COMMISSION STAFF WORKING PAPER IMPACT ASSESSMENT Accompanying the document Draft Proposal for a Regulation 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  
SWD(2012) 279 final 

COMMISSION STAFF WORKING PAPER 

IMPACT ASSESSMENT 

Accompanying the document 

Draft Proposal for a Regulation 

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

{COM(2012) 548 final} 
{SWD(2012) 278 final} 

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Disclaimer: This report commits only the Commission’s services involved in its preparation 
and does not prejudge the final form of any decision to be taken by the Commission. 

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1. 

Introduction 

2 

2. 

Procedural issues and consultation of interested parties 

3 

2.1. 

Identification 

3 

2.2. 

Organisation and timing 3 

2.3. 

Consultation and expertise 

3 

2.4. 

Scrutiny by the Commission Impact Assessment Board 

6 

3. 

Context 7 

3.1. 

Illicit drugs 

7 

3.2. 

International legislation and developments 

7 

3.3. 

EU legislation and institutional context  8 

4. 

Problem definition 

9 

4.1. 

The problem that requires action 9 

4.2. 

EU right to act  18 

5. 

Objectives 

19 

5.1. 

General policy objectives 

19 

5.2. 

Specific and operational policy objectives 20 

5.3. 

Consistency with other policies and objectives 

20 

6. 

Policy options  21 

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6.1. 

Option 1: no action: the current EU legislation will remain unchanged (baseline 
option)  21 

6.2. 

Option 2: strengthened reporting obligations 

22 

6.3. 

6.4. 

6.5. 

Option  3:  strengthened  rules  and  obligations  on  operators  related  to  customer 
declarations from end-users 

22 

Option  4:  require  operators  to  systematically  notify  new  end-users  to  the 
authorities to allow verification  23 

Option  5:  require  registration  for  end-users  and  reinforce  requirements 
regarding registration  23 

6.6. 

Option 6: move AA from category 2 to category 1 24 

7. 

Analysis of impacts 

24 

7.1. 

Analysis of costs 25 

7.2. 

Benefits 27 

7.3. 

Option 1: no action 

27 

7.4. 

Option 2: strengthened reporting obligations 

29 

7.5. 

7.6. 

7.7. 

Option  3:  strengthened  rules  and  obligations  on  operators  related  to  customer 
declarations from end-users 

32 

Option  4:  require  operators  to  systematically  notify  new  end-users  to  the 
authorities to allow verification  36 

Option  5:  require  registration  for  end-users  and  reinforce  requirements 
regarding registration  39 

7.8. 

Option 6: move AA from category 2 to category 1 42 

8. 

Comparing the options  46 

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8.1. 

Qualitative assessment of benefits 

46 

8.2. 

Assessment of costs 

47 

9. 

Monitoring and evaluation 

51 

9.1.  Measuring the fulfilment of objectives 

51 

9.2. 

Supporting the implementation of the new legislative measures 

52 

9.3.  Monitoring the implementation of the new legislative measures 

52 

Annexes 

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1. 

INTRODUCTION 

A large number of chemicals are used in a wide variety of legitimate and important industrial 
processes (e.g. in the synthesis  of plastics, pharmaceuticals, cosmetics, perfumes, detergents 
and aromas). Those chemicals are traded for these licit uses on regional and global markets, 
but  some  of  them  can  also  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 substantial 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.  In  order  to  prevent  their  diversion  to  illicit  drug  production,  a  specific  regulatory 
framework has been set up (both on international level and in the EU). The main aim of the 
regulatory  framework  is  to  monitor  the  trade  in  drug  precursors  and  to  identify  suspicious 
transactions.  The  most  important  actors  in  the  prevention  of  diversion  are  the  operators 
engaged  in  the  licit  trade  (the  manufacturers,  distributors,  brokers,  importers,  exporters  and 
wholesalers):  the  legislation  requires  them  to  take  measures  against  theft,  check  their 
customers,  detect  suspicious  transactions  and  alert  the  authorities.  An  effective  industry-
authority partnership is key to the implementation 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. 

Traffickers  purchase  the  drug  precursors  they  need  from  different  regions  in  the  world  and 
exploit  weaknesses  of  control  to  their  benefit.  This  impact  assessment  aims  to  addresses  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,  the  EU  alone  seized  75%  of  the  global  seizures  of  AA.  Even 
though the quantities have decreased very substantially since that year1, the EU has been and 
continues  to  be  under  international  criticism  that  the  European  legislative  control  measures 
are not sufficiently strong to prevent the diversion of the main heroin precursor from the intra-
EU trade. 

The  present  impact  assessment  concerns  the  intra-EU  trade  in  drug  precursors,  which  is 
governed by Regulation (EC) No 273/2004 under the responsibility of DG ENTR, and more 
specifically the diversion of acetic anhydride, the main precursor for the production of heroin. 
A second impact assessment has been conducted concerning the control of extra-EU trade of 
drug precursors, which is governed by Regulation (EC) No 111/2005 under the responsibility 
of  DG  TAXUD),  and  more  specifically  a  possible  control  of  export/transit  of  medicinal 
products containing ephedrine or pseudoephedrine, precursors for methamphetamines. Even 
though  both  initiatives  concern  the  drug  precursor  legislation,  they  tackle  different 

1   Seizures and stopped shipments of AA in the EU dropped from 241 tons (in 2008) to 33 tons (in 2009) and 

21 tons (in 2010). 

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substances  and  different  issues  which  are  not  interlinked,  and  are  therefore  best  dealt 
with separately. Nevertheless, the two DGs have ensured close coordination throughout the 
preparation of the respective impact assessments. 

2. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  

2.1. 

Identification  

Lead DG: DG Enterprise and Industry (DG ENTR) 

Other involved DGs: TAXUD, JUST, SANCO, HOME, RTD, SG, SJ and OLAF. 

Agenda Planning Reference: 2011/ENTR/021 

2.2. 

Organisation and timing 

The work on the present impact assessment started in mid-2010 when six policy options were 
developed  by  the  Commission  Services  and  a  written  consultation  of  Member  States  and 
industry  stakeholders  was  carried  out.  An  impact  assessment  steering  group  (IASG)  was 
created  on  28 January 2011  together  with  DG  TAXUD  to  oversee  the  preparation  of  the 
respective impact assessments and to ensure consistency between them. 

The IASG met four times (on 7 February, 23 June, 27 October and 14 December 2011). 

2.3. 

Consultation and expertise 

On 7 January 2010, the European Commission adopted a Report on the implementation and 
functioning of the existing EU legislation on drug precursors2. The underlying evaluation 
had been carried out by the Commission Services, with the assistance of a group of experts 
from national competent authorities, which had been established for the evaluation purposes. 
In  addition,  the  Commission  had  mandated  an  external  contractor,  the  consultancy  RPA, 
which gathered information from all relevant stakeholders (competent authorities and industry 
operators)  including  quantitative  data  where  available,  analysed  the  impacts  of  the  current 
legislative requirements on the trade in drug precursors, and collected proposals for improving 
the system in place.3  

While the Commission’s evaluation concluded that the legislation is overall functioning well4, 
it identified some weaknesses and made five recommendations how to address these: 

1)  Improving harmonised implementation of the current legislation;  

2   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 . 

3   Stakeholders  have  been  consulted  by  RPA  during  the  years  2006  and  2007  via  questionnaires  on  the 
functioning  of  (and  possible  problems  with)  the  current  EU  legislation.  These  data  were  subsequently 
analysed by RPA, which provided its Final Report to the Commission at the beginning of 2009.  

4   For  further  details,  see  under  Section  4.2.1  "Strength  and  weaknesses  of  the  legislation"  of  the  above-

mentioned Report COM(2009)209 final. 

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2)  Enhancing operator reporting on legal transactions in order to provide authorities with 

a better basis for carrying out their control and monitoring duties; 

3)  Modifying some requirements for category 2 substances (either specifically for AA or 
for  all  category  2  substances)  in  order  to  discourage  diversion  from  the  internal 
market; 

4)  Ensuring  appropriate  control  of  pharmaceutical  preparations  containing  ephedrine  or 
pseudo-ephedrine  in  order  to  enable  customs  authorities  to  stop  exports  of 
pharmaceutical preparations to be used for illicit drug production; and 

5)  Improving  and  adjusting  procedural  requirements  for  pre-export  notifications 

depending on the risk of diversion. 

The  legislation  on  intra-EU  trade  is  affected  by  the  first  three  recommendations  of  the 
Commission  Report  (while  recommendations  4  and  5  concern  the  legislation  on  external 
trade).  The  first  recommendation  has  been  implemented  by  organising  workshops  and 
seminars  to  facilitate  an  exchange  of  best  practices  among  competent  authorities. 
Recommendations 2 and 3 are addressed in the present impact assessment. 

In  reaction  to  the  Commission’s  Report,  the  Council  adopted  conclusions  in  May  2010, 
which  recognise  the  importance  of  continuing  active  co-operation  among  authorities  and 
industry and of improving the implementation of the European legislation. Furthermore, 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 operators5. 

The  Commission  Services  (DG  ENTR)  consulted  in  2009  and  early  2010  industry 
stakeholders through their EU associations6 on the weaknesses identified in the Commission's 
Report (notably the difficulties in preventing diversion of AA) and how to best address them. 
The  Commission  subsequently  developed  six  possible  options.  In  June  2010,  these  options 
were discussed with the Member States and industry representatives in a special meeting of 
the Drug Precursor Working Group. 

Subsequently, Member States and industry stakeholders were 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  has  been  carried  out  via  the  Enterprise 
Europe  network  from  1  October  until  24  November  2010.  This  specific  consultation  was 
chosen to ensure that the concerns of a specific target group – end-users of drug precursors 
most  of  which  are  SMEs  –  could  be  considered7.  Table  1  contains  an  overview  of  the 
responses received. 

5   Council  conclusions  on  the  functioning  and  implementation  of  the  EU  drug  precursor  legislation  –  3016th 

Competitiveness Council meeting Brussels, 25 May 2010. 

6   Cefic  (the  European  Chemicals  Industry  Council)/Acetyls  Sector  Group  and  FECC  (the  European 

Association of Chemical Distributors). 

7   See  statistical  summary  of  SME  consultation  contained  in  Annex  1.  It  should  also  be  noted  that  from  the 
group  of  consulted  end-users,  at  least  42  companies  of  the  106  respondents  have  been  identified  as  SMEs 
(this number of SMEs could even be much higher as many respondents did not provide the required turnover 
data to conduct the SME test). 

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Table 1  Responses to questionnaires on drug precursors 

Total number of responses (n) 

Target group 

Operators 

End-users 

SME end-users  

Competent Authorities of Member 
States 

54

106

60

17

The targeted consultation included a range of questions on the elements required to carry out a 
calculation of administrative costs of the possible options. The addressees were also asked to 
identify  the  option  that  they  would  consider  most  efficient  to  prevent  the  diversion  of  AA 
from legal trade. The results of this consultation are summarized in Table 2 below. 

Table 2  :  Best option according to different stakeholders (in %)  

Operators 
(n=54) 

End-users 
(n=1068) 

SME end-users 
(n=60) 

15%  

27%  

Option 1 

Option 2 

Option 3 

Option 4 

Option 5 

Option 6 

2% 

4% 

2% 

7% 

2% 

No opinion 

69% 

3% 

5% 

10% 

3% 

4% 

48% 

48%  

7%  

8%  

7% 

15% 

2% 

13% 

Member 
States 
(n=17) 

6% 

19% 

6% 

13% 

56% 

13% 

13% 

A  very  large  proportion  of  enterprises  did  not  have  any  opinion  whether  the  European 
legislation  should  be  changed  (69%  of  operators,  48%  of  end-users  and  13%  of  SME  end-
users). The baseline scenario was favoured by 15% of operators, 27% of end-users and 48% 
of  SMEs.  These  differences  between  the  three  enterprise  groups  level  out,  however,  if  one 
looks  only  at  those  enterprise  which  did  express  an  opinion  on  the  preferred  option,  within 
these groups, 48% of operators, 52% of end-users and 55% of SMEs prefer not to modify the 
existing legislation. In that context, however, it is worth noting that the two major European 
industry associations have consistently supported the view that a (reasonable) strengthening of 
European legislation is to be preferred over diverging national obligations. 

For Member States, only a minority prefers keeping the EU legislation unchanged (6% [7% if 
"no  opinion"  is  disregarded]),  whereas  a  large  majority  (56%  [64%  of  “no  opinion  is 

8   Including at least 42 SMEs. 

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disregarded”]) preferred option 5, the registration of end-users, as the most suitable option to 
prevent diversion9. 

The data collected in the consultation was analysed and complemented in a further study by 
the external consultant EIM, who carried out additional interviews with competent authorities 
and industry stakeholders. Based on the consultation, EIM provided the Commission with a 
study on administrative costs (“EIM Report”)10. 

The  Commission  Services  opted  for  the  above-described  targeted  consultations,  rather  than 
for a general public consultation, for several reasons: firstly, in view of the sensitive nature of 
the  subject  (preventing  traffickers  from  obtaining  the  key  chemical  substance  for  the  illegal 
production of heroin), the potential problems and possible solutions should not be publicised 
among  traffickers/criminals.  Secondly,  the  proposed  policy  options  concern  business-to-
business trade of a limited group of companies producing, trading or using a specific group of 
chemical substances. Citizens and civil society groups are actually not affected by the choice 
of policy options, and it would have been unlikely that they could have provided information 
on  the  costs  and  benefits  of  the  options.  Lastly,  the  options  developed  under  the  present 
impact  assessment  have  to  be  distinguished  from  the  overall  drug  problem  and  how  to 
address  it  as  part  of  the  general  European  Drug  Policy,  on  which  the  Commission  has 
recently carried out a public consultation11. 

2.4. 

Scrutiny by the Commission Impact Assessment Board 

The  Impact  Assessment  Board  of  the  European  Commission  assessed  a  draft  version  of  the 
present  impact  assessment  and  issued  its  opinion  on  17/02/2012.  The  Impact  Assessment 
Board  made  several  recommendations  and,  in  the  light  of  the  latter,  the  final  impact 
assessment report: 

 -  provides  a  more  detailed  overview  of  the  market  players  and  of  the  individual  measures 
taken  by  Member  States  to  prevent  the  diversion  of  drug  precursors  and  on  that  basis 
provides a more detailed presentation of the baseline scenario;  

-  strengthens the subsidiarity analysis to better justify the need for EU action; 

-  provides more information with regard to the assessment of the costs and effectiveness of 

the policy options examined; 

-  reports the views of stakeholders in more details. 

9   See also statistical summary of consultations contained in Annex 1.  
10   EIM:  Administrative  costs  and  administrative  burdens  imposed  by  amendments  of  the  EU  drug  precursor 
legislation.  EIM  had  provided  the  Commission  with  a  "Final  Report"  in  October  2011.  A  corrected  "Final 
Report" dated March 2012 eliminated a number of errors discovered subsequently. A copy of the March 2012 
Final  Report  is  accompanying  this  report  as  separate  document.  It  has  not  been  published  due  to  the 
sensitivity of the information concerned. 

11   See  HTTP://EC.EUROPA.EU/JUSTICE/NEWSROOM/ANTI-DRUGS/OPINION/111027_EN.HTM  for  details  on  this 

consultation. 

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3. 

CONTEXT 

3.1. 

Illicit drugs  

Drug  precursors  are  involved  in  the  illicit  production  of  both  plant-based  drugs  (such  as 
heroin and cocaine) and synthetic drugs, which are produced entirely from chemicals (such as 
amphetamine,  methamphetamine,  and  ecstasy).  Annex  2  contains  an  overview  of  the  major 
drug  precursors  and  the  illicit  drugs  produced.  In  other  words:  there  are  no  illicit  drugs 
without  drug  precursors.  The  term  “drug  precursor”  (or  just  “precursor”  in  the  international 
context)  refers  to  different  types  of  substances:  chemicals  that  are  "precursors  in  the  strict 
sense",  i.e.  substances  which  become  incorporated  into  the  molecule  of  the  drug,  or  other 
chemicals which are reagents12 or solvents13,14. 

3.2. 

International legislation and developments 

The United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic 
Substances  (“1988  UN  Convention”)15  contains  in  its  Article  12  specific  reference  to 
measures to prevent diversion of drug precursor chemicals for use in the illicit manufacture of 
narcotic drugs and psychotropic substances. Tables I and II of the 1998 UN Convention set 
out a list of 23 drug precursors (so-called "scheduled substances"), which are controlled by 
the Convention because they are most frequently used in the production of illicit drugs. 

The EU is a Contracting Party to the 1988 UN Convention, which has 185 Parties including 
all  major  chemical  producing  countries.  The  EU  has  implemented  its  obligations  through 
legislation and voluntary measures applied by the public and private sectors. 

The  United  Nations’  International  Narcotics  Control  Board  (“INCB”)  is  an  independent 
control  body  which  closely  monitors  the  implementation  of  the  United  Nations  drug 
conventions.  It  publishes  annual  reports  containing  diversion  statistics  and  their  analysis  as 
well as recommendations to the Parties concerned. 

In  its  2009  annual  report,  the  INCB  considered  that  the  measures  applied  to  monitor  the 
internal  trade  of  AA  in  the  EU  could  be  improved16.  In  the  2010  annual  report,  the  INCB 
noted  that  progress  has  been  made  in  the  EU,  but  upheld  its  call  on  the  EU  to  take  further 
measures to prevent diversion in the EU17 (see section 4.1.2 for further details). 

12   A reagent is a chemical substance that reacts with, or takes part in a reaction with, another substance (usually 
a  precursor  in  the  strict  sense)  during  the  processing  or  manufacturing  of  a  narcotic  drug  or  psychotropic 
substance. It does not become part of, or contributes to only a small portion of, the molecular structure of the 
end product. 

13   A solvent is a liquid chemical substance that is used to dissolve or disperse one or more substances. It does 
not itself react with other substances, nor is it incorporated into the molecular structure of the end products. A 
solvent may also be used to purify the end product. 

14   For further information see: Commentary on the United Nations Convention against illicit traffic in narcotic 

drugs and psychotropic substances 1998, on Article 12, page 251 – available at: 
HTTP://WWW.UNODC.ORG/DOCUMENTS/TREATIES/ORGANIZED_CRIME/DRUG%20CONVENTION/COMMENTARY
_ON_THE_UNITED_NATIONS_CONVENTION_1988_E.PDF  

15   The 1988 UN Convention is available at: HTTP://WWW.INCB.ORG/PDF/E/CONV/1988_CONVENTION_EN.PDF  
16   INCB Annual Report 2009 – Precursors, point 110, available at: 

HTTP://WWW.INCB.ORG/PDF/PRECURSORS-REPORT/2009/ENGLISH/PRECURSORS_REPORT_09_ENGLISH.PDF .  

17   INCB Annual Report 2010 – Precursors, points 74-76 and 89, available at: 

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3.3. 

EU legislation and institutional context 

Since the early nineties, the EU has put in place legislation to ensure that diversion of drug 
precursors  is  prevented  through  control  and  monitoring  of  their  legitimate  trade.  The 
legislation aims at striking a balance between necessary actions to prevent diversion of drug 
precursors  and  allowing  their  legitimate  trade  without  creating  unnecessary  administrative 
burdens.  

Based on the 1988 UN Convention, the European legislation contains a list of 23 scheduled 
substances, which are divided into three categories18: 

o  Category 1 covers the most sensitive substances; 

o  Category 2 covers less sensitive substances and so-called “pre-precursors” (substances 

which are used to produce other precursors); 

o  Category  3  covers  bulk  chemicals  that  can  have  different  types  of  uses  in  the 

manufacturing process (feedstock, but also solvents, impurities remover, etc). 

The  severity  of  control  imposed  on  companies  dealing  with  the  drug  precursors  in  question 
depends  on  the  category  concerned:  the  strictest  control  applies  to  category  1  substances, 
while the least control is imposed on substances in category 3. A summary of the obligations 
under the legislation is  attached in Annex 3. The legal obligations for  scheduled substances 
are complemented by a voluntary monitoring scheme for additional substances (so-called non-
scheduled  substances19),  which  provides  the  flexibility  required  to  respond  to  rapidly 
changing diversion patterns. 

The  legislation  builds  on  the  key  principle  of  partnership  between  authorities  and 
operators  in  identifying  diversion  attempts.  Companies  having  received  suspicious  orders 
have to inform the authorities. They may decide not to ship the ordered substances (so-called 
'stopped  shipments')  either  temporarily  until  the  doubts  regarding  the  transactions  can  be 
resolved,  or  –  if  the  doubts  remain  –  definitely  refrain  from  executing  the  order.  Another 
possibility is that there is an agreement between the operator and the authorities that delivery 
should  proceed  under  monitoring  of  the  authorities  to  track  down  trafficker  networks  (so-
called 'controlled delivery'). Authorities may also seize shipments that have been dispatched 
by a company that did not identify an order as suspicious, if they have sufficient indications 
from  other  sources  (e.g.  police,  customs  etc.)  that  a  shipment  is  being  diverted  for  drug 
production (so-called 'seized shipments').  

HTTP://WWW.INCB.ORG/PDF/PRECURSORS-
REPORT/2010/EN/PRECURSORSREPORT2010_REV_E_V10579291.PDF  

18  Annex 2 contains a list of the 23 scheduled substances. 
19   The list of non-scheduled substances is, due to its sensitivity, not published but is provided by the competent 

authorities directly to trusted operators. 

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4. 

PROBLEM DEFINITION  

4.1. 

The problem that requires action 

4.1.1.  Diversion of the main drug precursor for heroin within the EU internal market 

Preventing the diversion of drug precursors from legitimate trade is one of the main goals of 
the 1998 UN Convention and is the objective of the European legislation on drug precursors. 

Ineffective prevention of the diversion of Acetic Anhydride (AA), the key drug precursor 
for  the  production  of  heroin,  has  been  the  main  problem  over  the  last  years  under  the 
applicable legislation for drug precursors circulating in the internal market.  

AA  is  licitly  used  as  an  acetylating  agent20  for  producing  plastics,  textiles,  dyes, 
photochemical agents, perfumes, explosives and aspirin. AA is used illegally mainly for the 
production  of  heroin21  but  it  can  also  be  illegally  used  for  manufacturing  amphetamine, 
methaqualone and in some areas it is used as a reagent to produce coca paste and cocaine22. 
According  to  industry23,  it  would  be  difficult  to  find  a  substitute  for  the  licit  uses  of  AA, 
which  would  present  as  favourable  characteristics  in  terms  of  environmental  impact  on 
occupational  health.  In  addition,  it  is  precisely  the  acetylating  function  which  is  also  used 
during the illicit drug production, so that replacing AA with another acetylating agent would 
mean that the replacement chemical could also be misused. 

Heroin consumed in Europe originates predominantly in Afghanistan, which accounts for 
most of the global illicit opium output. Other producing countries include: Burma/Myanmar, 
which  mainly  supplies  markets  in  east  and  south-east  Asia,  Pakistan  and  Laos,  followed  by 
Mexico and Columbia, which are considered to be the larges suppliers of heroin to the United 
States24. 

Heroin  use  has  been  a  contributing  factor  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. 

AA  diverted  from  legal  trade  in  Europe  is  trafficked  via  the  so-called  "Balkan  Route"  to 
Afghanistan,  thus  following  the  "reverse  route"  of  heroin  trafficked  from  Afghanistan  to 
Europe.  The  Balkan  Route  is  the  largest  opiate  conduit  in  the  world  with  long  established 
criminal  networks  smuggling  significant  amounts  of  heroin  from  Afghanistan  through  Iran 
and  Turkey  towards  the  European  market  and  –  in  a  reverse  course  –  trafficking  acetic 
anhydride  towards  Afghanistan25.  The  second  major  route  is  the  "Southern  Route"  via 
Pakistan  towards  Asia  by  sea,  including  some  road  transportation  through  China  and  also 

20   i.e. to introduce the Acetyl Group (-(C=O)-CH2-CH3) into chemical substances. 
21   The size of the illicit acetic anhydride market is primarily driven by the demand for heroin,cf. UNODC, the 
Global  Afghan  opium  Trade,  under  2,  page  92  –  available  at  HTTP://WWW.UNODC.ORG/DOCUMENTS/DATA-
AND-ANALYSIS/STUDIES/GLOBAL_AFGHAN_OPIUM_TRADE_2011-WEB.PDF 

22   The size of the illicit acetic anhydride market is primarily driven by the demand for heroin, cf. UNODC, the 
Global  Afghan  opium  Trade,  under  2,  page  92  –  available  at  HTTP://WWW.UNODC.ORG/DOCUMENTS/DATA-
AND-ANALYSIS/STUDIES/GLOBAL_AFGHAN_OPIUM_TRADE_2011-WEB.PDF 

23   Consultation before the 2010 Commission Report: feedback from the Cefic Drug Precursor Issue Team. 
24   EMCDDA Annual Report 2011, Chapter 6, page 72 with reference to UNODC, the World Drug Report 2011. 
25   UNODC, The Global Afghan Opium Trade, under 2.2, The Balkan Route, page 114. 

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through  India  (to  a  lesser  extent).  The  third,  more  secondary,  route  is  the  "Northern  Route" 
via former GUS States which developed following the opening of borders after the dissolution 
of the Soviet Union26. Figure 1 contains a graphic illustration of the main transport routes. 

Figure 1: Global heroin flows from Asian points of origin27 

4.1.2.  The scale of the problem 

Seizure data are a commonly used indicator of trends in illicit markets. However, interpreting 
acetic anhydride seizure data is challenging since, in any given year, seizures constitute a very 
small percentage of what is estimated to be traded28. Globally, over 2 million tons of acetic 
anhydride  is  produced  annually.  Estimating  that  illicit  acetic  anhydride  demand  in 
Afghanistan  is  380-570  tons  per  annum,  only  a  tiny  percentage  (0.02%)  of  the  global 
production  would  need  to  be  diverted  and  trafficked  to  Afghan  heroin  laboratories.  These 
figures can be further narrowed for more accurate risk analysis, since as much as two thirds of 
global acetic anhydride production is utilized for intra-company industrial use (i.e. use by so-
called "end-users" for the production of other products – the AA involved is thus not sold or 
traded). It is the remainder (329,000 tons in 2009) which is traded internationally and presents 
a potential target for diversion by traffickers. Traffickers therefore have flexibility to seek the 

26   UNODC,  the  Global  Afghan  opium  Trade,  under  2.2,  Acetic  Anhydride  trafficking  to  Afghanistan,  pages 

103 et seq.  

27   Source: UNODC World Drug Report 2010 
28   UNODC, the Global Afghan opium Trade, under section 2.1 The current state of the acetic anhydride market, 

page 99. 

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fraction of AA which they require from the legal trade from the least-protected areas of the 
markets29. 

In  2008,  competent  authorities  in  the  EU  seized  about  151,000 litres  (163 tons)30  of  AA 
which represented approximately 75% of world-wide seizures. In addition, about 72,000 litres 
(78 tons)  of  AA  were  stopped  in  the  EU  (before  delivery)  because  the  orders  had  been 
suspected to be intended for illicit drug production. Added together, the total quantities of AA 
seized or stopped in 2008 amounted to 223,000 litres (241 tons)31. With this quantity, it would 
have been possible to produce approximately 150,000 -223,000 kg of heroin, as it is assumed 
that producers use 1-1.5 litres of acetic anhydride for every kilogram of Afghan heroin32. 

It  is  necessary  to  put  these  figures  in  perspective  of  the  total  Afghan  heroin  production:  in 
2009, Afghanistan produced 6,900 tons of opium, of which an (estimated) 2,700 tons were 
transformed  into  about  380 tons  of  heroin.  This  production  requires  between  380  and 
570 tons of acetic anhydride smuggled into the country33. Therefore, it can be assumed that 
the quantities of AA seized and stopped in Europe in 2008 would have satisfied about 50% of 
the yearly Afghan demand for AA to be used in heroin production. Drug users in Western and 
Central Europe, for whom Afghanistan is the main source for heroin, consume about 70 tons 
of  heroin,  which  amounts  to  about  18 %  of  the  total  yearly  Afghan  heroin  production  of 
380 tons. 

Seizure statistics of the subsequent years 2009-2010 have shown a clear and sharp decline of 
AA stopped and seized in the EU: 33 tons / 31,000 litres in 2009 and 21 tons / 19,000 litres 
in 2010. With these amounts, it would have been possible to produce approximately 20.4 – 31 
tons of heroin in 2009 and 13 - 19 tons of heroin in 2010.  

4.1.3.  Underlying drivers of the problem 

Despite the recent more promising trend of AA seizures and stopped shipments in the EU, a 
large number of Member States’ competent authorities have consistently voiced their concern 
that the control mechanisms provided under the European legislation for the control of AA - 
which  is  a  scheduled  substance  under  category  2  -  do  not  provide  the  authorities  with 
sufficient  tools  to  prevent  AA  diversion.  Notably,  these  authorities  have  pointed  to  the 
following difficulties: 

-  Lack of registration requirement for end-users of AA – and hence lack of knowledge of 
the  competent  authorities  about  companies  claiming  to  be  only  end-users  of  AA,  in 
contrast  to  the  registration  requirement  for  operators  placing  scheduled  substances  in 
category 2 on the market. 

-  No  licence  required  for  operators  trading  AA,  but  only  a  (less  stringent)  registration 
requirement.  A  licence  is  only  required  for  operators  of  scheduled  substances  in 
category 1. 

29   UNODC, the Global Afghan opium Trade, under section 2.1, pages 98, 99. 
30   1 kg of AA equals 0.926 litres of AA (international conversion rate used by the INCB). 
31   EU  Annual  Reports  on  Drug  Precursor  Seizures 

and  Stopped  Shipments, 

available 

at 

HTTP://EC.EUROPA.EU/ENTERPRISE/SECTORS/CHEMICALS/DOCUMENTS/SPECIFIC-
CHEMICALS/PRECURSORS/INDEX_EN.HTM  

32   UNODC, the Global Afghan opium Trade, under section 2.1, page 94. 
33   UNODC the Global Afghan opium Trade, under section 2.1, page 96. 

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-  Lack of control if substances are traded below the minimum threshold (for AA: 100 litres 
per  year).  Below  this  threshold,  operators  are  exempted  from  a  number  of  obligations 
under the Regulation.  

-  Difficulties  for  operators  to  verify  information  contained  in  the  customer  declaration, 

mainly: 

(cid:131)  whether  the  customer  is  legitimate  when  claiming  to  be  only  an  end-user  (cf. 

above: lack of registration number to be indicated on customer declarations); 

(cid:131)  when the customer is established in another Member State, the information in the 
customer declaration cannot be checked as easily as for customers in the operator’s 
own Member States. 

While  some  Member  States  have  addressed  these  difficulties  with  additional  controls  on 
national  level34  acting  under  Art.  10  of  Regulation  (EC)  No  273/2004,  which  requires 
Member  States  to  adopt  national  measures  necessary  to  enable  the  competent  authorities  to 
perform  their  control  and  monitoring  duties,  other  Member  States  have  considered  that  the 
required  additional  controls  would  go  beyond  the  scope  of  Art.  10  and  that  the  necessary 
additional measures would have to be adopted at the European level. 

It  should  be  noted  that  AA  is  subject  to  the  same  control  standards  as  applicable  to  all 
scheduled substances in category 235. Considering that the above-described characteristics (no 
registration of end-users, difficulties to verify information contained in customer declarations, 
etc) apply to all scheduled substances in category 2, the question arises whether the driver 
for the problem ´diversion of AA´ is an inadequate control mechanism for AA only or for all 
scheduled substances in category 2. Looking at the European seizure statistics for category 
2  substances,  there  is  evidence  that  only  for  the  substance  AA  diversion  has  not  been 
adequately  prevented36.  In  the  2010  stakeholder  consultation,  both,  Member  States  and 
enterprises  have  reported  more  than  double  the  amount  of  suspicious  transactions  for  AA 
alone than for the  four other category 2 substances combined37. It is the main principle of the 
European legislation that different levels of control apply to different substances – depending 
of  the  particular  diversion  risk  of  each  substance  concerned,  so  that  an  increased  diversion 
risk  for  one  particular  substance  does  not  automatically  point  to  ineffective  control 
mechanisms for other substances within the same category. 

A lack of operators’ compliance with the legislation has not been identified as a problem in 
the consultation process (even though it cannot be excluded as a contributing factor in specific 
cases). However, some diversion cases have shown that the authority-operator cooperation in 
the Member State concerned could still be improved.  

34  For  instance:  Belgium,  Hungary  and  Italy  require  their  operators  to  notify  each  AA  transaction  to  the 
authorities prior to the delivery of orders. Hungary has increased reporting obligations for legal transactions 
with the substances AA and potassium permanganate to every 2 months (instead of yearly as foreseen under 
EU law). Belgium, Denmark and Spain require end-users to register with the authorities. 

35  Additional  obligations  apply  to  AA  for  export  to  third  countries,  which  is,  however,  not  relevant  for  the 
present analysis (Art. 11(1) of Regulation (EC) No 111/2005, Commission Regulation (EC) No 1277/2005). 
36  See  Annex  4  (Statistics  of  seizures  and  stopped  shipments  for  all  scheduled  substances  in  category  2)  for 

further details. 

37  See Annex 1 (stakeholder consultation) sections a) and b) under question 3. 

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The underlying drivers of the problem and the direct and indirect consequences are visualised 
in Figure 2.  

Figure 2: Drivers, problem and consequences of the diversion of AA 

DRIVER 

            PROBLEM 

      DIRECT  

          CONSEQUENCES 

           INDIRECT
    CONSEQUENCES 

Ineffective 
prevention 
of AA 
diversion  

Current control 
mechanisms for 
category 2 
substances  are 
inadequate for 
AA: 

- No registration   
  of end-users  
  and lack of  
  knowledge  
  about them 

- Difficulties for  
  companies to  
  check customer  
  declarations 

-  Continuing 
diversion of 
AA for illegal 
purposes 

-  Internal market 
distortion due 
to MS' trying 
to address the 
ineffective 
prevention 
individually 

-  Failure to 

contribute to 
the global 
combat against 
production and 
supply of illicit 
drugs 

-  Aggravation of 

health and social  
problems 
associated with 
heroin use 
throughout the 
world 

-  Compromising 
the EU position 
within the UN's 
INCB 

4.1.4.  Who is affected, in what ways and to what extent? 

The following groups are affected by inadequate prevention of the diversion of AA from the 
intra-EU trade: 

4.1.4.1.  Member States 

Member States are affected by diversion when conducting enforcement actions on diverted 
substances, for instance detecting and monitoring traffickers' storage sites, destroying seized 
substances etc. These activities may be very labour-intensive and costly for the authorities. To 
give an example: UNODC has been informed by a national enforcement authority that it costs 

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almost € 1,000 per day to observe an AA storag e site; another authority reported to UNODC 
to have spent € 250,000 for storage of 93 tons of seized AA 38. 

targeted  (86,100 litres 

Member States have experienced diversion attempts for AA to different degrees. At the peak 
of  European  AA  seizures  in  2008  (151,000  litres),  Central  European  Member  States  were 
particularly 
in  Hungary).  This 
geographical trend could already be observed in 2007, where total EU seizures amounting to 
7,700  litres  took  place  also  in  central  EU  Member  States  (Slovenia  seized  6,500  litres  and 
Romanian  1,200  litres)39.  These  Member  States  are,  due  to  their  geographical  location, 
particularly attractive to traffickers using the “Balkan Route”40.  

in  Slovenia  and  63,600 litres 

Furthermore,  the  argument  has  been  made  that  traffickers  are  exploiting  the  benefits  of  the 
internal  market,  diverting  from  internal  trade  from  the  weakest-controlled  distributor  in  the 
EU to the least-controlled exit point, in order to smuggle the substances outside the EU41. 

More  indirectly,  Member  States  are  affected  by  the  effect  of  drugs  being  produced  with 
diverted  substances.  Via  their  social  security  systems,  they  bear  the  health  costs  resulting 
from  the  use  of  heroin  and  other  drugs.  In  addition,  there  are  significant  costs  to  the  public 
from drug-related crime42. 

4.1.4.2.  Citizens 

EU citizens are affected through the supply of drugs which have been illicitly produced with 
the diverted drug precursors and also through drug-related crime. 

AA  being  available  to  criminals/traffickers  from  diversion  in  Europe  can  be  an  important 
contributing  factor  to  heroin  production,  mainly  in  Afghanistan.  A  substantial  part  of  this 
heroin  (almost  20%)  is  then  sold  on  the  European  market.  The  ultimate  consequence  of 
diversion of AA in Europe is an aggravation of the health and social problems associated 
with heroin use in regions throughout the world, including a substantial part in Europe. 

The above analysis is, however, to be taken with caution. As set out in section 4.1.2, diverted 
AA  is  only  a  small  fraction  of  worldwide  AA  production.  While  it  is  true  that  there  is  no 
production of illicit drugs without (diversion of) chemical precursors, a better prevention of 
diversion in Europe may lead traffickers to source the substance in other regions of the world 
and,  in  consequence  may  have  little  effect  on  the  total  heroin  production  and, 
consequentially, very little effect on the supply of heroin to EU citizens. Furthermore, drug 
users  can,  in  case  of  reduced  heroin  supply,  switch  to  other  drugs  so  that  the  effect  of 

38   UNODC, The Global afghan opium trade, under 2.2, The cost of interdiction, page 116. 
39   INCB Annual Reports on Precursors 2000-2010, available at: 
HTTP://WWW.INCB.ORG/INCB/EN/PRECURSORS_REPORTS.HTML. 
40   For a description of the "Balkan Route" see above under Section 0. 
41   UNODC: The Global afghan opium trade, a threat assessment 2011, under 2.2, The Balkan Route, p. 116. 
42   It is very difficult to estimate drug-related public expenditure in Europe. Even though public expenditure on 
all aspects of the drug phenomenon has been under scrutiny during the last decade, comprehensive estimates 
are still a challenge; the amount and quality of information available varies greatly between countries. In the 
last decade, at least 12 Member States have attempted to arrive at comprehensive estimates of drug-related 
expenditure. These countries reported public expenditure on the drug problem ranging from 0.04% to 0.48% 
of GDP. For further information see: EMCDDA Annual Report 2011, Chapter 1, page 21 et seq. and table 2 
at page 22 with GDP-related estimates for 12 Member States.  

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reduced  diversion  of  AA  in  the  EU  on  the  overall  health  situation  in  Europe  may  be  very 
limited. 

Despite  these  possibilities  of  substitution,  the  EU  is  committed  to  continue  its  efforts  to 
prevent  diversion  within  its  territory,  in  order  not  to  contribute  to  the  production  of  illicit 
drugs.  In  addition,  joined  efforts  on  a  world-wide  level  in  the  framework  of  the  1988  UN 
Convention are aimed at curbing the global production and supply of illicit drugs, including 
also prevention of diversion of precursors from legal trade in all countries. 

4.1.4.3.  Companies 

In  the  EU,  over  5,000  companies  are  currently  registered  or  licensed  to  dealing  with  the 
legitimate  production  and  distribution  of  drug  precursors  (all  scheduled  substances 
combined)43.  More  specifically  for  the  substance  AA,  approximately  1,600  companies  are 
registered as “operators”, i.e. being either manufacturers or traders of AA. AA production in 
the EU is concentrated in only four Member States Greece, Italy, UK and Spain44 and in less 
than  10  companies45.  This  means  that  over  99%  of  operators  are  traders.  Based  on  the 
consultation  carried  out  by  the  Commission  services  in  2010,  the  majority  of  traders  are 
SMEs46. 

About  2,500  companies  in  Europe  are  estimated  to  be  AA  end-users47,  not  selling  AA 
themselves,  but  only  using  it  for  production  in  sectors  such  as  perfume  production,  food 
flavouring,  metal  cleaning,  colouring,  bleaching,  water  cleaning,  etc.  According  to  the 
consultation in 2010, the number of AA end-users is particularly high in some of the larger 
Member States (France, Germany) and in some central European countries (Czech Republic, 
Hungary).48 The consultation also confirmed that the majority of AA end-users are SMEs.49 

Companies dealing with AA may experience diversion (attempts) at any stage of handling 
of  the  chemical  substance.  Diversion  may  occur  in  the  production  facilities,  during 
transportation, sale, processing, recycling and even destruction. 

Apart from securing premises and processes against theft / unintentional disappearance of the 
substance,  companies  producing  and  trading  AA  have  to  be  vigilant  with  regard  to  the 
customers who order the substance and have to critically asses whether these customers use 
the substance only for the claimed licit purpose50. Under current European legislation it is an 
obligation  for  all  operators  involved  in  the  production  and  sale  of  AA,  to  notify  any 

43   EIM calculation, based on the ‘Ad Hoc Study to be used in the Evaluation of the Community Legislation on 
Drug Precursors. Final Report prepared for the European Commission’. RPA, February 2009, as detailed in 
Annex III to the EIM Report. 

44   Eurostat PRODCOM database (data from 2010), available at: 

HTTP://EPP.EUROSTAT.EC.EUROPA.EU/PORTAL/PAGE/PORTAL/PRODCOM/DATA/TABLES_EXCEL 

45   Acetic Anhydride Supply Chain Analysis conducted by the United States. 
46   Out of 54 respondents in the category “operators of category 2 substances”, at least 27 fell under the SME 
definition (many other respondents did not provide the required information), which amounts to at least 50%. 

47   2,473 companies are estimated to be end-users of AA in the EU (EIM Report, page 10). 
48   See Annex 1, Summary of stakeholder consultation and SME consultation. 
49   Out of 106 respondents in the category “end-users of category 2 substances”, at least 42 could be identified 
as SMEs (many other respondents did not provide the requested turnover and employee data), in addition the 
SME-specific consultation for which 60 responses were received, comprised exclusively end-users. 

50   AA is licitly used as an acetylating agent in chemical, photographic and pharmaceutical industry. It is used 

for producing plastic, textile, dyes, photochemical agents, perfumes, explosives and aspirin. 

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suspicious circumstances to the authorities. End-users so far have only limited obligations, in 
particular providing a customer declaration when placing orders for substances of category 2. 

Changes  of  the  drug  precursor  legislation  would  affect  many  companies  active  in  the 
production,  trade  and  further  processing  of  the  chemical  substances  concerned.  Changes 
imposed on operators dealing with AA would affect approximately 1,600 companies in the 
EU. If, on the other hand, the current problem was addressed on a more horizontal level, with 
changes  imposed  operators  dealing  with  all  scheduled  substances  in  category  2, 
approximately 4,000 companies would be affected in the EU; most of them are based in the 
larger Member States (Spain, United Kingdom, Germany and France).51 

A  strengthening  of  the  obligations  imposed  on  end-users  of  AA  would  particularly  affect 
about 2,500 companies in the EU who are only users (not manufacturers or traders) in sectors 
such  as  perfume  production,  food  flavouring,  metal  cleaning,  colouring,  bleaching,  water 
cleaning, etc. If obligations would be strengthened for end-users of all scheduled substances 
in category 2, about 8,500 companies would be affected in the EU52. 

4.1.5.  Foreseen evolution of the problem 

It  is  difficult  to  foresee  the  evolution  of  future  diversion  trends,  as  traffickers’  behaviour 
changes  over  time,  and  depends  on  many  factors,  including  insufficient  implementation  of 
existing legislation, insufficient international cooperation, or an inadequate legal framework.  

The statistics on diversion of acetic anhydride in the EU do not show a clear trend over the 
last decade. There have been two brief spikes in seizures, in 2001 (100,000 litres: 65,000 in 
the  UK,  16,000  in  Italy,  9,000  in  Slovenia  and  9,000  in  Belgium)  amounting  to  55%  of 
global  seizures  and  in  2008  (151,000  litres:  86,000  in  Slovenia  and  64,000  in  Hungary) 
amounting to 75% of global seizures53.  

However,  as  explained  in  section  4.1.2,  according  to  the  statistics  for  2009-2010,  there  has 
been  a  clear  and  sharp  decline  of  AA  stopped  and  seized  in  the  EU:  the  quantities  of  AA 
seizures dropped in 2009 to 900 litres only, amounting to less than 5% of global seizures. 
Seizures and stopped shipments combined dropped to 31,000 litres in 2009 and 19,000 litres 
in 2010. 

From  these  statistics,  two  different  assumptions  can  be  made  in  order  to  forecast  the  future 
diversion of AA in Europe: 

4.1.5.1.  Better implementation by itself will solve the problem 

One assumption would be that the activities by Member States over the last years have shown 
their  success.  Notably,  Member  States  reported  in  a  workshop  organised  by  the  European 

51   4,056  enterprises  are  registered  in  the  EU  to  deal  with  scheduled  substances  in  category  2  (EIM  Report, 

page 10 and Annex III to EIM Report with reference to RPA. 

52   8,548  companies  are  estimated  to  be  end-users  of  scheduled  substances  in  the  EU,  (EIM  Report,  page 10) 

with reference to the stakeholder consultation. 

53   INCB Annual Reports on Precursors 2000-2010, available at 

HTTP://WWW.INCB.ORG/INCB/EN/PRECURSORS_REPORTS.HTML.  

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Commission in June 201154 about activities they have been carrying out since 2008 in order to 
better prevent the diversion of AA: 

• 

• 

• 

• 

Reinforcing  cooperation  between  the  industry  and  the  authorities:  Member 
States  authorities  have  participated  in  annual  industry  conferences  or  have 
organised training of and visits to key economic players; 

Promoting the EU e-learning tool to economic operators; 

Inspecting operators on a risk-based approach; 

Improving  cooperation  activities  a)  between  different  authorities  within  the 
same  Member  State  (inter-agency  approach)  and  b)  between  authorities  of 
different Member States (cross-border cooperation); 

•  Making  use  of  the  EU  alert  systems  (AM55,  RIF56)  to  facilitate  the  rapid 
exchange  of information on diversion (attempts) among authorities across the 
EU. 

The success already achieved with these measures is evidenced by the dramatic decline of AA 
seizures over the last two years. It could, therefore, be concluded that traffickers have shifted 
their attention from the EU to other areas, so that AA diversion from EU-internal trade will 
not be an issue anymore in the future. 

4.1.5.2.  Traffickers  continue  to  target  the  EU  –  Member  States  will  react  by  increased 

national control 

Another  assumption,  however,  would  be  that  the  decrease  in  seizures  shows  that  traffickers 
have  learned  from  the  enforcement  successes in  2008  and  have  become  more  sophisticated. 
They  continue  to  target  the  EU-internal  market  for  diversion  of  AA  by  exploiting  the 
weaknesses of the current legislation. This view is in line with informal reports received from 
national enforcement bodies, which report continued activities aiming at diverting AA in the 
EU. 

Indeed,  a  significant  number  of  Member  States  have  criticised  that  without  adequate 
legislative  tools  on  European  level  their  control  possibilities  remain  inadequate,  especially 
regarding their means to control end-users. Not acting on European level would mean that the 
weaknesses of the current legislation would persist and that Member States who feel a need 
for acting not only by better implementation, but also by "more legislation" would (within the 
limits  of  Art.  10  of  Regulation  (EC)  No 273/2004)  adopt  more  stringent  measures  on 
national level to deal with the risk of diversion. In fact, several Member States have put in 

54   Workshop on countering heroin precursor diversion, Brussels, 9 June 2011. This workshop was organised as 
a special meeting of the Drug Precursor Working Group and within the framework of the European Pact to 
Combat Heroin and Cocaine Trafficking (where Germany and Italy had taken the lead on activities relating to 
heroin). 

55   The  alert  messaging  system  (AM)  connects  all  competent  authorities  (regulatory,  customs,  police)  and 
enables  them  to  rapidly  disseminate  information  about  diversion  (attempts).  This  ensures  a  coordinated 
approach by authorities across the EU and prevents traffickers from "shopping around" for substances in the 
EU. 

56   The Risk Information Forum (RIF) is a tool under the EU Customs Risk Management System which links 
Member States' customs authorities in all major ports/airports/frontiers. It allows for exchange of risk-related 
information directly among operational officials and risk analysis centres. 

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place extensive additional measures57. This would, on the one hand, lead to a fragmentation 
of the Internal Market affecting the wide variety of legitimate industrial uses of AA. On the 
other hand, the combination of different control standards risks by itself creating loopholes: 
for instance Member States requesting registration of end-users in their own territory cannot 
avoid  fraudulent  companies  placing  orders  in  that  territory,  when  operating  as  end-users  in 
another  Member  State  and  thereby  avoiding  registration.  Assuming  that  a  Member  State 
obliges its operators to notify all new end-users to the authorities, a fraudulent company will 
avoid this obligation by placing orders in another Member State which does not ask for such 
notification. 

4.2. 

EU right to act 

Regulation  (EC)  No  273/2004  on  drug  precursors  is  based  on  Article  114  TFEU  (formerly 
Article 95 TEC). The Regulation has set common requirements for monitoring and control of 
the trade in drug precursors, in order to ensure the free licit trade of these chemicals within the 
EU.  Nevertheless,  the  legislation  requires  Member  States  to  adopt  national  measures  which 
are  necessary  to  enable  the  competent  authorities  to  perform  their  control  and  monitoring 
duties (Art. 10 of Regulation (EC) No 273/2004). Many Member States have used this basis 
for  procedural  rules  only.  In  fact,  some  Member  States  feel  legally  prevented  from 
adopting national control measures going beyond the EU legislation (e.g. Germany and the 
Slovak Republic). In particular, the argument has been made by these Member States that the 
EU  legislation  subjects  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. 

However,  others  have  also  based  substantive  national  controls  on  Art.  10.  As  set  out  in  the 
previous  section,  different  approaches  of  control  in  different  Member  States  are,  firstly, 
detrimental  to  the  functioning  of  the  Internal  Market  and,  secondly,  risk  creating 
loopholes, which weaken the effectiveness of controls. If the EU-wide structural deficits of 
the  legislation  remain  unaddressed,  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  Internal  Market.  Also,  historically,  the  Member  States  targeted  have 
been different: in 2001 mainly the United Kingdom, Italy and Belgium, then in 2008 mainly 
Slovenia  and  Hungary.  These  examples  show  that  a  combination  of  different  national 
measures is not as effective as a harmonised approach at EU-level. This is also confirmed 
by that fact that both, Member States and industry 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. 

While  efforts  to implement  the  control  mechanism  to  a  similar  standard  throughout  the  EU 
and for an improved cooperation among competent authorities need to continue, these efforts 
for better implementation will not be sufficient to address the structural weaknesses of the 
legislative  system.  There  would  be  a  need  for  stricter  EU  legislation  to  ensure  a  uniform 
standard to adhere to by the competent authorities in the different Member States. The latter 
view has, for years, been expressed by INCB who has criticised the EU for non-action and 
it  is  very  likely  that  this  criticism  will  continue  in  the  future,  if  the  European  legislation 
remains unchanged. 

57   See footnote 34 for further details. 

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In  conclusion,  an  effective  strengthening  of  the  control  and  monitoring  mechanism,  which 
would neither create loopholes nor unduly hinder the licit trade of drug precursors in the EU 
would have to be adopted at the European level.  

5. 

OBJECTIVES  

5.1. 

General policy objectives 

There are two general objectives pursued with the present imitative:  

(1)   To  contribute  to  the  world-wide  combat  against  the  illicit  traffic  in 
narcotic drugs and psychotropic substances. Preventing the diversion of 
drug  precursors  is  an  important  element  by  which  the  EU  fulfils  its 
obligations under Art. 12 of the 1988 UN Convention. 

(2)   To  ensure  a  proper  functioning  of  the  internal  market  for  drug 
precursors, by ensuring that operators are subject to the same, harmonised 
rules  within  the  EU  whilst  avoiding  unnecessary  obstacles  to  legitimate 
trade and administrative burden for enterprises and competent authorities. 

5.2. 

Specific and operational policy objectives 

(1) 

 (2) 

Linked  to  the  first  general  objective,  the  present  initiative  aims  at 
preventing  diversion  from  the  EU  internal  market,  thus  achieving  a 
downward trend of diversion attempts and seizures of AA, and thereby 
limiting  the  input  of  diverted  AA  originating  from  the  EU  to  the 
production of illicit drugs, namely heroin.  

Linked  to  the  second  general  objective,  the  initiative  aims  at  avoiding 
market  distortions  by  introducing  a  uniform,  effective  and  efficient 
standard of controls for drug precursors within the EU and thereby limiting 
the costs for operators involved in the licit drug precursor value chain. 

5.3. 

Consistency with other policies and objectives 

The  control  of  drug  precursors  is  part  of  the  EU  Drugs  Strategy  2005-201258  and  the  EU 
Drugs  Action  Plan  (2009-2012)59,  which  sets  out  the  objective  to  reduce  the  diversion  and 
trafficking in/via the EU of drug precursors used for the illicit manufacture of drugs. 

As  the  drug  problem  is  a  complex  phenomenon,  it  requires  a  multidisciplinary  approach  of 
combining  demand  and  supply  reduction60.  Preventing  the  diversion  and  trafficking  of  drug 
precursors aims at reducing the supply of illegal drugs – the ultimate objective being a high 
level of protection, well-being and social cohesion of EU citizens by preventing and reducing 
drug  use,  in  line  with  the  EU  Drug  Strategy.  The  European  Commission  Services  are 

58   EU  Drugs  Strategy  2005-2012,  endorsed  by  the  European  Council  of  November  2004  (15074/04 

CORDROGUE 77 SAN 187 ENFOPOL 187 RELEX 564). 

59   EU Drugs Action Plan for 2009-2012 (2008/C 326/09). 
60   The EU Drug Strategy additionally complements these two key dimensions with three cross-cutting themes: 

coordination; international cooperation and information; research and evaluation. 

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currently carrying out an evaluation  of the 2005-2012  EU  Drugs Strategy;  in  preparation of 
the  EU  Drug  Strategy  from  201361.  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  Art.  12  of  the  1998  UN  Convention62  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 
in the area of drugs-related health damage where the Treaty invites the Union to complement 
Member States’ action on prevention of drug-use63. 

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 
authorities64. 

6. 

POLICY OPTIONS  

Based  on  the  weaknesses  identified  during  the  evaluation  of  the  existing  legislation,  the 
Commission  Services  (DG  ENTR)  developed  six  possible  policy  options  which  would 
address  the  identified  problem  drivers.  The  options  were  discussed  with  stakeholders  in  the 
Drug  Precursor  Working  Group.  The  main  problem  driver  being  the  insufficient  control  by 
competent  authorities  over  all  economic  players  involved  in  the  (legal)  trade  with  drug 
precursors,  all  identified  options  seek  to  improve  that  control  via  enhanced  reporting, 
notification or registration obligations imposed on the economic players. The following policy 
options have been analysed: 

6.1. 

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

In this option, the existing EU legislation will not be modified. This means that, notably the 
following provisions already aimed at controlling the trade of AA (and other drug precursors) 
will remain unchanged: 

o  Category  1  substances  are  subject  to  a  more  stringent  control  regime  than 
category  2  substances.  The  Regulation  requires  a  licence  for  any  dealing  with  the 
substance,  including  possession,  end-use  and  sale.  The  EU  legislation  contains 
detailed requirements for granting a licensing number and imposes obligations on the 
applicant to provide the authorities with documentation  on a number  of obligations, 
such  as  measures  taken  to  secure  premises,  a  description  of  all  places  of  storage, 
manufacturing  and  processing,  a  description  of  the  envisaged  operation  with  the 
substance.  Furthermore,  a  copy  of  the  customer  declaration  has  to  accompany  any 
transport of category 1 substances within the EU. 

61   For further details see http://ec.europa.eu/justice/newsroom/anti-drugs/opinion/111027_en.htm. 
62   See also under Section 0 above. 
63   Article 168 TFEU (Treaty on the Functioning of the European Union) 
64   Article 67 TFEU 

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o  Only  operators  for  category  2  substances  need  to  be  registered  if  they  place 
substances  on  the  market.  End-user  customers  of  category  2  substances  are  not 
registered with the competent authorities.  

o  The EU Regulation does not lay down requirements with regard to the granting 
of a registration number, so that some Member States give a registration number to 
any applicant for registration without particular verifications. Some even consider that 
registrations cannot be refused. 

o  Customer  declarations:  operators  supplying  category  1  or  2  substances  have  to 
obtain  a  declaration  from  each  customer,  which  contains  the  name,  address, 
registration  details  (if  applicable)  and  the  intended  use  of  the  substance65.  New 
customers  of  category  2  substances  are  treated  in  the  same  way  as  long-standing 
customers, i.e. solely the obligation to obtain the customer declaration applies. 

o  Reporting:  operators  are  currently  under  the  obligation  to  inform  the  competent 

authorities once a year about scheduled substances used or supplied66. 

The Commission and Member States will continue efforts to improve the implementation of 
current  rules,  following-up  on  the  results  of  the  ‘Best  Practice’  workshops  which  the 
Commission  organised  on  how  AA  diversion  can  be  prevented.  As  detailed  above  under 
section 4.1.5.2, Member States could adopt further national legislation in accordance with Art. 
10 of Regulation (EC) No 273/2004 if they consider this necessary. Draft national measures 
would  have  to  be  notified  in  accordance  with  Directive  98/34/EC,  to  allow  other  Member 
States and the Commission to verify that they are in compliance with the requirements of the 
EU Treaty.  

6.2. 

Option 2: strengthened reporting obligations  

The  existing  reporting  obligations  could  be  strengthened  to  allow  Member  States  to  use  the 
(more comprehensive) reporting by operators to increase their knowledge, target inspections 
and other enforcement activities, and exchange this information among competent authorities. 
To  avoid  unnecessary  burdens,  the  reporting  obligations  could  be  reduced  or  abolished  for 
holders of a special licence or a special registration67. 

Two  sub-options  could  be  distinguished  (which  could  be  applied  either  separately  or  in 
combination): 

a)    increasing the frequency of reporting (for example from once to four times per year) 

b)   extending  the  scope  of  reporting  (including  substances  received  and  produced  and 

requiring explicit reporting when no transactions are made over a given time). 

65   Art. 4 of Regulation (EC) No 273/2004 
66   Art.  8(2)  of  Regulation  (EC)  No  273/2004  in  combination  with  Article  17,  19  or  Regulation  (EC)  No 

1277/2005. 

67  Special licences and special registrations are foreseen in Article 3(2) and (6) of Regulation (EC) No 273/2004. 
Special licences or registrations 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 precursors within the scope of the official duties of the operators concerned. 

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6.3. 

Option  3:  strengthened  rules  and  obligations  on  operators  related  to  customer 
declarations from end-users 

The Regulation could be modified to establish that operators placing scheduled substances in 
category 2 on the market are not allowed to send a consignment following an order unless the 
customer declaration is completely filled in and they have conducted themselves a verification 
that the end-user has genuine motives for placing the order (e.g. verification that the end-user 
is a registered company active in the area of business mentioned under the ‘intended use’ of 
the  customer  declaration).  When  unable  to  conduct  such  verifications  themselves,  operators 
would have to involve their authorities. 

The completeness of the customer declaration and the verification of the information would 
have  to  be  documented  in  the  records  to  be  kept  in  accordance  with  Article  5  of  the 
Regulation.  Furthermore,  a  requirement  could  be  introduced  that  a  copy  of  the  customer 
declaration should accompany scheduled substances in category 2 similar to what is already 
foreseen  for  substances  in  category  1.  The  option  could  be  reinforced  by  reducing  or 
abolishing the threshold of minimum quantities foreseen in Article 6 of the Regulation. 

Two sub-options could be differentiated:  

a) new obligations will apply only to AA 

b) new obligations will apply to all or some category 2 substances  

6.4. 

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

In this option, operators placing scheduled substances in category 2 on the market would be 
obliged to systematically notify all orders from end-users who are first time customers to the 
competent  authorities,  and  would  only  be  allowed  to  ship  the  consignment,  after  having 
received the agreement of the authorities.  

The  authorities  would  verify  the  legitimate  motives  of  the  end-users,  if  necessary  by  co-
operating with the authorities of another Member State, if the new customer is established in 
that other Member State.  

The option could be reinforced by reducing or abolishing the threshold of minimum quantities 
foreseen in Article 6 of the Regulation. 

Two sub-options could be differentiated:  

a) new obligations will apply only to AA 

b) new obligations will apply to all or some category 2 substances  

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6.5. 

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

In this option, end-users for scheduled substances in category 2 would be required to register68 
and  obtain  a  registration  number  to  be  used  when  submitting  a  customer  declaration  in  the 
context  of  an  order  for  substances.  This  could  give  reassurance  to  operators  placing  the 
substances on the market that orders are legitimate, provided, of course, that they can easily 
verify that registration numbers are genuine (and not fake). 

Further  consideration  has  to  be  given  to  the  verification  that  competent  authorities  conduct 
before  granting  a  registration  number  to  end-users  (or  operators  in  general):  in  its  current 
form, the legislation does not lay down particular requirements with regard to the granting of 
registration  numbers69.  In  order  to  ensure  that  registration  of  end-users  will  be  an  effective 
tool in combating diversion of scheduled substances, authorities will have to verify that end-
users who register have genuine business activities – otherwise the registration number, which 
will  appear  on  customer  declarations  of  end-users,  could  give  a  false  impression  of  proven 
legitimacy to operators receiving orders from registered end-users. European legislation could 
specify more detailed requirements and conditions for the granting, refusal and withdrawal of 
registration of end-users (and of operators in general). 

The option could be reinforced by reducing or abolishing the threshold of minimum quantities 
foreseen  in  Article  6  of  the  Regulation,  and/or  foresee  exemptions  for  certain  categories  of 
end-users, such as universities or research institutions. 

Two sub-options could be differentiated: 

a) new obligations will apply only to AA 

b) new obligations will apply to all or some category 2 substances  

6.6. 

Option 6: move AA from category 2 to category 1 

In this option, AA would be moved from category 2 to category 1, which would mean that all 
those involved in the trade and use of AA would need to obtain a licence before they possess 
or place AA on the market, and would have to comply with all other requirements of licensed 
operators (see Annex 3 for an overview of these requirements). 

7. 

ANALYSIS OF IMPACTS  

In this chapter the impacts of the six identified options and their sub-options to introduce new 
requirements  for  AA  only  or  for  all  substances  in  Category  2,  respectively,  are  analysed. 
However, the possibility foreseen to reinforce options 3, 4, and 5 by reducing or abolishing 
the  threshold  of  minimum  quantities70  has  not  been  further  examined  for  the  following 
reasons: in the consultation, only a minority of Member States commented on this issue. For 

68   A registration requirement of end-users can be achieved with different means, for instance: adaptation of the 
definition  of  operators,  adaptation  of  the  definition  of  placing  on  the  market,  or  introducing  a  separate 
provision for end-user registration. 

69  Article 3, paragraph 6, of Regulation (EC) No 273/2004. 
70  This threshold is currently foreseen in Article 6 of Regulation (EC) No 273/2004. 

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those who did, half wanted to keep the threshold, about one third wanted to reduce it and only 
one sixth wanted to abolish the threshold. Those providing reasons for their choice argued in 
favour of keeping the threshold by pointing out that there were a very large number of users 
of small quantities and abolishing the threshold would amount to a disproportionate burden. 
Furthermore, all known diversion attempts for AA have targeted larger shipments well above 
the current threshold of 100 litres. The possibility considered under options 2 and 5 to foresee 
exemptions for certain categories of users (such as holders of special licences/registrations or 
of  universities/research  institutions)  has  not  been  analysed  due  to  very  limited  information 
received during the consultation71. 

The  most  relevant  economic  impacts  include  the  administrative  costs/burdens  on  businesses 
and  public  authorities;  they  have  been  quantified  in  the  present  report.  For  the  preferred 
option(s), the IA will also assess impacts on SMEs and competitiveness. 

Social impacts, including those on public health and safety as well as crime and security, are 
of  less  direct  character  than  economic  impacts,  as  they  are  related  to  the  total  amount  of 
heroin supplied to the EU. While they therefore correlate with the effectiveness of each option 
to prevent diversion of the heroin precursor AA, it has to be noted that heroin would even be 
supplied to the EU if all of the  diversion  of European AA  was effectively stopped, because 
traffickers  may  switch  to  other  AA  sources  in  the  world72.  Another  factor  of  uncertainty  in 
this  respect  are  the  actions  of  third  countries73,  which  may,  either  in  response  to  a 
strengthening  of  controls  in  the  EU  or  independently  thereof,  also  improve  control  of 
diversion. Social impacts have, therefore, not been analysed for the individual policy option 
as  it  would  not  have  been  possible  to  quantify  them  or  describe  differences  in  a  qualitative 
way  other  than  the  assessment  of  the  effectiveness  of  the  policy  options  in  preventing 
diversion. There are no environmental impacts associated with the problem identified and any 
of the options to address the problem. The only environmental aspect concerns the destruction 
of diverted drug precursors that have been seized. This is regulated by the applicable waste 
legislation  and  the  rules  foreseen  for  the  destruction  of  seized  goods  in  the  Community 
Customs  Code.  Nevertheless,  reducing  the  quantities  of  drug  precursors  seized  will  also 
reduce the amounts that have to be destroyed. 

While  administrative  cost/burdens  have  been  fully  monetized  in  the  present  report,  this  was 
not  possible  for  benefits  (i.e.  the  effectiveness  of  the  options);  these  have  therefore  been 
assessed qualitatively. 

7.1. 

Analysis of costs 

7.1.1.  Methodology 

As  the  main  problem  to  be  addressed  by  the  present  initiative  is  the  insufficient  control  by 
competent  authorities  over  the  economic  players  involved  in  the  (legal)  trade  with  drug 
precursors,  all  identified  options  seek  to  improve  that  control  via  enhanced  reporting, 

71  Only  three  Member  States  expressed  their  views,  two  were  favouring  an  exemption  for  holders  of  special 
licences  and  one  was  against  such  an  exemption.  This  limited  information  was  not  considered  a  sufficient 
basis to change the status quo. 

72  See also Section 0 above. 
73  For instance the United States have recently conducted a large scale supply chain analysis of AA production 
and  trade,  in  order  to  identify  most  vulnerable  points  for  potential  diversion,  where  enforcement  actions 
should be concentrated on. 

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notification or registration obligations imposed on the economic players – hence increasing 
administrative burdens on them, with variations as to the degree of that burden and to the 
group of economic players and authorities concerned.  

The administrative costs and administrative burdens stemming from the six policy options for 
enterprises  and  the  competent  authorities  of  the  Member  States  are  quantified,  based  on 
calculations carried out by an external contractor (EIM) using the Standard Cost Model (for 
detailed calculation tables please see Annex I of the final report of the study74). EIM based its 
calculations on a dataset created from the responses received by the Commission during the 
written consultation carried out in 2010 and further validated them through a series of targeted 
interviews. 

It should be noted that an increase in administrative burden, would, to a certain degree, even 
be  expected  under  the  baseline  scenario  where  existing  tendencies  of  Member  States  to 
develop supplementing national legislation would be expected to continue, and hence lead to 
a risk of fragmentation of the internal market, which would also have detrimental effects on 
operators. 

Therefore, the key question for the analysis of impacts is not whether there will be an increase 
of burden for industry but rather which kind of increase would be most proportionate in view 
of the expected benefits. 

7.1.2.  Assumptions 

The administrative cost study has been based on the following main assumptions: 

- Clustering of Member States according to blocks for extrapolation 

As there is data from only 17 Member States, Member States have been dived into 3 blocks 
on the basis of the total number of licensed and registered operators. In each block, Member 
States have a similar number of licensed and registered operators. It is assumed that Member 
States  within  the  same  block  need  equal  amounts  of  time  to  comply  with  their  monitoring 
obligations, and this assumption is used to extrapolate data from one Member State for which 
data is available to another Member State in the same block for which there is no information 
available75 – and eventually to the entire EU. For the calculation of administrative burdens in 
the present impact assessment, only the aggregated data for the entire EU have been used. 

- Hourly tariffs 
For  enterprises,  a  tariff  of  approximately  €  26  per  hour 76  has  been  used  for  quantifying  the 
administrative  costs,  which  is  the  (rounded)  average  of  the  tariffs  for  the  target  group 
‘professionals’  in  all  27  Member  States77  -  under  the  assumption  that  the  enterprise  staff 
performing the activities required to comply with information obligations fall into the target 
group ‘professionals’. 

74   A copy of the EIM Report is accompanying this report as separate document. 
75   For further information see EIM Report, page 9. 
76   As a basis for the calculations, the non-rounded hourly tariff of € 25.63 has been used. 
77   Tariff used in the Action Programme for reducing administrative burdens in 2008-2009. 

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For  Member  States,  the  average  (rounded)  tariff  has  been  calculated  for  each  of  the  above-
mentioned blocks, based on the Member State tariffs contained in each block78.  

- Number of enterprises 

The number of enterprises affected varies under the different options and sub-options. Options 
2, 3b, 4b have an impact on operators dealing with all scheduled substances of category 2. For 
these options the total number of registered operators is used: 4,05679. 

Options 3a and 4a have impacts only on registered operators dealing with AA. Based on the 
answers provided by Member States during the consultation carried out in 2010, 40% of the 
total  number  of  registered  operators  are  assumed  to  be  affected80,  corresponding  to  1,622 
enterprises. 

Option  5a  affects  end-users  of  AA.  According  to  the  consultation  carried  out  in  2010,  this 
figure  is  estimated  at  2,473  enterprises.  Option  5b  affects  end-users  of  all  category  2 
substances. According to the 2010 consultation, this figure is estimated at 8,548 enterprises.  

Option 6 affects (1) all currently registered  operators dealing with AA (1,622) and, all end-
users  of  AA,  which  are  currently  under  no  registration  requirement  (2,473).  In  total  4,095 
enterprises would be affected. 

- Calculated costs are maximum costs  

It should be noted that a number of Member States have, over the last years, adopted national 
measures (in order to prevent diversion of acetic anhydride) which partly implement elements 
of the options analysed in this impact assessment. Therefore, the costs calculated are expected 
to be maximum costs, as in those Member States where presently already some / part of the 
options are applied, the costs for both operators and Member States for enacting the option in 
question  would  be  lower  than  calculated  here  –  specific  examples  will  be  mentioned  as 
appropriate for the individual options. 

7.2. 

Benefits 

The  benefits  of  the  identified  options  essentially  relate  to  the  expected  likelihood  that  the 
option  will  be  effective  in  meeting  the  operational  objectives,  namely  to  decrease  diversion 
and  diversion  attempts  of  AA  and  avoiding  distortions  in  the  internal  market.  They  will  be 
described qualitatively.  

7.3. 

Option 1: no action 

7.3.1.  Costs 

No  additional  administrative  burden  would  be  imposed  on  European  level  on  either 
enterprises or competent authorities. However, a possible increase of administrative burdens 
at national level could be expected should Member States introduce complementing national 

78   Block A: €19 per hour, Block B: €21 per hour, Block C: €39 per hour. 
79   4,056  enterprises  are  registered  in  the  EU  to  deal  with  scheduled  substances  in  category  2  (EIM  Report, 

page 10) with reference to RPA. 

80   See Member State survey, questions 7 and 8. 

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measures. Drug precursors are used widely for a large variety of legitimate industrial uses. A 
system  which  would  subject  operators  to  different  control  standards  depending  on  the 
Member  State  they  are  selling  to/from  would  arguably  be  more  difficult  to  handle  for 
economic operators than a moderate increase of control applicable uniformly throughout the 
EU.  In  fact,  a  number  of  Member  States  have  introduced  national  measures  that  lead  to 
additional costs for the companies concerned. 

For example, in Denmark, Belgium and Spain, end-users of all category 2 substances above 
a threshold of 100 l/year purchase are obliged to be registered with the authorities (following 
from  an  interpretation  of  the  Regulation  that  the  term  'operators'  includes  end-users). 
Additionally,  in  Denmark,  operators  with  transaction  volumes  below  the  threshold  are 
encouraged to register voluntarily with the authorities. 

In the Czech Republic, all operators have been requested (without legally binding basis) to 
provide  the  authorities  with  information  about  their  new  customers,  including  also  cases 
where orders have not been executed. The same request has been made in Germany by the 
competent authorities. 

Hungary  has  increased  national  reporting  rules  for  the  category  2  substances  AA  and 
Potassium permanganate to every two months. Furthermore, operators have been requested to 
notify the authorities three days before all delivery of AA either a) above 20 litres or b) to a 
new customer. 

Italy  requires  its  companies  to  notify  every  single  transaction  to  a  national  database  before 
delivery  takes  place.  The  requested  information also  involves  providing  the  authorities  with 
information on end-users, so that authorities claim to have full knowledge on end-users and 
that, effectively, all end-users are registered via the national database. 

The above shows that there is quite a large disparity in the EU on how operators (and in case 
of  Belgium,  Denmark,  and  Spain:  also  end-users)  are  controlled.  Control  standards  vary 
between  registration  requirements  (BE,  ES,  DK)  notification  requirements  before  delivery 
(IT,  HU)  or  additional  reporting  obligations  (CZ,  DE,  HU),  all  of  which  lead  to  additional 
costs. For operators selling in more than one Member State, these different obligations are a 
substantial  burden,  plus  a  competitive  disadvantage  for  operators  located  in  these  Member 
States compared to those in others. 

7.3.2.  Benefits 

On  the  one  hand,  no  action  at  European  level  could  be  justified  by  the  fact  that  diversion 
attempts  concerning  AA  have  targeted  only  a  rather  limited  number  of  Member  States, 
mainly in central Europe (see section 4.1.4). Therefore, it could at first sight be assumed that 
the problem is not 'EU-wide' and thus does not need to be addressed at European level.  

Also,  in  terms  of  effectiveness  of  the  option  in  preventing  diversion,  the  recent  statistics  of 
seizures and stopped shipments have shown a clear downward trend, which suggests that the 
efforts  of  achieving  a  better  implementation  (notably  to  strengthen  the  authority-industry 
cooperation,  to  conduct  specific  industry-training  activities  and  to  increase  vigilance  of 
operators and enforcement authorities – see above under Section 4.1.5.1 on measures already 
taken  by  Member  States)  have  already  brought  about  a  tangible  improvement  of  the 
effectiveness of the current legislation in preventing diversion. It can be reasonably expected 
that the enforcement activities will continue to contribute to better prevention of diversion 
in the future, if Member States, the Commission and operators maintain their vigilance. 

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Further improvements might be expected from the implementation of the European database 
that  the  Commission  is  currently  preparing,  which  will  facilitate  reporting  of  and  access  to 
information  relating  to  seizures  and  stopped  shipments  by  Member  States,  and  allow  easier 
verification of the status of potential clients through a list of registered operators (and possibly 
also trusted end-users). The database is expected to start being operational from the beginning 
of 2013. 

On  the  other  hand,  it  is  to  be  expected  that  the  identified  structural  weaknesses  of  the 
current legislation with regard to the diversion of the main heroin precursor AA (and possibly 
other  drug  precursors  of  scheduled  substances  in  category  2)  would  persist  –  even  though 
these may be reduced by efforts of better implementation of the current provisions as can be 
seen from the latest trends with regard to stopped and seized shipments (see Section 4.1.5). 

If  considered  necessary,  Member  States  could  adopt  further  national  measures  under 
Article 10 of the current Regulation to reinforce control of trade in drug precursors. However, 
while this would be effective with regard to the objective of preventing the diversion of AA, it 
would  be  counterproductive  with  regard  to  the  objective  of  avoiding  fragmentation  of  the 
internal  market.  Indeed,  a  number  of  Member  States  have  already  introduced  national 
control measures which  have led  to  disruptions  of the Internal Market (see previous section 
for  details).  This  is  why,  during  the  consultations  carried  out  by  the  Commission  Services 
during  2010,  several  stakeholders  and  Member  States  held  the  view  that  diverging  national 
rules should be avoided as there would be no longer a level playing field for all operators in 
the EU. 

Finally, the international criticism of the EU as remaining "inactive" despite continued calls 
for stepping up the control of its internal market legislation would persist. In all of its recent 
annual  reports,  the  INCB  has  called  on  the  Commission  to  propose  amendments  to  the 
existing  legislation  in  order  to  eliminate  the  detected  weaknesses81  –  failure  to  do  so  might 
reinforce  the  criticism  voiced  by  the  INCB,  which  will  probably  also  be  shared  by  several 
Member States. 

7.4. 

Option 2: strengthened reporting obligations 

7.4.1.  Costs 

7.4.1.1.  Enterprises 

Operators  would  become  subject  to  increased  administrative  costs  by  additional  reporting 
obligations. The results of the EIM Report are summarised in Table 3. Under sub-option 2a 
the frequency of reporting would be increased from once to four times a year, which would 
cause additional annual costs of ca. € 5.6 millio n. Under sub-option 2b the scope of reporting 
would  be  increased,  leading  to  annual  cost  of  ca.  €  1.45  million.  If  both  sub-options  were 
implemented the total annual costs would amount to € 11.4 million (€ 5.6 million plus 4 x € 
1.45 million). 

81  See section 0. 

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Table 3  Administrative burdens for registered operators under Option 2 

Total costs per year 

Time 

spent/ 

Average price 

Total number  

Number of 

Policy option 

Sub-option 

action 

/ action 

of actions/year 

 firms 

Administrative 

costs

(AC)

2  Strengthened 

2a) Increasing 

18h

€ 461.34

3

4,056 

€ 5,613,585

reporting 

frequency of 

obligations 

reporting by 

operators 

(quarterly) 

2b) Extending the 

14h

€ 358.82

1

4,056 

€ 1,455,374

scope of reporting 

(including 

substances 

received, produced) 

  2a) + 2b): 

extending the scope 

and increasing the 

frequency 

18h

14h

€ 461.34

€ 358.82

3

4

4,056 

4,056 

€ 5,613,585

+ € 5,821,496

= € 11,435,081 

7.4.1.2.  Competent authorities 

The  administrative  costs  for  Member  States'  competent  authorities  as  calculated  in  the  EIM 
Report are set out in Table 4. Under sub-option 2a (quarterly reporting) the additional annual 
costs  are  € 1  million/year.  Under  sub-option  2b  (increased  scope)  the  annual  costs  for  the 
limited  (€ 0.27  million/year).  If  both  sub-options  were 
authorities  would  be  more 
implemented the total annual costs would amount to € 2.1 million (€ 1 million + 4 x € 0.27 
million, as the information under the extended scope will have to be reported 4 times/year). 

It  should  be  noted,  though,  that  according  to  the  results  of  the  consultations,  Hungary  has 
already  increased  its  national  reporting  rules  for  two  of  the  category  2  substances  (AA  and 
potassium permanganate): the frequency has been increased from 1 to 6 times/year. An even 
further-reaching system has been enacted in Italy, where all transactions have to be registered 
in a national database before delivery takes place. For operators and competent authorities in 
these two Member States, the introduction of more frequent reporting rules would thus be less 
costly than calculated in this section. 

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Table 4  Administrative burdens for authorities under Option 2 

Total costs per year 

Policy option 

Sub-option 

action 

action 

actions/year 

(AC)

Time 

Total number 

spent/ 

Average price/ 

of 

Administrative costs

2  Strengthened 

2a) Increasing 

11,722h

€ 342,306

reporting 

frequency of 

obligations 

reporting by 

operators 

(quarterly) 

2b) Extending 

9,377h

€ 273,845

the scope of 

reporting 

(including 

substances 

received, 

produced) 

  2a) + 2b): 

11,722h

€ 342,306

extending the 

9,377h

+ € 273,829

scope and 

increasing the 

frequency 

3

1

3

4

 € 1,026,918 

 € 273,829 

€ 1,026,918

+ € 1,095,316

= € 2,122,234

7.4.2.  Benefits 

In  terms  of  effectiveness  of  the  option  in  preventing  diversion,  competent  authorities  could 
expect to have a better knowledge of the legal trade flows – this could allow them to detect 
more  easily  unusual  trade  patterns  which  could  indicate  diversion  to  illicit  channels.  By 
having a more complete picture of the trade flows (by including not only substances supplied 
and used, but also substances produced and received, by making explicit notifications to the 
authorities  also  if  no  transactions  have  been  made  in  the  reporting  period)  authorities  could 
compare  data  received  from  different  operators  and  thereby  find  conflicting  information 
which could point at diversion to illicit drug production. By getting the reported information 
more  regularly  (quarterly  instead  of  yearly)  the  data  would  be  of  more  relevance  to  detect 
recent diversions than if that data is already one year old. 

However, a majority Member States’ competent authorities has been sceptical about the real 
benefits of this option. In order to be able to match trade data from all operators within the 
EU, a very large amount of data would need to be collected and would have to be matched 
across EU-internal borders. Even under the assumption that this collection and cross-matching 
of  data  could  be  done,  the  assumed  benefits  for  detecting  diversion  of  AA  were  considered 
not  very  high.  It  has  to  be  born  in  mind,  that  only  0.02%  of  AA  production  is  potentially 
diverted,  so  that  a  general  "check  all  transactions"  approach  is  less  promising  than  more 
targeted, risk-based actions. 

With regard to the objective of preserving the internal market, the situation would probably be 
similar  to  Option  1:  Member  States  might  still consider  that  it  would  be  necessary  to  adopt 

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further  national  measures  under  Article 10  of  the  current  Regulation  to  reinforce  control  of 
trade  in  drug  precursors.  While  this  would  also  be  effective  with  regard  to  the  objective  of 
preventing the diversion of AA, it would be counterproductive with regard to the objective of 
avoiding fragmentation of the internal market 

7.5. 

Option  3:  strengthened  rules  and  obligations  on  operators  related  to  customer 
declarations from end-users 

7.5.1.  Costs 

7.5.1.1.  Enterprises 

For an assessment of the costs of this option for enterprises it has been assumed that operators' 
obligations will no longer be limited to obtaining a customer declaration but, in addition, the 
legislation would require them to conduct the verification that the information filled in is both 
complete  and  genuine,  i.e.  the  registered  customer  is  indeed  in  possession  of  the  declared 
registration number or (for the end-user customer) he is indeed active in the declared business. 
This  administrative  cost  (in  form  of  carrying  out  verifications)  is  calculated  to  amount  to  6 
hours,  plus  an  additional  1  hour  of  documenting  the  verification  conducted.  The  (yearly) 
frequency  of  this  operation  depends  on  the  average  number  of  customer  declaration,  which 
each operator obtains per year. 

Sub-option a): the new obligations will apply only to AA. With 52 customer declarations / 
year,  the  yearly  administrative  costs  (including  business  as  usual  costs)  for  all  operators 
dealing with AA would amount to € 15.1 million.  The requirement that a copy of the customer 
declaration should accompany the substances when transported in the EU which is currently 
not the case for schedule 2 substances, would amount to an additional € 0.2 million 82. 

Sub-option b): the new obligations will apply to all category 2 substances: with 116 customer 
declarations / year, the yearly administrative costs (including business as usual costs) for all 
operators  dealing  with  substances  of  category  2  would  amount  to  over  € 84.4 million.  The 
requirement that a copy of the customer declaration should accompany the substances when 
transported in the EU, would amount to an additional € 1 million.  

It  is  debatable,  however,  to  what  extent  the  administrative  costs  resulting  from  this  option 
could  be  considered  business  as  usual  costs,  as  diligent  operators  do  actually  conduct  the 
verifications already today. Therefore, two different scenarios will be considered. 

SCENARIO 1: 100% business as usual costs for customer verification 

The  EIM  Report  suggests  that,  according  to  the  interviews  the  consultancy  carried  out, 
operators declared that they did only conduct business with companies that are known to them 
and for which they can check the authenticity, their activities and creditworthiness. Under this 
scenario, the costs linked to the main obligation under option 3, verification of the customer 
declaration,  could  be  considered  100%  business  as  usual  costs  and  there  would  be  no 
additional administrative burdens. 

82  EIM Report, section 3.4, p. 16. 

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The only remaining administrative costs would be the costs involved in sending a copy of the 
customer declaration. This would amount to € 0.2 million for sub option a) and € 1 million 
under sub-option b). A summary of the calculations is set out in Table 5. 

Table 5  Administrative burdens for registered operators under option 3, SCENARIO 1 
(100% business as usual for verification of customer declarations) 

Policy option 

Sub-option 

Total costs per year 

Administrative 

Business as  

Additional 

costs

usual costs 

administrative 

(AC)

(in % of AC) 

burdens

3  Strengthened  rules  and 

3a) Verification of the 

 € 15,132,157 

100% 

 €0

obligations  on  operators 

authenticity of the customer 

related 

to 

customer 

declaration data for AA only 

declarations 

from  end-

users (completely filled in 

customer 

declaration, 

verification  -  if  necessary 

by  authorities,  copy  of 

customer  declaration  on 

3b) Verification of the 

 € 84,411,687 

100% 

 €0 

authenticity of the customer 

declaration data for all 

substances of category 2 

3a ) Send a copy of the customer 

 € 180,145 

0% 

 € 180,145 

substances in category 2)  

declaration only for AA 

3b) Send a copy of the customer 

 € 1,004,901 

0% 

 € 1,004,901 

declaration for all substances 

SCENARIO 2: 70% business as usual costs for customer verification 

The assumption made in the EIM Report that all operators only do business with customers 
which they have thoroughly checked could be challenged as not realistic, given that there are 
still  cases  of  diversion  which  have  not  been  signalled  to  the  authorities  (as  evidenced  by 
seizures).  

In an alternative assumption, 30% of operators do currently not act in an ideal way and would 
have  to  increase  their  efforts  under  Option  2.  This  would  lead  to  higher  administrative 
burdens as detailed in Table 6: € 4.7 million  (4.5 million + 0.2 million) for sub-option a), and 
€ 26.3 million (25.3 million + 1 million) for sub-option b). 

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Table 6  Administrative burdens for registered operators under option 3: SCENARIO 2 
with 70% business as usual for verification of customer declaration 

Policy option 

Sub-option 

Total costs per year 

Administrative 

Business as usual 

Additional 

costs

(AC)

costs 

administrative 

(in % of AC) 

burdens

3  Strengthened rules and 

3a) Verification of the 

 € 15,132,157 

70% 

 €4,539,647

obligations on operators 

authenticity of the 

related to customer 

customer declaration 

declarations from end-

data for AA only 

users (completely filled in 

customer declaration, 

verification - if necessary 

by authorities, copy of 

customer declaration on 

substances in category 2) 

3b) Verification of the 

 € 84,411,687 

70% 

 € 25,323,506 

authenticity of the 

customer declaration 

data for all cat. 2 

substances  

3a) Send a copy of 

€ 180,145 

0% 

 € 180,145 

the customer 

declaration for AA 

only 

3b) Send a copy of 

€ 1,004,901 

0% 

 € 1,004,901 

the customer 

declaration for all 

cat. 2 substances 

7.5.1.2.  Competent authorities 

The costs for competent authorities under this option would depend on whether / how often 
operators have to involve their authorities because they cannot check the legitimacy of their 
customers by themselves.  

SCENARIO 1: No involvement of competent authorities 

The  EIM  Report  assumes  that  enterprises  are  able  to  verify  themselves  the  data  concerning 
their customers via sources such as Chambers of Commerce, banks, and others and that there 
is hence no need to involve competent authorities in this verification exercise. Consequently, 
there would be no additional costs for competent authorities. 

SCENARIO 2: Occasional involvement of competent authorities  

An  assumption  of  no  involvement  of  authorities  contradicts  one  of  the  key  findings  in  the 
Commission’s  own  evaluation  of  the  functioning  of  the  current  legislation,  where  it  was 
found, and subsequently confirmed by competent authorities on several occasions, that it was 
very  difficult  –  even  for  competent  authorities  themselves  –  to  verify  data  on  customers  in 
other  Member  States,  particularly  if  those  customers  claimed  to  be  end-users  which  are  not 
registered. It is, therefore, assumed that also for operators themselves, it is difficult to verify 
the  accuracy  of  information  provided  in  a  customer  declaration,  if  the  customer  is  based  in 
another Member State, in particular if that customer claims to be an end-user.  

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Under scenario 2, it is, therefore, considered plausible that competent authorities would need 
to invest the similar amount of time (per request) for a verification of a customer on request of 
an operator as they would under option 4 (assessed under Section 7.6.1.2 below) according to 
which  authorities  would  have  to  verify  all  new  end-user  customers  before  giving  an 
agreement for delivery. The time per verification (1 hour) amounts – as under option 4 – to an 
average administrative cost per verification of about € 26 in the EU. 

For the required frequency, it is assumed that about 10% of all customer declarations would 
require  verification  by  authorities,  because  operators  cannot  conduct  full  verification 
themselves.  Combined  with  the  relevant  number  of  customer  declarations  received  per 
operator in the EU (52/year for customer declarations for AA only; and 116/year for customer 
declarations  for  all  category  2  substances);  the  administrative  costs  for  the  involvement  of 
authorities would amount to € 0.2 million (sub- option a), and € 1.2 million (sub-option b) per 
year. 

Table 7  Administrative costs competent authorities under option 3 – SCENARIO 2 

(10% of customer declarations verified by authorities) 

Total costs per year 

Time spent/ 

10% of AA 

action 

Average 

customer 

Policy 

option 

Sub-option 

action 

operator 

operators 

costs 

price/ MS 

declarations / 

Number of 

Administrative 

3 

3a) Only for 

1h 

€ 25.63

5.2

1,622 

€ 216,174

1h 

€ 25.63

11.6

4,056 

€ 1,205,881

AA 

3b) For all 

substances 

cat. 2 

7.5.2.  Benefits 

With  regard  to  the  objective  of  preventing  diversion  of  AA,  option  3  would  increase  the 
responsibility of operators for the choice of their customers. The legislation already requires 
customers  to  fill-in  a  customer  declaration  with  details  including:  the  company  name  and 
address, its registration details (if applicable), and the intended use of the substance. However, 
the legislation does not add expressis verbis a mirroring responsibility for operators to prevent 
them  from  delivering  the  substance  ordered  if  the  customer  cannot  demonstrate  genuine 
motives for placing an order or if the customer declaration is incomplete. This option would 
remove this uncertainty.  

It should be noted that diligent operators and authorities do already conduct these verifications 
under the current Regulation – hence, the effectiveness of the option in preventing diversion is 
probably comparable to that of Option 1 (in particular in the assumption of a 100% Business 
as Usual Scenario). Still, it can be expected that the clarification of the legal text as foreseen 
in this option would lead to an increased vigilance of operators to verify the genuine motives 
of clients placing orders with them (in particular also for those who do not act as diligently as 
they  should)  and  would  increase  the  number  of  cases  where  operators  would  contact  their 

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authorities to signal suspicious transactions, e.g. when customer declarations are incomplete 
and/or when the indicated uses and quantities of substances ordered do not match the profile 
of the company having placed the order. 

This option would be fully in line with the spirit of the current legislation, which intends to 
emphasize the responsibility of operators. The co-operation between economic operators and 
authorities – which is a cornerstone for the success of the drug precursor legislation – might 
intensify  and  improve.  However,  this  will  only  work  if  operators  are  prepared  to  genuinely 
verify the content of customer declarations (rather than limit themselves to a 'tick-box' check 
of  completeness  without  verification  of  the  content  of  the  customer  declaration).  Good  and 
fast responsiveness of authorities to requests for assistance from operators will also be crucial 
as otherwise the climate of good co-operation might deteriorate quickly – this could become 
an  issue  where  potential  clients  are  based  in  other  Member  States  and  the  'inquiry  chain' 
would  have  to  involve  the  authorities  of  several  Member  States,  which  could  easily  lead  to 
delays.    

On the other hand, this option will not prevent traffickers from trying to find a 'weak link' and 
place orders with many different operators, hoping to find at least one who will not put too 
many efforts in verification of customer declarations before delivering the order.  

With regard to the objective of preserving the internal market, the situation would probably be 
similar  to  Option  1:  Member  States  might  still consider  that  it  would  be  necessary  to  adopt 
further  national  measures  under  Article 10  of  the  current  Regulation  to  reinforce  control  of 
trade  in  drug  precursors.  While  this  would  also  be  effective  with  regard  to  the  objective  of 
preventing the diversion of AA, it would be counterproductive with regard to the objective of 
avoiding fragmentation of the internal market. 

7.6. 

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

7.6.1.  Costs 

7.6.1.1.  Enterprises 

As detailed in Table 8, option 4 would cause administrative burdens of about € 0.04 million to 
notify all new end-user customers for AA to the authorities (sub-option a). The obligation to 
notify new end-user customers for all scheduled substances in category 2 to the authorities 
(sub-option b) would cost operators about € 0.5 million. 

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Table 8  Administrative burdens for registered operators under Option 4 

Policy option 

Su- option 

Total costs per year 

Administrative 

Business as usual 

Administrative 

costs

(AC)

costs 

burdens

(in % of AC) 

(AC – BAU)

4  Require operators to 

4a) Only for AA 

 € 41,572 

0% 

 € 41,572 

systematically notify new end-

users to the authorities to allow 

verification and request agreement 

for delivery from CA  

4b) For all  
substances cat. 2

 € 467,799 

0% 

 € 467,799 

7.6.1.2.  Competent authorities 

It  is  assumed  that  competent  authorities  would  need  about  1  hour  for  each  new  end-user 
verification.  As  detailed  in  Table  9,  this  would  involve  an  annual  cost  of  € 0.005 million  in 
the  EU  for  the  verification  of  notified  new  AA  end-user  customers  and  authorisation  of 
delivery (sub-option a).  If the verification and authorisation were required for new end-users 
of all category 2 substances (sub-option b), the annual costs would amount to € 0.03 million. 

Table 9  Administrative costs competent authorities under Option 4 

Policy option 

Sub-option 

Member States 

(AC)

4a) Only for AA 

4b) For all substances cat. 2 

All MS (27) 

All MS (27) 

 € 4,939 

 € 26,725 

Total costs per year

Administrative costs

It should be noted that Hungary has already requested its operators to make a notification to 
the authorities three days before any delivery to a new customer. In the Czech Republic and in 
Germany, operators have recently been requested to provide the authorities with information 
about their new customers. A notification of all (not only new) customers to the authorities is 
part of the national legislations of Italy and happens voluntarily in Austria. Consequently, in 
all  of  these  Member  States,  the  costs  incurred  by  the  proposed  option  4  are  expected  to  be 
lower  than  calculated  above,  depending  on  the  details  of  the  current  notification  to  the 
authorities. 

7.6.2.  Benefits 

This  option  has  the  potential  to  be  very  effective  in  preventing  diversion  while  keeping  the 
administrative burden both for operators and authorities directly proportionate to the risk. It is 
reasonable to assume that long-standing customer relations between a supplier and distributor 

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or end-user of a substance have a very low risk of diversion. In such situations the 'know your 
customer' principle is fully complied with. On the other hand, new customers – in particular 
those  claiming  to  be  end-users  and  hence  not  having  a  registration  number  attributed  by  an 
authority  –  always  present  a  bigger  challenge  for  operators  in  terms  of  verification  of  their 
genuine motives for placing an order. The risk that operators limit their efforts for verification 
of a new client is relatively high as delays in their acceptance of an order can lead to the result 
that the order is lost and placed elsewhere.  

The obligation  to systematically notify  all new clients to  the authorities will  ensure that the 
authorities themselves can conduct all appropriate verifications – if necessary also involving 
their homologues in other Member States – and in case of doubt they can prevent the operator 
from delivering the order and/or they can monitor delivery. It would also be more difficult for 
traffickers to try to find 'a weak link' in the EU as they should be subject to the same scrutiny 
by authorities in all Member States. As set out above, Hungary has already implemented this 
option by requesting notification of every transaction of AA with a new customer (or above a 
certain  threshold)  and  has  reported  to  find  this  measure  very  effective.  Germany,  however, 
which  recently  also  requested  its  operators  to  provide  them  with  information  on  new  end-
users, considered the systematic registration of all end-users to be more effective.  

On  the  other  hand,  this  option  would  entail  the  risk  of  de  facto  creating  different  control 
standards between end-users that have been involved in trade with drug precursors for a long 
time  and  new  market  entrants.  Whilst  it  is  true  that  an  end-user  who  changes  supplier  will 
become a new customer for the new supplier (and then be reported to the authorities) this will 
not happen if the end-user does not switch his long-standing supplier(s). On the other hand, 
new  market  entrants  (i.e.  companies  starting  to  buy  for  the  very  first  time),  will  always  be 
reported  to  the  authorities,  possibly  even  multiple  times  if  they  start  ordering  from  several 
suppliers. This might even become a barrier for new market entrants.  

Furthermore, during the consultations, some stakeholders held the opinion that option 4 could 
also  lead  to  some  counter-productive  effects.  The  drug  precursor  legislation  relies  on  the 
sensitisation  of  the  industry  to  the  risks  of  diversion  to  illicit  uses  of  the  substances  and  a 
(mainly voluntary) cooperation of the industry. A systematic notification of new customers to 
the  authorities  could  weaken  this  effect  of  self-responsibility  of  the  industry  for  detecting 
suspicious orders indicative of a diversion attempt. In fact, operators already now voluntarily 
involve  the  authorities,  if  they  are  uncertain  about  a  particular  order.  This  happens  in 
particular for orders from new customers83. 

This option would instead shift the responsibility to authorities who would ultimately decide 
on  the  fate  of  potential  new  business  relationships.  If  authorities  were  slow  in  replying  to 
operators  with  the  results  of  their  verifications,  operators  might  lose  potentially  genuine 
business which could create incentives to not comply with the notification obligation and the 
option could thus become ineffective. Also, some comments in the consultation added that it 
was only possible for the authorities to respond quickly, if the end-users had previously been 
registered  with  the  authorities,  so  that  authorities  would  have  the  information  available. 

83  For instance, Germany reported in the written consultation that requests from operators to the authorities to 
verify  new  customers  were  an  important  element  within  the  industry-authority  partnership  to  prevent 
diversion. 

EN 

39 

   EN 

 
                                                 
According to these views, a notification of new end-user customers would only be effective if 
combined with an end-user registration84. 

There  could  be  further  negative  effects  for  the  monitoring  of  the  non-scheduled  substances 
(loss of effectiveness of industry cooperation), which is entirely voluntary and necessary to be 
able to react to new diversion trends. 

With  regard  to  the  objective  of  preserving  the  internal  market,  Option  4  would  increase  the 
knowledge  of  authorities  related  to  a  part  of  the  end-users  (i.e.  those  placing  orders  for  the 
first time with operators). This would probably reduce somewhat the likelihood that Member 
States consider that it would be necessary to adopt further national measures under Article 10 
of the current Regulation to reinforce control of trade in drug precursors. However, given that 
Member  States  would  still  not  know  all  end-users  (i.e.  not  those  having  long-standing 
business relations with operators), some could still  consider  it  necessary  to  adopt  additional 
national control measures, which would be detrimental for the Internal Market.  

7.7. 

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

7.7.1.  Costs 

7.7.1.1.  For enterprises 

As detailed in Table 10, option 5 would create considerable one-off costs for the registration 
of  all  existing  end-users:  € 0.16 million  under  s ub-option  5a  (for  AA  end-users  only)  and 
€ 0.5 million under sub-option 5b (for all end-users of category 2 substances). 

the  option 

the  other  hand, 

On 
low  annual  costs  for  enterprises,  with 
€ 0.01 million/year  if  the  new  re gistration  requirements  would  apply  only  to  AA  end-users 
(sub-option  a)  and  € 0.07 million/year  for  a  registration  requirement  for  end-users  of  all 
category 2 substances (sub-option b)). 

involves 

84  Contribution of Hungary during the written consultation. 

EN 

40 

   EN 

 
                                                 
Table 10  Administrative burdens for registered end-users under Option 5 

Policy option 

Sub-option 

Total costs (per year for ongoing costs) 

Administrative 

Business as 

Administrative 

costs

(AC)

usual costs 

burdens

(in % of AC) 

(AC – BAU)

5  Require registration 

5a) One off costs end-

 € 158,457 

0% 

€ 158,457 

for end-users and 

user registration (current 

reinforce 

requirements 

regarding registration 

end-users only AA) 

5b) One off costs end-

 € 547,713 

0% 

€ 547,713

user registration (current 

end-users all subst. cat. 2) 

5a) Ongoing costs end-

 € 12,559 

0% 

€ 12,559

user registration (new end-

users only AA) 

5b) Ongoing costs end-

 € 65,357 

0% 

€ 65,357

user registration (new end-

users all subst. cat. 2) 

However, it cannot be excluded that Member States' authorities will charge registration fees to 
pass on the administrative costs which they will have to bear under Option 5 for granting the 
registration to enterprises (see next section for details). So far, only few Member States have 
already  introduced  registration  fees,  in  order  to  carry  over  their  costs  to  the  companies 
concerned85, but it cannot be excluded that the significant costs for authorities from Option 5 
would  lead  others  to  follow  this  example.  Should  Member  States  decide  to  levy  fees  for 
registration of end-users, the costs for enterprises would increase by the amounts calculated in 
Section 7.7.1.2. As micro-SMEs might be disproportionately affected by such a 'roll-over' of 
Member States' costs, it might be necessary to consider mitigation measures if Option 5 was 
implemented,  e.g.  the  legislative  proposal  could  prevent  Member  States  from  imposing 
registration fees on micro-SMEs. 

7.7.1.2.  Competent authorities 

As detailed in Table 11, registration of all existing AA end-users (sub-option a) would create 
one-off costs of € 0.4 million for authorities for regist ration of all exiting end-users of AA and 
annual costs of € 0.05 million for registrati on of new end-users of AA.  

In  sub-option  b,  competent  authorities  would  have  to  bear  one-off  costs  of  € 1.8 million  for 
the registration of existing category 2 end-users and, in addition, annual costs of € 0.2 million 
for registration of new category 2 end-users. 

85  Fore example, the UK currently charges £435 (approximately € 520) for issuing a new registration Article 2 
of  UK  Statutory  Instrument  2010  No.  2564  -  Dangerous  Drugs  -  The  Controlled  Drugs  (Drug  Precursors) 
(Intra-Community  Trade  and  Community  External  Trade)  Regulations  2010,  in  force  since  15 November 
2010, available at: HTTP://WWW.LEGISLATION.GOV.UK/UKSI/2010/2564/PDFS/UKSI_20102564_EN.PDF. Also 
the  Czech  Republic  and  Estonia  have  informed  the  Commission  during  the  written  consultation  that  they 
charge fees for granting licences and registrations. 

EN 

41 

   EN 

 
 
 
                                                 
As  mentioned  in  the  previous  section,  competent  authorities  could  decide  to  pass  on  these 
costs to end-users in the form of registration fees. In that case, they would have no additional 
costs to bear. 

Table 11  Administrative costs for competent authorities under Option 5 

Total costs (per year 

for ongoing costs) 

Administrative costs

Policy option 

Sub-option 

Member States 

(AC)

5a) One off costs only for AA 

All MS (27) 

 € 392,559 

5b) One off costs for all 

All MS (27) 

 € 1,801,674 

substances cat. 2 

5a) Ongoing costs only for AA 

All MS (27) 

5 b) Ongoing costs for all 

All MS (27) 

 € 47,934 

 € 236,190 

substances cat. 2 

It  should  be  noted  that  Belgium,  Denmark  and  Spain  register  end-users  already  under  the 
current  national  legislation.  An  introduction  of  a  registration  requirement  at  European  level 
would,  to  the  extent  that  the  current  national  system  is  comparable  in  terms  of  registration 
requirements, involve considerably fewer costs for the companies and competent authorities 
concerned in these Member States. 

7.7.2.  Benefits 

This option has been proposed by several Member States who have repeatedly stated during 
the  consultations  that  the  main  difficulty  which  currently  precludes  Member  States’ 
competent  authorities  from  effectively  preventing  diversion  is  their  lack  of  control  and 
knowledge  over  end-users.  As  end-users  are  not  registered  under  the  present  European 
legislation,  they  are  “unknown”  to  the  authorities  who  have,  hence,  difficulties  to  control 
them. 

Member  States  who  have  experience  with  an  end-user  registration  requirement  either  from 
past86 or current87 national legislation reported that the end-user registration has proved to be 
an effective tool. As is already required for operators, it will allow Member States to verify 
the  genuine  motives  of  end-users  with  regard  to  the  use  of  drug  precursors  during  the 
registration  process  and  thus  before  they  can  place  any  orders  to  purchase  drug  precursors. 
This would also facilitate the tasks of operators to verify that their customers have genuine 
motives as end-users placing an order would have to provide a customer declaration including 

86  This is the case for Germany, who had in its national legislation, prior to entry into force or Regulation (EC) 
No  273/2004,  a  requirement  for  all  end-users  of  category  2  substances  to  be  registered,  as  well  as  for  the 
Eastern  European  Member  States  (EU  12)  which  had  scheduled  AA  as  a  category  1  substance  prior  to 
accession. 

87  National legislation in Belgium, Denmark and Spain contains an obligation for end-users to register with the 
authorities.  Italy  has  a  very  detailed  database  system,  in  which  companies  are  required  to  notify  every 
transaction  before  delivery,  so  that  the  authorities  claim  to  have  effectively  an  overview  of  all  end-users. 
Austria and France apply a voluntary registration of end-users. 

EN 

42 

   EN 

 
 
 
 
 
 
                                                 
also an official registration number attributed by an authority. In line with these experiences, 
option 5 is the most favoured option by Member States according to the consultation carried 
out  in  2010:  58%  of  MS  considered  option  5  to  be  the  best  option  to  effectively  prevent 
diversion. 

However, the expected improvements in preventing diversion will only materialise if Member 
States  do  in  fact  control  applicants  for  registration  before  attributing  a  registration  number. 
Information  provided  during  the  consultations  has  cast  some  doubt  on  whether  this  actually 
happens: in fact, several Member States have claimed that the current wording of Article 3 (6) 
in Regulation (EC) No 273/2004 does not allow them to refuse registration – an opinion not 
shared  by  others  or  the  Commission  Services.  In  order  to  eliminate  any  doubts,  it  would 
therefore  be  necessary  to  amend  Article  3  (6)  and,  in  addition,  to  agree  certain  minimum 
requirements with regard to registration including also a visit to the premises of the applicant. 

Secondly, the option will only have the intended effect, if operators maintain their vigilance 
and verify that registration numbers of their (potential) clients are genuine and do not accept 
them  at  face  value  when  they  appear  on  a  customer  declaration.  Otherwise,  the  fact  that 
presumably official registration numbers appear on customer declarations of end-users could 
actually lead to decreased vigilance as operators would (wrongly) believe that the indication 
of  the  registration  number  does  automatically  legitimise  the  client.  Consequently,  operators 
will  have  to  conduct  the  same  efforts  as  described  under  option  1  (or  even  3),  involving, 
where necessary also the authorities. The Commission's intention to provide a data base with 
all registered operators (and also end-users in this option) would facilitate such verification. 

With  regard  to  the  objective  of  preserving  the  internal  market,  Option  5  would  greatly 
increase the knowledge of authorities related to end-users and this would strongly reduce the 
likelihood that Member States consider it necessary to adopt further national measures under 
Article 10 of the current Regulation to reinforce control of trade in drug precursors. Option 5 
would thus be very effective in preserving the Internal Market. 

7.8. 

Option 6: move AA from category 2 to category 1 

7.8.1.  Costs 

7.8.1.1.  Enterprises 

As  detailed  in  Table  12,  option  6  involves  one-off  costs  of  € 0.3 million  for  all  existing 
operators and end-users of AA for obtaining a licence to possess or sell AA within the EU.  

In  addition,  the  option  involves  yearly  costs  for  licensing  new  AA  operators  and  new  end-
users.  The  number  of  new  AA  end-users  has  been  calculated  based  on  the  Member  States' 
survey  as  196  per  year88),  which  (based  on  the  total  number  of  AA  end-users  of  2,473) 
amounts  to  a  ratio  of  8%  fluctuation  per  year.  The  answers  to  the  survey  did  not  contain 
information on the number of new AA operators per year. However, applying the same ratio 
of 8% fluctuation to the total number of AA operators in the EU 1,622, the number of new 
AA  operators  can  be  estimated  at  49  per  year89.  Based  on  these  calculations,  245  (196+49) 
companies per year would need to be considered for the yearly costs of this option. Combined 

88  See EIM Report page 20 "origin of some figures" and Annex 1 to that Study "Detailed calculations". 
89  49 new operators/year can be considered as a maximum, as the number of AA producers and traders (whose 

businesses requires a certain infrastructure) should be more stable than the number of end-users. 

EN 

43 

   EN 

 
                                                 
with the calculated price under this option for obtaining a licence (€ 76.89), the ongoing costs 
would amount to just under € 20,000. 

An  additional  annual  cost  of  € 180,000  has  to  be  added  for  the  obligation  of  operators  to 
stamp  and  date  a  copy  of  the  customer  declaration  and  have  it  accompany  AA  shipments 
being moved within the EU. 

Additional  yearly  costs  would  be  incurred  by  companies  if  the  change  of  category  would 
also  be  considered  under  Regulation  (EC)  No  111/2005  concerning  external  trade.  Under 
Art. 20  of  that  Regulation,  import  authorisations  are  required  for  each  individual  import 
consignment  of  category  1  substances.  According  to  the  consultation  carried  out  in  2010, 
enterprises  spend  55  minutes/year  to  obtain  an  import  authorisation  and  they  obtain  on 
average  3  individual  import  assignments  for  AA.  An  obligation  to  obtain  import 
authorisations for AA would amount to additional yearly costs of € 0.3 million. 

These costs would be further increased if Member States passed on the administrative costs 
which they bear for granting licences to enterprises. So far, some Member States have already 
introduced licensing fees, in order to recover their costs from the companies concerned90. In 
such  a  scenario,  the  costs  for  authorities  as  calculated  in  the  next  section  would  have  to  be 
the  costs  for  enterprises  calculated  above.  As  micro-SMEs  might  be 
added 
disproportionately affected by such a 'roll-over' of Member States' costs, it might be necessary 
to  consider  mitigation  measures  if  Option  6  was  implemented,  e.g.  the  legislative  proposal 
could prevent Member States from imposing licensing fees on micro-SMEs 

to 

90  Fore example, the UK currently charges £3,655 (approximately € 4,370) for issuing a new licence, Article 2 
of  UK  Statutory  Instrument  2010  No.  2564  -  Dangerous  Drugs  -  The  Controlled  Drugs  (Drug  Precursors) 
(Intra-Community  Trade  and  Community  External  Trade)  Regulations  2010,  in  force  since  15 November 
2010, available at: HTTP://WWW.LEGISLATION.GOV.UK/UKSI/2010/2564/PDFS/UKSI_20102564_EN.PDF. Also 
the  Czech  Republic  and  Estonia  have  informed  the  Commission  during  the  written  consultation  that  they 
charge fees for granting licences and registrations. 

EN 

44 

   EN 

 
                                                 
Table 12  Administrative burdens for licensed companies under Option 6 

Total costs (per year for ongoing costs) 

Policy option 

Costs per activity 

action

actions 

burdens

Labour costs per 

Number of 

Administrative 

6  Move AA from category 2 

One off costs obtaining a 

€ 76,89 

4,095 

€ 314,865 

to category 1 

license for AA 

Ongoing costs obtaining a 

€ 76,89

245 

€ 18,838

license for AA 

Ongoing cost: operators 

€ 2,13

84,344 

€ 180,145

must stamp and date a copy 

of the customer declaration 

and accompany it with AA 

being moved within EU  

If  move  of  category  is 

Ongoing costs for obtaining 

€ 28.83

12,285 

€ 292,793

also 

considered  under 

import authorisations for 

external trade 

each consignment of AA 

7.8.1.2.  Competent authorities 

Option  6  involves  one-off  costs  of  € 1.7 million  for  competent  authorities  for  licensing  all 
existing  companies  handling  AA,  which  is  almost  equivalent  to  the  one-off  costs  for  the 
authorities under option 5b. 

In  addition,  the  option  involves  yearly  costs  for  licensing  new  AA  operators  and  new  end-
users. According to the calculation above (section7.8.1.1) 245 companies need to be licensed 
by  the  authorities  each  year  (i.e.  all  new  AA  end-users  and  all  new  AA  operators).  The 
average price per action (issuing a licence for AA) in the EU has been calculated at € 414. As 
a result, the total yearly costs of option 6 amount to about € 0.4 million as detailed in Table 
13. 

Additional yearly costs would be incurred by competent authorities if the change of category 
would  also  be  considered  under  Regulation  (EC)  No  111/2005  concerning  external  trade. 
Under  Art. 20  of  that  Regulation,  import  authorisations  are  required  for  each  individual 
import  consignment  of  category  1  substances.  According  to  the  consultation  carried  out  in 
2010,  Member  States  spend  648  hours  /year  for  granting  679  import  authorisations  for 
category  1  substances91.  Based  on  the  estimates  provided  by  enterprises,  12,285  individual 
import  authorisations  would  have  to  be  granted  for  AA  each  year.  A  requirement  to  obtain 
import authorisations for AA would thus amount to additional yearly costs of € 0.1 million. 

91  This amounts to an average time of 57 minutes per import authorisation. 

EN 

45 

   EN 

 
 
 
 
 
                                                 
Table 13  Administrative costs competent authorities under Option 6 

Total costs (per year for ongoing costs) 

Authorities' 

average costs 

Number of 

Administrative 

Policy option 

Costs per activity 

per action

actions 

costs

6  Move AA from category 2 

One off costs obtaining a 

€ 414

4,095 

€ 1,697,070

to category 1 

license for AA 

Ongoing costs obtaining a 

€ 414

245 

€ 101,534 

license for AA 

If move of category is 

Ongoing costs for obtaining 

€ 24.38

12,285 

€ 299,549

also considered under 

import authorisations for 

external trade 

each consignment of AA 

7.8.2.  Benefits 

The benefits of option 6 in terms of a reduced likelihood of diversion of AA from legal trade 
are expected to be similar or even higher than those of option 5a. A change of category for 
AA  from  category  2  to  category  1,  would  automatically  subject  all  end-users  of  AA  to  the 
direct  control  of  the  authorities,  as  these  end-users  would  now  need  to  be  licensed  (which 
involves  even  stricter  requirements  than  a  registration).  In  addition,  also  operators  of  AA 
would  be  subjected  to  the  stricter  regime  of  a  licence,  instead  of  the  current  registration 
requirement. 

Option 6 would thus enable a better control of competent authorities over both end-users and 
operators of AA than the baseline scenario or any other option. 

However,  this  improved  control  is  linked  to  the  substance  AA  only.  This  can  be  seen  as 
beneficial in the sense that any increase in administrative burden is limited to that substance 
for which high volumes of diversions and diversion attempts have been shown in the past. On 
the  other  hand,  however,  limiting  the  option  to  AA  means  that  the  detected  structural 
weaknesses  of  the  regime  for  category  2  substances  are  not  addressed.  In  case  the  focus  of 
traffickers  should  shift  from  AA  to  another  substance  in  category  2,  the  legislative  changes 
carried out under option 6 would not be able to address this changed diversion trend92. 

With  regard  to  the  objective  of  preserving  the  internal  market,  Option  6  would  greatly 
increase the knowledge of authorities related to end-users and this would strongly reduce the 
likelihood that Member States consider it necessary to adopt further national measures under 
Article 10 of the current Regulation to reinforce control of trade in drug precursors. Option 6 
would thus be very effective in preserving the Internal Market. 

92  The same reasoning applies to sub-options 3a, 4a, and 5a which are also limited to AA. 

EN 

46 

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8. 

COMPARING THE OPTIONS 

Table 1493 compiles the information regarding expected benefits (in terms of effectiveness to 
achieve the operational objectives) and costs for each of the (sub-)options.  

8.1. 

Qualitative assessment of benefits  

The  effectiveness  scores  of  Option  1  (baseline  scenario)  have  been  set  at  "0",  both  for  the 
prevention of diversion and the preservation of the internal market. 

The analysis for Option 2 (increased reporting) has revealed that it is not an effective tool to 
prevent  the  diversion  of  AA  (Option  2a)  or  of  all  category  2  substances  (Option  2b),  as 
competent  authorities  would  not  have  the  means  to  check  very  large  datasets  on  legal 
transactions  to  find  a  relatively  small  percentage  of  diverted  substance  (0.02%  of  totally 
produced AA is diverted). This leads to a '0' score. 

Option  3  (increased  obligations  on  operators  relating  to  checking  of  customer  declarations) 
would require operators 'expressis verbis' not to deliver any orders if the customer declaration 
has  not  been  correctly  filled  in.  Even  though  diligent  operators  will  already  now  do  these 
checks,  the  option  will  provide  legal  clarity  on  the  obligation  to  do  so  and  is  therefore 
considered to bring about some improvement in preventing diversion (score: +). With regard 
to  the  preservation  of  the  internal  market,  Member  States  are  likely  to  consider  it  equally 
necessary under option 2 and option 3 to adopt national measures, so that the score for both 
options would be "0", as in the baseline scenario. 

Options 4 and 5 have both the potential to be very effective in preventing diversion, but with 
conceptually  different  approaches:  Option  4  focuses  on  new  end-user  customers,  which  are 
placed  under  scrutiny  through  a  notification  obligation  of  operators  (to  authorities)  for  their 
new  end-user  customers.  This  has  the  advantage  that  the  authorities  focus  their  limited 
resources  on  the  group  of  "most  risky  customers",  the  ones  not  previously  known  to  the 
operator. This focussed risk-based approach could be considered more efficient than a general 
"register all end-users" approach under option 5, where fraudulent customers may be lost in 
the higher numbers of many licit end-user customers. On the other hand, option 4 entails the 
risk  of  creating  different  control  standards  for  end-users,  who  are  new  market  entrants  or 
switch suppliers, compared to well-established end-users, who remain with existing suppliers, 
whilst option 5 has the advantage of providing the authorities with a complete overview of all 
end-users  in  their  territories.  In  case  of  need,  this  enables  them  to  act  quickly  and  target 
enforcement actions on some of these end-users following specific market intelligence (i.e. to 
carry out an individual risk-based measure).  

As a result, it is considered that options 4 and options 5 can be considered as having almost an 
equivalent  score  of  effectiveness  in  preventing  diversion  (++),  option  4  scoring  arguably 
slightly weaker if one factors in that it does imply different control standards, which has been 
indicated as (+[+]) in the table. In terms of preserving the internal market, however, due to the 
overwhelming preference of Member States for option 5, option 4 involves a non negligible 
risk of national measures being adopted in addition. Therefore Option 5 scores better (+++) 
than option 4 (++) in this respect.  

93  Total costs in this table are based on the sum of the exact individual components. Therefore they do not fully 

correspond with the totals of the (rounded) components in this table. 

EN 

47 

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Under option 6, the strongest tools available under the current legislation would be applied to 
AA.  Therefore  it  has  the  highest  effectiveness  score  for  preventing  diversion  (+++)  and, 
together with option 5, the highest score for preserving the internal market (+++). 

8.2. 

Assessment of costs 

When comparing the costs to the expected effectiveness, Option 2 can be discarded as it will 
trigger  significant  costs  –  in  particular  for  companies  –  without  clear  benefits  in  terms  of 
reducing the risk of diversion of drug precursors in category 2 from legal trade.  

For  options  3,  4,  and  5,  a  choice  has  to  be  made  whether  the  options  should  apply  to  all 
scheduled  substance  in  category  2  or  to  AA  only,  whereas  option  6  is  targeted  at  AA 
exclusively. At first sight, it may seem more consistent to apply the options to all substances 
in  the  same  category  as  the  weaknesses  identified  in  the  prevention  of  diversion  (especially 
insufficient  control  of  end-users)  apply  equally  to  all  substances  in  that  category.  However, 
the  sub-options  affecting  all  category  2  substances  subject  a  considerably  higher  number  of 
companies to obligations and create significantly higher additional administrative burdens and 
costs, whilst only AA has been consistently identified by both the INCB and Member States' 
competent  authorities  as  problematic  during  the  consultation  process.  In  addition,  the  main 
principle of the legislation is that there are different levels of control for different substances – 
depending on the particular diversion risk of each substance concerned. Therefore, the choice 
should be limited to options addressing AA only. Consequently, sub-options 3b, 4b and 5b 
should be eliminated. 

The  cost  calculation  of  Option  3a  distinguishes  two  alternative  scenarios.  The  EIM  Report 
suggested  that  all  (100%  of)  enterprises  are  already  verifying  the  legitimacy  of  their 
customers' business before delivery (scenario 1: no additional costs for enterprises), and that 
enterprises never need to involve their authorities in this verification (scenario 1: no additional 
costs for authorities). As explained under Section 7.4, under a more realistic assumption only 
70%  of  operators  do  already  act  in  an  ideal  way  and  verify  their  customers  before  delivery 
(scenario 2 for enterprise costs), and for 10% of all customer declarations, enterprises need to 
involve  their authorities  (scenario 2 for authority costs).  Based  on scenario 2,  option  3a has 
the  highest  total  yearly  costs  from  the  remaining  options  (€  4.7  million),  without  clear 
benefits  both  for  reducing  diversion  and  for  preserving  the  internal  market  and  should 
therefore be eliminated as well. 

EN 

48 

   EN 

 
 
1 

2 

2a 

2b 

2a+2b 

3 

3a  
(AA only) 

3b 

4 

5 

4a  
(AA only) 

4b 

5a  
(AA only) 

Table 14  Comparative table on costs and benefits 

Option 

Benefits/Effectiveness 

Costs for companies 

Costs for authorities 

Total Costs 

Prevent  
diversion 

Preserve int. 
market  

0 

0 

0 

0 

+ 

+ 

0 

0 

0 

0 

0 

0 

€ 0
Risk of fragmented market 

€ 5.6 mio/year 

€ 1.5 mio/year 

€ 11.4 mio/year 

€ 0.2 mio/year 

€ 4.7 mio/year 

Scen. 1: (no authority  
involvement) 

Scen. 2: (authorities  
involved in 10% of cases) 

€ 0 

€ 0 

€ 1 mio/year 

€ 0.3 mio/year 

€ 2.1 mio/year 

€ 6.6 mio/year  

€ 1.8 mio/year 

€ 12.5 mio/year 

€ 0

Scen. 1: 

€ 0.2 mio/year 

€ 0.2 mio/year 

Scen. 2:  

€ 4.9 mio/year 

€ 1 mio/year 

Scen. 1: 

€ 0 

Scen. 1: 

€ 1 mio/year 

€ 26.3 mio/year 

Scen. 2: 

€ 1.2 mio/year 

Scen. 2: 

€ 27.5 mio/year 

Scen. 1 (100%  
business as usual): 
Scen. 2: (70%  
business as usual):  

Scen. 1: 

Scen. 2: 

+[+] 

++ 

€ 0.04 mio/year 

€ 0.005 mio/year 

€ 0.05 mio/year 

+[+] 

++ 

++ 

+++ 

€ 0.5 mio/year 

€ 0.16 mio
+ € 0.01 mio/year 

Alt. Scen: (company 
registration fees)  

€ 0.55 mio
+ € 0.06 mio/year 

Alt. Scen:  

  5b 

++ 

+++ 

€ 0.5 mio
+ €0.07 mio/year 

6    (AA only) 

+++ 

+++ 

Alt. Scen: (company 
registration fees) 

€ 2.3 mio
+ € 0.3 mio/year 

Alt. Scen: 

[or: incl. ext. trade 

Alt. Scen:(company 
licensing fees) 

€ 0.3 mio
+ € 0.2 mio/year
+ 0.5 mio/year] 

€ 2.0 mio
+ € 0.3 [or + 0.9] 
mio/year 

[or: incl. ext. trade 

Alt. Scen: 

€ 0.03 mio /year 

€ 0.39 mio
+€ 0.05 
mio/year 

€ 0 

€ 1.8 mio
+ € 0.2 
mio/year 

€ 0 

Alt. Scen:  

Alt. Scen: 

€ 1.7 mio
+ € 0.1 
mio/year
+ 0.4 mio/year] 

€ 0 

[or incl. ext.tr. 

Alt. Scen: 

€ 0.53 mio/year 

€ 0.55 mio 
+ € 0.06 mio/year 

€ 0.55 mio 
+ € 0.06 mio/year 

€ 2.3 mio 
+ € 0.3 mio/year 

€ 2.3 mio 
+ € 0.3 mio/year 

€ 2.0 mio 
+ € 0.3 mio/year 
+ 0.9 mio/year] 

€ 2.0 mio 
+ € 0.3 [or + 0.9] 
mio/year 

EN 

49 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Options 4a, 5a and 6 have similar benefits, both in preventing diversion and in preserving the 
internal  market.  However,  Option  6  can  be  singled  out  for  creating  very  high  additional 
costs: it involves one-off costs of € 2.0 million (a gainst € 0.55 million for option 5a and none 
for option 4a) and yearly costs of at least 0.3 million94 (against € 0.06 million for option 5a 
and  € 0.05  million  for  option  4a).  Looking  at  th e  costs  for  companies  only,  the  differences 
between Option 6 and options 4a/5a are even more striking. In terms of cost efficiency, option 
6 therefore scores as least favourable and can also be excluded. 

Options 4a and 5a remain as most promising. The overall costs for Option 5a compared to 
its benefits are clearly higher than for Option 4a. However, this is mainly due to the 'one-off' 
costs  for  the  registration  of  a  high  number  of  existing  end-users  –  the  main  part  of  these 
registration  costs  will  be  for  the  authorities:  € 0.39 million  compared  to  € 0.16 million  for 
companies. 

Based  solely  on  the  overall  cost/benefits-ratio  for  authorities  and  companies  combined  (and 
including the one-off registration costs) Option 4a would prevail as the preferred option. 

However, leaving the fixed costs aside (they can be disregarded once all existing companies 
have  been  registered),  cost  differences  are  less  pronounced:  Option  5a  is  better  from  the 
perspective of companies (Option 5a amounts to only 25 % of the yearly costs expected for 
Option 4a), whereas Option 4a is advantageous from the perspective of authorities (only 10% 
of the yearly costs expected for Option 5a). 

Considering that Option 5a thus involves lower annual costs for companies and that it has, at 
the same time, the greatest political support from the majority of Member States would be an 
argument  for  choosing  Option  5a  as  the  preferred  option.  The  argument  of  lower  annual 
costs for companies would, however, no longer be true if Member States decided to recover 
their  costs  from  registrants  by  charging  registration  fees,  as  for  example  the  UK  has 
introduced  recently.  The  effects  of  a  potential  passing-on  of  the  authorities'  costs  to 
companies have therefore been calculated as an "alternative scenario" under Option 5. 

However,  putting  the  combined  total  yearly  costs  of  either  option  (€ 0.05 million  for 
Option 4a and € 0.06 million for Option  5a into perspective with the total European market 
value of AA (> € 257 million/year 95), their impact is quite limited. Also the one-off costs of 
€ 0.16 million for companies and of € 0.29 milli on for authorities are low in comparison. 

In conclusion, both Options 4a and 5a are considered good choices to address the identified 
objectives. The selection of either of them is primarily a political choice. The strong political 
support which Option 5a 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  may  tip  the  balance  in  the  end  in  favour  of  Option  5a.  An  additional 
argument for Option 5a would be considering the specific impacts on SMEs (see below).  

94  If the change of category for AA is also carried out in Regulation (EC) No 111/2005 on external trade, the 

yearly costs under option 6 would rise by an additional 0.6 million to 0.9 million. 

95  An exact relation with the European turnover of AA is not possible, as there are no published market prices 
for AA. However, based on market research, the production of AA in the Europe amounts to approximately 
330,000 tons/year and the EU import value per ton amounted to 780 Euros on average over the last three years 
(2007-2009), which corresponds to a market value of the European production of € 257,4 mio/year. See: 2010 
CEH  Marketing  Research  Report  on  Acetic  Anhydride  ©  by  the  Chemical  Economics  Handbook  –  SRI 
Consulting, page 30 (European production) and page 32 (price). 

EN 

50 

   EN 

 
                                                 
Competitiveness check and SME check  

In view of the relatively low costs of either option in relation to the overall market value of 
the European AA production, a tangible impact of the competitiveness of European industry 
is not expected. 

The  preferred  options  would  both  have  effects  on  SMEs.  SMEs  dealing  with  AA  are 
primarily end-users. SMEs have been involved in the consultation with a targeted consultation 
via the Enterprise Europe network96. While about 50% of them expressed a preference for not 
changing the legislation at all, option 5 was the second preferred option (15% or respondents), 
while options 2, 3 and 4 were chosen by respectively 7-8% of the respondents. This result is 
in  line  with  the  analysis  that  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),  an 
argument which is particular relevant for SMEs. 

The  present  initiative  would,  under  none  of  the  options,  envisage  a  general  exclusion  of 
micro-companies,  as  this  would  create  an  easy  possibility  of  circumventing  the  controls  of 
the  legislation.  Traffickers  could  establish  themselves  as  micro-entities  in  order  to  evade 
controls  by  the  authorities.  It  should,  however,  be  born  in  mind  that  micro-companies  are 
most  likely  to  benefit  from  the  existing  thresholds  under  the  current  legislation:  Art. 6  of 
Regulation (EC) No 273/2004 foresee that companies with sales/purchases of drug precursors 
below the maximum yearly quantities97 are excluded from most of the obligations under the 
legislation98.  

Finally,  as  mentioned  in  Section  7.6.1.1  a  specific  protection  of  micro-SMEs  would  be 
foreseen in option 5 to prevent Member States to impose registration costs on micro-SMEs. 

9. 

MONITORING AND EVALUATION  

9.1.  Measuring the fulfilment of objectives 

The  Commission  will  continue  to  collect  Member  States'  annual  statistics  of  seizures  and 
stopped shipment of drug precursors diverted in the EU99. These statistics will show whether 
under the new legislative measures a downward trend of seizures of diverted substances and 
of  stopped  shipments  (indicating  diversion  attempts)  can  be  observed.  These  statistics  will 
have to be compared to the overall quantity of AA produced and traded in the EU. 
The  extent  to  which  Member  States  will  legislate  in  addition  to  the  European  legislation100 
will  provide  the  Commission  with  an  indication  whether  the  objective  of  ensuring  a  proper 
functioning of the internal market will be achieved. 

9.2. 

Supporting the implementation of the new legislative measures 

The  Commission  will  develop,  together  with  Member  States  experts  and  interested 
stakeholders, a number of accompanying activities to facilitate the implementation of the new 

96  See Section 0. 
97  For AA the yearly maximum quantity amounts to 100 litres. 
98  Notably  the  obligation  to  register  with  the  authorities,  the  obligation  to  comply  with  the  rules  on  customer 

declarations and on documentation of transactions. 

99  As foreseen in Article 13 of Regulation (EC) No 273/2004 and Art. 29 of Regulation (EC) No 1277/2005.  
100  

Member States are obliged to inform the Commission of national measures they adopted according to 

Art. 16 of Regulation (EC) No 273/2004. 

EN 

51 

   EN 

 
                                                 
measures,  such  as  an  update  of  the  existing  guidelines,  e-learning  tool,  FAQ  document  and 
other awareness-raising activities. 

9.3.  Monitoring the implementation of the new legislative measures 

Member  States  will  have  to  continue  their  ongoing  monitoring  activities  with  regard  to  the 
correct  implementation  of  Regulation  (EC)  No  273/2004,  which  will  include  the  amended 
provisions.  

As in previous years, the Commission will analyse the data provided by EU Member States 
which  forward  results  relating  to  the  licit  and  illicit  trade  of  drug  precursors  to  the 
Commission  on  a  quarterly  basis  and  will  report  yearly  on  statistics  of  stopped  or  seized 
shipments of AA. 

The  system  will  be  improved  with  the  implementation  of  the  database,  which  is  currently 
being  developed  by  the  Commission  that  shall  facilitate  the  collection  and  analysis  of 
statistics. The database is expected to start being operational in the beginning of 2013. 

The  Drug  Precursors  Committee/Working  Group,  composed  of  the  Member  States  and  the 
Commission,  will  continue  to  analyse  any  issue  related  to  the  implementation  of  the 
Regulation, including the new measures it will provide for. 

The Commission will  ensure that  all  stakeholders are given  the opportunity to  express their 
views  and  concerns  with  regards  to  the  application  of  the  Regulation,  including  the  new 
measures,  through  the  appropriate  channels.  In  particular,  if  considered  appropriate, 
stakeholders  will  be  invited  to  participate  in  a  meeting  of  the  Drug  Precursors  Working 
Group/Committee together with the Commission and representatives of Member States. 

Five  years  following  the  implementation  of  the  legislative  amendments,  the  Commission 
Services  intend  to  carry  out  an  evaluation  in  consultation  with  Member  States  and 
stakeholders, to assess whether the amended legislation will have been effective to prevent the 
diversion of AA. 

EN 

52 

   EN 

 
ANNEXES  

Annex 1 :   Summary of stakeholder consultation and SME consultation 

Annex 2 :   Overview of major drug precursors, their legitimate and illicit uses 

Annex 3 :  Summary of obligations for drug precursors 

Annex 4 :  Statistics of seizures and stopped shipments for all scheduled substances 

in category 2

EN 

53 

   EN 

 
 
 
Annex 1: 

Summary of stakeholder consultation and SME consultation 

a) Member States consultation 

Results Member States survey 

Option 1 

Option 2

Option 3 

Option 4

Option 5

Option 6

Benefits

additional national legislation?
number of suspicious transactions category 1 substances
number of suspicious transactions AA
number of suspicious transactions category 2 except AA
follow-up-time suspicious transactions (hours)
time spent on verification of record of transactions (hours)
number of operators to verify
percentage of total number of licenced operators
percentage of total number of registered operators
Processing time reported info current EU legislation per year (hours)
Processing time reported info additional from national legislation per year (hours)
Number of end-users purchasing cat. 2 substances
Number of registered operators purchasing cat. 2 substances
Exempted number of end-users purchasing cat. 2 substances
Exempted number of operators purchasing cat. 2 substances
Number of end-users purchasing AA
Number of registered operators purchasing AA
Exempted number of end-users purchasing AA
Exempted number of operators purchasing AA
Number of new end-users all substances cat. 2 
Number of new end-users AA 
Time spent on processing applications for registration (in hours)
Number of applications for registration per year

Time spent on processing per application (in hours)
Time spent on verification and granting of an application for a licence (hours)
Time spent on a check on requirements of licence (hours)
Costs of such a check (euro)
Time spent on a check of necessary documentation when moving cat 1 substances (hours)
Costs of such a check (euro)
Number of movements of cat 1 substances per year
Number of import authorisations granted per year
Time spent on granting an import authorisation (hours)
Number of individual import consignments of AA
Experience of diversion?
Best option

EN 

Average 
per MS 

0
0
0

19
4
20 26
15 42

yes -
0 2
1
0
1 -
0
0
0
0 -
0
115
16 480 80
0
320 130 240 20 178
15 58 27
30 5
35
30 60 57

MT EE IE LT RO SE
no yes yes yes yes
1
0
0
0
0
0
-
0
-
-
4
5
0
67
67 20
-
-
1
9
0
2
1
6
0
3
0
-
-
10 7

160 160 528 160 100 222
120
-
800 252
-
34 26 32 26
22 25
-
-
-
-
-
4
12 6
3
15 175 40 58
-
-
24
6
-
-
50
46 -
-
-
-
10
-
400 70
112 -

180 1010 680 468
9
15 4

0
80 44
2
20
25 34

120 49
40 13
6

-
200 8

144 10 7

6
151

120 -

65

17

-
-

8

8

16 9
40 10
-
56 32 92 20
-
20 8
-
-
-
-
-
-
16 8
-
-
-
-
-
-
1
-
1
-
6
0
1
-
48 30 15
-
-
-
-
0
0
no no no
no -
5
3
5
2

5
-
-
-
-
9

5

-

15
1
48
40
11
-
-
-
12
-
-
-
1
2
25 8
30
25
0
0
no -
-
6

Total all 
MS 
-
5
2
0
1037
1598
170
236
374
1994
1080
2270
224
4208
441
115
75
518
74
396
54
1355
305

136
432
99
-
108
-
12
74
266
0
-
-

54 

Block A (9 MS)

Block B (10 MS)

CZ GR
yes
yes
0
20
0
10
0
3
0
48
560 320
15
41
28
10
8
23
800 80
120 -
450 90
45
49
1000 -
15
40
10
80
10
26
-
70
5
3
-
2
-
-
104 -
4

10

SK HU
yes
yes
-
1
3
1
-
1
80
-
1800 480
655 30
100 60
40
1

AT FI
yes no
8
12
34 0
26 1
0
-
-
-
15 5
80 50
60 5
120 120 880
-
80
40
-
140 107 400
-
56
53 50
100 92
-
10
10
-
37
-
40
33
34 15
31
30
-
6
5
-
-
20
-
-
-
3
32
80 80
6
10
5

56
300
3
70
18
65
2
65
15
264
11

1440

Average 
per MS

15
7
5
26

NL PT
no yes -
0
0
0
0
80 648
121

66
-
-
200 5
56 10 49
20
5
-
400
-
-
420
-
-
237
-
-
78 55
-
373
-
-
16
-
-
-
-
47
26 23
-
49
-
-
4
-
-
29
-
-
9
-
-
50 102
-
18 9
-

Total all 
MS 
-
153
69
52
256
6480
1208
493
203
4000
4200
2374
553
3730
156
474
231
490
42
290
90
1017
91

DK DE
yes no
0
4
0
23
0
2
-
-
64 3750
75
-
-
-
-
-
16 1760
-
-
125 650
550
-
25000
-
-
-
140
-
260
-
-
-
-
-
50 -
3
-
60 27
18
9

Block C (8 MS)
Average 
per MS 

2

9
2

FR
yes -
26 10
4
3
240 240
240 1351
30 53
10 10
2
320 699
35 35
689 488
763 657
25000
-
-
-
331 236
339 300
-
-
-
-
35 43
10 7
18 35
35 21

5

26
112 200
-
-
-
-
-
-
-
-
200 5
1
11
40
40
0
-
no
yes
4 and 5 5
-

16 8
80 100 32
-
-
-
-
-
5
6
-
yes no

24
80
8
8
2
2500 232 -
-
-
-
-
-
-
-
-
1
3
2
0
104
16
-
2
0
-
yes
yes
2, 3 and 4 1
5

14
3
40 92
-
-
-
-
-
-
-
-
-
-
2
21 3
4
-
60 -
yes no -
-
6

6
1366
-
-
52
6
35
16

5

137
920
60
13660
-
-
520
58
350
155
-
-

2
7
2
3
-
-
-
-
-
-
-
-
2500
-
167
8
1
3
5
50
no yes
-

3
2
2

1
2
2
100 100
50 50
100 100
-
30 68
8
-
no -
-

4
28

2500

2 and 5 5

Total all 
MS 
-
80
72
13
1920
10811
420
80
16
5589
280
3904
5252
200000
-
1884
2396
-
-
340
52
280
165

23
19
16
800
400
800
20000
547
32
220
-
-

EN 

 
  
 
b) stakeholder consultation (operators and end-users) 

1

General
Number of respondents
W hich countries

2 Have you ever noticed something suspicious?

3

How many notifications of suspicious  
transactions for scheduled substances in 
category 2 other than AA do you make to the 
authorities per year?

How many notifications of suspicious  
transactions for AA do you make to the 
authorities per year?

4 How much time do you spend per year on 
contacts with competent authorities on 
suspicious transactions?

5

How much time do you spend per year  for 
reporting of information to authorities under EU-
legislation?
How much time do you spend per year for 
reporting of information to authorities under  
national reporting rules (if applicable)?

End-users 

Answer

Austria
Czech Republic
France
Germany
Greece
Hungary
Ireland
Lithuania
Norway
Slovakia
Spain
UK
Several MS
No answer

Option 1
Yes
No

n
106
9
-
49
2
5
3
1
7
-
5
6
1
14
4

7
99

Option 2

Operators

Answer

Austria
Czech Republic
France
Germany
Greece
Hungary
Ireland
Lithuania
Norway
Slovakia
Spain
UK
Several MS
No answer

mean = 0,4

0
mean = 0,9

0
0

mean = 21 hours

mean = 9 hours

n
54
3
1
5
4
4
1
5
-
1
2
2
1
10
15

36

32
37

31
26

42

23

EN 

55 

   EN 

 
 
 
Option 3

6

7

8

9

How many end-user-clients do you have for 
scheduled substances in category 2?
How many registered-operators-clients do you 
have for scheduled substances in category 2?
How many customer declarations do you receive 
per year from end-users?
How many customer declarations do you receive 
per year from registered operators?
How many end-user-clients are exempted form 
the registration obligations because they fall 
under the threshold?
How many registered-operators-clients are 
exempted form the registration obligations 
because they fall under the threshold?
How many end-user-clients do you have for AA?

How many registered-operators-clients do you 
have for AA?
How many customer declarations do you receive 
per year from end-users?
How many customer declarations do you receive 
per year from registered operators?
How many end-user-clients are exempted from 
the registration obligations because they fall 
under the threshold?
How many registered-operators-clients are 
exempted form the registration obligations 
because they fall under the threshold?
How much time do you spend to verify a 
customer declaration (if registered operator)?
How much time do you spend to verify a 
customer declaration (if end-user)?
How many customer declarations do you verify 
per year (if registered operator)?
How many customer declarations do you verify 
per year (if end-user)?
How much time do you spend to fill in a 
customer declaration for your purchases of 
category 2 substances?
How many customer declarations do you fill in 
per year?

mean = 56

mean = 7

mean = 134

mean = 21

mean = 22

mean = 4

mean = 31

mean = 5

mean = 60

mean = 12

mean = 10

mean = 2

mean = 17 minutes

mean = 41 minutes

mean = 39

mean = 154

mean = 46 minutes

mean = 10

37

32

29

28

20

17

35

33

26

26

25

23

6

11

26

23

19

22

EN 

56 

   EN 

 
 
Option 4

Option 5

Option 6

10 Do you have information how many new end-
users of substances in category 2 there are?
11 Do you have information how many new end-

users of AA there are?

12 How much time do you spend to register for 

placing on the market of scheduled substances 
in category 2?

13 Please provide us with the description of the 

process of registration 

14

How much time have you spend to obtain a 
licence for scheduled substances in category 1?

How much costs have you spend to obtain a 
licence for scheduled substances in category 1?

How much fees have you spend to obtain a 
licence for scheduled substances in category 1?

15 Please provide us with the description of the 

process of obtaining a licence 

16 How much time and costs do you spend per 

year to implement all requirements to the licence 
of a scheduled substance in category 1?

17

18

How much time do you spend per year to 
provide for certefied copies of customer 
declarations accompanying every move of 
scheduled substances of category 1?
How much costs do you spend per year to 
provide for certefied copies of customer 
declarations accompanying every move of 
scheduled substances of category 1?
How many movements of scheduled substances 
in category 1 do you make within the EU each 
year?
How many import authorisations do you obtain 
each year?
How much time do you spend each year to 
obtain import authorisations?
How much costs do you spend each year to 
obtain import authorisations?

19 How many individual import consignments of AA 

do you obtain each year?

mean = 11

mean = 3

mean = 136 minutes

open answers

mean = 82 minutes

mean = 101 euro

mean = 445 euro

open answers

open answers        
(no categories)

25

28

18

47

21

10

8

47

17

mean = 668 minutes

10

-

mean = 243

mean = 3

mean = 175 minutes

-

mean = 3

1

19

24

28

2

27

EN 

57 

   EN 

 
 
20 Do you have experienced specific cases of 

diversion or diversion attempts of scheduled 
substances in category 2?

21 Which of the described options would be most 
efficient to achieve a better to achieve a better 
prevention of diversion of AA or other scheduled 
substances in category 2? (multiple response )

Benefits

Best option 
option 1

option 2
option 3
option 4
option 5
option 6

29

3
5
11
3
4

yes

no

option 1

option 2
option 3
option 4
option 5
option 6

3

28

8

1
2
1
4
1

EN 

58 

   EN 

 
 
 
 
 
 
 
c) SME consultation 

A) Profile of your company  

 In which country is your company based? Please indicate: 

Number of 
requested 
records 

% Requested 
records(60) 

% of 
total number 
records(60) 

Austria 

Belgium 

Bulgaria 

Cyprus 

Czech Republic 

Denmark 

Estonia 

Finland 

France 

4 

3 

0 

0 

0 

0 

1 

0 

0 

6,67% 

5,00% 

0,00% 

0,00% 

0,00% 

0,00% 

1,67% 

0,00% 

0,00% 

6,67% 

5,00% 

0,00% 

0,00% 

0,00% 

0,00% 

1,67% 

0,00% 

0,00% 

Germany 

13 

21,67% 

21,67% 

Greece 

Hungary 

Ireland 

Italy 

Latvia 

Lithuania 

Luxembourg 

Malta 

Netherlands 

Poland 

0 

1 

2 

4 

0 

9 

0 

0 

0 

8 

0,00% 

1,67% 

3,33% 

6,67% 

0,00% 

0,00% 

1,67% 

3,33% 

6,67% 

0,00% 

15,00% 

15,00% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

13,33% 

13,33% 

EN 

59 

   EN 

 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Portugal 

Romania 

Slovakia 

Slovenia 

Spain 

Sweden 

United Kingdom 

Other 

0 

0 

0 

0 

4 

7 

0 

4 

0,00% 

0,00% 

0,00% 

0,00% 

6,67% 

0,00% 

0,00% 

0,00% 

0,00% 

6,67% 

11,67% 

11,67% 

0,00% 

6,67% 

0,00% 

6,67% 

2. How many employees does your company employ?  

Number 
requested 
records 

of 

Requested 

% 
records(60)      

of 

% 
total number 
records(60)      

a) 0-9    

b) 10-49  

c) 50-250 

17 

21 

22 

28,33% 

35,00% 

36,67% 

28,33% 

35,00% 

36,67% 

4.  For  what  purposes  are  drug  precursors  used  in  your  business?(more  than  1  choice 

possible) 

Number of 
requested 
records 

% Requested 
records(60)      

% of 
total number 
records(60)      

• plastics 

• rubber  

• textiles 

• dyes  

• photochemical 
agents  

• perfumes  

6 

1 

2 

7 

3 

0 

10,00% 

10,00% 

1,67% 

3,33% 

11,67% 

5,00% 

1,67% 

3,33% 

11,67% 

5,00% 

0,00% 

0,00% 

EN 

60 

   EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
• explosives  

0 

• pharmaceuticals 

13 

• biocides and 
plant protection 
products  

4 

• cleaning  

11 

6 

5 

1 

3 

2 

• bleaching  

• disinfectant  

• deodorants  

• food  

• flavouring  

• other (please 
specify): 

0,00% 

21,67% 

6,67% 

18,33% 

10,00% 

8,33% 

1,67% 

5,00% 

3,33% 

0,00% 

21,67% 

6,67% 

18,33% 

10,00% 

8,33% 

1,67% 

5,00% 

3,33% 

23 

38,33% 

38,33% 

B) Questions in relation to option 1: no changes of EU legislation 

5. Have you ever noticed anything suspicious, or have you noticed negligent behaviour, 
when you were offered scheduled substances for purchase?  

Number of 
requested 
records 

% Requested 
records(60)      

% of 
total number 
records(60)      

      % of 
total number 
records(59)      

a) Yes 

b) No (go to 
question 6) 

N/A 

3 

56 

- 

5,00% 

93,33% 

5,00% 

5,08% 

93,33% 

94,92% 

- 

1,67% 

- 

5.a) How many times have such situations occurred, on average, per year? 

Number of 
requested 
records 

% Requested 
records(3)      

% of 
total number 
records(60)      

a) 0 times 

0 

0,00% 

0,00% 

EN 

61 

   EN 

 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
b) 1-2 times 

c) 3-5 times 

d) 6-10 times 

e)  more  than  10 
times 

2 

0 

0 

0 

66,67% 

0,00% 

0,00% 

0,00% 

3,33% 

0,00% 

0,00% 

0,00% 

5.b) For which substances? (more than one choice possible)  

Number of 
requested 
records 

% Requested 
records(3)      

% of 
total number 
records(60)      

a) acetic anhydride 
(AA) 

b) phenylacetic 
acid 

c) anthranilic acid 

d) piperidine 

e) potassium 
permanganate 

0 

0 

0 

0 

2 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

66,67% 

0,00% 

0,00% 

3,33% 

5.c) Have you contacted the authorities regarding suspicious or negligent behaviour?  

Number of 
requested 
records 

% Requested 
records(3)      

% of 
total number 
records(60)      

a) Yes 

b) No 

1 

1 

33,33% 

33,33% 

1,67% 

1,67% 

i. How many times, on average, per year? 

Number of 
requested 
records 

% Requested 
records(1)      

% of 
total number 
records(3)      

0 times 

0 

0,00% 

0,00% 

EN 

62 

   EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
1-2 times 

3-5 times 

6-10 times 

1 

0 

0 

more than 10 times  0 

100,00% 

33,33% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

ii. How much time have you spent on such contacts, on average, per year? 

Number of 
requested 
records 

% Requested 
records(1)      

% of 
total number 
records(3)      

• up to 30 min 

• 30 min to 1 hour 

• 1-2 hours 

• 3-5 hours 

• 6-10 hours 

0 

1 

0 

0 

0 

•  more 
hours 

than  10 

0 

0,00% 

0,00% 

100,00% 

33,33% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

C)  Questions  in  relation  to  option  3:  Strengthened  rules  and  obligations  related  to  the 
customer declarations from end users 

6.  How  much  time  do  you  spend,  on  average,  to  fill  in  one  customer  declaration  for 
purchases of scheduled substances in category 2? 

Number of 
requested 
records 

% Requested 
records(60)      

% of 
total number 
records(60)      

      % of 
total number 
records(27)      

a) up to 15 min 

b) 15-30 min  

8 

14 

c) 30 min to 1 hour  3 

d) 1-2 hours 

2 

EN 

13,33% 

23,33% 

5,00% 

3,33% 

63 

13,33% 

23,33% 

5,00% 

3,33% 

29,63% 

51,85% 

11,11% 

7,41% 

   EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
  
e)  more 
hours 

than  2 

0 

0,00% 

0,00% 

0,00% 

N/A 

- 

- 

55,00% 

- 

7. How many customer declarations do you fill in, on average, per year? 

Number of 
requested 
records 

% Requested 
records(60)      

% of 
total number 
records(60)      

      % of 
total number 
records(53)      

a) 0 

b) 1-2  

c) 3-5  

d) 6-10 

e) more than 10 

N/A 

15 

15 

12 

4 

7 

- 

25,00% 

25,00% 

20,00% 

6,67% 

11,67% 

- 

25,00% 

25,00% 

20,00% 

6,67% 

11,67% 

11,67% 

28,30% 

28,30% 

22,64% 

7,55% 

13,21% 

- 

D) Questions on possible benefits of changing the legislation 

8.  Did  you  experience  specific  cases  of  diversion  or  diversion  attempts  of  scheduled 

substances in category 2? 

Number of 
requested 
records 

% Requested 
records(60)      

% of 
total number 
records(60)      

      % of 
total number 
records(54)      

a) Yes 

b) No (go to 
question 9) 

N/A 

3 

51 

- 

5,00% 

85,00% 

5,00% 

5,56% 

85,00% 

94,44% 

- 

10,00% 

- 

a) Please specify, whether the diversion or diversion attempts related to: 

Number of 
requested 
records 

% Requested 
records(3)      

% of 
total number 
records(60)      

EN 

64 

   EN 

 
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
• acetic anhydride, 
and/or: 

• other scheduled 
substance in 
category 2 

1 

2 

33,33% 

1,67% 

66,67% 

3,33% 

b) Please describe the specific circumstances of the diversion or diversion attempts, such 
as:  

i. Which market participants were involved (more than one choice possible): 

Number of 
requested 
records 

% Requested 
records(3)      

% of 
total number 
records(60)      

• producers of drug 
precursors 

• traders 

• end-users 

0 

1 

2 

0,00% 

0,00% 

33,33% 

66,67% 

1,67% 

3,33% 

iii. In case diversion was not prevented, what were the reasons? 

Number of 
requested 
records 

% Requested 
records(3)      

% of 
total number 
records(60)      

1 

0 

0 

Lack of industry 
collaboration  

Lack of knowledge 
by market 
participants  

Lack of 
information flow 
(please specify 
from where to 
where): 

Lack of 
supervision (please 
specify by whom): 

0 

33,33% 

1,67% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

0,00% 

Other reasons? 

0 

0,00% 

0,00% 

EN 

65 

   EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
9. Which of the described option(s) would in your opinion be most efficient to achieve a 
better prevention of diversion of acetic anhydride (AA) or other scheduled substances in 
category 2? (For a short description of all options please refer to the background 
document) 

Number of 
requested 
records 

% Requested 
records(60)      

% of 
total number 
records(60)      

      % of 
total number 
records(52)      

• Option 1  

29 

48,33% 

48,33% 

55,77% 

• Option 2  

• Option 3  

• Option 4  

• Option 5  

• Option 6 

N/A 

4 

5 

4 

9 

1 

- 

6,67% 

8,33% 

6,67% 

15,00% 

1,67% 

- 

6,67% 

8,33% 

6,67% 

7,69% 

9,62% 

7,69% 

15,00% 

17,31% 

1,67% 

1,92% 

13,33% 

- 

EN 

66 

   EN 

 
  
  
  
  
  
  
Annex 2: 

Overview of major drug precursors ("scheduled substances") and their 
main legitimate and illicit uses 

  1. CATEGORY 1 

NAME: 
Other Names: 

CAS Numbers: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

EPHEDRINE  
alpha-[1-(methylamino)ethyl]-benzene-methanol, alpha-[1-
(methylamino)ethyl]benzyl alcohol, 2-methylmino-1-phenyl-1-
propanol, 1-phenyl-1-hydroxy-2-methylaminopropane, 1-phenyl-2-
methylaminopropanol, alpha-hydroxy-beta-methylaminopropyl-
benzene. 
299-42-3  
29394100 
206-080-5 
C10H15NO 
Production of methamphetamine and N-methylcathinone. 
Used in manufacturing of bronchodilators, as a nasal decongestant, to 
test blood pressure. 

NAME: 
Other Names: 

CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

ERGOMETRINE  
Ergonovine, dextrolysergic acid, 1-(hydroxymethyl)ethylamid, 
ergobasine, ergotocine. 
60-79-7 
29396100 
200-485-0 
C19H23N3O2 
Production of LSD. 
Medical use such as the treatment of migraine. 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

ERGOTAMINE  
5’alpha-benzyl-12’-hydroxy-2’-methylergotaman-3’,6’,18-trion 
113-15-5 
29396200 
204-023-9 
C33H35N5O5 
Production of LSD. 
Medical use such as the treatment of migraine. 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

LYSERGIC ACID  
9,10-didehydro-6-methylergoline-8-beta-carboxylic acid.  
82-58-6 
29396300 
201-431-9 
C16H16N2O2 
Production of lysergide (LSD). 
Used in organic synthesis and medical investigations. 

NAME: 
Other Names: 

1-PHENYL-2-PROPANONE 
phenyl-2-propanone, phenylacetone, P2P, benzyl methyl ketone, 
methyl benzyl ketone, BMK. 

EN 

67 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

103-79-7 
29143100 
203-144-4 
C9H10O 
Production of amphetamine and methamphetamine.  
Production of propylhexedrine. Used in organic synthesis. 

NAME: 
Other Names: 

CAS Numbers: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

PSEUDOEPHEDRINE  
alpha-[1-(methylamino)ethyl]-benzenemethanol, 2-methylamino-1-
phenyl-1-propanol, 1-phenyl-1-hydroxy-2-methylamino-propane, 
alpha-hydroxy-beta-methylaminopropylbenzene, alpha-[1-
(methylamino)ethyl] benzyl alcohol, PSE. 
90-82-4  
29394200 
202-018-6 
C10H15NO 
Production of methamphetamine and methcathinone. 
Manufacturing of bronchodilators and nasal decongestants. 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

N-ACETYLANTHRANILIC ACID  
Orto-acetamidobenzoic acid, 2-acetamidobenzoic acid. 
89-52-1 
29242300 
201-914-4 
C9H9NO3 
Production of methaqualone and mecloqualone. 
Used in the manufacture of pharmaceuticals, plastics and fine 
chemicals.  

NAME: 
Other Names: 

CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

3,4-METHYLENEDIOXYPHENYLPROPAN-2-ONE 
1-(1,3-benzodioxol-5-yl)propan-2-one, 3,4-methylenedioxybenzyl 
methyl ketone, 1-(3,4-methylenedioxyphenyl)-2-propanone, 5-
acetonyl-1,3-benzodioxole, 1-(acetonyl)-3,4-methylenedioxybenzene, 
1,3-benzodioxol-5-yl-propane-2-one, 1-(1,3-benzodioxal-5-yl-)-2-
propanone, 3,4-MDP-2P, PMK 
4676-39-5 
29329200 
225-128-6 
C10H10O3 
Production of MDA, MDMA, MDE and N-hydroxy-MDA 
Perfume industry. 

NAME: 
Other Names: 

CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 

ISOSAFROLE  
1,2-(methylenedioxy)-4-propenylbenzene, 5-(1-propenyl)-1,3-
benzodioxole. 
120-58-1 
29329100 
204-410-2 
C10H10O2 

EN 

68 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Major Illicit Uses: 

Legitimate uses: 

Ring-substituted derivatives of amphetamine and methamphetamine, 
production of MDMA. 
Used in the manufacture of piperonal (heliotropin), fragrances and 
artificial food flavourings. 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

NAME: 
Other Names: 

CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

NAME: 

Other Names: 
Harmonized Code: 
Legitimate uses: 

PIPERONAL  
3,4-(methylenedioxy)benzaldehyde, heliotropin, piperonylaldehyde  
120-57-0 
29329300 
204-409-7 
C8H6O3 
Production of ring-substituted derivatives of amphetamine and 
methamphetamine, production of MDMA. 
Used in perfumery, in cherry and vanilla flavours, mosquito repellent. 

SAFROLE  
5-(2-propenyl)-1,3-benzodioxole, 4-allyl-1,2methylenedioxybenzene, 
allylcatechol methylene ether. 
94-59-7 
29329400 
202-345-4 
C10H10O2 
Production of ring-substituted derivatives of amphetamine and 
methamphetamine, production of MDMA. 
Used as a flavouring agent, preservative and in the production of other 
chemicals. 

SASSAFRAS OIL (contains a large share safrole, can be obtained 
from several plant varieties) 
ocotea cymbarum, ocotea pretiosa, sassafras albidum, sassafras 
officinale 
330129 
Perfumes and flavours. 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

NOREPHEDRINE  
Phenylpropanolamine, PPA. 
14838-15-4 
ex 29394900 
211-850-9 
C9H13NO 
Production of amphetamines, methamphetamines and phenmetrazine. 
Pharmaceutical industry. 

2. CATEGORY 2 

NAME: 
Other Names: 

ACETIC ANHYDRIDE  
Acetic oxide, acetyl oxide, ethanoic anhydride. 

EN 

69 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

NAME: 
Other Names: 

CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

108-24-7 
29152400 
203-564-8 
C4H6O3 
Acetylating agent in the production of heroin, P2P and N-
acetylanthranilic acid, methaqualone and mecloqualone. Precursor for 
n-acetylanthranilic acid, reagent for heroin. 
Acetylating agent used in chemical, photographic and pharmaceutical 
industry. It is used in making plastic, textile, dyes, photochemical 
agents, perfumes, explosives and aspirin. 

ANTHRANILIC ACID  
Ortho-aminobenzoic acid, 1-amino-2-carboxybenzene, vitamin L1, 2-
aminobenzoic acid, ortho-carboxyaniline. 
118-92-3 
29224300 
204-287-5 
C7H7NO2 
Production of methaqualone and mecloqualone. Production of n-
acetylanthranilic acid. 
Manufacturing of dyes, pharmaceutical industry, perfumes and insect 
repellents. 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

PHENYLACETIC ACID  
Benzeneacetic acid, alpha-tolyic acid. 
103-82-2 
29163400 
203-148-6 
C8H8O2 
Production of methamphetamine and P2P. 
Used in chemical and pharmaceutical industry, perfumes, herbicides, 
penicillin, cleaning solutions and flavouring agent for foods. 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

PIPERIDINE  
Hexahydropyridine, hexazane, pentamethyleneimine. 
110-89-4 
29333200 
203-813-0 
C5H11N 
Manufacturing of phencyclidine and its analogues. Precursor for 
thienylcyclohexylpiperidine (TCP). 
Solvent and reagent in chemical and pharmaceutical industry. Used in 
rubber products, plastic manufacturing and flavours. 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 

POTASSIUM PERMANGANATE  
Permanganic acid potassium salt, chameleon mineral, PP. 
7722-64-7 
28416100 
231-760-3 

EN 

70 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

KMnO4 
Oxidizing agent to remove impurities in coca paste (cocaine).  
Reagent in organic, photographic chemistry, bleaching applications, 
disinfectants and deodorizer. 

3. CATEGORY 3 

NAME: 
Other Names: 

CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

NAME: 
Other Names: 

CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 
Legitimate uses: 

ACETONE  
Dimethyl ketone, beta-ketopropane, pyroacetic ether,  
2-propanone. 
67-64-1 
29141100 
200-662-2 
C3H6O 
Cocaine, heroin, lysergic acid diethylamide (LSD), methcathinone, 
ring-substituted derivatives of amphetamines and methamphetamines, 
used as a solvent in the production of chlordiazepoxide, diazepam, 
UB329, MDA, phenmetrazine, trimetoxyamphetamine and TMA. 
It is used as a solvent in chemical, pharmaceutical and photographic 
industries, used in manufacturing of plastics, also used as a nail polish 
remover, etc. 

ETHYL ETHER  
1,1’-oxybisethane, ethyl oxide, diethyl oxide, ethoxyethane, sulphuric 
ether, diethyl ether. 
60-29-7 
29091100 
200-467-2 
C4H10O 
Heroin, cocaine, amphetamine, methamphetamine, lysergide (LSD), 
methaqualone, mecloqualone. Used as a solvent in the production of 
DOB, 4-methoxy-2,5-dimethoxyphenylethylamine, chlordiazepoxide, 
diazepam, 2,5-dimethoxyamphetamine, dimethyltryptamine, 
hydromorphone, JB318, JB329, JB336, MDA, mescalin, methadone, 
PCP, PCE, PHP, phenmetrazine, BMK, psilocin, STP, TCP, TMA. 
Widely used as a solvent in the extraction of waxes, fats, oils, 
perfumes and dyes, and to manufacture other chemicals. It has also 
been used as an anaesthetic. 

METHYL ETHYL KETONE  
2-Butanone, ethyl methyl ketone, 2-oxobutane, methyl acetone, MEK.
78-93-3 
29141200 
201-159-0 
C4H8O 
Heroin, solvent used in cocaine hydrochloride production.  
Manufacturing of coatings, lacquers, resins, etc. Used in the 
photographic industry. Commonly used as solvent. Secondary uses in 
perfumes and flavours. 

EN 

71 

   EN 

 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

TOLUENE  
Methylbenzene, toluol, phenylmethane, methacide. 
108-88-3 
29023000 
203-625-9 
C7H8 
Solvent used in the production of cocaine hydrochloride and heroin, 
and other controlled substances like amphetamine, methamphetamine, 
lysergide (LSD), methaqualone, mecloqualone, methadone, 
methylphenidate, PCP, PHP, BMK, psilocin, TCP 
In manufacturing of explosives, dyes. Gasoline additive. Industrial 
solvent. Used in the photographic industry. 

SULPHURIC ACID  
Oil of vitriol, hydrogen sulphate. 
7664-93-9 
28070010 
231-639-5 
H2SO4 
Heroin, cocaine, amphetamine, methamphetamine. Reagent used in the 
production of chlordiazepoxide, diazepam, LSD, MDA, mescaline, 
methylphenidate, phenmetrazine, BMK. 
Used in fertilizers, chemicals, dyes, petroleum refining, etching, 
photographic industry, analytical chemistry, in making iron and steel, 
and in industrial explosives. 

NAME: 
Other Names: 
CAS Number: 
Harmonized Code: 
EC number (EINECS inventory) 
Molecular formula: 
Major Illicit Uses: 

Legitimate uses: 

HYDROCHLORIC ACID  
Muriatic acid, hydrogen chloride. 
7647-01-0 
28061000 
231-595-7 
HCl 
Heroin, cocaine, amphetamine, methamphetamine, lysergide, 
methaqualone, mecloqualone. Reagent used in the production of 
Barbiturate, DOB, 4-bromo-2,5-dimethoxyphenylethylamine, 
chlordiazepoxide, diazepam, diethyltryptamine, dimethyltryptamine, 
hydromorphone, JB318,JB329, JB336. MDA, methadone, 
methylamine,methylphenidate, PCE, PCP, PHP, psilocin, STP TCP, 
TMA, phenimetrazine. 
Used in manufacturing of chlorides and hydrochlorides. Used in the 
photographic industry, in metal products cleaning, etc. 

EN 

72 

   EN 

 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
Annex 3: Summary of obligations for drug precursors 

Category 1

Category 2

Category 3

Notify suspicious transactions or orders 

…to the competent authorities

Common 
obligations 

(external / intra 
Community trade) 

Appoint a responsible officer 
Appoint a responsible officer 

…who ensures compliance with legislation
…who ensures compliance with legislation

Secure premises 
Secure premises 

…against theft
…against theft

Obtain a licence 
Obtain a licence 

Register premises 
Register premises 

Register premises 
Register premises 

…with the authorities
…with the authorities

…only in the case of export
…only in the case of export

Report annually to the competent authorities 

…on exports, imports, intermediary activities 

Document and label all transactions 

External 
trade 

Obtain an export authorisation 

…and keep records for 3 years 

…Only for certain 
countries of 
destination

Obtain  an  import 
authorisation 

Report  annually 
authorities 

to 

the  competent 

…Only upon request 

Intra 
Community 
trade 

Document and label all transactions 

…and keep records for 3 years

Obtain a customer declaration 

…per substance, indicating its uses, 

EN 

Supply only to 
customers holding 
a licence 

73 

NB:  This  chart  provides  an  overview 
of  the  legislation  and  does  not  repeat 
it  exhaustively.  For  example, 
the 
legislation  exempts  category  2  and  3 
substances  from  certain  obligations  if 
in 
they  are 
quantities below certain thresholds. 

traded  or  exported 

   EN 

 
 
 
 
Annex 4: 

Statistics  of  seizures  and  stopped  shipments  for  all  scheduled 
substances in category 2 

Scheduled substances in category 2 

2008 

2009 

2010 

Acetic anhydride (Liters) 

Phenylacetic acid (Kg) 

Potassium permanganate (Kg) 

Anthralinic Acid 

Piperidine  

240,963 

30,510 

21,123 

153 

2,029 

0 

0 

277 

1 

0 

1 

1 

3 

0 

0 

EN 

74 

   EN