 1-boc-4-piperidone. The scheduling of those substances in Category 1 would consequently entail limited additional administrative burden for economic operators and for the competent authorities in the Union.

• (11) Regulations (EC) No 273/2004 and (EC) No 111/2005 should therefore be amended accordingly.

• (12) Regulations (EC) No 273/2004 and (EC) No 111/2005 jointly implement certain provisions of the 1988 UN Convention. In view of the close substantive link between the empowerments contained in those Regulations, it is appropriate to adopt the amendments by way of one single delegated act,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 273/2004

Annex I to Regulation (EC) No 273/2004 is amended in accordance with Annex I to this Regulation.

Article 2

Amendments to Regulation (EC) No 111/2005

The Annex to Regulation (EC) No 111/2005 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 May 2025.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_202501475EN.000101-E0001]: OJ L 47, 18.2.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/273/oj.

[^ntr2-L_202501475EN.000101-E0002]: OJ L 22, 26.1.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/111/oj.

[^ntr3-L_202501475EN.000101-E0003]: Council Decision 90/611/EEC of 22 October 1990 concerning the conclusion, on behalf of the European Economic Community, of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (OJ L 326, 24.11.1990, p. 56, ELI: http://data.europa.eu/eli/dec/1990/611/oj).

ANNEX I

In Annex I to Regulation (EC) No 273/2004, in the table for Category 1, the following entries are inserted in the list of substances in the appropriate place sequentially according to the CN Code:

ANNEX II

In the Annex to Regulation (EC) No 111/2005, in the table for Category 1, the following entries are inserted in the list of substances in the appropriate place sequentially according to the CN Code:

ELI: http://data.europa.eu/eli/reg_del/2025/1475/oj

ISSN 1977-0677 (electronic edition)