REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Evaluation of the EU drug precursors regulations
Date: 2020-11-30
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EU action, UN convention, chemical product, drug addiction, drug traffic, fight against crime, illicit trade, international cooperation, psychotropic substance

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 30.11.2020  COM(2020) 768 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Evaluation of the EU drug precursors regulations  
 
 
1.  CONTEXT  

The production of illicit drugs such as heroin, cocaine and amphetamines requires the use of 
chemicals.  However,  these  chemicals  have  primarily  large  and  varied  legitimate  uses,  for 
example  in  the  production  of  pharmaceuticals,  cosmetics,  plastics  and  perfumes.  These 
chemicals  are  referred  to  as  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. This pattern (which had informed international and EU legislation regarding drug 
precursors  until  now)  is  suffering  changes  with  the  advent  of  the  so-called  designer-
precursors (see p.4 et seq).  

The trade in drug precursors is not in itself prohibited because of their important legitimate 
uses. Effective monitoring and control of the legitimate trade of these chemicals is the best 
way  of  fighting  against  their  diversion  for  illicit  drug  manufacture.  To  this  end,  a  specific 
regulatory framework has been set up both at international and at EU level. 

At international level, the 1988 UN Convention against the Illicit Traffic in Narcotic Drugs 
and Psychotropic Substances (hereafter, “the 1988 UN Convention”) was adopted in Vienna 
on  19  December  1988  and  contains  provisions  aiming  at  preventing  the  diversion  of 
substances frequently used in the illicit manufacture of drugs. 

At EU level, Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules 
for  the  monitoring  of  trade  between  the  Union  and  third  countries  in  drug  precursors1 
(further  ‘the  external  trade  regulation’)  and  Regulation  (EC)  No  273/2004  of  the  European 
Parliament and of the Council of 11 February 2004 on drug precursors2 (further ‘the intra-
EU  trade  regulation’)  and  their  joint  delegated  and  implementing  regulations  have  been 
enacted to this end. These will be hereafter referred to as "the Regulations". 

Measures countering diversion and trafficking of drug precursors are an essential part of the 
EU Action Plan on Drugs 2017-2020, established under the overall EU Drugs Strategy set up 
for the period 2013-20203. Drug precursor control is one of the priorities identified under the 
chapter  dealing  with  drug  supply  reduction.  Tackling  the  diversion  and  trafficking  of  drug 

1  Council  Regulation  (EC)  No  111/2005  of  22  December  2004  laying  down  rules  for  the  monitoring  of  trade 
between the Community and third countries in drug precursors, OJ L 22, 26.1.2005, p. 1. 
2 Regulation (EC)  No 273/2004 of the European Parliament and of  the  Council of 11 February 2004 on drug 
precursors, OJ L 47, 18.2.2004, p. 1. 
3  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52012XG1229(01)&from=EN 

1 

 
 
                                                           
precursors are also among the aims of the EU Agenda and Action Plan on Drugs 2021-20254. 
The  concerned  measures  are  included  under  the  overall  strategic  priority  of  enhancing 
security through the disruption of drugs markets.   

This  report  presents  the  results  of  the  evaluation  of  the  Regulations  which  was  conducted 
between 2017 and 2019. It was supported by a study commissioned by the Commission from 
an  external  contractor.  Also  stakeholder  and  public  consultations,  interviews  and  a 
stakeholder workshop have been carried out.  

The  evaluation  addresses  the  requirement  of  both  Regulations  to  submit  by  31  December 
2019  “a  report  to  the  European  Parliament  and  to  the  Council  on  the  implementation  and 
functioning  of  these  two  Regulations,  and  in  particular  on  the  possible  need  for  additional 
action to monitor and control suspicious transactions with non-scheduled substances”5.  

2.  FINDINGS OF THE EVALUATION  

The  evaluation  assesses  the  implementation,  effectiveness,  efficiency,  relevance,  coherence 
and EU added value of the Regulations. 

2.1. 

Implementation  

The  Regulations  on  drug  precursors  are  directly  applicable  in  the  Member  States.  There  is 
therefore no need for the Member States to transpose them into national legislation.  

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  the  bona  fides  of  their 
customers,  detect  suspicious  transactions  and  alert  the  authorities.  An  effective  industry-
authority  partnership  is  therefore  the  keystone  of  the  implementation  of  the  regulatory 
framework. 

The  Regulations  apply  to  drug  precursors  that  are  defined  as  “scheduled  substances”  and 
which  are  included  in  the  annexes  to  the  Regulations.  However,  they  also  contain  some 
provisions that are applicable to “non-scheduled substances”, in particular the need to report 
suspicious  transactions  to  the  authorities.  Non-scheduled  drug  precursors  are  substances 
which, although not listed in the EU drug precursors legislation, can be used for illegal drug 
production.  The  most  commonly  used  non-scheduled  substances  are  included  in  the  EU 
Voluntary  Monitoring  List  of  Non-scheduled  Substances.  This  list  is  confidential  and 

4  European  Commission,  Communication  from  the  European  Commission  to  the  European  Parliament,  the 
Council,  the  European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions,  EU  Agenda  and 
Action Plan on Drugs 2021-2025, COM(2020) 606 final.  
5 See Article 16(3) of Regulation 273/2004 and Article 32(4) of Regulation 111/2005. 

2 

 
                                                           
distributed  to  trusted  economic  operators  only;  they  are  requested  to  report  suspicious 
transactions concerning the substances on the list to the authorities.  

The chemicals are “scheduled” – i.e. formally included in the Regulations – when the cost of 
scheduling for operators and competent authorities would not outweigh the benefits of stricter 
control or because the substance can be easily substituted for illegal drug manufacture. 

The requirements of the Regulations are modulated according to the aptness and importance 
of the substances for illegal drug manufacture, which are grouped into several categories (3 
categories for intra-EU trade and 4 categories for external trade).  

The  evaluation  has  shown  that  the  implementation  of  the  Regulations  varies  substantially 
between  Member  States.  This  is  a  result  of,  inter  alia,  the  different  amounts  of  human 
resources devoted to these tasks by different Member States, the significant differences in the 
frequency  of  on-site  verifications  checks  to  licence  or  registration  holders,  the  different 
interpretations of the definition of mixtures containing drug precursors, the level of penalties 
applicable  to  infringements  of  the  Regulations,  as  well  as  of  the  large  differences  in  the 
number  of  notifications  of  suspicious  transactions  in  various  Member  States.  A  significant 
degree  of  variability  can  be  accounted  for  by  the  existence  of  specific  circumstances  at 
Member State level though. For instance there are huge differences in scale and development 
of  the  chemicals  industries  among  Member  States.  Additionally,  the  scale  of  illicit  drug 
production varies  greatly between Member States and this has an impact on the importance 
which is given to drug precursor policy. Moreover, also huge differences as to which illicit 
drugs  cause  the  most  health  or  social  problems  explain  why  Member  States  give  different 
attention  to  monitoring  certain  drug  precursors.  For  instance,  a  Member  State  where  illicit 
methamphetamine production or consumption is non-existent or marginal may not give high 
priority  to  monitoring  the  drug  precursors  needed  for  illicit  methamphetamine  production. 
Nevertheless, some of these differences,  for instance the considerable variation  of penalties 
for infringements  against  the EU drug precursor  legislation may  require further attention in 
particular to assess whether they are dissuasive, effective and proportionate. 

2.2.  Effectiveness  

Analyses starting from the suspected illegal drug manufacture 

To assess the overall effectiveness of the Regulations a distinction is made between the main 
types of drug precursors which are relevant for EU policy and the regions in which they are 
typically used for illegal drug manufacture. 

3 

 
 
 
a) Synthetic drug manufacture in the EU (mostly MDMA and amphetamines6) 

Key drug precursors7  

Generally  speaking  the  key  drug  precursors  -  that  in  the  manufacturing  process  become 
incorporated in  full or in part into the molecule of the drug (i.e. the final  product) and thus 
which are fully or partly responsible for the psychotropic effects which the drug user seeks - 
are not produced in the EU and are thus legally or illegally imported into the EU.  

The  evaluation  indicates  that  these  drug  precursors  are  not  ‘diverted’  in  a  traditional  way. 
Key  drug  precursors  for  amphetamines  and  MDMA  production  in  the  EU  are  now  almost 
exclusively  designer-precursors.  Designer-precursors  are  close  chemical  relatives  of  a 
scheduled drug precursor that are purpose-made to circumvent controls by the authorities and 
usually do not have any known legitimate use. Additionally, methamphetamine is also often 
produced  in  the  EU  on  the  basis  of  the  key  precursors  ephedrine  and  pseudoephedrine.  In 
many cases these are extracted from medicines containing these substances which have been 
legally purchased over the counter in pharmacies in certain Member States. In other words, 
these precursors are also not ‘diverted’ in the traditional sense. Therefore, as far as the supply 
of  key  chemicals  for  the  illicit  synthetic  drug  production  in  the  EU  is  concerned,  we  can 
conclude  that,  generally  speaking,  the  prevention  of  diversion  of  drug  precursors  has  been 
effective. However, the successful prevention of diversion combined with the emergence of 
new  production  techniques  which  do  not  require  scheduled  substances  have  most  likely 
prompted traffickers to use increasingly designer-precursors (see Relevance). 

Auxiliary drug precursors8  

On  top  of  the  key  drug  precursors,  synthetic  drug  production  in  the  EU  also  requires  large 
amounts and different types of auxiliary drug precursors like reagents, solvents, separation or 
dispersing agents that are used in the course of a chemical synthesis but are not incorporated 
into the drug. 

The evaluation shows that many of these auxiliary drug precursors are traditionally diverted 
from  legal  to  illegal  channels  within  the  EU.  This  is  supported  by  the  fact  that  the  EU 
customs authorities hardly ever seize auxiliary drug precursors at the EU’s external borders 
which suggests they originate from within the EU.  

These chemicals, many of which are ‘bulk chemicals’, are typically produced and traded in 
very  large  volumes  which  makes  prevention  of  diversion  particularly  challenging.  Only  a 
minor  percentage  of  the  total  produced  and  traded  volume  is  needed  to  supply  the  illicit 

6 Amphetamines include amphetamine and methamphetamine. 

7 Usually Category 1 and 2  in the Regulations  
8 Usually Category 3 substances in the Regulations 

4 

 
                                                           
synthetic  drug  producers.  This  means  that  even  though  the  overwhelming  majority  of 
operators  may  fully  comply  with  the  Regulations  it  takes  only  a  very  limited  number  of 
careless  or  corrupt  operators  to  provide  the  illegal  drug  manufactures  with  the  required 
auxiliary  drug  precursors.  Nevertheless,  this  suggests  that  in  relation  to  the  synthetic  drug 
manufacture  in  the  EU  and  for  the  auxiliary  chemicals  the  prevention  of  diversion  of  drug 
precursors has not been effective in the EU. 

b) Heroin manufacture typically in Central and South East Asia  

Acetic anhydride (AA) is used as an acetylation agent to process morphine into heroin and is 
subject to international drug precursor control because of this critical role in the manufacture 
of heroin9. It is one of the drug precursors which receives the most attention by the authorities 
around the world because heroin is one of the most addictive drugs, being responsible for a 
disproportionately large share of the health problems and mortality associated with drug use, 
and  also  because  the  production  of  heroin  in  Afghanistan  is  suspected  to  be  linked  to 
terrorism financing. 

The  global  legitimate  manufacture  and  trade  in  AA  is  large  and  expanding,  and  this, 
combined  with  the  fact  that  comparatively  small  amounts  are  required  in  illegal  heroin 
manufacture  (about  0.01%),  makes  preventing  diversion  for  illicit  purposes  a  very 
challenging  task.  In  December  2013,  the  EU  strengthened  its  precursor  legislation  by 
introducing  a  requirement  for  the  registration  of  end-users  of  AA  with  the  aim  to  reduce 
diversion in the EU. However, despite the stringent controls, diversion of AA still occurs in 
the EU. Turkey in particular regularly seizes AA which is allegedly coming from the EU and 
is  on  its  way  to  Afghanistan.  Also,  the  latest  reports  of  the  International  Narcotics  Control 
Board10 have drawn attention to this problem and called upon the authorities in the EU to take 
appropriate measures.  

Additionally,  in  certain  EU  Member  States,  illegal  laboratories  producing  heroin  from 
morphine  have  been  discovered.  The  reason  for  this  atypical  production  location  –  usually 
heroin  is  synthesised  closer  to  the  regions  where  the  plants  from  which  it  is  made,  namely 
poppies, grow – is according to experts the cheaper and easier availability of AA in the EU 
than  in  Afghanistan  or  other  traditional  heroin  producing  regions.  This  suggests  that  the 
prevention of diversion of (AA) in the EU has not been effective. 

9 The main steps in the production process of heroin are: Poppy(cultivation)opiummorphineheroin 
10  Annual  Reports  on  Precursors  (2018  and  2019)  -  Precursors  and  chemicals  frequently  used  in  the  illicit 
manufacture of narcotic drugs and psychotropic substances, INCB. 

5 

 
 
 
                                                           
Analysis starting from the number of seizures and stopped shipments 

An analysis of the seizures and stopped shipments over time can also give an insight into the 
evolution of diversion and the effectiveness of the EU drug precursor policy11. Seizures are 
shipments detained on the basis of an instruction issued by a court or a competent authority. 
Stopped shipments are shipments permanently withheld at the initiative of an operator or of 
the  competent  authorities  because  reasonable  grounds  exist  to  believe  that  the  transaction 
may constitute an attempted diversion of drug precursors.  

Such an analysis has been carried out in the context of this evaluation. However, practically 
the  only  general  conclusion  which  can  be  drawn  is  that  the  continued,  although  erratic, 
seizures of almost all scheduled precursor substances indicate that diversion from licit trade is 
continuing  to  occur.  Moreover,  and  that  whilst  strengthening  some  of  the  Regulations  (e.g. 
the reclassification in 2013 of AA as Category 2A with obligations for end-users to register 
as well  as operators) has resulted in  strengthened monitoring controls, there have still been 
significant levels of seizures after the implementation of these changes. 

Another  way  to  look  into  this  is  via  the  seizures  of  key  chemicals,  usually  scheduled  in 
Category 1, together with the non-scheduled substances which can be used as their substitute. 
This  has been done in  a recent  report of the Dutch customs authorities12. According to  this 
report, at least 189 tonnes of key chemicals were seized in 2017 and 2018 in the EU. About 
170 million MDMA tablets and 103 tonnes of amphetamine paste could be produced on the 
basis of the 189 tonnes of key chemicals.  

However, the real scale of the diversion or smuggling is probably much bigger. This can be 
deduced  from  the  many  empty  packages  which  are  found  at  the  illegal  labs  and  the  many 
dumping sites of used chemicals. According to the European Reporting Instrument on Sites 
related to Synthetic Production (ERISSP) 311 dumping sites have been reported in 2018. 

An  additional  consequence  of  this  large  synthetic  drug  production  in  the  EU  which  can  be 
deduced  from  the  significant  quantities  of  key  chemicals  that  have  been  discovered  is  that 
even  more  auxiliary  substances  (solvents,  reagents,  etc.)  must  somehow  have  reached  the 
illegal  labs  –  and  hence  must  have  been  diverted13.  According  to  intelligence  from  law 

11 It should be remarked that interpreting this indicator should be done with care. An increase in the number of 
seizures and/or the seized quantities may at first sight be viewed as positive since it means that the authorities 
have  been  more  effective  in  preventing  that  chemicals  will  be  used  for  illegal  drug  manufacture.  However,  it 
could equally  simply  mean that the diversion  has increased and that ‘the problem’ has become in  fact  worse. 
Conversely,  a  decrease  in  the  number  seizures  or  the  quantities  seized  does  not  necessarily  mean  that  the 
authorities have been less effective in addressing diversion. This may mean that diversion is decreasing, which 
would obviously be a positive development 
12  The  smuggling  of  (pre-)precursors  for  the  production  of  synthetic  drugs  –  Situation  Report  2017-2018, 
Douane Belastingdienst, 2019 
13  For  instance,  acetone  is  used  in  the  manufacture  of  cocaine,  heroin,  lysergic  acid  diethylamide  (LSD), 
amphetamine and methamphetamine derivatives. Several tens of litres of this substance are necessary to obtain 1 
kg of  these drugs (Source: Drug Precursors Brochure by DG TAXUD, 2012) 

6 

 
                                                           
enforcement  authorities,  most  of  the  auxiliary  substances  in  the  illegal  laboratories  are 
sourced intra-EU as they are almost never seized by customs authorities at the EU’s external 
borders.  In  conclusion,  it  is  very  likely  that  the  number  of  cases  of  intra-EU  diversion  of 
auxiliary substances  is  very high in  the EU. This confirms  the above-mentioned conclusion 
that the prevention of diversion of auxiliary substances in the EU has not been effective. 

2.3.  Efficiency  

Efficiency generally considers the relationship between the resources used by an intervention 
and  the  changes  generated  by  it.  In  the  context  of  this  particular  evaluation,  establishing  a 
clear relationship was not possible. There is no method with any reasonable degree of rigour 
that  allows  for  the  monetary  quantification  of  the  effects  in  terms  of  reduced  drugs  supply 
further to the prevention of precursors needed for their production from  being diverted into 
this use.  

Although  the  key  benefit  (prevention  of  diversion)  cannot  be  monetised,  the  evaluation 
offered  sufficient  indications  to  the  effect  that  the  efficiency  of  the  Regulations  is  not  in 
doubt.  The  costs  they  engender  for  both  authorities  and  operators  cannot  be  regarded  as 
excessive  and  their  contribution  to  obtaining  significant  benefits  (though  not  amenable  to 
quantification) was widely recognised. 

Nevertheless, the evaluation has also shown that there may be room for improving efficiency, 
in  particular  in  the  field  of  external  trade,  by  shortening  the  deadlines  for  pre-export 
notifications and introducing thresholds for a number of obligations and an electronic system 
for  import  and  export  authorisations  (eLicensing)  and  to  automate  the  validation  of  those 
authorisations  by  national  customs  authorities  in  context  of  the  EU  Single  Window 
environment for customs initiative14. 

2.4.  Relevance 

Since the illicit drug market is very dynamic, with constant changes in available illicit drugs 
and  the  precursors  used  to  produce  them,  the  relevance  of  drug  precursor  legislation  is 
determined by the extent to which it continues to limit the supply of precursors for the illicit 
production  of  drugs  thereby  contributing  to  limiting  the  amount  of  illegal  drug  which  are 
produced and subsequently supplied to our society.  

Speed with which new drug precursors can be included in the Regulations  

Since the revision of the legislation in 2013 substances can be added to the Regulations (also 
called  “scheduling”)  via  a  Commission  Delegated  Regulation.  This  has  reduced  the  time 

14 https://ec.europa.eu/taxation_customs/general-information-customs/electronic-customs/eu-single-window-
environment-for-customs_en 

7 

 
                                                           
 
needed to adapt the Regulations to 12 to 15 months. Although the situation has significantly 
improved  compared  to  the  period  before  2013  when  additions  were  only  possible  via  the 
ordinary  legislative  procedure  (which  often  took  several  years),  12  to  15  months  is  still 
considered  too  long.  This  offers  drug  criminals  a  substantial  period  during  which  they  can 
continue to relatively easily use the substance for illegal drug manufacture and furthermore 
can develop alternatives while the process for scheduling new substances is being completed.  

It can thus be concluded that the Regulations are to an extent able to address the emergence 
of new substances used in illegal drug manufacture but that there is also a need to continue to 
explore ways to accelerate the scheduling process considering the speed and ease with which 
illegal  drug  manufactures  are  able  to  develop  new  ones  which  are  outside  the  scope  of  the 
Regulations.  

Are  the  Regulations  able  to  cope  with  the  increased  use  of  non-scheduled  substances,  in 
particular ‘designer-precursors’?  

As  mentioned  before,  illegal  synthetic  drug  producers  in  the  EU  currently  use  almost 
exclusively designer-precursors.  

Law  enforcement  authorities  and  specialists  in  chemistry  explain  that  there  are  hardly  any 
limitations to  the  innovations  of  the  producers  of  designer-precursors.  In  other  words,  each 
time a new substance is scheduled the criminals will be able to ‘tweak some molecules’ and 
come up with a new designer-precursor. The time needed for this can be short and in any case 
is often shorter than the period needed to schedule a new substance. So authorities will never 
be  able  to  react  quickly  enough  to  address  this  problem  within  the  existing  legislative 
framework.  

To illustrate this mechanism, we can look at the evolution of the main precursor used in the 
EU for the production of amphetamine in the last ten years. Before 2010, illegal manufacture 
of  this  drug  in  the  EU  was  based  mainly  on  the  scheduled  precursor  substance  BMK. 
However,  presumably  because  of  the  effective  control  and  monitoring  measures  by  the 
authorities  illicit  drug  producers  looked  for  alternatives.  This  led  to  the  subsequent 
development  of  APAAN,  then  APAA  and  finally  MAPA;  these  are  all  designer-precursors 
used  to  replace  BMK  in  the  manufacture  of  amphetamine.  In  the  meantime  there  are 
indications  that  the  amount  of  amphetamine  illegally  produced  in  the  EU  continues  to 
increase. This process clearly shows the limits and the challenges of a drug precursor control 
approach which is mainly based upon substance-by-substance scheduling.  

It should also be noted that traditional techniques of “prevention of diversion of substances” 
that have a legal use have thus become outdated and are much less effective in this context. In 
particular  cooperation  with  the  chemical  industry  via  the  obligation  to  notify  suspicious 
transactions, which is a key feature in the EU’s drug precursors approach, is problematic. The 
economic  operators  involved  in  the  production  of  these  designer-precursors  are  most  likely 

8 

 
knowingly  operating  illegally  and  will  thus  never  cooperate  with  the  authorities  or  notify 
suspicious transactions. 

During  the  revision  of  the  legislation  in  2013  the  legislators  were  already  aware  of  this 
problem (the emergence of APAAN having occurred before 2013) and therefore they enacted 
the  so-called  ‘catch-all’-provisions  in  the  Regulations.  The  aim  of  these  provisions  was  to 
allow  the  competent  authorities  to  intervene  in  cases  where  non-scheduled  substances, 
including  designer-precursors,  were  traded  or  smuggled  with  a  view  to  use  in  illegal  drug 
manufacture. 

The catch-all provision  in  the external  trade regulation  obliges  the competent authorities of 
the  EU  Member  States  to  prohibit  the  introduction  of  consignments  of  non-scheduled 
substances  into  the  customs  territory  of  the  EU  or  their  departure  from  it  where  there  is 
sufficient  evidence that those substances are intended for the illicit manufacture of narcotic 
drugs  or  psychotropic  substances.  In  the  intra-EU  trade  regulation  each  EU  Member  State 
may adopt the measures necessary to enable its competent authorities to control and monitor 
suspicious  transactions  involving  non-scheduled  substances,  and  in  particular,  where 
necessary,  to  detain  and  seize  consignments  to  prevent  the  use  of  specific  non-scheduled 
substances for the illicit manufacture of narcotic drugs or psychotropic substances. 

However,  experience  since  the  entry  into  force  of  these  provisions  has  shown  that  most 
Member States  do not  or cannot  apply these  catch-all provisions mainly because of lack of 
clarity as to what constitutes “sufficient evidence”. 

The problems with the catch-all provisions and possible ways to overcome them have been 
the  subject  of  many  discussions  by  the  EU  Group  of  Experts  on  Drug  Precursors  in  recent 
years. All experts and law enforcement authorities agree that there is an absolute and urgent 
need  for  a  method  which  can  effectively  address  the  issue  of  non-scheduled  substances,  in 
particular designer-precursors, without the need to schedule the substances in question.  

It should however also be remarked that although alternative ways need to be developed to 
address  the  challenge  posed  by  designer-precursors,  the  'prevention  of  diversion'  of 
traditional key chemicals such as safrole, BMK and PMK remain relevant because traffickers 
will always use the path of least resistance. Any loosening by the authorities will be exploited 
immediately by the criminals and thus  illegal  drug producers will go back to  using safrole, 
BMK, PMK etc. 

It can thus be concluded that the current drug precursor control and monitoring regime is not 
able  anymore  to  successfully  address  the  overall  needs  in  society  which  it  was  intended  to 
cater for. 

In this context it should be remarked that drug precursor diversion and trafficking is a global 
phenomenon  which  also  requires  international  cooperation.  At  multilateral  level  the  legal 
basis  for  this  is  provided  for  by  the  UN  1988  Convention  and  it  is  the  Commission  on 

9 

 
Narcotic Drugs (CND) of the UN and the Precursor Task Force of the International Narcotics 
Control  Board  (INCB)  that  give  shape  to  this  cooperation.  As  to  the  problem  of  designer-
precursors  all  parties  agree  that  no  ready-available  solution  is  at  hand  and  that  novel 
approaches will be required, including via international cooperation. 

Additionally,  the  EU  has  concluded  agreements  on  drug  precursors  with  11  third  countries 
such as China, the US, Mexico, Colombia and Turkey. At this moment the cooperation with 
China is the most important because, as far as is known, all designer-precursors used in illicit 
drug manufacture in the EU originate in China.  

Assessing international cooperation is outside the scope of this evaluation however. It should 
be  noted  that  the  ongoing  evaluation  of  the  EU-China  Cooperation  and  Mutual  Assistance 
Agreement  in  Customs  Matters  does  look  into  the  need  to  strengthen  EU-China  customs 
cooperation on drug precursors.  

Are the Regulations able to cope with the misuse of online-trading platforms 

A  concern  highlighted  by  stakeholders  from  industry  during  the  evaluation  was  the  lack  of 
control over online-trading platforms. Such trading platforms can take various forms: some 
only provide buyer and supplier information, for a fee or free of charge, and are not involved 
in  transactions;  others  act  as  trading  platforms  and  are  directly  engaged  in  sales;  and 
manufacturers often sell their products via their corporate websites. 

However,  at  the  moment  there  is  very  little  reliable  information  available  on  this  topic. 
Whether or not these online-trading platforms need to be regulated with special provisions in 
the  Regulations  is  a  difficult  matter  and  depends  also  on  the  precise  form  they  take  or 
services  they  provide.  This  will  need  to  be  further  analysed.  In  this  context  it  will  be 
important to ensure coherence with the European Digital Strategy. 

2.5.  Coherence 

The  evaluation  of  coherence  as  concerns  the  Regulations  on  drug  precursors  has  examined 
several dimensions. 

How well the Regulations work internally and in relation to each other 

The  public  and  targeted  consultations  carried  out  allowed  to  identify  a  number  of  concrete 
elements  of  criticism  with  the  internal  coherence  of  the  legislation  being  evaluated.  These 
referred  to:  the  definition  of  mixtures;  the  fact  that  Category  4  substances15  (listed  in  the 

15  Medicinal  products  and  veterinary  medicinal  products  containing  ephedrine  and/or  pseudo-ephedrine  or  its 
salts 

10 

 
                                                           
 
Annex to the external trade regulation) are not covered also by the intra-EU trade regulation; 
and the desirability of merging the existing two distinct Regulations. 

The  analysis  of  these  criticisms  (which  have  been  formulated  only  by  a  minority  of 
respondents)  led  to  the  conclusion  that  they  do  not  in  themselves  call  into  question  the 
internal  coherence  of  the  Regulations  per  se.  The  difficulties  related  to  the  definition  of 
mixtures is not attributable to contradictions or ambiguities in the legal texts, but rather to its 
non-uniform implementation. The absence of Category 4 substances from the intra-EU trade 
Regulation  does  not  hamper  in  any  way  the  effectiveness  of  the  relevant  provisions  of  the 
external  trade  regulation,  as  the  latter  sets  obligations  related  to  these  substances  only  in 
respect  of  exports,  i.e.  whose  effects  are  felt  outside  the  EU.  As  concerns  the  possible 
merging  of  the  two  Regulations,  all  reasons  cited  for  such  decision  were  informed  by 
considerations  of  convenience,  no  specific  provisions  having  been  identified  that  are 
engendering  uncertainty  about  the  required  course  of  action,  let  alone  contradicting  each 
other.  

How do the Regulations relate to other EU-level interventions  

By  taking  measures  to  avoid  the  diversion  of  key  chemicals  into  drug  production,  the 
Regulations contribute to fulfilling one of the five objectives of the EU Drugs Strategy 2013-
2020,  namely  “to  contribute  to  a  disruption  of  the  illicit  drugs  market  and  a  measurable 
reduction of the availability of illicit drugs”. The number of seizures and stopped shipments 
of drug precursors indicates that the existing drug precursor legislation leads to a reduction of 
the supply of illicit channels with drug precursors and, consequently, to reducing the supply 
of illicit drugs. However, it is not possible to quantify the exact impact of this legislation on 
the overall reduction of drug precursors diverted into illicit channels.  

Nevertheless, it will continue to be important that the EU drug precursor policy remains fully 
aligned with the EU Drugs Agenda and Action Plan. One particularly important aspect in this 
context  relates  to  the  support  that  the  European  Monitoring  Centre  for  Drugs  and  Drug 
Addition  (EMCDDA)  could  give  in  terms  of  collection,  consolidation  and  analysis  of  drug 
precursors-related data.  

Can the Regulations co-exist without tensions with related national interventions which are 
allowed by the EU Treaties  

A potential problem of coherence originates in the fact that one particular substance, gamma-
butyrolactone (GBL), is both a drug precursor and a drug on its own. The ambiguous status of 
the substance has led to a situation whereby it is regulated in very different ways across the 
Member States. Also, a number of substances have been identified which are scheduled as a 
drug  in  the  narcotics  legislation  at  Member  State  level  and  as  a  drug  precursor  in  the 
Regulations.  By  themselves,  these  issues  are  not  affecting  the  effectiveness  of  the 
Regulations, but in specific cases they may pose problems for the integrity of the EU internal 
market.  This,  however, is not  due to  the provisions of the Regulations themselves, nor is  it 

11 

 
possible to remove this threat by amending the Regulations. Indeed, the substances included 
in  the  Tables  of  the  UN  1988  Convention  have to  remain  scheduled  in  the  drug  precursors 
Regulations  irrespective  of  whether  some  of  them  are  considered  (and  treated)  as  drugs  by 
some Member States.  From the standpoint of the  Regulations, it is important to  ensure that 
the scheduling of substances is done according to criteria that are applied consistently, though 
this cannot be ensured with full certainty given the binding obligations deriving from the text 
of the UN 1988 Convention. 

12 

 
 
 
Compatibility of the Regulations with international obligations 

The  Regulations  incorporate  the  obligations  that  the  UN  1988  Convention  imposes  on  its 
signatories, such as in particular the obligation to take measures to prevent the diversion of 
specifically-designated  substances  for  the  purpose  of  illicit  manufacture  of  drugs  (Article 
12:1  of  the  Convention)  and  the  obligation  to  establish  and  maintain  a  system  to  monitor 
international trade in specifically-designated substances (Art.12:9:a).  

With respect to the substances in relation with which these obligations apply, there are some 
differences between the substances listed in Tables I and II of the UN 1988 Convention and 
the substances scheduled under the Regulations. However, these differences exist because the 
EU legislation, while scheduling all substances listed  in  the UN 1988 Convention, includes 
additional  substances  that  were  scheduled  in  order  to  tackle  specific  problems  identified  in 
the EU. As such, there appear to be no coherence issues with the 1988 UN Convention. Apart 
from  the  obligations  stemming  from  the  UN  1988  Convention,  the  CND  regularly  adopts 
resolutions on drug precursor control and monitoring. These resolutions are not binding and, 
moreover,  in  many  cases  the  EU  is  implementing  the  recommendations  of  the  resolutions 
already  before  their  adoption  as  the  EU  is  often  an  early  adopter  of  ‘good  practices’  or 
innovative approaches on drug precursor policy. 

As a general conclusion, the evaluation did not lead to the identification of serious coherence 
problems related to the drug precursors Regulations. In particular, no elements of incoherence 
appear to exist internally and from the standpoint of the international obligations binding the 
EU in this area.  

2.6.  EU added value  

The examination of the added value brought by the Regulations on drug precursors has two 
important specificities: 

-  because  of  the  existence  of  the  1988  UN  Convention,  which  counts  all  the  EU 
Member  States  as  signatories,  legislating  in  this  area  would  have  been  required 
anyway, irrespective of whether at national or EU level; 

- 

the  counterfactual  to  an  intervention  at  EU  level  (i.e.,  Member  States  implementing 
measures  at  national  level)  is  either  impossible  from  a  legal  standpoint  or  feasible 
only in narrowly defined circumstances. 

It  should  also  be  pointed  out  that  the  regulation  at  EU  level  of  the  external  trade  in  drug 
precursors  is  the  direct  consequence  of  EU’s  exclusive  competence  in  the  matter  and 
coherence considerations render desirable the symmetrical regulation of intra-EU trade. 

Notwithstanding  the  fact  that  the  room  for  national-level  interventions  is  limited  anyway, 
there  are  compelling  reasons  why  EU-level  intervention  is  intrinsically  preferable.  In 
particular, the Regulations on drug precursors make reference to  mutual  assistance between 

13 

 
the  administrative  authorities  of  the  Member  States  and  cooperation  between  the  latter  and 
the  Commission.  This  is  an  extremely  valuable  (and  almost  indispensable)  tool  for  a 
regulatory intervention whose purpose is to avoid that specific goods are diverted into illicit 
channels and used for criminal activities because such activities are by definition not publicly 
known and information related to them can only be obtained by competent authorities and is 
often confidential.        

The  targeted  questionnaires  provided  additional  insights  into  what  concrete  benefits  are 
deriving  from  controlling  drug  precursors  at  EU  level,  such  as  the  existence  of  common 
definitions,  criteria  and  approaches,  which  ensure  greater  consistency  in  implementing 
controls and also provide clear and predictable rules for economic operators.  

The  negative  effects  attributed  to  the  EU  intervention  relate  to  the  slowness  of  the 
amendments  of  the  Regulations  in  order  to  have  additional  substances  scheduled  (see 
Relevance)  and  to  the  problems  that  arise  when  individual  Member  States  have  different 
priorities in terms of substances they wish to place under control.  

On balance, however, the responses received  from  both  Member State authorities and from 
economic operators have highlighted significantly more benefits than negatives.  

The  evaluation  has  also  convincingly  shown  that  legislative  interventions  at  national  level, 
besides being inherently limited by the provisions of the Treaties, tend to be inferior not only 
from the standpoint of legal certainty, but also from that of efficacy, to the intervention at EU 
level. 

3.  CONCLUSIONS 

The evaluation has shown that additional action with regard to non-scheduled substances, in 
particular designer-precursors, is necessary.  

Therefore the Commission will consider a revision of the EU drug precursor Regulations and 
related legal instruments such as Council Framework Decision 2004/757/JHA of 25 October 
2004  laying  down  minimum  provisions  on  the  constituent  elements  of  criminal  acts  and 
penalties  in  the  field  of illicit  drug  trafficking,  taking  into  account  this  finding  and  without 
prejudging the outcomes of the better regulation process.  

This  opportunity could  also  be used to consider strengthening a number of other aspects  of 
the Regulations such as those concerning the diversion of auxiliary drug precursors and AA 
from  intra-EU  trade,  reducing  the  administrative  burden  for  economic  operators  and 
competent authorities and stricter control of online-trading platforms.  

To  this  end  a  holistic  approach  will  be  required  so  as  to  ensure  consistency  with  other 
initiatives and policies at EU level, and in particular with: the EU Drugs Agenda and Action 
Plan;  the  revision  of  the  mandate  of  the  European  Monitoring  Centre  for  Drugs  and  Drug 
Addiction  (EMCDDA);  the  European  Digital  Strategy;  the  new  Customs  Action  Plan,  in 

14 

 
particular in relation to customs risk management (and the possibilities for strengthening the 
contribution of customs risk analysis and controls to precursors detection); the new initiative 
on  customs  sanctions;  the  EU  Single  Window  environment  for  customs  initiative;  and  the 
evaluation of the customs cooperation between the EU and China.  

15