EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) XXX  draft 
  
COMMISSION DELEGATED REGULATION (EU) No …/.. 
of XXX  
supplementing Regulation (EC) No 273/2004 of the European Parliament and of the 
Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules 
for the monitoring of trade between the Union and third countries in drug precursors, 
and repealing Commission Re gulation (EC) No 1277/2005 
(Text with EEA relevance) 
 EN 0   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
Drug precursors are chemicals which have wide le gitimate uses but which can also be used to 
produce illegal drugs. Regulation (EC) No 273/2004 lays down measures for monitoring trade 
in drug precursors within the EU, while Re gulation (EC) No 111/2005 governs trade in drug 
precursors between the EU and third countries. 
In December 2013 these two Regulations were ame nded in order to strengthen the control of 
acetic anhydride (main heroin precursor) by maki ng the registration of end-users compulsory 
in intra-EU trade. The cont rol of the external trade of  medicinal products containing 
ephedrine and pseudoephedrine (methamphetami ne precursors) was strengthened through the 
introduction of a new Category 4 for those products.  
Commission Regulation (EC) No  1277/2005 contains the implementing rules for the overall 
trade in drug precursors. The present Commis sion Delegated Regulation is intended to (1) 
align the rules contained in Commission Re gulation (EC) No 1277/2005 with the Lisbon 
Treaty and (2) adapt those rules to the latest amendments to the drug precursors legislation. The Delegated Regulation and a parallel new Implementing Act will replace Commission 
Regulation (EC) No 1277/2005, once bot h new Acts will be in force. 
The main features of Commission Regulation (E C) No 1277/2005 are maintained in this draft 
Delegated Regulation (and in the accompanyi ng Implementing Regulation). The changes 
relate in particular to the conditions for granting registrati ons and the possibility to use 
simplified procedures for pre-export notifications  and for export authorisations for medicinal 
products. 
2. CONSULTATIONS
 PRIOR  TO THE  ADOPTION  OF THE  ACT 
In line with paragraph 4 of the Common U nderstanding on delegated acts between the 
European Parliament, the Council and the Euro pean Commission, appropriate and transparent 
consultations, including at expert  level, have been carried out  in the preparation of this 
delegated act. The relevant documents have been transmitted in a timely and appropriate 
manner to the European Parliament and to  the Council. The Group of Experts on drug 
precursors was consulted in the meeting held on 10 November 2014. 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT 
On the basis of Council Regulation (EC)  No 111/2005, as amended by Regulation (EU) 
No 1259/2013 of the European Parliament and of  the Council, the Commission is empowered 
to adopt Delegated acts to lay down conditions for granting licences and to determine cases 
where a licence is not required, by the third subparagraph of Article  6(1); to lay down 
conditions for granting registrations and to determine cases where a registration is not 
required, by the third subpa ragraph of Article 7(1); to establish the criteria to demonstrate the 
licit purpose of a transaction by Article 8(2); to determine the information required to monitor trade, by the second subparagraph of Article 9( 2); to fix the conditions for determining the 
lists of the countries of destin ation for exports of scheduled s ubstances of Categories 2 and 3, 
by Article 11(1); to establish the criteria for determining simplified proc edures for pre-export 
notifications, by Article 11(3), and for export au thorisations, by Article 19; to specify the 
requirements concerning the information to  be provided on the implementation of the 
monitoring measures as regards trade in drug pr ecursors, by Article 32(2) of Regulation (EC) 
No 111/2005. EN 1   EN On the basis of Regulation (EC) No 273/2004 of the European Parliament and of the Council, 
as amended by Regulation (EU) No 1258/2013, the Commission is empowered to adopt 
Delegated acts concerning the requirements and conditions for gr anting licences and 
registrations by Article 3(8); for operators to provide info rmation by Article 8(3); and 
concerning the information to be provided on the implementation of the monitoring measures 
as regards trade in drug precursors by Article 13(2). EN 2   EN COMMISSION DELEGATED REGU LATION (EU) No …/.. 
of XXX  
supplementing Regulation (EC) No 273/2004 of  the European Parliament and of the 
Council on drug precursors and Council Regula tion (EC) No 111/2005 laying down rules 
for the monitoring of trade between the Unio n and third countries in drug precursors, 
and repealing Commission Regulation (EC) No 1277/2005 
(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 precursors
1, and in particular Ar ticles 3(8), 8(3) and 
13(2)  thereof, 
Having regard to Council Regulation (EC)  No 111/2005 of 22 December 2004 laying down 
rules for the monitoring of trade between th e Union and third countries in drug precursors2, 
and in particular in the third subparagraph of Article 6(1), the third subparagraph of Article 
7(1), Article 8(2), the second subparagraph of Article 9(2), Article 11(1) and (3), Articles 19 
and Article 32(2) thereof, 
Whereas: (1) Commission Regulatio n (EC) No 1277/2005
3 lays down provisions for the 
implementation of Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 in 
the field of drug precursors. Both Regul ation (EC) No 273/2004 and Regulation (EC) 
No 111/2005 have been amended after the adoption of Regulation (EC) No 1277/2005 
so as to include empowerments to adopt de legated and implementing acts pursuant to 
Articles 290 and 291 of the Treaty. Theref ore, new rules should be adopted in 
accordance with the new empowerments. 
(2) Although Regulation (EC) No 273/2004 deals with domestic trade and Regulation 
(EC) No 111/2005 deals with international tr ade, many of the provisions are common 
to both Regulations. In order to ensure cohe rence, it is justified to adopt a single 
delegated act covering both Regulations. 
(3) Licenses and registrations which are requi red for operators willing to carry out 
activities involving cert ain substances (drug precursors ), which can be used for the 
illicit manufacture of narcotic  drugs or psychotropic subs tances, should be granted 
only to reliable operators applying for it. These operators should have taken adequate 
measures aiming at the secure handling and storage of thos e drug precursors and 
                                                 
1 OJ L 47, 18.2.2004, p. 1, as amended by Regulation (EU) No 1258/2013 (OJ L 330, 10.12.2013, p. 21). 
2 OJ L 22, 26.1.2005, p. 1, as last amended by Regulation (EU) No 1259/2013 (OJ L 330, 10.12.2013, p. 
30). 
3  Commission Regulation (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for 
Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and 
for Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the 
Community and third countries in drug precursors - (OJ L 202, 3.8.2005, p.7. EN 3   EN should have appointed an identifiable responsib le officer able to ensure that activities 
involving these substances take place in compliance with the pertinent legal 
provisions. 
(4) Certain operators dealing with drug precurs ors for medical use, such as pharmacies 
and retailers of veterinary medicinal products, could be exempted from the 
requirement of having been granted a license  or a registration in order to carry out 
activities involving such  substances. The same could be  applicable to certain public 
authorities. 
(5) Operators carrying out activities related to drug precursors which are not intended for 
the Union market, but have been brought in to the customs territo ry of the Union, 
should provide information showing that the exportation of those substances was made 
in compliance with relevant International conventions to demonstr ate the licit purposes 
of the correspondi ng transaction. 
(6) Operators established in the Union should pr ovide certain basic de tails on the activities 
they have carried out in orde r to facilitate the monitoring, by the competent authorities, 
of trade in drug precursors. 
(7) For the purposes of minimising the risk of diversion of certain drug precursors, their 
exportation should be preceded by a pre- export notification and by an export 
authorisation. 
(8) In order to ease the administ rative burden for trade in certain categories of drug 
precursors, a simplified procedure for pre-export notification and for export 
authorisation should be provided. 
(9) To improve the coordination of the implem entation of the monitoring measures, it is 
appropriate that the Member States provide the Commission regularly with information concerning drug precu rsors seized or detained. 
(10) In order to ensure consistency, legislative coherence and legal certainty, this Delegated 
Regulation should apply from the same date as the Implementing Regulation, 
HAS ADOPTED THIS REGULATION: 
Article 1  
Subject matter 
This Regulation lays down conditions for granti ng licences and registrations, determines cases 
where a licence and a registration are not require d, establishes the criteria to demonstrate the 
licit purpose of a transaction, dete rmines the information required  to monitor trade, fixes the 
conditions for determining the lists of the count ries of destination fo r exports of scheduled 
substances of Categories 2 and 3, establis hes the criteria for determining simplified 
procedures for pre-export notifications and for export authorisations and specifies the 
requirements concerning the information to  be provided on the implementation of the 
monitoring measures as regard s trade in drug precursors. EN 4   EN Article 2 
Definitions 
For the purposes of this Regulation, ‘business pr emises’ shall mean building(s) together with 
the land occupied by an operato r at each single location.  
Article 3 
Conditions for granting licences 
1. In order to obtain a licence pursuant to Article 6(1) of  Regulation (EC) No 111/2005, the 
operator shall appoint an officer responsible fo r the trade in scheduled substances listed in 
Category 1 of the Annex, notify the competent aut horities of the name and contact details of 
that officer and notify them immediately of a ny subsequent modification of this information. 
The responsible officer shall ensure that import,  export or intermediary activities take place in 
compliance with the pertinent legal provisions  and shall be empowered to represent the 
operator and to take the decisions necessary for performing that task.  
2. The operator concerned shall fulfil a ll the following requirements and conditions: 
(a) the operator shall take ade quate measures against the unaut horised removal of scheduled 
substances of Category 1 of Annex I to Regulation (EC) No  273/2004 and of the Annex to 
Regulation (EC) No 111/2005 from the places  of storage, production, manufacture and 
processing of scheduled substances and to secure business premises; 
(b) the operator shall make an a pplication containing the following: 
i. the full name, address, telephone and/or fax numbers and e-mail address of the 
applicant; 
ii. the AEO certificate number, if the operator  has already been granted the status 
of an Authorised Economic Operator in  accordance with Article 5a of Council 
Regulation (EEC) No 2913/924; 
iii. the full name of the responsible o fficer and his/her contact details; 
iv. a description of the position and ta sks of the responsible officer; 
v. the full addresses of the business premises; 
vi. the description of all the places where operations described under point x take 
place; 
vii. information showing that the adequate m easures referred to in paragraph 2(a) 
have been taken; 
viii. the name and the CN code of the scheduled  substances as stated in Annex I to 
Regulation (EC) No 273/2004 and in th e Annex to Regulation No 111/2005; 
                                                 
4 Council Regulation (EEC) No 2913/92 establishing the Community Customs Code, OJ L 117, 4.5.2005, 
p. 13, as amended by  Regulation (EC) No 648/2005 of the European Parliament and of the Council of 
13 April 2005. EN 5   EN ix. in the case of a mixture or natural product an indication of the following: 
a. the name of the mixture or natural product; 
b. the name and CN code of the scheduled substances as stated in Annex I 
to Regulation (EC) No 273/2004 and in the Annex to Regulation No 
111/2005 contained in the mixt ure or natural product; 
c. the maximum percentage of such sc heduled substances in the mixture 
or natural product; 
x. a description of the envisa ged type of operations refe rred to in Article 3 of 
Regulation (EC) No 273/2004 and in Ar ticle 6(1) of Regulation (EC) No 
111/2005; 
xi. an authenticated copy of the Register  of companies or activities, where 
relevant; 
xii. a certificate of good conduct of the operat or concerned and of the responsible 
officer or a document showing that they  offer the necessary guarantee for the 
proper conduct of the operations or the information allowing the competent 
authority to obtain such document. 
3. Upon written request from the relevant compet ent authority, the applicant shall submit any 
relevant additional information. 
4. Where the applicant is a natural person, points (ii) , (iii) and (iv) of para graphs 2(b) shall not 
apply, and point (v) of paragraph 2( b) shall only apply where relevant. 
5. Without prejudice to measures  adopted in accordance with  Article 10(1) of Regulation 
(EC) No 273/2004 and with Article 26(3) of Regulation (EC) 111/2005, the competent 
authorities shall refuse the granting of the licence  if the conditions set out in Article 3(2) (b) 
of this Regulation are not fulf illed or if there are reasonabl e grounds for suspecting that the 
scheduled substances are intended for the illicit manufacture of narcotic drugs or psychotropic 
substances. 
6. In the case of trade between the Union and th ird countries referred to in Regulation (EC) 
No 111/2005, the competent authorities may either limit the validity of th e licence to a period 
not exceeding three years or may require operators to demonstrate at intervals not exceeding three years that the conditions under whic h the licence was granted are still fulfilled. 
The validity of licences issued before the entry into force of this Regulation shall not be 
affected. 
7. A licence shall not be transferable. 8. The licence holder shall apply for a new licence where any of the following are envisaged: (a) the addition of a scheduled substance; (b) the start of a new operation; (c) the change of the location of the business premises where the operations take place. 
In such cases, the existing licence shall cease to  be valid on the earlier of the following dates: 
(i) the date of expiry of  validity where a term of validity has been fixed in 
accordance with Article 2(6) of  this Regulation or in accordance with Article 3(5) of 
Regulation (EC) No 273/2004; 
(ii) the date of commencement of validity of the new licence. EN 6   EN 9. Paragraph 8 shall apply to licences issued befo re the date of applica tion of this Regulation . 
10. Paragraphs 2 to 5 and 7, 8 an d9 shall also apply for the pu rpose of obtaining licences 
pursuant to Article 3(2) of  Regulation (EC) No 273/2004, w ith the exception of special 
licences. 
11. The public authorities referred to in Arti cle 3(2) and (6) of Re gulation (EC) No 273/2004 
shall comprise customs, police and official  laboratories of competent authorities . 
Article 4 
Cases where a licence is not required 
Pharmacies, retailers of veterinary medicina l products, customs, police, armed forces and 
official laboratories of competent authorities may be exempted from the requirement of licensing pursuant to Article 6(1) of Regulati on (EC) No 111/2005 insofa r as these operators 
use drug precursors within the sc ope of their official duties. 
The operators set out in the first paragra ph are also exempted from the following: 
(a) the provision of documentation referred to in Article 3 of Regulation (EC) No 111/2005; 
(b) the obligation to appoint a responsible officer set out in Article 3(1) of this Regulation. 
Article 5 
Conditions for granting registrations 
1. In order to obtain a registration pursuant to Article 7(1) of Regula tion (EC) No 111/2005, 
the operator shall appoint an offi cer responsible for the trade in scheduled substances listed in 
Categories 2 of the Annex to th at Regulation, notify the compet ent authorities of the name 
and contact details of that officer and not ify them immediately of any subsequent 
modification of this information. 
The responsible officer shall ensure that import, export or intermediary activities take place in 
compliance with the pertinent legal provisions  and shall be empowered to represent the 
operator and to take the decisions necessary for performing that task. 
2. The operator of scheduled substances of Ca tegories 2 of the Annex to Regulation (EC) 
No 111/2005 and the operator engaged in the export of scheduled substances of Category 3 of 
the Annex to Regulation (EC) No 111/2005 sh all make an application containing the 
information and documents as referred to in Arti cle 3(2)(b) with the ex ception of points (vii), 
(xi) and (xii) .of Article 3(2)(b). 
3. Article 3(3) and (4)shall  also apply.  
4. Paragraph 2 and 3 shall also apply to opera tors and users referred to Article 3(6) of 
Regulation No 273/2004. 
5. Users of scheduled substances of category 2A of Annex I to Regul ation (EC) No 273/2004 
shall also provide information on th e use of the scheduled substances. EN 7   EN Article 6 
Cases where a registration is not required 
The following categories may be ex empt from the registration requirement pursuant to Article 
7(1) of Regulation (EC) No 111/2005: 
(a) Pharmacies, dispensaries of veterinary medici ne, customs, police, offi cial laboratories of 
competent authorities and armed forces, insofar as these operators use drug precursor s within 
the scope of their official duties; 
(b) Operators engaged in the e xport of scheduled substances lis ted in Category 3 of the Annex 
to Regulation (EC) No 111/2005, if the sum of quantities concerned by  their exports during 
the course of the preceding calendar year  (1 January-31 December) does not exceed the 
amounts specified in Annex I to this Regulati on. When those amounts are exceeded within the 
current calendar year, the operator shall comply with the registration requirement immediately. 
(c) Operators engaged in export of mixtures containing scheduled substances listed in 
Category 3 of the Annex to Re gulation (EC) No 111/2005, if th e amount of the scheduled 
substance contained in the mixtures does not  exceed, during the course of the preceding 
calendar year, the amounts specified in Annex I to this Regulation. When those amounts are 
exceeded within the current calendar year, th e operator shall comply with the registration 
requirement immediately. 
Article 7 
Conditions for exemptions from certain requirements 
For the purposes of Article 6 of Regulation (EC) No 273/2004, customers shall inform their 
suppliers whether that Article is applicable to them. 
Article 8 
Criteria for determining the li cit purposes of a transaction 
1. The operator shall provide information that th e consignment has left the country of export 
in accordance with the national provisions in force adopted pursuant to Article 12 of the 
Convention of the United Nations  against illicit traffic in Na rcotic Drugs and Psychotropic 
substances
5 to demonstrate the licit purpose of his transaction pur suant to Article 8(1) of 
Regulation (EC) No 111/2005. 
2. For that purpose, the operator shall either use the model set out in Annex II to this 
Regulation or present the import authorisation refe rred to in Article 20 of Regulation (EC) No 
111/2005 or the customer declara tion referred to in Articl e 4 of Regulation (EC) No 
273/2004. 
                                                 
5  Council Decision of 22 October 1990, OJ L 326, 24.11.1990, p.56. EN 8   EN Article 9 
Information required to monitor trade 
1. For the purposes of Article 8(2) of Regula tion (EC) No 273/2004 operators shall inform the 
competent authorities in a summary form of th e quantities of scheduled substances used or 
supplied and, in the case of supply, of the quantity supplied to each third party. 
For scheduled substances of Category 3 of A nnex I to Regulation (EC) No 273/2004, the first 
paragraph shall apply only upon requ est by the competent authorities. 
2. For the purposes of Article  9(2) of Regulation (EC) No  111/2005, operators shall inform 
the competent authorities about the following: 
(a) exports of scheduled substances subject to an export authorisation; 
(b) all imports of scheduled substances of Ca tegory 1 of the Annex to Regulation (EC) No 
111/2005 requiring an import auth orisation or all cases wher e scheduled substances of 
Category 2 of the Annex to Re gulation (EC) No 111/2005 are en tered into a free zone of 
control type II, placed into a suspensive proce dure other than transit, or released for free 
circulation; 
(c) all intermediary act ivities involving schedule d substances of Catego ries 1 and 2 of the 
Annex to Regulation (EC) No 111/2005. 
3. The information referred to in paragraph 2(a)  shall be organised by making reference to the 
countries of destination, quantities exporte d and the reference numbers of the export 
authorisations as the case may be. 
4. The information referred to in paragraph 2(b) shall be organised by making reference to the 
third country of export and the reference number of  the import authorisa tions as the case may 
be. 
5. The information referred to in paragraph 2(c)  shall be organised by making reference to the 
third countries involved in thes e intermediary activities and th e export or import authorisation 
as the case may be. Operator s shall provide further info rmation, upon request of the 
competent authorities. 
6. The competent authorities shall treat the in formation referred to in this Article as 
confidential business information. 
Article 10 
Conditions for determining the lists of the coun tries of destination for exports of scheduled 
substances of Categories 2 and 3 
The lists as referred to in Article 11(1) of Regulation (E C) No 111/2005 are set out in 
Annex III to this Regulation. 
Such lists shall include all of the following: (a) third countries with whom the Union has concluded a specific agreement on drug 
precursors; 
(b) third countries which have requested to recei ve pre-export notifications  in accordance with 
Article 12(10) of the 19 88 United Nations Convention  against illicit traffic in narcotic drugs 
and psychotropic substances; EN 9   EN (c) third countries which have re quested to receive pre-export no tifications in accordance with 
Article 24 of the 1988 United Nations Convention ag ainst illicit traffic in  narcotic drugs and 
psychotropic substances. 
Article 11 
Criteria for determining simplified pro cedures for pre-ex port notifications 
1. Pursuant to Article 11(3) of Regulation (E C) No 111/2005, the competent authorities may 
send a simplified pre-export notification covering  several export operations  carried out within 
a specific time period of either 6 or 12 months, in case of exports intended for the simplified 
export authorisation procedure. 
2. The competent authority of the country of ex port shall supply the info rmation specified in 
Article 13(1) of Regulation No  111/2005 to the competent authority of the third country of 
destination. 
3. The competent authorities shall inform the c ountry of destination accordingly and use to 
that purpose the PEN-online system or the 'Multilateral Chemical Reporting Notification' set 
out in Annex IV. 
Article 12 
Criteria for determining simplified pr ocedures for export authorisations  
1. Following an application by the operator con cerned the competent authority may grant an 
export authorisation by  simplified procedure pursuant to  Article 19 of Regulation (EC) 
111/2005 in cases of frequent exports of one sp ecific scheduled substance listed in Categories 
3 and 4 of the Annex to that Regulation involving the same exporter established in the Union 
and the same importer in the same third countr y of destination covering a specific time period 
of either 6 or 12  months. 
Such simplified export authorisation may only be granted in the following cases: 
(a) where during previous exports the operator ha s shown the capacity to fulfil all obligations 
in relation to those exports, and has not committed any offences against relevant 
legislation; 
(b) where the competent authorit y can satisfy itself as to the licit purposes of those export 
operations. 
2. The application for a simplified export author isation shall contain at  least the following: 
(a) the names and addresses of the exporter, importer in the third country, and the ultimate 
consignee; 
(b) the name of the scheduled substance, as stated in the Annex to Regulation (EC) No 
111/2005, or, in the case of a mixtur e or natural product, its name  and CN code and the name 
of any scheduled substance, as stated in  the Annex to Regula tion (EC) No 111/2005, EN 10   EN contained in the mixture or natural product; 
(c) the maximum quantity of the scheduled substance intended for export; (d) the intended specific time pe riod for the export operations. 
3. The competent authority shall take the d ecision on the application for simplified export 
authorisation within a period of 15 working days from th e date on which it received the 
required information. 
4. In case of emergency medical care, where th e conditions under paragraph 1 (a) and (b) of 
this Article are fulfilled, the competent author ity shall take the decisi on on the application for 
simplified export authorisation for exports of sche duled substances of Category 4 listed in the 
Annex to Regulation (EC) No 111/2005 immediately or at the latest within 3 working days 
after receipt of the application. 
Article 13 
Conditions and requirements concerning the information to be provided on the 
implementation of the monitoring measures 
1. Member States shall submit th e communications referred to in  Article 32(2) of Regulation 
(EC) No 111/2005 and Article 13(1) of Regul ation (EC) No 273/2004 to the Commission, in 
the month following each calendar quarter. The communications shall contain the information 
on all cases where the release of scheduled a nd non-scheduled substances was suspended or 
the scheduled and non-scheduled substances were detained. 
2. That information shal l include the following: 
(a) the name of the substances;  
(b) if known, the origin, provenance a nd destination of the substances; 
(c) the quantity of the substan ces, their customs status and the means of transport used. 
3. At the end of every calendar year, the Comm ission shall communicate to all Member States 
the information received pursuant to paragraph 1. 
Article 14 
Repeal 
Regulation (EC) No 1277/2005 is repealed. 
Article 15 
This Regulation shall enter into force th ree days following 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. EN 11   EN Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER