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 (Text with EEA relevance)
Date: 2010-01-07
Institutions: European Commission
Subjects: administrative cooperation, application of EU law, chemical product, export monitoring, illicit trade, narcotic, psychotropic substance, report, surveillance concerning imports, third country

EN 

EN 

   EN 

 
 
COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 7.1.2010 
COM(2009)709 final 

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 

(Text with EEA relevance) 

EN 

   EN 

 
 
 
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 

(Text with EEA relevance) 

1. 

INTRODUCTION  

Drug precursors are chemicals that are used for the manufacturing of illicit drugs. There is, in 
fact,  no  production  of  illicit  drugs  without  precursors.  However,  in  the  majority  of  cases 
chemicals used as drug precursor have primarily multiple legitimate and important uses (e.g. 
in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents, or aromas). 

The United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic 
Substances  (hereafter  referred  as  UN  1988  Convention),  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. 

In  this  context,  the  EU  has  put  in  place  since  the  early  nineties  legislation  to  ensure  that 
diversion of drug precursors is prevented through control and monitoring of their legitimate 
trade. Historically, the EU was a significant exporter of precursors and an importer of illicit 
drugs,  but  progressively  the  EU  has  become  a  major  exporter  of  illicitly  manufactured 
synthetic drugs and an importer of the precursors required to manufacture them.  

Consequently, the  most recent  Community legislation on monitoring and control of trade in 
drug precursors, namely Regulation (EC) No  273/20041 and Regulation (EC) No  111/20052 
were, therefore, designed to strengthen the import controls as well as to extend the previously 
existing monitoring requirements.  

Article 16 of Regulation (EC) No 273/2004 and Article 32 of Regulation (EC) No 111/2005 
foresee that three years after their entry into force, an evaluation of their implementation and 
functioning is performed and reported to the European Parliament and to the Council. In the 
interest of efficiency, this report presents the conclusion of the evaluation of both Regulations. 

2. 

COMMUNITY LEGISLATION ON THE CONTROL OF TRADE IN DRUG PRECURSORS  

The  Community  system  of  control  of  operators  and/or  transactions  relies  on  the  close 
cooperation  between  competent  authorities  and  the  economic  operators  concerned  (mainly 
chemical manufacturers and traders). In particular, the notification of suspicious transactions 

1 
2 

OJ L47 of 18.02.2004, p.1 
OJ L22 of 26.01.2005, p.1 

EN 

2 

   EN 

 
                                                 
by operators is key in preventing diversion of precursors while allowing gathering intelligence 
to identify traffickers.  

The severity of controls applied to operators and/or transactions depends on the sensitivity of 
the regulated  drug precursors (the so-called scheduled substances),  which are  classified  into 
three  categories  entailing  different  requirements,  thus  allowing  to  strike  an  appropriate 
balance  between  all  possible  means  to  prevent  drug  precursors  reaching  illicit  drug 
laboratories and avoiding the creation of unnecessary burdens for the legitimate needs of all 
operators.  

Building  on  this  cooperation,  a  voluntary  monitoring  system  is  in  operation  for  additional 
substances  -  so  called  non-scheduled  substances  -  frequently  found  to  be  diverted  for  illicit 
drug manufacture. It provides flexibility to address rapidly changing diversion patterns, while 
avoiding increasing administrative burdens for legitimate operators.  

The  current  regulatory  framework  of  the  Community  for  drug  precursors  is  made  up  of 
Regulation  (EC)  No  273/2004,  which  lays  down  harmonised  rules  for  the  intra-Community 
control  and  monitoring,  and  Regulation  (EC)  No  111/2005,  which  lays  down  the  rules 
governing  the  monitoring  of  the  trade  between  the  Community  and  third  countries  in  drug 
precursors. 

3. 

IMPLEMENTATION OF THE COMMUNITY LEGISLATION  

3.1. 

Regulation (EC) No 1277/20053 

Regulation (EC) No 1277/2005 sets up detailed implementing rules for Regulation (EC) No 
273/2004  and  Regulation  (EC)  No  111/2005.  Aiming  at  ensuring  a  more  uniform 
implementation  of  the  Community  legal  framework  by  competent  authorities  and  economic 
operators, it lays down provisions on the licensing of operators, the provision of information 
by  operators  to  competent  authorities,  the  pre-export  notification  system,  the  export  and 
import authorisations as well as the control of transit and transshipments.  

3.2. 

Guidance 

To  complement  the  legal  instruments,  the  Commission  has  developed  and  agreed  with 
Member  States  and  operators  comprehensive  guidance  documents  and  activities  to  assist 
competent authorities and industry operators with their tasks.  

•  Questions & Answers  

A guidance document was drawn up to provide Member States competent authorities 
and economic operators with consensual answers to questions of interpretation raised 
since 2005 for a smooth and harmonised implementation of some provisions of the 
Community legislation. It is regularly updated and publicly available4.  

•  EU Guidelines on drug precursors' control for operators  

3 
4 

OJ L202 of 3.08.2005, p.7 
http://ec.europa.eu/enterprise/chemicals/legislation/precursors/index_en.htm 

EN 

3 

   EN 

 
                                                 
In  order  to  facilitate  the  partnership  and  co-operation  between  the  competent 
authorities  and  operators,  the  "EU  Guidelines  on  Drug  Precursors  Control  for 
Operators"  have  been  agreed  in  2006.  These  guidelines  provide  a  set  of  practical 
recommendations  (e.g.  risk  indicators  for  identification  of  suspicious  transactions) 
and  lists  of  scheduled  substances  and  non-scheduled  substances  (i.e.  the  “EU 
voluntary  monitoring  list”-)  aimed  at  helping  the  economic  operators  to  fulfil  their 
obligations in close cooperation with authorities. Given that these Guidelines contain 
sensitive  information,  they  are  disseminated  directly  by  Member  States'  competent 
authorities only to trustworthy operators. 

•  Seminars 

The Commission services and the Member States have organised a series of seminars 
in close cooperation with economic operators aimed at increasing knowledge about 
the  new  Community  legislation  on  drug  precursors  and  further  promoting  the 
importance of partnership. 

•  Expert roundtables 

The  Commission  services  and  Member  States  have  conducted  ad-hoc  expert 
roundtable meetings to address specific issues regarding the diversion and trafficking 
of heroin precursors (acetic anhydride) and of synthetic drug precursors for making 
amphetamine or ecstasy (BMK, PMK). 

3.3.  Mutual Administrative Assistance 

Council  Regulation  (EC)  No  515/97  provides  a  legal  basis  for  exchange  of  information, 
including rules of confidentiality, between Member States, and between Member States and 
the Commission. 

Through  the  exchange  of  information  on  suspect  consignments,  prevented  diversion  and 
seizures  of  drug  precursors  between  all  Member  States  and  the  Commission,  a  coordinated 
approach  within  the  EU  is  ensured,  Member  States'  investigations  are  supported  and 
traffickers  are  prevented  from  “shopping  around”  for  potential  weaknesses  in  the  Intra-
Community  market.  In  addition,  assistance  with  enquiries  into  established  or  suspected 
irregularities  involving  drug  precursors  may  be  requested/provided  to  third  countries  with 
which the EU has concluded bilateral drug precursor agreements. 

3.4. 

EU Action Plan on Drugs5 

Measures countering diversion and trafficking of drug precursors continue to be an essential 
part of the new EU Action Plan on Drugs 2009-20126, established under the overall EU Drugs 
strategy set up for the period 2005-2012. Action 42 of the EU Drugs Action Plan for 2009 - 
2012 calls for the evaluation of EU drug precursor legislation and its implementation.  

3.5. 

Actions under the Customs 2013 Programme 

Customs 2013 is an EU cooperation programme providing national administrations with the 
possibility  to  create  and  exchange  information  and  expertise.  It  allows  developing  and 

5 
6 

COM (2008) 567/4 
OJ C 326, 20.12.2008, p. 7–25 

EN 

4 

   EN 

 
                                                 
operating  major  trans-European  IT  systems  in  partnership  and  establishing  human  networks 
by  bringing  together  national  officials  from  across  Europe.7  Several  activities  have  been 
conducted to enhance the implementation of the Community legislation on drug precursors.  

An eLearning Course on Drug Precursor Control for Economic Operators, developed on 
the basis of the "EU Guidelines on Drug Precursors control for operators", has been released 
in June 2009. 

An  eLearning  Course  for  Customs  is  being  prepared  in  close  cooperation  between  the 
Commission services and Member States experts from Customs, Police and other competent 
authorities for the Drug Precursor legislation. 

A  Project  Group  of  operational  customs  controls  experts  was  set  up  to  enhance 
operational performance in detecting suspicious drug precursor consignments entering and/or 
leaving the Community Customs territory. Several operational workshops were organised to 
exchange best practices. 

A  mind-mining  exercise  was  organised  with  operational  customs  officers  to  establish  risk 
analysis criteria for drug precursors entering and/or leaving the Community. 

3.6. 

Bilateral agreements  

The  Community  has  concluded  ten  bilateral  agreements  with  third  countries  in  order  to 
strengthen control with major players by addressing specific issues of mutual interest in the 
area of drug precursor control. Such agreements have been concluded with Bolivia, Colombia, 
Ecuador,  Peru  and  Venezuela8,  Chile9,  Mexico10,  United  States11,  Turkey12  and  China13. 
Moreover, in March 2009, the Council has authorised the Commission to negotiate a bilateral 
agreement with the Russian Federation. 

These  agreements  aim  at  strengthening  regulatory  co-operation  with  third  countries  on  the 
basis of the instruments set out in Regulation (EC) No 111/2005, activating the mechanisms 
of mutual assistance and creating 'Joint Follow-Up Groups' of contracting parties. 

3.7. 

Actions at United Nations level  

The  Commission  and  the  Member  States  have  been  closely  involved  in  the  review  of  the 
achievements  of  the  targets  set  by  the  Special  Session  of  the  United  Nations  General 
Assembly of 1998 (UNGASS) and regularly and actively participate in the yearly session of 
the Commission on Narcotic Drugs (CND), the central United Nations' drugs policy making 
body. 

At  the  50th  session  of  the  United  Nations  Commission  on  Narcotic  Drugs  (CND),  a 
Community  proposal  was  adopted  as  Resolution  50/10  on  "Prevention  of  diversion  of  drug 
precursors  and  other  substances  used  for  the  illicit  manufacture  of  narcotic  drugs  and 

7 
8 
9 
10 
11 
12 
13 

OJ L 154/25-31 
OJ L 324, 30.12.95, p. l 
OJ L 336, 11.12.1998, p. 46 
OJ L 77, 19.03.1997, p.22 
OJ L 164, 21.06.1997, p. 22 
OJ L 64, 07.03.2003, p. 28 
OJ L 56 of 28.2.2009, p. 6. 

EN 

5 

   EN 

 
                                                 
psychotropic  substances"14.  This  Resolution  promotes  the  main  principles  of  drug  precursor 
control in the Community.  

In  addition,  the  Commission  services  and  Member  States  actively  participate  and  support 
specific UN led operational initiatives to address particular challenges regarding the diversion 
and  trafficking  of  drug  precursors.  In  particular,  the  EU  participates  in  project  "PRISM"  to 
address diversion of synthetic drug precursors and project "COHESION" to tackle diversion 
and trafficking of heroin and cocaine precursors, and their related specific operations. 

4. 

EVALUATION  

4.1. 

Commission actions taken  to evaluate the implementation and functioning of the 
Community legislation 

In 2007, the Commission requested Member States to inform it about the national measures 
they had adopted as foreseen in the Community  legislation (i.e. measures to enable them to 
perform  their  control  and  monitoring  duties  as  well  as  rules  on  penalties  applicable  for 
infringements to the provisions of the Community Regulations). Most had adopted adequate 
measures,  except  eight  Member  States  against  which  the  Commission  started  infringement 
procedures.  In  the  course  of  2008  most  of  the  Member  States  concerned  adopted  or  put  in 
place  steps  towards  the  adoption  of  the  required  measures  and  consequently  all  required 
national measures should be adopted before the end of 2009. 

In order to evaluate the functioning of the Community legislation, a working group of experts 
from  national  competent  authorities  was  established  to  assist  the  Commission  services.  In 
addition,  the  Commission  mandated  an  external  contractor  to  gather  information  from  all 
stakeholders (competent authorities and industry operators) through questionnaires, including 
quantitative  data  where  available,  as  well  as  to  analyse  the  impact  of  delays  caused  by 
legislative  requirements  placed  on  the  trade  in  drug  precursor  and  to  collect  proposals  for 
improving the system in place. 

All Member States replied in full or partially for the years 2006 and 2007. Detailed interviews 
were  conducted  with  competent  authorities  in  a  sample  of  Member  States.  A  total  of  72 
companies and 8 industry associations (from 10 different Member States) provided responses 
to the industry survey. Five of them accounted for over 90 % of all responses. The report on 
this  study,  was  finalised  at  the  end  of  January  2009,  contains  a  detailed  presentation  of  the 
results  of  the  surveys.  It  summarises  main  findings  and  proposes  recommendations  on 
identified  weaknesses.  Due  to  the  sensitive  information  contained  in  the  report,  the 
information is not publicly available. Despite considerable efforts by the contractor, the data 
gathered  has  been  limited  and  cannot  be  considered  as  fully  representative.  It  proved 
particularly difficult to gather quantified data on the costs incurred by competent authorities 
or by operators to implement the legal requirements.  

As Regulation (EC) No 111/2005 puts strong emphasis on customs controls, a further study 
was conducted in 2007 to examine whether drug precursors control is a priority for customs, 
whether there is capacity for making controls and whether controls are actually carried out.  

14 

EN 

Resolution  50/10 
(E/CN.7/2007/16/Corr.1) http://www.unodc.org/unodc/en/commissions/CND/session/50.html 

,  p.42  of 

report  of 

the 

the  50th  Commission  on  Narcotic  drugs 

6 

   EN 

 
                                                 
4.2. 

Findings of the evaluation 

4.2.1.  Main trends in diversion and diversion attempts  

Overall,  the  Community  legal  framework  for  controlling  trade  in  drug  precursors  seems  to 
provide  proportionate  measures  to  prevent  diversion  of  drug  precursors  for  illicit  drug 
manufacture. Since 2005, the reported seizures and stopped shipments of scheduled and non-
scheduled substances show an overall increase in number of seizures and stopped shipments 
Furthermore  backtracking  investigations  allow  estimating  a  posteriori  the  quantities  of 
substances  most  probably  diverted.  These  data  show  on  the  one  hand  that  the  system  is 
functioning well but on the other hand that traffickers are continuously trying to divert drug 
precursors  from  the  legitimate  trade.  It  seems  still  most  valuable  for  traffickers  to  use 
diversion from legitimate circuits for accessing drug precursors. Even though there is a lack of 
available  quantitative  evidence  that  control  of  legal  trade  is  indeed  reducing  globally 
diversion and trafficking of drug precursors, it is clear that the control system in place raises 
important barriers to access to drug precursors by traffickers and reduce overall availability of 
drug precursors for illicit drug manufacture. Current attempts for diversion seem to focus on a 
limited number of substances – both scheduled and non-scheduled: 

Acetic anhydride, which is a key precursor for heroin production, continues to be targeted by 
traffickers in some Member States as evidenced by data of seizures and stopped shipments. 
Bilateral  and  regional  assistance  and  cooperation  between  the  competent  authorities 
concerned  were  instrumental  to  prevent  diversion  and/or  seize  in  2008,  approximately  220 
tonnes  of  acetic  anhydride,  which  represents  more  than  15  %  of  the  quantities  of  acetic 
anhydride estimated to be necessary for the illicit heroin manufacture in Afghanistan.  

The Customs authorities in the EU have increased vigilance on control of trade in ephedrine 
and  pseudo-ephedrine  in  bulk  or  when  contained  in  pharmaceutical  preparations/medicinal 
products,  mostly  transiting  through  the  EU,  but  on  occasions  also  being  exported,  to  third 
countries  where  methamphetamine  illicit  production  take  place.  This  has  led  to  important 
increase  in  seizures,  more  importantly  for  pharmaceutical  preparations  containing  pseudo-
ephedrine.  Since  2005,  suspicious  consignments  of  approximately  86  tons  of  ephedrine  or 
pseudo-ephedrine in bulk or tablet form have been detected, seized or stopped, preventing up 
to 65 tons of methamphetamines of being produced (depending on the methods of synthesis 
employed) with an estimated street value of US $ 9,7 billion.  

Gamma  butyro  lactone  (GBL)  is  a  non-scheduled  substance  included  in  the  voluntary 
monitoring scheme in the Community. The data available shows that the cooperation with the 
industry  through  voluntary  monitoring  and  notification  is  functioning  well  but  also  that 
traffickers  continue  to  be  interested  in  diverting  GBL  –  and  also  other  chemical  substances 
submitted  to  less  stringent  control.  In  2008,  diversion  attempts  or  seizures  of  2170  litres  of 
GBL have been achieved.  

Since  2005,  there  is  no  evidence  that  the  Community  is  targeted  for  diversion  of  other 
important  precursors.  For  example,  there  was  no  major  seizures  or  stopped  shipments  for 
potassium permanganate, a key precursor for cocaine. 

4.2.2. 

Strengths and weaknesses of the legislation 

It has to be noted that the time period foreseen in the Regulations to carry out an evaluation of 
their  functioning  was  rather  short  in  order  to  detect  clear  effects.  This  has  been  further 

EN 

7 

   EN 

 
exacerbated by the fact that many Member States were late in adopting all necessary measures 
to fully comply with their obligations under the Regulations. 

Nevertheless,  all  actions  developed  since  2005  have  with  no  doubt  contributed  to  the  good 
and harmonised implementation and functioning of the Community legislation. Furthermore, 
the progressive adoption by Member States of the national measures and powers foreseen in 
the  Community  legislation  have  considerably  strengthened  their  capacity  to  act  upon 
infringements of the Community legislation. 

Overall, the provisions of Regulation (EC) No 273/2004, Regulation (EC) No 111/2005 and 
the implementing rules contained in Regulation (EC) No 1277/2005 function well and reach 
the objective pursued, i.e. prevention of diversion without creating unnecessary barriers to the 
legitimate trade activities for the scheduled drug precursors. Control and monitoring focus on 
operators rather than on each transaction. The division of the scheduled substances into three 
categories has proven to be an efficient way to apply a modulated approach, depending on the 
sensitivity of the substances and of the quantities traded legitimately. 

The  key  principle  embedded  in  the  legislation  for  intra-Community  trade  and  for  the  trade 
between  the  Community  and  third  countries  –  the  cooperation  between  economic  operators 
and  competent  authorities  -  works  well.  This  cooperation,  although  differently  implemented 
and used by Member States, facilitates the mandatory or voluntary notifications of suspicious 
transactions  or  orders,  and  prevents  early  diversion  of  scheduled  and  non-scheduled 
substances while allowing legal trade to function smoothly. It is a flexible, rapid and efficient 
tool in response to the ever changing patterns of trafficking and growing interest of traffickers 
in less controlled substances. The "EU Guidelines on drug precursors' control for operators" 
and the new eLearning course on drug precursor control for economic operators successfully 
complement the legislation. 

The  implementation  and  functioning  of  the  common  licensing  system  introduced  for  intra-
Community trade and for the trade between the Community and third countries for operators 
handling precursors in Category 1 (the most sensitive substances) proves to work efficiently 
from both the competent authorities' and industry's perspectives. 

The  registration  requirement  for  operators  handling  somewhat  less  sensitive  precursors  in 
Category  2  both  as  regards  intra-Community  trade  and  trade  between  the  Community  and 
third countries appears to be insufficient to allow adequate control by competent authorities 
and prevention of diversion from the important volume of intra-Community trade within these 
substances. In fact, end-users of Category 2 substances, who do not place on the market the 
substances, are neither required to register nor to report the quantities they buy for their own 
end-use.  Thus  they  are  hardly  known  to  competent  authorities.  It  is  also  very  difficult  for 
manufacturers  or  brokers  of  Category  2  substances  to  exercise  their  obligation  to  check  the 
legitimacy of their customers and of the reported end-use of the substance and consequently 
to  notify  as  appropriate  any  suspicious  transaction  to  the  competent  authorities.  The  control 
by competent authorities of the legitimacy of operators  is  difficult  and  even  more  when  the 
manufacturers/brokers and the end-users of the Category 2 substances are based in different 
Member States, and when the trade chain involves more than two entities based in more than 
one Member State. These problems have been highlighted particularly for acetic anhydride, a 
key precursor for illicit heroin manufacture. 

The evaluation found differing interpretation of some legislative provisions that would need 
to  be  addressed  in  order  to  facilitate  their  correct  harmonised  implementation  within  the 

EN 

8 

   EN 

 
Community.  This  includes  in  particular,  the  mandatory  fields  to  be  filled  in  the  customer 
declaration,  and  the  criteria  for  considering  products  containing  scheduled  substances  as 
mixtures,  the  application  of  existing  thresholds  for  exemption  of  registration  for  mixtures 
containing  Category  2  substances  in  accordance  with  Article  6  of  Regulation  (EC)  No 
273/2004, when compared to the wording of Article 14 of Regulation (EC) No 1277/2005. 

The  provisions  regarding  the  frequency  of  reporting  by  the  operator  to  the  competent 
authorities does not provide sufficient basis for carrying out the control and monitoring duties. 
An  overview  of  the  legal  trade  movements  constitutes  an  important  instrument  to  detect 
suspicious consignments. 

The instruments governing the control of exports and imports allow competent authorities to 
make prior verifications of the licit purposes of a transaction and, in consequence, provide the 
means  to  prevent  diversion  at  an  early  stage.  The  use  of  the  pre-export  notification  system 
allows third countries who have requested so to verify the intended transaction and thereby to 
inform the Member States competent authorities whether the transaction is licit or not. 

The stronger emphasis on customs procedures and controls has proven to be very useful. The 
Community  is  increasingly  confronted  with  consignments  diverted  from  legal  distribution 
channels  prior  to  entering  the  Community  customs  territory.  This  requires  heightened 
attention  by  customs  and  border  control.  The  provisions  regarding  the  control  of  transit  or 
transhipments  seem  to  have,  to  a  certain  extent,  increased  the  possibility  to  verify  the  licit 
purposes of such shipments however do not seem allowing competent authorities to verify the 
licit purposes in every case. 

The  study  on  customs  controls  of  drug  precursors  in  2007  identified  weaknesses  relating  to 
the detection of suspicious consignments for which false customs declarations are made. The 
evaluation  revealed  pockets  of  excellence,  but  also  showed  that  in  general  important 
improvements still need to be made. In particular, the report revealed a lack of priority for the 
drug precursor legislation by customs administrations, lack of awareness and expertise as well 
as insufficient resources (e.g. testing equipment). 

Pharmaceutical  preparations  /  medicinal  products  for  human  use  containing  drug  precursors 
are  currently  excluded  from  the  scope  of  the  drug  precursor  legislation.  The  manufacture, 
import  and  wholesale  distribution  of  medicinal  products,  including  products  for  export  is 
subject  to  an  authorisation,  specific  obligations  and  regular  inspections  in  line  with 
Community pharmaceutical legislation (Directive 2001/83/EC). Therefore it is considered that 
these  activities  should  be  under  sufficient  systematic  control  by  Member  States'  competent 
authorities.  However,  such  manufacturers,  importers  and  wholesale  distributors  are  not 
subject  to  specific  pre-notification  requirements  from  drug  precursors'  legislation  when 
exporting those medicinal products which contain drug precursors. This has led to a situation 
where  in  some  Member  States  exports  and  transit/transhipments  of  pharmaceutical 
preparations/medicinal  products  containing  drug  precursors  -  in  particular  ephedrine  or 
pseudoephedrine - have not been stopped or seized even though it was very likely that they 
would be misused for illicit drug manufacture. 

There appear to be further minor weaknesses related to the precursor legislation regarding the 
external trade. These include in particular the lack of flexibility for competent authorities as 
regards  the  period  required  to  wait  for  the  response  to  pre-export  notifications,  the  lack  of 
simplified  authorisation  procedures  for  repetitive  consignments  between  well-known 

EN 

9 

   EN 

 
operators in the Community and in the EFTA countries, and the need to further streamline the 
authorising procedures with the electronic customs environment. 

5. 

RECOMMENDATIONS FOR IMPROVEMENTS 

5.1. 

Improving harmonised implementation of the current legislation 

As  a  first  measure  for  improvements,  the  sharing  of  best  practices  between  Member  States' 
authorities,  including  customs  and  practical  implementation  of  a  real  partnership  between 
authorities  and  economic  operators  should  be  further  promoted  and  facilitated.  Exchange  of 
best  practices  through  workshops,  seminars,  roundtables,  and  tracking  exercises  on  specific 
topics and/or specific drug precursors can be facilitated at Community level, in order to gain 
immediately from best practices in place in some Member States and in fine to strengthen the 
control systems overall. 

Harmonised  interpretation  of  some  current  legislative  provisions,  e.g.  application  of 
thresholds for registration when scheduled substances are contained in mixtures – in particular 
interpretation of Article 6 of Regulation (EC) No 273/2004, when compared to the wording of 
Article 14 of Regulation (EC) No 1277/2005, or uniform criteria for mixtures containing drug 
precursors,  can  be  achieved  by  updating  and  complementing  the  'Questions  &  Answers' 
guidance. 

This  will  strengthen  implementation  of  the  Community  rules  while  avoiding  that  traffickers 
focus  their  diversion  attempts  on  Member  States,  where  Community  rules  appear  to  be  less 
strictly implemented and/or penalties are perceived as weak. 

5.2. 

Enhancing reporting 

The reporting obligations as defined in Article 19 of Regulation (EC) No 1277/2005 should 
be  reviewed  in  order  to  obtain  a  more  accurate  and  timely  collection  of  information  on 
notifications  by  operators.  This  can  be  achieved  by  increasing  the  reporting  frequency  from 
annually to bi-annually or quarterly while facilitating this reporting by using modern secured 
electronic  means  of  exchanging  information,  including  if  appropriate  creating  a  secured 
European database.  

5.3.  Modifying some requirements for Category 2 substances  

In the light of the identified weaknesses, it seems necessary  to reinforce the controls for  all 
Category  2  substances  or  specifically  for  acetic  anhydride  (key  precursor  in  heroin 
production) in order to ensure that operators possessing or trading Category 2 substances – or 
specifically acetic anhydride - are subject to adequate control in order to discourage diversion 
attempts. This can be achieved in different ways:  

•  Amending Regulation (EC) No 273/2004 in order to require registration for end-users who 
possess Category 2 substances for their own use, by for example amending the definition 
of  "operator"  or  the  definition  of  "placing  on  the  market"  or  amending  Article  3.6 
establishing the registration system; 

•  Amending  Regulation  (EC)  No  1277/2005  in  order  to  introduce  common  registration 

conditions and procedures; 

EN 

10 

   EN 

 
•  Amending Annex I of Regulation (EC) No 273/2004 and accordingly Annex of Regulation 

No 111/2005 in order to reschedule acetic anhydride from Category 2 to Category 1. 

5.4. 

Ensuring  appropriate  control  of  pharmaceutical  preparations/medicinal  products 
containing ephedrine or pseudo-ephedrine  

Without  duplicating  administrative  provisions  on  manufacturers,  importers  and  wholesale 
distributors of medicinal products consideration should be given to a reinforcement of control 
provisions  of  pharmaceutical  preparations/medicinal  products  containing  ephedrine  or 
pseudo-ephedrine transhipped or transiting through the EU. As regards exports of medicinal 
products  the  pharmaceutical  legislation  already  includes  provisions.  Reflections  should  take 
place  on  whether  specific  harmonised  practical  provisions  for  the  export  of  medicinal 
products  containing  ephedrine  or  pseudo-ephedrine  and  their  supervision  by  competent 
authorities  for  medicinal  products  would  be  beneficial  or  whether  the  drug  precursors 
legislation  should  provide  a  possibility  to  stop  exports  of  pharmaceutical  preparations  / 
medicinal products when there are reasonable grounds for suspecting that the substances are 
intended for the illicit drugs manufacture. 

5.5. 

Improving  and  adjusting  procedural  requirements  with  regard  to  the  risk  of 
diversion 

In order to reach level of controls proportionate to the risk of diversion, the procedure with 
regard to pre-export notifications should be adapted to allow competent authorities to act on a 
case  by  case  basis,  simplified  authorisation  procedures  for  repetitive  consignments  between 
well-known operators in the Community and in the EFTA countries should be introduced, and 
authorising procedures in the electronic customs environment should be further streamlined. 

6. 

NEXT STEPS 

The identified weaknesses can be addressed through different means, some of which require 
amendments  to  the  Community  legislation.  Any  option  pursued  would  need  to  be  carefully 
examined  in  particular  towards  its  impact  on  economic  operators  legally  trading  those 
substances for legitimate purposes and its effectiveness in preventing their diversion for the 
illicit drug manufacture. 

Given that the current legislation has been fully operational for only a short time period, the 
Commission  will  primarily  support,  organise  and  facilitate  measures  aiming  at  a  better 
implementation in order to gain immediately from established best practices. 

However, the Commission will also continue to gather the necessary information with a view 
to  identify  the  best  options  to  address  possible  identified  weaknesses  in  legislation  and  to 
evaluate  the  impacts  of  selected  options  for  both  competent  authorities  and  economic 
operators. 

EN 

11 

   EN