Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Amending Regulation (EC) No 273/2004 on drug precursors
Date: 2012-09-27
Institutions: European Commission
Subjects: drug traffic, market supervision, marketing standard, medicinal product, psychotropic substance

EUROPEAN 
COMMISSION 

Brussels, 27.9.2012  
COM(2012) 548 final 

2012/0261 (COD) 

[…] 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

Amending Regulation (EC) No 273/2004 on drug precursors 

(Text with EEA relevance) 

{SWD(2012) 278 final} 
{SWD(2012) 279 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

General Context 

Many  chemicals  are  used  in  a  wide  variety  of  important  industrial  processes  (e.g.  in  the 
synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they 
are traded for these licit uses on regional and global markets. Some of these chemicals can, 
however,  be  misused  for  the  illicit  manufacture  of  narcotic  drugs  and  psychotropic 
substances.  The  chemicals  produced  for  a  licit  purpose  which  can  be  misused  in  the  illegal 
drug production are called drug precursors. 

Drug  precursors  are  rarely  produced  by  the  criminals  that  intend  to  use  them  in  the  illicit 
manufacture  of  drugs,  as  their  production  often  requires  important  industrial  infrastructure. 
Therefore, criminals try to divert these substances from the licit trade.  

The trade in drug precursors is  not in  itself prohibited  because  of  their important  legitimate 
uses.  However,  in  order  to  prevent  their  diversion  to  illicit  drug  production,  a  specific 
regulatory framework has been set up on international level through Article 12 of the United 
Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances 
(hereafter  referred  as  UN  1988  Convention).  The  European  Union  is  a  Party  to  the 
Convention  and  has  implemented  its  obligations  through  Regulation  (EC)  No  273/2004 
governing  the  monitoring  of  the  intra-EU  trade  in  drug  precursors  and  Regulation  (EC) 
No 111/2005 governing the external trade. The Union regulatory framework provides for the 
monitoring  and  control  of  the  legitimate  trade  in  drug  precursors.  Operators,  i.e. 
manufacturers,  distributors,  brokers,  importers,  exporters  and  wholesalers  of  chemicals 
engaged in the legitimate trade of drug precursors are required to take measures against theft, 
check their  customers, detect  suspicious transactions and notify the authorities thereof. This 
industry-authority partnership is key to the well functioning of the regulatory framework. 

Public  authorities  monitor  that  companies  dealing  with  drug  precursors  properly  exercise 
their obligations under the legislation by conducting on-site inspections and via administrative 
procedures such as granting licences and registrations. 

Grounds for and objectives of the proposal 

Traffickers  purchase  the  drug  precursors  they  need  from  different  regions  of  the  world  and 
exploit  weaknesses  of  control  to  their  benefit.  This  proposal  aims  to  address  a  specific 
weakness  which  has  been  detected  in  the  European  Union,  when  large  quantities  of  acetic 
anhydride  ("AA"),  the  main  drug  precursor  for  heroin,  were  diverted  from  the  EU-
internal trade: in 2008, 75% of the global seizures of AA happened in the EU. Heroin use 
has been contributing to public health problems in Europe since the 1970s. It still accounts for 
the greatest share of morbidity and mortality-related drug use in the European Union. 

Even  though  the  quantities  of  AA  seized  in  the  EU  have  decreased  very  substantially  since 
2008,  the  INCB1  continues  to  mention  in  its  annual  reports  that  the  European  legislative 

1 

United Nations’ International Narcotics Control Board. 

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control  measures  are  not  sufficiently  strict  to  prevent  the  diversion  of  the  main  heroin 
precursor from the intra-EU trade. 

On 7 January 2010, the European Commission adopted a Report on the implementation and 
functioning  of  the  existing  EU  legislation  on  drug  precursors2  which  concluded  that  the 
legislation  is  overall  functioning  well  but  also  identified  some  weaknesses  and  made 
recommendations how to address these3. 

This proposal addresses, by amending Regulation (EC) No 273/2004, the recommendation of 
the  Commission  Report  to  improve  the  prevention  of  the  diversion  from  the  EU-internal 
trade  of  AA,  the  main  drug  precursor  for  heroin,  by  extending  the  registration 
requirement,  which  so  far  applies  only  to  operators  placing  AA  on  the  market,  to  also 
include  users  of  the  substance  and  by  enhancing  the  harmonised  registration  provisions  to 
achieve a more robust level playing field preserving the internal market and avoiding adoption 
of divergent national measures. 

Consistency with other policy and objectives of the Union  

This proposal is fully consistent with the objectives of the EU Drugs Strategy 2005-20124 and 
the EU Drugs Action Plan (2009-2012)5, which set out the objective to reduce the diversion 
and trafficking in/via the Union of drug precursors used for the production of illicit drugs. 

As  the  drug  problem  is  a  complex  phenomenon,  it  requires  a  multidisciplinary  approach  of 
combining  demand  and  supply  reduction6.  Preventing  the  diversion  and  trafficking  of  drug 
precursors aims at reducing the supply of illicit drugs – the ultimate objective being a high 
level of protection, well-being and social cohesion for EU citizens by preventing and reducing 
drug use in line with the EU Drug Strategy. The European Commission Services are currently 
carrying  out  an  evaluation  of  the  2005-2012  EU  Drugs  Strategy;  in  preparation  of  the  EU 
Drug  Strategy  from  20137.  This  evaluation  is,  however,  not  questioning  the  pillar  ‘supply 
reduction’  (which  includes  the  prevention  of  diversion  of  drug  precursors)  and  the  Union 
being a Party to Article 12 of the 1988 UN Convention is in any case bound to work towards 
the objective of preventing the diversion of drug precursors. 

A high level of human health  protection is a basic principle of  the Treaty,  which shall be 
ensured  in  the  definition  and  implementation  of  all  policies  and  activities  of  the  EU.  The 
control of drug precursor diversion contributes to the protection of human health, specifically 

2 

3 

4 

5 
6 

7 

Report  from  the  Commission  to  the  Council  and  the  European  Parliament  pursuant  to  Article  16  of 
Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 and 
to  Article  32 of  Council  Regulation  (EC) No  111/2005 on  the  implementation  and functioning  of  the 
Community  legislation  on  monitoring  and  control  of  trade  in  drug  precursors,  COM(2009)709  final, 
available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0709:FIN:en:PDF. 
For further details, see under Section 4.2.2 "Strength and weaknesses of the legislation" of the above-
mentioned Report COM(2009)709 final. 
EU  Drugs  Strategy  2005-2012,  endorsed  by  the  European  Council  of  November  2004  (15074/04 
CORDROGUE 77 SAN 187 ENFOPOL 187 RELEX 564). 
EU Drugs Action Plan for 2009-2012 (2008/C 326/09). 
The  EU  Drug  Strategy  additionally  complements  these  two  key  dimensions  with  three  cross-cutting 
themes: coordination; international cooperation and information; research and evaluation. 
For further details see http://ec.europa.eu/justice/newsroom/anti-drugs/opinion/111027_en.htm. 

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in the area of drugs-related health damage where the Treaty invites the Union to complement 
Member States’ actions on prevention of drug-use8. 

In addition, the initiative is also in line with the principle of the Treaty that the Union shall 
endeavour to ensure a high level of security through measures to prevent and combat crime, 
and through measures for coordination and cooperation between police and other competent 
authorities9. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

Consultations of interested parties, collection and use of expertise  

The  Commission  Services  consulted  in  2009  and  early  2010  all  stakeholders  on  the 
implementation of Regulation (EC) No 273/2004 and presented its findings in a Report to the 
European Parliament and the Council, which was adopted on 7 January 201010. In May 2010, 
the Council adopted conclusions on the Commission’s Report, recognising the importance of 
continuing  active  co-operation  among  authorities  and  industry  and  of  improving  the 
implementation of the European legislation. The Council invited the Commission to set up a 
work programme to address the identified weaknesses of the legislation in co-operation with 
Member States and to propose legislative amendments before the end of 2011 after carefully 
assessing their potential impacts on Member States authorities and economic operators11. 

The Commission subsequently developed six potential policy options (see the next section for 
details) and discussed them with the Member States and industry representatives in a special 
meeting of the Drug Precursor Working Group in June 2010.  

Member  States  and  industry  stakeholders  were  further  consulted  on  the  six  options  via  a 
written consultation, carried out from 23 July to 18 October 2010. Three main target groups 
were identified: manufacturers and traders (operators), end-users and competent authorities of 
Member States. In addition, an SME-consultation was carried out via the Enterprise Europe 
network  from  1  October  until  24  November  2010  to  ensure  that  the  concerns  of  a  specific 
target group – end-users of drug precursors most of which are SMEs – were considered. 

Finally, the Commission mandated a study to an external consultant to evaluate in detail the 
administrative  costs  on  companies  and  authorities  that  would  result  from  each  of  the  policy 
options.  

Impact assessment  

The  main  problem  driver  being  the  insufficient  control  by  competent  authorities  over  all 
economic  players  involved  in  the  legitimate  trade  with  drug  precursors,  all  policy  options 
examined  seek  to  improve  control  via  enhanced  reporting,  notification  or  registration 
obligations imposed on the economic players. The impacts of the following six policy options 
have been analysed: 

8 
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10 
11 

Article 168 TFEU (Treaty on the Functioning of the European Union). 
Article 67 TFEU. 
See footnote 1. 
Council  conclusions  on  the  functioning  and  implementation  of  the  EU  drug  precursor  legislation  – 
3016th Competitiveness Council meeting Brussels, 25 May 2010. 

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–  Option 1 (baseline option): no action: the current EU legislation will remain unchanged; 

–  Option 2: strengthened reporting obligations;  

–  Option 3: strengthened rules and obligations on operators related to customer declarations 

from end-users; 

–  Option  4:  require  operators  to  systematically  notify  new  end-users  to  the  authorities  to 

allow verification; 

–  Option  5:  require  registration  for  end-users  and  reinforce  requirements  regarding 

registration; 

–  Option 6: move AA from category 2 to category 1 scheduled substances. 

For options 2 to 5, two sub-options were analysed, i.e. to either limit them specifically to AA 
or to apply them to all scheduled substances in category 2. 

The overall conclusion of the impact assessment12 was that both, option 4 (for only AA) and 
option  5  (for  only  AA)  would  be  good  choices  to  address  the  identified  objectives.  Both 
would have effects on SMEs as end-users dealing with AA are primarily SMEs, but option 5 
would  be  less  burdensome  than  option  4  in  terms  of  annual  costs  for  enterprises  (provided 
authorities  do  not  pass  on  all  costs  to  registrants  by  imposing  fees),  an  argument  which  is 
particular relevant for SMEs. All in all the strong political support which option 5 has from 
most  Member  States,  combined  with  views  expressed  on  international  level  that  a  more 
systematic  control  of  (all)  AA  end-users  is  lacking  in  the  European  legislation,  and  the 
somewhat lower burden on SMEs tip the balance in the end in favour of option 5. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Legal basis  

The legal basis of the proposal is Article 114 of the Treaty on the Functioning of the European 
Union (TFEU). Article 114 has the objective to establish an internal market while ensuring a 
high level of protection of human health and the environment. 

Subsidiarity principle  

The  subsidiarity  principle  as  set  out  in  Article  5(3)  of  the  Treaty  on  the  European  Union 
applies insofar as the proposal does not fall under the exclusive competence of the Union.  

The  general  objective  of  Regulation  (EC)  No  273/2004  is  to  prevent  the  diversion  of  drug 
precursors from legitimate trade in accordance with the Union's obligations under Article 12 
of  the  1988  UN  Convention.  It  contributes  to  the  world-wide  combat  against  the  illicit 
production  and  trafficking  of  narcotic  drugs  and  psychotropic  substances,  while  ensuring  a 
proper  functioning  of  the  internal  market  for  drug  precursors  by  subjecting  operators  to  the 
same,  harmonised  rules  within  the  EU  whilst  avoiding  unnecessary  obstacles  to  legitimate 
trade and administrative burden for enterprises and competent authorities.  

12 

The report on the impact assessment is available at: 
http://ec.europa.eu/governance/impact/ia_carried_out/cia_2012_en.htm.  

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The  objective  of  this  proposal,  namely  to  strengthen  control  measures  on  AA  in  order  to 
prevent it diversion from the EU internal market while avoiding market distortions, cannot be 
sufficiently  achieved  by  the  Member  States  alone  and  action  by  the  Union  will  be  more 
efficiently achieved for the following reasons: 

–  Some Member States feel legally prevented from adopting national control measures going 
beyond  the  EU  legislation  on  the  basis  of  Article  10  of  Regulation  (EC)  No 273/2004, 
which empowers Member States to adopt national measures which are necessary to enable 
its  authorities  to  perform  their  control  and  monitoring  duties.  They  argue  that  the  EU 
legislation is subjecting only operators to control measures (no obligations are imposed on 
end-users),  which  should  be  understood  as  a  deliberate  and  binding  decision  of  the  EU-
legislator  that  end-users  should  not  be  subject  to  the  control  of  the  drug  precursor 
legislation 

–  On the contrary, other Member States are contemplating or have already based substantive 
national controls on Article 10, leading in first instance to different approaches of control 
in  different  Member  States  which  might  be  detrimental  to  the  functioning  of  the  Union 
Market  and,  secondly,  isolated  actions  in  individual  Member  States  risks  shifting  the 
problem from one Member State to the next, as traffickers will exploit the “weakest link” 
in the Union market. A combination of different national measures will not be as effective 
as  a  harmonised  approach  at  EU-level.  This  is  also  confirmed  by  the  fact  that  both, 
Member  States  and  concerned  industry  sectors  have  called  on  the  Commission  to  act  to 
preserve  the  internal  market  with  a  level  playing  field,  and  not  to  rely  too  much  on 
supplementary national measures.  

Proportionality principle 

The  proposal  does  not  go  beyond  what  is  necessary  in  order  to  achieve  the  intended 
objectives, in accordance with the principle of proportionality, as set out in Article 5(4) of the 
Treaty on European Union. By preventing the diversion of drug precursor from the legal trade 
to  illicit  drug  production,  this  proposal  is  expected  to  contribute  to  the  fight  against  illicit 
trafficking in narcotic drugs and psychotropic substances, and consequently to protect citizens 
from the health damage related to drug addiction. Furthermore by ensuring that operators and 
users  engaged  in  the  legal  trade  of  those  drug  precursors  are  subject  to  harmonised  rules,  it 
should ensure a proper functioning of the Union market by avoiding unnecessary barriers to 
such  legitimate  trade  and  by  reducing  administrative  burdens  for  operators  and  competent 
authorities. 

The proposal only tackles the weaknesses identified in the evaluation on the functioning and 
on  the  implementation  of  the  Regulations  on  Drug  Precursors,  namely  by  requiring 
registration not only for operators placing AA on the market but also for users possessing it 
for their own uses or processes (i.e. end-users). The proposal does not extend the envisaged 
provisions for AA to other scheduled substances in category 2. 

Choice of the instrument 

The  chosen  legal  instrument  is  a  Regulation  as  it  aims  to  harmonise  the  rules  applicable  to 
economic operators (end-users) dealing with AA for their own uses or processes. It amends 
the already existing Regulation (EC) No 273/2004. 

Main provisions of the proposal  

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The  proposal  introduces  the  requirement  that  end-users  of  AA  must  obtain  a  registration  as 
already exists for operators placing the substance on the market, and strengthens the rules for 
registration.  

Additionally it proposes to establish and maintain a European Database on Drug Precursors in 
order  to  modernize  the  collection  of  the  information  provided  by  Member  States  on  drug 
precursor seizures and stopped shipments, in accordance with current Article 13 of Regulation 
(EC)  No  273/2004,  and  to  maintain  a  list  of  EU  licensed  or  registered  operators  and  users 
legally trading or using drug precursors, as well as to enable operators to provide competent 
authorities  in  summary  form  with  information  about  their  transactions  involving  scheduled 
substances in accordance with current Article 8 (2) of Regulation (EC) No 273/2004.  

Finally, the draft Regulation adapts the provisions of Regulation (EC) No 273/2004 regarding 
ex-Comitology to the new rules of the Lisbon Treaty. 

4. 

BUDGETARY IMPLICATION  

The proposal has no impact on the European Union budget  because  no additional resources 
are  required  to  implement  the  action  proposed.  The  necessary  resources  to  implement  the 
European database are already included in the allocations granted during the budget procedure 
and within the Internal Market line. Therefore it does not have a budgetary impact over and 
above the appropriations already foreseen for the years to come in the official programming 
of the Commission. 

5. 

ADDITIONAL INFORMATION 

–  The  proposal  is  subject  to  a  notification  to  the  WTO  in  the  framework  of  the  TBT 

Agreement.  

–  The proposed act is relevant for the European Economic Area (EEA).  

–  The  proposed  act  contains  transitional  period  for  the  coming  into  force  of  the  new 

registration obligations for end-users of AA. 

–  The proposed act includes a review clause to assess whether the amended Regulation will 

have been effective to prevent the diversion of AA. 

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2012/0261 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

Amending Regulation (EC) No 273/2004 on drug precursors 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee1, 

Having regard to the opinion of the European Data Protection Supervisor2, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

1 
2  
3 
4 

Pursuant  to  Article  16  of  Regulation  (EC)  No  273/2004  of  the  European  Parliament 
and of the Council of 11 February 2004 on drug precursors3, the Commission adopted 
on  7  January  2010  a  report  to  the  Council  and  the  European  Parliament  on  the 
implementation and functioning of the existing EU legislation on drug precursors4. 

In that report, the Commission recommended further analysing ways to strengthen the 
control of the trade of acetic anhydride (scheduled substance in Category 2) in order to 
better prevent the diversion of acetic anhydride for the illicit production of heroin.  

In its Conclusions on the functioning and implementation of the EU drug precursor's 
legislation of 25 May 2010, the Council invited the Commission to propose legislative 
amendments  after  assessing  their  potential  impacts  on  competent  authorities  and 
economic operators. 

OJ C , , p. . 
OJ C…p…. 
OJ L 47, 18.2.2004, p. 1. 
Report  from  the  Commission  to  the  Council  and  the  European  Parliament  pursuant  to  Article  16  of 
Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 and 
to  Article  32 of  Council  Regulation  (EC) No  111/2005 on  the  implementation  and functioning  of  the 
Community legislation on monitoring and control of trade in drug precursors, COM(2009)709 final. 

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(4) 

(5) 

(6) 

The  definition  of  scheduled  substances  should  be  clarified:  the  term  'pharmaceutical 
preparation'  stemming  from  the  United  Nations  Convention  against  Illicit  Traffic  in 
Narcotic  Drugs  and  Psychotropic  Substances  adopted  in  Vienna  on  19  December 
1988, (hereinafter referred to as the "United Nations Convention") should be replaced 
by the relevant terminology of the Union legislation, 'medicinal products', and the term 
'other preparations' should be deleted as it duplicates the term 'mixtures' already used 
in the definition. 

A  definition  of  the  term  'user'  should  be  introduced  for  companies  possessing 
substances for purposes other than placing them on the market.  

It  should  be  clarified  that  companies  using  scheduled  substances  in  category  1  for 
other purposes than placing them on the market are obliged to obtain a licence. 

(7)  More detailed rules on registration should be introduced to ensure uniform conditions 
of registration in all Member States for scheduled substances in category 2 of Annex I. 
For substances scheduled in a new subcategory 2A of Annex I, not only operators but 
also users should be subject to a registration requirement. 

(8) 

(9) 

In  order  to  safeguard  the  competitiveness  of  microenterprises,  no  fees  should  be 
imposed on them for obtaining a registration or a licence. 

Explicit  provisions  should  be  foreseen  to  clarify  that  Member  States  have  the 
possibility  to  act  with  regard  to  suspicious  transactions  involving  non-scheduled 
substances in order to enable them to react more quickly with regard to new trends in 
the illicit production of drugs. 

(10)  A European database on drug precursors should be created to simplify the reporting by 
Member  States  with  regard  to  seizures  and  stopped  shipments,  to  create  a  European 
register of operators and users holding a license or a registration which will facilitate 
verification  of  the  legitimacy  of  commercial  transactions  involving  scheduled 
substances,  and  to  enable  operators  to  provide  the  competent  authorities  with 
information about their legal transactions involving scheduled substances. 

(11)  Regulation  (EC)  No  273/2004  envisages  the  processing  of  data.  Such  processing  of 
data  may  also  cover  personal  data  which  should  be  carried  out  in  accordance  with 
Union Law. 

(12)  Acetic anhydride, currently scheduled in category 2 of Annex I, should be included in 
a  new  subcategory  2A  of  Annex  I  to  allow  increased  control  of  its  trade.  The 
remaining substances of category 2 should be listed as subcategory 2B. 

(13)  Regulation  (EC)  No  273/2004  confers  powers  on  the  Commission  in  order  to 
implement some of its provisions, to be exercised in accordance with the procedures 
laid  down  in  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission5 as 
amended by Council Decision 2006/512/EC6. 

5 
6 

OJ L 184, 17.7.1999, p. 23. 
OJ L 200, 22.7.2006, p. 11. 

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(14)  As a consequence of the entry into force of the Lisbon Treaty, those powers need to be 
aligned  to  Articles  290  and  291  of  the  Treaty  on  the  Functioning  of  the  European 
Union.  

(15) 

In order to achieve the objectives of Regulation (EC) No 273/2004, the power to adopt 
acts in accordance with Article 290 of the Treaty on the Functioning of the European 
Union  should  be  delegated  to  the  Commission  to  specify  the  requirements  and 
conditions  for  the  granting  of  the  licence  and  registration,  for  obtaining  and  using 
customer declarations, for the documentation and labelling of mixtures, for provision 
of  information  by  the  operators  on  transactions  involving  scheduled  substances,  for 
listing  operators  and  users  having  obtained  a  licence  or  registration  in  the  European 
register  and  in  order  to  amend  the  Annexes.  It  is  of  particular  importance  that  the 
Commission carry out appropriate consultations during its preparatory work, including 
at expert level.  

(16)  The  Commission,  when  preparing  and  drawing-up  delegated  acts,  should  ensure  a 
simultaneous,  timely  and  appropriate  transmission  of  relevant  documents  to  the 
European Parliament and Council. 

(17) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  Regulation  (EC) 
No 273/2004,  implementing  powers  should  be  conferred  on  the  Commission.  Those 
powers should be exercised in accordance with Regulation (EU) No 182/2011 of the 
European  Parliament  and  of  the  Council  of  16  February  2011  laying  down  the  rules 
and general principles concerning mechanisms for control by the Member States of the 
Commission's exercise of implementing powers7. 

(18)  The examination procedure should be used for the adoption of the implementing acts 
in  order  to  set  up  details  on  how  customer  declarations  should  be  provided  in 
electronic form; to set up details on how to provide the information about transactions 
of operators with scheduled substances to a European database. 

(19)  Since the objectives of this Regulation, namely to strenghen the rules for registration 
of  operators  placing  on  the  internal  market  or  possessing  scheduled  substances  of 
category 2, in particular acetic anhydride, in order to prevent its diversion towards the 
illicit production of drugs, cannot be sufficiently achieved by Member States because 
traffickers gain from national differences in registration and move their illicit business 
where drug precursors are easiest to divert and can therefore be better achieved at the 
level of the Union, the Union may adopt measures, in accordance with the principle of 
subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on  European  Union.  In  accordance 
with the principle of proportionality, as set out in that Article, this Regulation does not 
go beyond what is necessary in order to achieve those objectives. 

Regulation (EC) No 273/2004 should therefore be amended accordingly, 

7 

OJ L 55, 28.2.2011, p. 13. 

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HAVE ADOPTED THIS REGULATION: 

Article 1 

Regulation (EC) No 273/2004 is amended as follows: 

(1) 

Article 2 is amended as follows: 

(a)  point (a) is replaced by the following: 

"(a) 
'scheduled  substance’  means  any  substance  used  for  the  illicit 
manufacture of narcotic drugs or psychotropic substances and listed in Annex I 
including  mixtures  and  natural  products  containing  such  substances.  This 
excludes  natural  products  and  mixtures  which  contain  scheduled  substances 
and which are compounded in such a way that the scheduled substances cannot 
be easily used or extracted by readily applicable or economically viable means 
and  medicinal  products  within  the  meaning  of  Article  1(2)  of  Directive 
2001/83/EC of the European Parliament and of the Council8;" 

(b) 

the following point (h) is inserted: 

"(h) 
'user'  means  any  natural  or  legal  person  who  possesses  a  scheduled 
substance and is engaged in the processing, formulation, consumption, storage, 
keeping,  treatment,  filling  into  containers,  transfer  from  one  container  to 
another,  mixing, 
transformation  or  any  other  utilisation  of  scheduled 
substances." 

(2) 

Article 3 is amended as follows: 

(a)  paragraphs 2 and 3 are replaced by the following:  

"2. 
Operators  and  users  shall  be  required  to  obtain  a  licence  from  the 
competent  authorities  before  they  may  possess  or  place  on  the  market 
scheduled  substances  of  category  1  of  Annex  I.  Special  licences  may  be 
granted by the competent authorities to pharmacies, dispensaries of veterinary 
medicine,  certain  types  of  public  authorities  or  armed  forces.  Such  special 
licences shall only be valid for the use of scheduled substances of category 1 of 
Annex I within the scope of the official duties of the operators concerned. 

3. 
Any operator holding a licence referred to in paragraph 2 shall supply 
scheduled substances of category 1 of Annex I only to operators or users who 
hold such a licence and have signed a customer declaration as provided for in 
Article 4(1)." 

(b)  paragraph 5 is replaced by the following: 

"5.  Without prejudice to paragraph 9, the competent authorities may either 
limit  the  validity  of  the  licence  to  a  period  not  exceeding  three  years  or  may 
oblige the operators to demonstrate at intervals not exceeding three years that 

8 

OJ L 311, 28.11.2001, p. 67. 

EN 

11 

   EN 

 
                                                 
the  conditions  under  which  the  licence  was  granted  are  still  fulfilled.  The 
licence shall mention the operation or operations for which it is valid, as well 
as the substances concerned. Special licences within the meaning of paragraph 
2 shall be granted in principle for an unlimited duration but may be suspended 
or  revoked  by  the  competent  authorities  under  the  conditions  of  paragraph  4, 
third sentence." 

(c)  paragraph 6 is replaced by the following: 

From  [18  months  after  the  date  of  publication]  operators  shall  be 
"6. 
required to obtain a registration from the competent authorities before placing 
on  the  market  scheduled  substances  of  category  2  of  Annex  I.  Furthermore, 
users shall be required to obtain a registration from the competent  authorities 
before possessing scheduled substances of subcategory 2A of Annex I. Special 
registrations  may  be  granted  by  competent  authorities  to  pharmacies, 
dispensaries  of  veterinary  medicine,  certain  types  of  public  authorities  or  the 
armed  forces.  Such  registrations  shall  be  considered  valid  only  for  the  use  of 
scheduled substances of category 2 of Annex I within the scope of the official 
duties of the operators or users concerned." 

(d) 

the following paragraphs 6a and 6b are inserted: 

"6a.  Any  operator  holding  a  registration  referred  to  in  paragraph  6  shall 
supply  scheduled  substances  of  subcategory  2A  of  Annex  I  only  to  other 
operators  or  users  who  hold  such  a  registration  and  have  signed  a  customer 
declaration as provided for in Article 4(1). 

6b.  When  considering  whether  to  grant  a  registration,  the  competent 
authorities shall take into account in particular the competence and integrity of 
the applicant the registration is to be refused if there are reasonable grounds for 
doubting  the  suitability  and  reliability  of  the  applicant  or  of  the  officer 
responsible  for  the  trade  in  scheduled  substances.  The  registration  may  be 
suspended  or  revoked  by  the  competent  authorities  whenever  there  are 
reasonable  grounds  for  believing  that  the holder  is  no  longer  a  fit  and  proper 
person to hold a registration, or that the conditions under which the registration 
was granted are no longer fulfilled." 

(e) 

in paragraph 7, the following sentence is added: 

"An  operator  or  user  who  is  a  microenterprise  within  the  meaning  of  Article 
2(3)  of  the  Annex  to  the  Commission  Recommendation  of  6  May  2003 
concerning  the  definition  of  micro,  small  and  medium-sized  companies9  shall 
not be required to pay any such fees." 

(f) 

the following paragraphs 8 and 9 are added: 

The  competent  authorities  shall  enter  operators  and  users  having 
"8. 
obtained  a  licence  referred  to  in  paragraph  2  or  a  registration  referred  to  in 

9 

OJ L 124, 20.5.2003, p.36. 

EN 

12 

   EN 

 
                                                 
paragraph 6 in a European Database on drug precursors to be developed by the 
Commission as provided for in Article 13a. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in 

9. 
accordance with Article 15a concerning: 

(a) 

(b) 

(c) 

the requirements and conditions for the granting of the licence referred to 
in paragraph 2; 

the  requirements  and  conditions  for  the  granting  of  the  registration 
referred to in paragraph 6. 

the  requirements  and  conditions  for  listing  operators  and  users  having 
obtained  a  licence  or  registration  in  a  European  Database  on  drug 
precursors referred to in paragraph 8." 

(3) 

Article 4 is amended as follows: 

(a)  paragraph 1 is replaced by the following: 

"1.  Without  prejudice  to  paragraph  4,  Articles  6  and  14,  any  operator 
established  within  the  Community  who  supplies  a  customer  with  a  scheduled 
substance  of  categories  1  or  2  of  Annex  I  shall  obtain  a  declaration  from  the 
customer which shows the specific use or uses of the scheduled substances. A 
separate  declaration  shall  be  required  for  each  scheduled  substance.  This 
declaration shall conform to the model set out in point 1 of Annex III. In the 
case of legal persons, the declaration shall be made on headed notepaper." 

(b) 

the following paragraph 4 is added: 

"4. 
The  Commission  shall  be  empowered  to  adopt  delegated  acts  in 
accordance  with  Article  15a  concerning  the  requirements  and  conditions  for 
obtaining and using customer declarations." 

(4) 

In Article 5, the following paragraph 7 is added: 

"7.  The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance 
with Article 15a concerning the requirements and conditions for the documentation 
of mixtures containing substances listed in Annex I." 

(5) 

In Article 7, the following second paragraph is added: 

"The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 15a concerning the requirements and conditions for the labelling of mixtures 
containing substances listed in Annex I." 

(6) 

Article 8 is replaced by the following: 

"1  Operators  shall  notify 
immediately  of  any 
circumstances, such as unusual orders or transactions involving scheduled substances 
to be placed on the market, which suggest that such substances might be diverted for 
the  illicit  manufacture  of  narcotic  drugs  or  psychotropic  substances.  To  this  end, 

the  competent  authorities 

EN 

13 

   EN 

 
operators shall provide any available information allowing the competent authorities to 
verify the legitimacy of the relevant order or transaction. 

Operators  shall  provide  the  competent  authorities  in  summary  form  with 

2. 
relevant information about their transactions involving scheduled substances.  

3. 
The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance 
with Article 15a concerning the requirements and conditions for operators to provide 
information as referred to in paragraph 2."  

(7) 

In Article 9, paragraph 1 is replaced by the following: 

“In  order to facilitate cooperation between the competent  authorities, the operators, 
and  the  chemical  industry,  in  particular  as  regards  non-scheduled  substances,  the 
Commission shall draw up and update guidelines to assist the chemical industry.” 

(8) 

In Article 10, paragraph 2 is replaced by the following: 

"2.  Each Member State may adopt the measures necessary to enable its competent 
authorities  to  control  and  monitor  suspicious  transactions  with  non-scheduled 
substances, in particular: 

(a) 

(b) 

to obtain information on any orders for non-scheduled substances or operations 
involving non-scheduled substances; 

to enter operators' business premises in order to obtain evidence of suspicious 
transactions with non-scheduled substances. 

3. 

The competent authorities shall respect confidential business information." 

(9) 

The following Article 13a is inserted: 

"Article 13a 

Database 

The  Commission  shall  develop  a  European  Database  on  drug  precursors  with  the 
following functions:  

(a) 

(b) 

(c) 

facilitating  the  communication  of  information  pursuant  to  Article  13(1),  its 
synthesis  and  analysis  on  the  level  of  the  Union,  and  the  reporting  to  the 
International Narcotics Control Board pursuant to Article 13(2); 

creating a European register of operators and users, which have been granted a 
licence pursuant to Article 3(2) or registration pursuant to Article 3(6); 

enabling operators to provide the competent authorities with information about 
their  transactions  according  to  Article  8(2)  in  electronic  form,  as  specified  in 
implementing measures adopted pursuant to Article 14." 

(10) 

The following Article 13b is inserted: 

EN 

“Article 13b 

14 

   EN 

 
Data protection 

1. 
The  processing  of  personal  data  by  the  competent  authorities  in  the  Member 
States  shall  be  carried  out  in  accordance  with  Directive  95/46/EC10  and  under  the 
supervision  of  the  public  independent  authority  of  the  Member  State  referred  to  in 
Article 28 of this Directive. 

2. 
The processing of personal data by the Commission, including for the purpose 
of  the  European  Database  provided  for  in  Article  13a,  shall  be  carried  out  in 
accordance with Regulation (EC) No 45/2001 of the European Parliament and of the 
Council11 and under the supervision of the European Data Protection Supervisor." 

(11) 

Articles 14 and 15 are replaced by the following:  

“Article 14 

Implementing Acts 

1. 

The Commission may adopt the following implementing acts: 

(a) 

(b) 

rules  on  how  to  provide  customer  declarations  referred  to  in  Article  4  in 
electronic form, where appropriate; 

rules on how to provide the information referred to in Article 8(2) in electronic 
form to a European database, where appropriate. 

The  acts  referred  to  in  paragraph  1  of  this  Article  shall  be  adopted  in 

2. 
accordance with the examination procedure referred to in Article 14a(2). 

Article 14a 

Committee Procedure 

1. 
The  Commission  shall  be  assisted  by  the  Drug  Precursors  Committee 
established  by  Article  30  of  Council  Regulation  (EC)  No  111/200512.  That 
the  meaning  of  Regulation  (EU) 
committee  shall  be  a  committee  within 
No 182/2011. 

2.  When  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU) 
No 182/2011 shall apply. 

Article 15 

Adaptation of Annexes 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 15a in order to adapt Annexes I, II and III to new trends in diversion of drug 

10 
11 
12 

OJ L 281, 23.11.1995, p. 31. 
OJ L 8, 12.1.2001, p. 1. 
OJ L 22, 26.1.2005, p.1. 

EN 

15 

   EN 

 
                                                 
precurors  and  to  follow  an  amendment  to  the  tables  in  the  Annex  to  the  United 
Nations Convention. 

Article 15a 

Exercise of delegation 

The power to adopt delegated acts is conferred on the Commission subject to 

1. 
the conditions laid down in this Article. 

2. 
The delegation of power referred to in Article 3(9), 4(4), 5(7), 7, 8(2), 13a(2), 
15  shall  be  conferred  for  an  indeterminate  period  of  time  from  [date  of  entry  into 
force of this amending Regulation]. 

3. 
The delegation of powers referred to in Article 3(9), 4(4), 5(7), 7, 8(2), 13a(2), 
15  may  be  revoked  at  any  time  by  the  European  Parliament  or  by  the  Council.  A 
decision  of  revocation  shall  put an end to the delegation of power spedified in that 
decision. It shall take effect the day following the publication of the decision in the 
Official Journal of the European Union or at a later date specified therein. It shall not 
affect the validity of any delegated acts already in force. 

As  soon  as  it  adopts  a  delegated  act,  the  Commission  shall  notify  it 

4. 
simultaneously to the European Parliament and the Council. 

A delegated act adopted pursuant to Article 3(9), 4(4), 5(7), 7, 8(2), 13a(2), 15 
5. 
shall enter into force only if no objection has been expressed either by the European 
Parliament or the Council within a period of 2 months of notification of that act to 
the European Parliamant and the Council or if, before the expiry of that period, the 
European Parliament and the Council have both informed the Commission that they 
will  not  object.  That  period  shall  be  extended  by  2  months  at  the  initiative  of  the 
European Parliament or the Council.” 

(12) 

Article 16 is replaced by the following: 

"Article 16 

Information about measures adopted by Member States 

1.  Member States shall inform the Commission of the measures it adopts pursuant 
to this Regulation, and in particular of the measures adopted pursuant to Articles 10 
and 12. They shall also notify any subsequent amendments thereof. 

The  Commission  shall  communicate  that  information  to  the  other  Member 

2. 
States.  

3. 
The  Commission  shall  evaluate  the  implementation  and  functioning  of  this 
Regulation  by  [78  months  after  of  the  date  of  entry  into  force  of  this  amending 
Regulation]." 

(13) 

Annex I is amended as follows: 

(a) 

the title of Annex I is replaced by the following: 

EN 

16 

   EN 

 
"List of scheduled substances"; 

(b) 

the text set out for Category 2 is replaced by the text set out in the Annex to 
this Regulation; 

(14) 

In Annex III, the term "authorisation/" shall be deleted. 

Article 2 

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 European Parliament 
The President 

For the Council 
The President 

EN 

17 

   EN 

 
ANNEX 

"CATEGORY 2 

SUBCATEGORY 2A 

Substance 

CN designation  
(if different) 

CN code(1) 

CAS No(2) 

Acetic anhydride 

2915 24 00 

108-24-7 

The salts of the substances listed in this category, whenever the existence of such salts is possible. 

___________________________________________________________________________ 

(1) OJ L290, 28.10.2002, p.1. 

(2) The CAS No is the 'chemical abstracts service registry number', which is a unique numeric identifier specific 
to each substance and its structure. The CAS No is specific to each isomer and to each salt of each isomer. It 
must be understood that the CAS Nos for the salts of the substances listed above will be different to those given.  

___________________________________________________________________________ 

SUBCATEGORY 2B 

Substance 

CN designation  
(if different) 

CN code(1) 

CAS No(2) 

Phenylacetic acid 

Anthranilic acid 

Piperidine 

Potassium 
permanganate 

2916 34 00 

2922 43 00 

2933 32 00 

103-82-2 

118-92-3 

110-89-4 

2841 61 00 

7722-64-7 

The salts of the substances listed in this category, whenever the existence of such salts is possible. 

___________________________________________________________________________ 

(1) OJ L290, 28.10.2002, p.1. 

(2) The CAS No is the 'chemical abstracts service registry number', which is a unique numeric identifier specific 
to each substance and its structure. The CAS No is specific to each isomer and to each salt of each isomer. It 
must be understood that the CAS Nos for the salts of the substances listed above will be different to those given.  

___________________________________________________________________________

EN 

18 

   EN 

 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1.  Title of the proposal/initiative  

1.2.  Policy area(s) concerned in the ABM/ABB structure 

1.3.  Nature of the proposal/initiative  

1.4.  Objective(s)  

1.5.  Grounds for the proposal/initiative  

1.6.  Duration and financial impact  

1.7.  Management method(s) envisaged  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1.  Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

3.2.  Estimated impact on expenditure  

3.2.1. Summary of estimated impact on expenditure  

3.2.2. Estimated impact on operational appropriations  

3.2.3. Estimated impact on appropriations of an administrative nature 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party participation in financing  

3.3.  Estimated impact on revenue

EN 

19 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  amending 
Regulation (EC) No 273/2004 on Drug Precursors  

1.2. 

Policy area(s) concerned in the ABM/ABB structure25  

Title 2: Enterprise and Industry 

Chapter 02.03: Internal market for goods and sectoral policies 

1.3. 

Nature of the proposal/initiative  

(cid:133) The proposal/initiative relates to a new action  

(cid:133) The proposal/initiative relates to a new action following a pilot project/preparatory action26  

X The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

1.4. 

Objectives 

1.4.1.  The Commission's multiannual strategic objective(s) targeted by the proposal/initiative  

1a. Competitiveness for growth and employment 

Following the continuous review of existing internal market acquis and its implementation, 
the  new  legislative  proposal  aims  at  improving  efficiency  of  exiting  legislation  on  drug 
Precursors.  

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned  

Specific objective No. 

The  development  of  a  European  Database  aims  at  facilitating  exchange  of  information 
between the Member States Competent Authorities and the Commission, and the economic 
operators and the Member States Competent Authorities.  

ABM/ABB activity(ies) concerned 

Title 2 – Chapter 02.03 Internal market for goods and sectoral policies 

25 
26 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

EN 

20 

   EN 

 
 
                                                 
1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The  proposal,  amending  Regulation  (EC)  No  273/2004  aims  mainly  at  improving  the 
prevention  of  the  diversion  from  the  EU-internal  trade  of  acetic  anhydride,  the  main 
drug  precursor  for  heroin,  by  extending  the  registration  requirement,  which  so  far 
applies only to operators placing acetic anhydride on the market, to also include users of 
the substance and by enhancing the harmonised registration provisions to achieve a more 
robust level playing field preserving the internal market and avoiding adoption of divergent 
national measures.  

Additionally,  it  proposes  to  establish  and  maintain  a  European  Database  on  Drug 
Precursors  in  order  to  modernize  the  annual  collection  of  the  information  provided  by 
Member States on seizures and stopped shipments of drug precursors, in accordance with 
Article 13 of Regulation (EC) No 273/2004, as well as to maintain a list of EU licensed or 
registered operators and users legally trading or using drug precursors; 

The  EU  Database  on  Dugs  precursors  aims  at  providing  a  modern  tool  for  strengthening 
the control of legitimate trade in drug precursors:  

- to  Member  States'  Competent  Authorities 
 the  Commission 
 Article 29 of Commission Regulation (EC) No1277/2005;  

in  accordance  with  Article  13  of  Regulation 

to  comply  with 

their 

reporting  obligations 

to  
(EC)  No  273/2004  and  

the 

facilitate  
- to  Member  States'  Competent  Authorities 
 checking 
for  operators  
 related to the yearly reporting of their transactions involving drug precursors in accordance with Articles 4 
and 
Articles17  
 and 19 of Council Regulation (EC) No 111/2005, 

legitimacy  of  potential  clients  and 

industry  operators 

to  EU 
to 

the  burdens 

Regulation 

273/2004 

reduce 

(EC) 

with 

and 

and 

8.2 

No 

of 

to 

the  Commission 

- to 
 Narcotics  Control  Board  under  Article  13 
 Article  32 
 Article 29 of Commission Regulation ( EC) No 1277/2005.  

facilitate  completion  of 

(1)  of  Regulation  No  111/2005  as  well  as 

its  obligations 
(1)  of  Regulation 

to 

towards 
International  
(EC)  No  273/2004  and  
towards  Member  States  under  

the 

Finally, the proposal adapts the provisions of Regulation (EC) No 273/2004 regarding ex-
Comitology to the new rules of the Lisbon Treaty. 

1.4.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

The  proposed  Regulation  aims  to  improve  the  prevention  of  the  diversion  of  drug 
precursors  –  in  particular  acetic  anhydride  -  by  traffickers  from  the  legitimate  trade 
towards production of illicit drugs. Annual trends in EU diversion of drug precursors will 
continue  to  be  collected  and  reported,  to  the  general  public,  the  Member  States  and  the 
International  Narcotics  Control  Board.  The  objective  is  to  achieve  a  decreasing  trend  in 
seizures and stopped shipments. 

EN 

21 

   EN 

 
1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term  

The  main  aim  of  the  proposal  to  amend  Regulation  (EC)  No  273/2004  is  to  address  the 
weaknesses identified in the functioning of that Regulation in preventing the diversion of 
certain  drug  precursors  (in  particular  acetic  anhydride)  from  the  legitimate  trade  to 
production of illicit drugs, through control and monitoring of this legitimate trade.  

The  EU  Drug  Precursors'  Database  should  facilitate  the  monitoring  and  control  activities 
by Member States, as well as the reporting tasks for Member States and operators.  

1.5.2.  Added value of EU involvement 

The objective of this proposal, namely to strengthen control measures on acetic anhydride 
in  order  to  prevent  it  diversion  from  the  EU  internal  market  while  avoiding  market 
distortions, cannot be sufficiently achieved by the Member States alone and action by the 
Union will be more efficient for the following reasons: 

1.  Some  Member  States  feel  legally  prevented  from  adopting  national  control  measures 
going  beyond  the  EU  legislation  on  the  basis  of  Article  10  of  Regulation  (EC) 
No 273/2004,  which  empowers  Member  States  to  adopt  national  measures  which  are 
necessary  to  enable  its  authorities  to  perform  their  control  and  monitoring  duties.  They 
argue  that  the  EU  legislation  is  subjecting  only  operators  to  control  measures  (no 
obligations  are  imposed  on  end-users),  which  should  be  understood  as  a  deliberate  and 
binding decision of the EU-legislator that end-users should not be subject to the control of 
the drug precursor legislation. 

2.  On  the  contrary,  other  Member  States  are  contemplating  or  have  already  based 
substantive national controls on Article 10, leading in first instance to different approaches 
of control in different Member States which might be detrimental to the functioning of the 
Union Market and, secondly, isolated actions in individual Member States risks shifting the 
problem from one Member State to the next, as traffickers will exploit the “weakest link” 
in the Union market. A combination of different national measures will not be as effective 
as  a  harmonised  approach  at  EU-level.  This  is  also  confirmed  by  the  fact  that  both, 
Member  States  and  concerned  industry  sectors  have  called  on  the  Commission  to  act  to 
preserve  the  internal  market  with  a  level  playing  field,  and  not  to  rely  too  much  on 
supplementary national measures. 

1.5.3.  Lessons learned from similar experiences in the past 

The  Commission  has  conducted  a  thorough  analysis  of  the  functioning  of  the  existing 
Regulation (EC) No 273/2004 and on 7 January 2010, the European Commission adopted a 
Report on the implementation and functioning of the existing EU legislation on drug 
precursors27. While the Commission’s evaluation concluded that the legislation is overall 

27 

Report from the Commission to the Council and the European Parliament pursuant to Article 16 of Regulation 
(EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 and to Article 32 of 
Council Regulation (EC) No 111/2005 on the implementation and functioning of the Community legislation on 
monitoring and control of trade in drug precursors, COM(2009)709 final, available at: 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0709:FIN:en:PDF. 

EN 

22 

   EN 

 
                                                 
 
functioning  well28,  it  identified  some  weaknesses  and  made  recommendations  how  to 
address these, including in particular a modification of some requirements for category 2 
substances  –  either  specifically  for  acetic  anhydride  or  for  all  category  2  substances  –  in 
order to discourage diversion from the EU internal market.  

This  proposal  aims  to  address  this  recommendation  of  the  Commission  Report  by 
amending  Regulation  (EC)  No  273/2004,  mainly  to  improve  the  prevention  of  the 
diversion from the EU-internal trade of acetic anhydride, the main drug precursor for 
heroin,  by  extending  the  registration  requirement,  which  so  far  applies  only  to  operators 
placing  acetic  anhydride  on  the  market,  to  also  include  users  of  the  substance  and  by 
enhancing  the  harmonised  registration  provisions  to  achieve  a  more  robust  level  playing 
field preserving the internal market and avoiding adoption of divergent national measures. 

1.5.4.  Coherence and possible synergy with other relevant instruments 

This  proposal  is  fully  consistent  with  the  objectives  of  the  EU  drugs  strategy  2005-2012 
and  the  EU  drugs  Action  Plan  (2009-2012),  setting  out  the  objective  to  reduce  the 
diversion  and  trafficking  in/via  the  Union  of  Drug  Precursors  used  in  the  production  of 
illicit drugs, ultimately aiming at reducing the supply of illicit drugs to EU citizens while 
ensuring a high level of human health protection and a high level of security.  

28 

For  further  details,  see  under  Section  4.2.1  "Strength  and  weaknesses  of  the  legislation"  of  the  above-
mentioned Report COM(2009)209 final. 

EN 

23 

   EN 

 
                                                 
1.6. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

–  (cid:133)  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–  (cid:133)  Financial impact from YYYY to YYYY  

⌧ Proposal/initiative of unlimited duration 

–  Implementation with a start-up period from January 2014 to December 2014, 

–  followed by full-scale operation from 01 January 2015 (Estimated). 

1.7.  Management mode(s) envisaged29  

⌧ Centralised direct management by the Commission  

(cid:133) Centralised indirect management with the delegation of implementation tasks to: 

–  (cid:133)  executive agencies  

–  (cid:133)  bodies set up by the Communities30  

–  (cid:133)  national public-sector bodies/bodies with public-service mission  

–  (cid:133)  persons entrusted with the implementation of specific actions pursuant to Title V of 
the  Treaty  on  European  Union  and  identified  in  the  relevant  basic  act  within  the 
meaning of Article 49 of the Financial Regulation  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the "Comments" section. 

Comments  

29 

30 

Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: 
http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 
As referred to in Article 185 of the Financial Regulation. 

EN 

24 

   EN 

 
 
                                                 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

(1) Members  States  will  yearly  communicate  to  the  Commission  the  information  on  the 
cases where the delivery of drug precursors was suspended or seized.  

(2) The  Member  States  will  regularly  forward  to  the  Commission  the  information 
concerning  their  licensed  and  registered  operators  and  users  trading  or  possessing  drug 
precursors, their respective transactions.  

(3) The Commission in turn will regularly compile a report on the basis of the information 
collected  from  Member  States  and  will  yearly  submit  the  overall  EU  information  on 
seizures and stopped shipments of drug precursors in the Union to the Member States and 
to the International Narcotics Control Board. Furthermore the Commission will prepare for 
public release its annual report on EU drug precursor's seizures and stopped shipments. 

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

The main risks are:  

- Failure of Members States to comply with their reporting obligations and/or the provision of information on 
licensed/registered operators and users;  

- Non uniform implementation of the legislation in the Member States;  

- Insufficient control systems in the Members States in particular on licensed and/or registered operators and 
users.  

2.2.2.  Control method(s) envisaged  

The  Member  States  have  already  designated  authorities  responsible  for  overseeing  the 
implementation  of  the  legislation  and  for  granting  licenses  &  registration  to  legitimate 
operators & users involved in the trade of drug precursors;  

Implementation of the legislation is monitored through regular meetings of the designated 
national competent authorities responsible for the EU Drug Precursors legislation; 

The  day  to  day  management  of  the  EU  Database  on  Drug  Precursors  will  fall  under  the 
responsibility of the Commission Services in charge of following the EU Drug Precursors 
legislation, mainly DG ENTR and DG TAXUD. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

No particular risk of fraud or irregularities has been identified. 

EN 

25 

   EN 

 
3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1. 

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

•  Existing expenditure budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description………………………...……….] 

Diff./non-
diff 
(31) 

from 
EFTA32 
countries 

from 
candidate 
countries33 

from third 
countries 

within the 
meaning of 
Article 18(1)(aa) 
of the Financial 
Regulation  

Article 02.03.01 

Operation  and  development  of  the 
internal  market,  particularly  in  the 
fields  of  notification,  certification  and 
sectoral approximation 

Diff./ 

DA 

YES 

NO 

NO 

NO 

•  New budget lines requested  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure

Contribution  

Number  
[Heading……………………………………..] 

Diff./non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the 
meaning of 
Article 18(1)(aa) 
of the Financial 
Regulation  

Heading of 
multiannual 
financial 
framework 

1a. 
Competi
tiveness 
for 
growth 
and 
employ
ment 

Heading of 
multiannual 
financial 
framework 

31 
32 
33 

Diff. = Differentiated appropriations / Non-Diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

26 

   EN 

 
 
 
 
 
 
 
 
                                                 
3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial 
framework:  

Number 
1a 

Competitiveness for growth and employment 

EUR million (to 3 decimal places) 

DG: ENTR 

Year 
201434 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
202035 

TOTAL 

(cid:121) Operational appropriations  

Article 02.03.01 – Operation and development 
of the internal market, particularly in the fields 
of  notification,  certification  and  sectoral 
approximation 

Number of budget line 

of 

Appropriations 
administrative 
from the envelope for specific programmes36 
Number of budget line 

an 

TOTAL appropriations 
for DG ENTR 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 

(1a) 

(2a) 

nature 

financed 

Commitments 

Payments 

(3) 

= 1+1a 
+3 

= 2+2a 

+3 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.045 

0.315 

0.315 

0.315 

0.315 

34 
35 
36 

EN 

Year N is the year in which implementation of the proposal/initiative starts. 
Costs also foreseen after 2020 because of the nature of the project (database maintenance). 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, direct 
research. 

27 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121) TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes 

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADING <….> 
of the multiannual financial framework 

Commitments 

= 4+ 6 

Payments 

= 5+ 6 

If more than one heading is affected by the proposal / initiative: 

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121) TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount) 

Commitments 

= 4+ 6 

Payments 

= 5+ 6 

EN 

28 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial framework:  

5 

" Administrative expenditure " 

DG: ENTR 

(cid:121) Human resources  
(cid:121) Other administrative expenditure  

Year
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.756 

EUR million (to 3 decimal places) 

TOTAL DG ENTR  

Appropriations  

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.756 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.756 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

EUR million (to 3 decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

0.153  0.153 

0.153 

0.153 

0.153 

0.153 

0.153 

Payments 

0.153 

0.153 

0.153 

0.153 

0.153 

0.153 

0.153 

1.071 

1.071 

EN 

29 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations  

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations. 

–  ⌧ The proposal/initiative requires the use of operational appropriations, as explained below37: 

Indicate 
objectives 
and outputs  

(cid:216) 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

Commitment appropriations in EUR million (to 3 decimal places) 

OUTPUTS 

Type 
of 
output
38 

Avera
ge 
cost  
of the 
output 

  Cost 
s
t
u
p
t
u
o

f
o

r
e
b
m
u
N

  Cost 
s
t
u
p
t
u
o

f
o

r
e
b
m
u
N

  Cost 
s
t
u
p
t
u
o

f
o

r
e
b
m
u
N

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

  Cost 
s
t
u
p
t
u
o

f
o

r
e
b
m
u
N

  Cost 
s
t
u
p
t
u
o

f
o

r
e
b
m
u
N

  Cost 
s
t
u
p
t
u
o

f
o

r
e
b
m
u
N

Total 
number 
of 
outputs 

Total  
cost 

1 

0.045

1 

0.045 

1 

0.045 

1 

0.045 

1 

0.045

1 

0.045 

1 

0.045 

7 

0.315 

SPECIFIC OBJECTIVE No 139… 

- Output 

- Output 

- Output 

Sub-total for specific objective N°1 

SPECIFIC OBJECTIVE No 2… 

- Output 

Sub-total for specific objective No 2 

TOTAL COST 

1 

0.045

1 

0.045 

1 

0.045 

1 

0.045 

1 

0.045

1 

0.045 

1 

0.045 

7 

0.315 

37 
38 
39 

No information on the outputs is yet available as the pilot project of the European Database is not yet developed. 
Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in Section 1.4.2. "Specific objective(s)…" 

EN 

30 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

–  (cid:133)  The  proposal/initiative  does  not 

require 

the  use  of  administrative 

appropriations  

–  ⌧ The  proposal/initiative  requires  the  use  of  administrative  appropriations,  as 

explained below: 

EUR million (to 3 decimal places) 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

HEADING 5 
of the multiannual 
financial framework 

Human resources  

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.756 

Other administrative 
expenditure  

Subtotal HEADING 5 
of the multiannual 
financial framework  

Outside HEADING 540 
of the multiannual 
financial framework  

Human resources  

Other expenditure  
of an administrative 
nature 

Subtotal  
outside HEADING 5 
of the multiannual 
financial framework  

TOTAL 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.756

40 

Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU 
programmes and/or actions (former "BA" lines), indirect research, direct research. 

EN 

31 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.2.  Estimated requirements of human resources  

–  (cid:133)  The proposal/initiative does not require the use of human resources  

–  ⌧ The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Estimate to be expressed in full amounts (or at most to one decimal place) 

Year
2014 

Year
2015 

Year 
2016 

Year 
2017 

Year 2018 

Year 
2019 

Year 
2020 

(cid:121) Establishment plan posts (officials and temporary agents) 

02 01 01 01 (Headquarters and Commission’s 
Representation Offices) 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

(cid:121) External personnel (in Full Time Equivalent unit: FTE)41 

XX 01 02 01 (CA, INT, SNE from the "global 
envelope") 

XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 

XX 01 04 yy 42 

- at Headquarters43 

- in delegations  

XX 01 05 02 (CA, INT, SNE - Indirect 
research) 

10 01 05 02 (CA, INT, SNE - Direct research) 

Other budget lines (specify) 

TOTAL 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

02 is the policy area or budget title concerned. 

The human resources required will be met by staff from the DG who are already assigned to 
management of the action and/or have been redeployed within the DG, together if necessary 
with any additional allocation which may be granted to the managing DG under the annual 
allocation procedure and in the light of budgetary constraints. 

Description of tasks to be carried out: 

Officials and temporary agents 

Management  and  development  of  EU  legislation  ensuring  a  Single  Market  for  chemicals  –  in 
particular for drug precursors.  

Prepare,  chair  and  write  reports  of  meetings  of  working  groups  and  regulatory  committees  to 
ensure uniform implementation of the legislation. Assist Member States and industry.  

Prepare  relevant  guidance  documents,  as  well  as  agreed  'questions  and  answers'  in  close  co-

41 

42 
43 

CA= Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune Expert en Délégation" (Young 
Experts in Delegations); LA= Local Agent; SNE= Seconded National Expert. 
Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially  for  Structural  Funds,  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
European Fisheries Fund (EFF). 

EN 

32 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
operation with Member States authorities and other stakeholders. 

Publish annual reports on seizures and stopped shipments.  

Oversee maintenance and further development of European Database on Drug Precursors. 

Answer parliamentary questions. 

Prepare adaptations to technical progress and conduct interservices consultations.  

Ensure close co-operation with DG TAXUD, who is responsible for monitoring external trade in 
drug precursors. 

External personnel 

EN 

33 

   EN 

 
 
3.2.4.  Compatibility with the current multiannual financial framework  

–  ⌧ Proposal/initiative  is  compatible  with  the  multiannual  financial  framework  2014-

2020. 

–  (cid:133)  Proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

Explain  what  reprogramming  is  required,  specifying  the  budget  lines  concerned  and  the  corresponding 
amounts. 

–  (cid:133)  Proposal/initiative requires application of the flexibility instrument or revision of the 

multiannual financial framework44. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts. 

3.2.5.  Third-party contributions  

–  ⌧ The proposal/initiative does not provide for co-financing by third parties  

–  (cid:133)  The proposal/initiative provides for the co-financing estimated below: 

Appropriations in EUR million (to 3 decimal places) 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

… enter as many years as 
necessary to show the duration 
of the impact (see point 1.6) 

Total 

Specify  the  co-financing 
body  

TOTAL appropriations 
cofinanced  

44 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

34 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.3. 

Estimated impact on revenue  

–  ⌧ Proposal/initiative has no financial impact on revenue. 

–  (cid:133)  Proposal/initiative has the following financial impact: 

– 

– 

(cid:133) 

(cid:133) 

on own resources  

on miscellaneous revenue  

Appropriations 
available for the 
ongoing budget 
year 

Budget revenue line: 

Article …………. 

EUR million (to 3 decimal places) 

Impact of the proposal/initiative45 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

… insert as many columns as necessary 
in order to reflect the duration of the 
impact (see point 1.6) 

For miscellaneous assigned revenue, specify the budget expenditure line(s) affected. 

… 

Specify the method for calculating the impact on revenue. 

… 

45 

As  regards  traditional  own  resources  (customs  duties,  sugar  levies),  the  amounts  indicated  must  be  net 
amounts, i.e. gross amounts after deduction of 25% for collection costs. 

EN 

35 

   EN