EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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 certain drug 
precursors in the list of scheduled substances  
 
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Drug precursors are chemicals which may be used for the illicit manufacture of narcotic  drugs 
or psychotropic substances. Regulation (EC) No 273/2004 of the European Parliament and of 
the Council1 lays down measures for monitoring trade in drug precursors within the EU, while 
Council Regulation (EC) No 111/20052 governs trade in drug precurs ors between the EU and 
third countries.  
The two Regulations jointly implement the measures envisaged by Article 12 of the United 
Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 
19 December 19883 (the '1988 UN Con vention').  
Drug precursors may be scheduled substances (listed in the Annexes of the two Regulations, 
with various legal obligations attached  depending on their category - license, registration, 
export/import authorisation etc.). Drug precursors may also b e non -scheduled substances, 
meaning they are not listed in the Annexes. Each Member State may adopt the measures 
necessary to enable its competent authorities to control and monitor suspicious transactions 
involving non -scheduled substances.  
Since December 2013 the Commission is empowered to adopt delegated acts to add new 
substances to the list of scheduled substances in order to adapt to new trends in diversion of 
drug precursors, in particular substances which can be easily transformed into  scheduled 
substances, and to follow any amendment to the tables in the Annex to the United Nations 
Convention.  
The Commission on Narcotic Drugs of the United Nations decided at its 65th session from 14 
to 18 March 20 22, that three substances, 4-AP, 1 -boc-4-AP and norfentanyl are to be added to 
Table I of the 1988 UN Convention.  
In accordance with Article 12, paragraph 6 of the 1988 UN Convention, decisions 65/4, 65/5  
and 6 5/6 shall become fully effective with respect to each Party 180 days afte r the date of 
communication of the decisions, which is 23 November 2022 . Consequently, by this date each 
Party to the Convention should be in the process of scheduling 4 -AP, 1 -boc-4-AP and 
norfentanyl in its drug precursor legislation.  
4-AP is a substitut e chemical for N -phenethyl -4-piperidone (NPP) to synthesize 4 -anilino -N 
phenethylpiperidine (ANPP), which itself is an immediate precursor for the manufacture of 
fentanyl and some of its analogues.  
1-boc-4-AP is a chemically protected derivative of 4 -AP, w hich could be converted to 4 -AP, 
norfentanyl or a number of norfentanyl analogues.  
Norfentanyl is an immediate precursor of fentanyl and a number of fentanyl analogues.  
NPP and ANPP are already scheduled substances in the Regulations. Fentanyl and fentany l 
analogues are very potent narcotic drugs, typically 10 to 100 times stronger than hero in. Their 
high potency continues  to result in overdose deaths in users . 
                                                 
1 Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on 
drug precursors, OJ L 47, 18.2.2004, p. 1.  
2 Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of 
trade between the Community and third countries in drug precursors, OJ L 22, 26.1.2005, p. 1.  
3 OJ L 326, 24.11.1990, p. 57.   
EN 2  EN National competent authorities have indicated the seizure of diethyl (phenylacetyl) 
propanedioate (DEPAPD)  and PMK  ethyl glycidate .  
DEPAPD is used to produce 1 -Phenyl -2-propanone (P -2-P), also known as benzyl methyl 
ketone (BMK). BMK is a precursor of amphetamine and methamphetamine, two of the most 
common drugs illicitl y produced in the  EU. Both have  severe consequences for the human 
health.  
PMK  ethyl glycidate is a precursor of PMK , which, in its turn, is used to prod uce 3,4 -
methylenedioxymethamphetamine (MDMA), commonly known as ‘ecstasy’.  
BMK, as well as some of its other pre -precurs ors which are very similar to DEPAPD (such as 
methyl alpha -phenylacetoacetate (MAPA)  or alpha -phenylacetoacetamide (APAA)) , as well 
as PMK are already scheduled substances in the Regulations.  
Following the strict control  of the scheduled substances mentioned above , 4-AP, 1 -boc-4-AP, 
norfentanyl , DEPAPD and PMK  ethyl glycidate have been designed by criminal organisations 
to avoid these controls. Therefore, 4-AP, 1 -boc-4-AP, norfentanyl , DEPAPD and PMK  ethyl 
glycidate shoul d also be scheduled at EU level  to reinforce their control and monitoring . The 
scheduling will provide national authorities with the legal means to fight effectively against 
their use in the i llicit production of narcotic drugs.  
Therefore, the Commission n eeds to adopt a Delegated Regulation amending Regulation (EC) 
No 273/2004 and Council Regulation (EC) No 111/2005 as regards the inclusion of certain 
drug precursors in the list of scheduled substances so as to add 4 -AP, 1 -boc-4-AP, 
norfentanyl , DEPAPD and  PMK  ethyl glycidate  to the annexes of these regulations.  
The Commission has discretion as regards the category in which to schedule a drug precursor .  
Substances scheduled in Category 1 pose the greatest risk when diverted and usually become 
incorporated in full or in part into the molecule of the narcotic drug or psychotropic 
substa nce. The Regulations set out the strictest control and monitoring measures for such 
substances: they need to be stored in secured premises (e.g. locks, video -camera surveillanc e, 
etc.); each operator dealing with t hese substances needs a licence;  they also require an import 
and export authorisation.   
4-AP, 1 -boc-4-AP, norfentanyl , DEPAPD and PMK  ethyl glycidate should be scheduled as a 
Category 1  substance s because they can be e asily transformed to support the production of 
fentanyl and its analogues  (4-AP, 1 -boc-4-AP, norfentanyl ) or support the production of 
methanphetamine , amphetamine  and MDMA  (DEPAPD and PMK  ethyl glycidate ) and the 
subsequent social and public health problems related to the consumption of these n arcotic 
drugs are important . 
Based on the information available, 4-AP, 1 -boc-4-AP, norfentanyl, DEPAPD and PMK  ethyl 
glycidate have no kn own licit uses, except research . Therefore, t heir scheduling in Category 1 
will not create significant administrative burden for economic oper ators and competent 
authorities .  
The Commission Implementing Regulation  (EU) 2021/18324 of 12 October 2021 reclassified 
ANPP and NPP. The corrigendum will correcct the CN Code, the name of the substance as 
                                                 
4 Commission Implementing Regulation  (EU) 2021/1832 of 12 October 2021 amending Annex I to 
Council  Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common 
Customs Tariff , OJ L 385, 29.10.2021, p. 1 .  
EN 3  EN determined in the European Customs Inventory of Chemical Substances5 and the CN 
designation.  
 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
In accordance  with the Interinstitutional  Agreement on Better Law -Making of 13 April 20164, 
appropriate and transparent consultations, including at expert level, have been carried out in 
the preparation of this delegated act. The Group of Experts on Drug Precursors has  discussed 
the proposal in detail during its meeting from 12 to 13 May 2022 and Member States did not 
oppose to schedule the additional subtstances. . 
The draft has been published for feedback on ‘Have -your-say’ portal. [add details on the 
contributions rec eived, if any] .  
The draft has been noti fied based on Article 2(9)(2) of the Agreement on Technical Barriers 
to Trade. No comments have been received [to be changed if needed] .  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
Based on  Article 15 of Regulation (EC) No 273/2004 and Article 30a of Regulation (EC) No 
111/2005, the Commission is empowered to adopt delegated acts in order to adapt the 
Annexes to new trends in diversion of drug precursors.  
Regulation (EC) No 273/2004 and Regu lation (EC) No 111/2005 are closely linked. They 
jointly implement the measures envisaged by Article 12 of the 1988 UN  Convention. 
Therefore , the bundling of two empowerments based on different basic legislative acts into 
one single delegated act is justif ied by the close material link between the empowerments in 
question.  
                                                 
5 ECICS - European Customs Inventory of Chemical Substances : https://taxation -
customs.ec.europa.eu/online -services/online -services -and-databases -customs/ecics -european -customs -
inventory -chemical -substances_en    
EN 4  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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 certain drug 
precursors in the list of scheduled substances  
 
(Text with EEA relevance)  
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 precursors1, and in particular Article 15 thereof,  
Having regard to Council Regulation (EC) No 111/2005 of 22 December 2004 laying dow n 
rules for the monitoring of trade between the Union and third countries in drug precursors2, 
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 Re gulation (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 a number  of harmonised control and 
monitoring measures provided for by those Regulations.  
(2) By means of Decisions 65/4, 65/5 and 65/6 of the Commission on Narcotic Drugs of 
the United Nations, taken at its sixty -fifth session from 14 to 18 March 20 22, the 
substances  N-phenylpiperidin -4-amine  (4-AP), tert-butyl 4 -anilinopiperidine -1-
carboxylate  (1-boc-4-AP) and N-phenyl -N-(piperidin -4-yl)propanamide ( norfentanyl ) 
have been added to Table I of the United Nations Convention against Illicit Traffic in 
Narcotic Drugs and Psychotropic Substances done at Vienna on  19 December 1988  
and approved by Council Decision 90/611/EEC3 (‘the 1988 UN Convention ’). 
(3) 4-AP is a substi tute chemical for N-phenethyl -4-piperidone (NPP) to synthesize 4 -
anilino -N-phenethylpiperidine (ANPP), which itself is an immediate precursor for the 
manufacture of fentanyl and some of its analogues . 
(4) 1-boc-4-AP is a chemically protected derivative of 4 -AP, which could be converted to 
4-AP, norfentanyl or a number of norfentanyl analogues.  
                                                 
1 OJ L 47, 18.2.2004, p. 1.  
2 OJ L 22, 26.1.2005, p. 1.  
3 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).   
EN 5  EN (5) Norfentanyl is an immediate precursor of fentanyl and a number of fentanyl analogues.  
(6) NPP and ANPP are already scheduled substances in Regulations  (EC) No 273/2004 
and (EC) No 111/2005 . Fentanyl and fentanyl analogues  are very potent narcotic 
drugs, typically 10 to 100 times stronger than heroin. Their high potency continue s to 
result in overdose deaths in users . 
(7) National competent authorities have indicated the seizure of diethyl (phenylacetyl) 
propanedioate (DEPAPD) and ethyl 3 -(2H-1,3-benzodioxol -5-yl)-2-methyloxirane -2-
carboxylate  (PMK  ethyl glycidate ).  
(8) DEPAPD is used to produce 1 -Phenyl -2-propanone (P -2-P), also known as benzyl 
methyl ketone (BMK). BMK is a precursor of amphetamine and methamphetamine, 
two of the most common drugs illicitly produced in the U nion. Both have severe 
consequences for human health.  
(9) PMK  ethyl glycidate is a precursor of 3,4-Methylenedioxyphenylpropan -2-one 
(PMK ), which, in turn, i s used to prod uce 3,4 -methylenedioxymethamphetamine 
(MDMA), commonly known as ‘ecstasy’.  
(10) BMK, as well as some of its other pre -precursors which are very similar to DEPAPD 
(such as methyl alpha -phenylacetoacetate (MAPA) or alpha -phenylacetoacetamide 
(APAA)) , and PMK are already scheduled substances in Regulations  (EC) No 
273/2004 and (EC) No 111/ 2005 .  
(11) Amphetamine, methamphetamine and MDMA are some of the most common drugs 
illicitly produced in the Union. They have severe consequences for human health and 
are causing serious social and public health problems in some regions of the Union.  
(12) 4-AP, 1 -boc-4-AP, norfentanyl, DEPAPD and PMK  ethyl glycidate have been 
designed by criminal organisations to avoid the  strict  controls  of scheduled substances  
provided for  by Regulations (EC) No 273/2004 and (EC) No 111/2005 . Therefore, 4 -
AP, 1 -boc-4-AP, norfentanyl, DEPAPD and PMK  ethyl glycidate should also be 
scheduled at Union  level to reinforce the control and monitoring  of those substances .  
(13) The scheduled substances l isted 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 subs tance and the burden on licit trade. The strictest control and 
monitoring measures apply to subst ances of C ategory 1.  
(14) 4-AP, 1 -boc-4-AP and  norfentan yl, should be scheduled as Category 1 substances 
because they can be easily transformed to support the prod uction of fentanyl and its 
analogues  and pose a significant  threat  to social  and public  health  in the Union . 
(15) DEPAPD and PMK  ethyl glycidate should be scheduled as Category 1 substances 
because they can be easily transformed to support the production of 
methamphetamine , amphetamine and MDMA  and pose a significant threat to social 
and public health in the Union .  
(16) 4-AP, 1 -boc-4-AP, norfentanyl, DEPAPD and PMK  ethyl glycidate have no known 
licit production, trade or use, except for research purposes . Therefo re, including those 
substances  under  Category 1 in Annex I to Regulation (EC) No 273/2004 and under  
Category 1 in  the Annex to Regulation (EC) No 111/2005 would be an adequate 
response to avoid their use in the illicit manufacture of narcotic drugs and, at the same 
time, would not entail any significant  extra administrative burden for economic 
operators and competent authorities  in the Union .  
EN 6  EN (17) Regulation s (EC) No 273/2004 and (EC) No 111/2005 should therefore be amended 
accordingly.  
(18) The Commission Implementing Regulation (EU) 2021/1832 of 12 October 2021  
amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and 
statistical nomenclature and on the Common Customs Tariff4 reclassified  ANPP and 
NPP. Regulations (EC) No 273 /2004 and (EC) No 111/2005 should therefore  be 
amended and corrected accordingly.  
(19)  
(20) Regulations (EC) No 273/2004 and (EC) No 111/2005 jointly implement the drug 
precursors related provisions of the 1988 UN Convention . In view of the close 
substantive link b etween 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 ame nded 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,  
 For the Commissio n 
 The President  
 Ursula VON DER LEYEN  
 
  
 
                                                 
4 OJ L 385, 29.10.2021, p. 1.