Proposal for a Council Regulation laying down rules for the monitoring of trade in certain substances used for the illicit manufacture of narcotic drugs and psychotropic substances
Date: 2004-04-07
Institutions: European Commission
Subjects: chemical product, drug traffic, illicit trade, psychotropic substance

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 7.4.2004 
COM(2004) 244 final 

2004/0078 (ACC) 

. 

Proposal for a  

COUNCIL REGULATION 

laying down rules for the monitoring of trade in certain substances used for 
the illicit manufacture of narcotic drugs and psychotropic substances 

(presented by the Commission) 

EN 

   EN 

 
 
 
EXPLANATORY MEMORANDUM 

1. 

INTRODUCTION 

On  13  December  1990  the  Council  adopted  Regulation  (EEC)  No  3677/90  laying 
down measures to be  taken  to discourage the diversion of certain substances to the 
illicit  manufacture  of  narcotic  drugs  and  psychotropic  substances.  This  act 
implemented  Article  12  of  the  United  Nations  Convention  against  illicit  traffic  in 
narcotic  drugs  and  psychotropic  substances  of  1988  concerning  trade  in  drug 
precursors which are chemical substances frequently used in the illicit manufacture 
of narcotic drugs and psychotropic substances.  

Within its sphere of competence, the Community participated in the negotiation and 
concluded the Convention through Council Decision 90/611/EEC. 

Article  12  of  the  United  Nations  Convention  against  illicit  traffic  in  narcotic  drugs 
and psychotropic substances requires a system to monitor international trade in drug 
precursors.  The  aim  of  this  system  is  to  ensure  that  the  chemicals  required  to 
manufacture  narcotic  drugs  and  psychotropic  substances  are  denied  to  those  who 
illegally perform these operations.  

Taking account of their multiple licit uses and that in principle their trade is lawful, 
access to these substances cannot generally be denied but measures need to be taken 
that strike an appropriate balance between the desire to exploit all possible means to 
prevent  drug  precursors  reaching  illicit  drug  manufacturers  and  the  commercial 
needs of the chemical industry.  

Regulation  (EEC)  No  3677/90  therefore  lays  down  rules  to  monitor  trade  of  drug 
precursors between the Community and third countries and has established a system 
of  reporting  suspicious  transactions.  This  system,  which  is  based  on  close  co-
operation with operators, is reinforced through measures, such as documentation and 
labelling,  licensing  and  registration  of  operators,  procedures  and  requirements 
governing exports. 

The  legislative  scheme  having  being  adopted  more  than  a  decade  ago,  it  seemed 
appropriate to evaluate the Community monitoring system of trade in precursors with 
a view to drawing conclusions from the implementation of the existing Community 
legislation in this field and in order to be able to effectively counter new patterns and 
trends  of  precursor  diversion  and  illicit  traffic  in  narcotic  drugs  and  psychotropic 
substances. 

2 

 
 
  
 
2. 

OBJECTIVE OF THIS PROPOSAL 

Following the European Union Action plan on Drugs 2000 – 2004, endorsed by the 
European Council at Feira in June 2000, the Commission organised an assessment of 
the Community monitoring system of trade in drug precursors conducted in close co-
operation with the Community Member States. 

According  to  this  assessment,  it  is  necessary  to  further  strengthen  mechanisms  and 
procedures  to  monitor  trade  between  the  Community  and  third  countries  in  drug 
precursors  and  to  adapt  the  existing  control  system  to  new  trends  and  patterns  of 
diverting drug precursors. In particular, it was found necessary to extend monitoring 
requirements with regard to operators based within the Community facilitating trade 
between  third  countries,  to  introduce  a  Community  approach  with  regard  to 
procedures  for  granting  licences  and  to  strengthen  monitoring  requirements 
governing suspensive customs procedures. Procedures and requirements for exports 
should be further intensified to target and concentrate controls on the most sensitive 
consignments  mainly  depending  on  the  sensitivity  of  the  precursor  and  the  third 
country of the trading partner. 

The primary aim of this proposal concerns the need to further strengthen the import 
control  for  the  main  synthetic  drug  precursors  in  order  to  address  the  heightened 
concern relating to amphetamine type stimulants (ATS). It is necessary to introduce 
requirements  and  procedures  for  individual  import  authorisations  to  allow  the 
monitoring of individual consignments towards the Community and thereby further 
intensifying  the  Community's  efforts  to  prevent  synthetic  drug  precursors,  in 
principle  not  produced  in  the  Community,  reaching  illegal  manufacturers  and 
traffickers of synthetic drugs. 

In order to allow operators to fulfil these requirements, provisions governing external 
trade in drug precursors should, to the extent possible, be aligned with the provisions 
governing intra-Community trade of drug precursors in accordance with Regulation 
(EC)  No  273/2004  of  the  European  Parliament  and  of  the  Council  of  11  February 
2004. 

Regulation  (EEC)  No  3677/90  should  therefore  be  amended  accordingly  and 
replaced for the sake of clarity. 

3 

 
 
  
 
3. 

MAIN ARTICLES 

Article 1: 

Article 1 indicates the subject matter of the Regulation and clarifies its scope. 

Article 2: 

Article  2  lays  down  definitions.  The  definitions  relating  to  trade  between  the 
Community and third countries have been redrafted for the sake of completeness and 
clarity  in  order  to  ensure  harmonised  application  throughout  the  Community.  A 
provision on drop shipments, namely activities carried out by operators based within 
the Community facilitating trade between third countries has been inserted in order 
to allow monitoring requirements linked to these activities. 

Articles 3 to 6: 

Articles 3 to 6 relate to documentation, record keeping and labelling requirements. 

The  provisions  on  documentation  have  been  modified  in  order  to  allow  control 
authorities  to  facilitate  the  identification  of  trade  in  precursors  and  subsequently 
target their control. Account has been taken of natural products. Exemptions from the 
record keeping requirement should be allowed if the competent authorities deem the 
documentation to be sufficient. 

Articles 7 to 9: 

Articles 7 to 9 relate to licensing, registration and other requirements. 

Intermediary activities including 'drop shipments' are now covered by licensing and 
registration  requirements.  It  is  also  proposed  that  operators  dealing  with  customs 
warehouses  are  no  longer  exempted  from  licensing  and  registration.  Standard 
licensing  conditions  and  procedures  should  be  set  up  to  reach  a  level  playing  field 
throughout the Community.  

In  order  to  better  ensure  the  monitoring  of  cases  where  licences  or  registration  are 
not  required,  it  is  proposed  that  the  operator  furnishes  a  proof  of  legitimacy  of  the 
country  of  export.  Such  proof  will  facilitate  the  competent  authorities  to  verify 
whether  the  exporting  country  has  authorised  the  export  consignment  without 
creating  unnecessary  additional  administrative  burden.  At  the  same  time,  this  will 
allow  the  Community  to  fulfil  its  international  obligation  to  set  up  a  monitoring 
system to control international trade in precursors. 

4 

 
 
  
 
Article 12: 

Article 12 concerns pre-export notifications. 

The proposed Article clarifies the current practice of sending pre-export notifications 
involving Category 2 and Category 3 substances, namely in the case of agreements 
and in cases of sensitive consignments. 

The internationally agreed principle of pre-export notifications is fully recognised.  

However,  the  additional  administrative  burden  of  sending  pre-export  notifications 
should be accepted only where such instrument is used in a meaningful way, namely 
allowing the competent authorities to assess whether an export authorisation can be 
granted.  Hence,  the  absence  of  a  reply  from  the  authorities  in  the  country  of 
destination should not automatically lead to the granting of an export authorisation, 
but  the  quality  of  the  follow-up  required  from  the  authorities  in  the  country  of 
destination should depend on the degree of sensitivity attached to the consignment. 
Consequently,  it  is  proposed  to  have  a  more  nuanced  approach  in  accordance  with 
the  guidance  given  by  the  International  Narcotics  Control  Board  (INCB)  in  this 
matter. 

Articles 13 to 21: 

These Articles concern export authorisations. 

It is proposed to discontinue the "open individual export authorisation system" and to 
generalise the use of individual export authorisations in principle for all Category 1 
and Category 2 substances. Such extension adds additional administrative burden on 
the  shoulders  of  both  competent  authorities  and  operators,  but  would  allow  the 
monitoring of individual export consignments and thereby enhance the effectiveness 
of control. 

However,  in  order  to  strike  an  appropriate  balance  between  the  administrative 
procedures  and  requirements  and  the  desired  increased  effectiveness  of  control, 
resources should be concentrated on the sensitive drug precursors. Therefore, exports 
of  Category  3  substances  should  only  exceptionally  be  subject  to  authorisation, 
namely in cases where pre-export notifications are applied and in cases of sensitive 
consignments. Moreover, simplified authorisation procedures should be elaborated. 

5 

 
 
  
 
Articles 22 to 27: 

These Articles relate to import authorisations. 

When  the  legislation  came  into  force,  the  Community  was  a  major  exporter  of 
precursors and an importer of illicitly manufactured drugs. This is still the situation 
but unfortunately the Community is now also in the position of an exporter of illicitly 
manufactured  synthetic  drugs  and  an  importer  of  precursors  required  for  that  illicit 
manufacture.  

Hence  the  primary  purpose  of  this  Regulation  to  further  strengthen  the  import 
controls  of  the  main  synthetic  drug  precursors  in  order  to  address  this  growing 
problem, in particular as the Community is generally reported to be one of the main 
leaders of the worlds' ecstasy manufacture and trade.  

It is therefore proposed to introduce individual import authorisation requirements and 
procedures  with  regard  to  Category  1  substances.  This  will  allow  competent 
authorities  monitor  individual  consignments  entering  the  customs  territory  of  the 
Community and to carry out consignment based controls. 

Article 34: 

Article 34 concerns the communication of information on the implementation of the 
rules concerning the trade in precursors. This information is necessary to evaluate the 
effectiveness  of  these  rules  and  their  application  and  to  allow  the  necessary 
adjustments  to  be  made.  This  information  is  also  necessary  to  draw  up  an  annual 
report  to  be  submitted  to  the  International  Narcotics  Control  Board  in  accordance 
with  Article  12  of  the  United  Nations  Convention  against  illicit  traffic  in  narcotic 
drugs and psychotropic substances of 1988. 

6 

 
 
  
 
2004/0078 (ACC) 

Proposal for a  

COUNCIL REGULATION 

laying down rules for the monitoring of trade in certain substances used for 
the illicit manufacture of narcotic drugs and psychotropic substances 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 133 thereof,  

Having regard to the proposal from the Commission1, 

Whereas: 

(1) 

(2) 

(3) 

The  United  Nations  Convention  against  Illicit  Traffic  in  Narcotic  Drugs  and 
Psychotropic Substances adopted in Vienna on 19 December 1988, hereinafter referred 
to  as  the  'United  Nations  Convention',  is  part  of  the  world-wide  efforts  to  combat 
illegal  drugs.  Within  its  sphere  of  competence,  the  Community  participated  in  the 
negotiation  and  concluded  the  Convention  on  behalf  of  the  Community  through 
Council Decision 90/611/EEC.2 

Article 12 of the United Nations Convention concerns trade of substances frequently 
used  in  the  illicit  manufacture  of  narcotic  drugs  and  psychotropic  substances 
hereinafter referred to as 'drug precursors'. As provisions on trade in drug precursors 
affect Community rules in customs matters, it is appropriate to lay down Community 
rules on trade between the Community and third countries. 

Article 12 of the United Nations Convention requires a system to monitor international 
trade  in  drug  precursors  taking  account  of  the  fact  that  in  principle  trade  in  these 
substances is lawful. Consequently measures have been taken to strike an appropriate 
balance  between  the  desire  to  exploit  all  possible  means  to  prevent  drug  precursors 
reaching illicit drugs manufacturers and the commercial needs of the chemical industry 
and other operators. 

1 
2 

OJ C […], […], p. […]. 
OJ L 326, 24.11.1990, p. 56. 

7 

 
 
  
 
                                                 
(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

To  implement  the  requirements  of  Article  12  of  the  United  Nations  Convention  and 
taking account of the report of the Chemical Action Task Force, Council Regulation 
(EEC)  No  3677/90  of  13  December  1990  laying  down  measures  to  be  taken  to 
discourage  the  diversion  of  certain  substances  to  the  illicit  manufacture  of  narcotic 
drugs and psychotropic substances3 has established a system for reporting suspicious 
transactions.  This  system,  which  is  based  on  close  co-operation  with  operators,  is 
reinforced  through  measures  such  as  documentation  and  labelling,  licensing  and 
registration of operators, procedures and requirements governing exports.  

Following  the  European  Union  Action  Plan  on  Drugs  2000  –  2004,  endorsed  by  the 
European Council at Feira in June 2000, the Commission organised an assessment of 
the Community control system of trade in drug precursors to draw conclusions from 
the implementation of the Community legislation in this field.  

According  to  that  assessment,  it  is  necessary  in  order  to  improve  the  control 
mechanisms aiming at preventing diversion of drug precursors, to extend monitoring 
requirements  with  regard  to  operators  based  within  the  Community  facilitating  trade 
between third countries, to introduce a Community approach with regard to procedures 
for granting licences and to strengthen monitoring requirements governing suspensive 
customs procedures. 

Procedures  and  requirements  for  exports  should  be  further  intensified  to  target  and 
concentrate controls on the most sensitive drug precursors, thereby allowing to reduce 
excessive  administrative  burden  through  simplified  procedures  for  exports  of  high 
volume  substances.  While 
the  effectiveness  and  practicability  of  pre-export 
notifications  is  fully  recognised,  a  strategy  should  be  developed  striving  to  fully 
exploit the system. 

In  order  to  address  the  heightened  concern  of  production  of  amphetamine  type 
stimulants, import control mechanisms for the main synthetic drug precursors should 
be  further  strengthened  through  common  procedures  and  requirements  allowing 
individual consignment based controls to be carried out.  

In order to allow operators to fulfil these requirements, provisions governing external 
trade in drug precursors should, to the extent possible, be aligned with the provisions 
governing intra-Community trade of drug precursors wholly obtained or produced, or 
released for free circulation in the Community. 

(10)  Taking account of the requirements of the internal market, and in the interest of this 
Regulation's  effectiveness,  uniform  application  of  the  provisions  should  be  ensured 
through adoption of comparable and converging means of action by Member States. 

3 

OJ  L  357,  20.12.1990,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1232/2002 
(OJ L 180, 10.7.2002, p. 5). 

8 

 
 
  
 
                                                 
(11)  Mutual assistance between the Member States and between the Member States and the 
Commission  should  be  reinforced,  in  particular  by  recourse  to  Council  Regulation 
(EC) No. 515/97 of 13 March 1997 on mutual assistance between the administrative 
authorities  of  the  Member  States  and  cooperation  between  the  latter  and  the 
Commission to ensure the correct application of the law on customs and agricultural 
matters4.  

(12) 

In accordance with the principle of proportionality, it is necessary and appropriate for 
the achievement of the basic objective of preventing the diversion of drug precursors 
for  the  illicit  manufacture  of  narcotic  drugs  or  psychotropic  substances  to  lay  down 
rules for the thorough monitoring of trade between the Community and third countries 
of these substances. This Regulation does not go beyond what is necessary in order to 
achieve the objectives pursued, in accordance with the third paragraph of Article 5 of 
the Treaty. 

(13)  The measures necessary for the implementation of this Regulation should be adopted 
in accordance with Council Decision 1999/468/EC of 28 June 1999, laying down the 
procedures for the exercise of implementing powers conferred on the Commission.5 

(14)  Regulation (EEC) No. 3677/90 should therefore be amended accordingly and replaced 

for the sake of clarity. 

HAS ADOPTED THIS REGULATION: 

TITLE I 

SUBJECT MATTER AND DEFINITIONS 

Article 1 

This Regulation lays down rules for the monitoring of trade between the Community and third 
countries  in  drug  precursors  for  the  purpose  of  preventing  the  diversion  of  such  substances 
and applies to the following situations: 

a) 

4 

5 
6 

any  entry  of  scheduled  substances  having  the  status  as  non-Community  goods  into 
the  customs  territory  of  the  Community,  including  temporary  storage,  entry  into  a 
free zone or free warehouse, the placing under a suspensive procedure and the release 
for free circulation within the meaning of Council regulation (EEC) No. 2913/92 of 
19 October 1992 establishing the Community Customs Code6; 

OJ  L  82,  22.3.1997,  p.  1.  Regulation  as  last  amended  by  Council  Regulation  (EC)  No.  807/2003 
(OJ L 122, 16.5.2003, p. 36). 
OJ L 184, 17.7.1999, p.23. 
OJ  L  302,  19.10.1992,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No.  2700/2000 
(OJ L 311, 12.12.2000, p. 17). 

9 

 
 
  
 
                                                 
b) 

any departure of scheduled substances from the customs territory of the Community, 
including the departure of scheduled substances that requires a customs declaration 
and the departure of scheduled substances from a free zone or free warehouse within 
the meaning of Regulation (EEC) No. 2913/92 

For the purposes of this Regulation the following definitions shall apply: 

Article 2 

(a) 

(b) 

(c) 

(d) 

(e) 

«scheduled substance» means any substance listed in the Annex, including mixtures 
and natural products containing such substances, but excluding medicinal products as 
defined  by  Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council7, 
pharmaceutical  preparations,  mixtures,  natural  products  and  other  preparations 
containing scheduled substances that are compounded in such a way that they cannot 
be easily used or extracted by readily applicable or economically viable means; 

«non-scheduled  substance»  means  any  substance  which,  although  not  listed  in  the 
Annex, is identified as having been used for the illicit manufacture of narcotic drugs 
or psychotropic substances; 

«import»  means  any  entry  of  scheduled  substances  having  the  status  as  non-
Community goods into the customs territory of the Community, including temporary 
storage,  entry  into  a  free  zone  or  free  warehouse,  the  placing  under  a  suspensive 
procedure  and  the  release  for  free  circulation  within  the  meaning  of  Regulation 
(EEC) No. 2913/92;  

«export» means any departure of scheduled substances from the customs territory of 
the  Community,  including  the  departure  of  scheduled  substances  that  requires  a 
customs  declaration  and  the  departure  of  scheduled  substances  from  a  free  zone  or 
free warehouse within the meaning of Regulation (EEC) No. 2913/92; 

«intermediary  activities»  means  any  activity  involving  any  financial  implication  to 
arrange  purchase  and  sale  or  supply  of  scheduled  substances  carried  out  by  any 
natural  or  legal  person  which  aims  to  obtain  agreement  between  two  parties  or 
through  acting  on  behalf  of  at  least  one  of  these  parties  without  taking  these 
substances  into  its  possession  or  taking  control  of  the  carrying  out  of  such 
transaction; this definition shall also include any activity carried out by any natural or 
legal person established in the Community involving purchase and sale or supply of 
scheduled substances without these substances being introduced into the Community 
customs territory; 

(f) 

«operator» means any natural or legal person engaged in import, export of scheduled 
substances or intermediary activities relating thereto, including persons pursuing the 
activity of making customs declarations for clients on a self-employed basis, either as 
their principal occupation or as a secondary activity related to another occupation; 

7 

OJ L 311, 28.11.2001, p. 67. 

10 

 
 
  
 
                                                 
(g) 

(h) 

(i) 

1. 

(a) 

(b) 

(c) 

«ultimate  consignee»  means  any  natural  or  legal  person  to  which  the  scheduled 
substances are delivered; this person may be different from the end-user; 

«committee procedure» means the procedure provided for in Article 32 (2). 

«international Narcotics Control Board» means the Board established by the Single 
Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol. 

CHAPTER II 

MONITORING OF TRADE  

SECTION 1 

DOCUMENTATION, RECORDS AND LABELLING 

Article 3 

All  imports,  exports  or  intermediary  activities involving  scheduled  substances  shall 
be documented by the operators by way of customs and commercial documents, such 
as  summary  declarations,  customs  declarations,  invoices,  cargo  manifests, transport 
and other shipping documents.  

Those documents shall contain the following information: 

the  name  of  the  scheduled  substances  as  stated  in  the  Annex,  or  in  the  case  of 
mixtures or natural products their name and the name of any scheduled substance as 
stated 
the  word  "DRUG 
therein, 
in 
PRECURSORS";  

the  Annex  contained 

followed  by 

the quantity and weight of the scheduled substances and, where a mixture or a natural 
product  is  concerned,  the  quantity,  weight,  and,  if  available,  the  percentage  of  any 
scheduled substance contained therein, and 

the names and addresses of the exporter, the importer, the ultimate consignee and the 
person involved in the intermediary activities.  

The documentation may be provided via image medium or other data medium, provided that 
the  data,  when  made  readable,  match  the  documentation  in  appearance  and  content,  are 
available at all times, can be made readable without delay and can be analysed by automated 
means. 

11 

 
 
  
 
Article 4  

Operators  involved  in  import,  export  or  intermediary  activities  in  respect  of  scheduled 
substances shall keep records of those activities.  

Such records need not be provided, where the competent authorities deem the documentation 
to be sufficient. 

Article 5 

The documentation and records referred to in Articles 3 and 4 respectively shall be kept for a 
period of three years from the end of the calendar year in which the operation took place, and 
must be readily available for inspection by the competent authorities upon request. 

Article 6 

Operators  involved  in  import,  export  or  intermediary  activities  in  respect  of  scheduled 
substances shall affix labels indicating the name of the scheduled substances as stated in the 
Annex,  or,  where  a  mixture  or  natural  product  is  concerned,  the  name  of  the  mixture  or 
natural product, followed by the word "DRUG PRECURSORS". 

SECTION 2  

LICENSING AND REGISTRATION OF OPERATORS 

Article 7 

1. 

2. 

Operators,  other  than  customs  agents  and  transporters  when  acting  solely  in  that 
capacity  engaged  in  import,  export  or  intermediary  activities  involving  scheduled 
substances  listed  in  Category  1  of  the  Annex  shall  hold  a  licence  issued  by  the 
competent authority of the Member State in which they are established certifying that 
they qualify for this activity.  

In  considering  whether  to  grant  a  licence,  the  competent  authority  shall  take  into 
account the competence and integrity of the applicant. 

Provisions determining cases where a licence shall not be required, setting out further 
conditions for the granting of licences and establishing a model for licences may be 
laid down in accordance with the committee procedure. 

The  licence  may  be  suspended  or  revoked  by  the  competent  authorities  whenever 
there are reasonable grounds for belief that  the holder is no longer a fit and proper 
person  to  hold  a  licence,  or  that  the  conditions  under  which  the  licence  was  issued 
are no longer fulfilled. 

12 

 
 
  
 
Article 8 

1. 

Operators,  other  than  customs  agents  and  transporters  when  acting  solely  in  that 
capacity  engaged  in  import,  export  or  intermediary  activities  involving  scheduled 
substances  listed  in  Category  2  of  the  Annex,  or  in  the  export  of  scheduled 
substances  listed  in  Category  3  of  the  Annex  shall  register  with  the  competent 
authorities  and  shall  update  with  those  authorities  the  addresses  of  the  premises  at 
which they conduct those activities. 

The first subparagraph shall not apply in respect of operators engaged in the export 
of such small quantities of scheduled substances listed in Category 3 as shall be laid 
down in accordance with the committee procedure. 

2. 

Provisions determining further cases where registration shall not be required may be 
laid down in accordance with the committee procedure. 

Article 9 

When  the  scheduled  substances  are  entered  into  the  customs  territory  of  the  Community, 
including their temporary  storage,  entry into a  free zone  or free warehouse, or  their placing 
under  the  Community  external  transit  procedure,  the  licit  purposes  of  export  within  the 
meaning of Article 12 of the United Nations Convention must be demonstrated, upon request.  

Means  to  demonstrate  such  licit  purposes  shall  be  determined  in  accordance  with  the 
committee procedure. 

SECTION 3 

OBLIGATION OF INFORMATION 

Article 10  

1. 

2. 

Operators  shall  notify  the  competent  authorities  immediately  of  any  circumstances, 
such  as  unusual  orders  and  transactions  involving  scheduled  substances,  which 
suggest that such substances intended for import, export or intermediary activities are 
intended for the illicit manufacture of narcotic drugs or psychotropic substances. 

Operators shall provide the competent authorities with information in summary form 
about their export, import or intermediary activities to be determined in accordance 
with the committee procedure. 

13 

 
 
  
 
Article 11 

1. 

In order to facilitate co-operation between the competent authorities of the Member 
States,  the  operators  and  the  chemical  industry,  in  particular  as  regards  non-
scheduled substances, the Commission shall in consultation with the Member States 
draw up and update guidelines. 

2. 

These guidelines shall provide in particular: 

(a) 

information on how to identify and notify suspect transactions; 

(b) 

a regularly updated list of non-scheduled  substances to enable the industry to 
monitor on a voluntary basis the trade in such substances. 

3. 

The competent authorities shall ensure that the guidelines are regularly disseminated 
in accordance with the objectives with these guidelines.  

SECTION 4 

PRE-EXPORT NOTIFICATION 

Article 12 

1. 

Any export of scheduled substances listed in Category 1 of the Annex and exports of 
scheduled substances listed in Category 2 and 3 of the Annex to certain countries of 
destination  to  be  determined  in  accordance  with  the  committee  procedure  shall  be 
preceded  by  a  pre-export  notification  sent  from  the  competent  authorities  in  the 
Community to the competent authorities of the country of destination in accordance 
with Article 12(10) of the United Nations Convention. 

The country of destination shall be allowed a period of 15 working days to reply, at 
the end of which the export operation may be authorised by the competent authorities 
of  the  Member  State  of  export,  if  no  advice  from  the  competent  authorities  of  the 
country  of  destination  is  received  indicating  that  this  export  operation  might  be 
intended for the illicit manufacture of narcotic drugs or psychotropic substances. 

2. 

The competent authorities of the Member State concerned shall, prior to any export 
of  scheduled  substances,  supply  the  information  specified  in  Article  14  (1)  to  the 
competent authorities of the country of destination. 

The  authority  furnishing  such  information  shall  require  the  authority  in  the  third 
country  receiving  the  information  to  keep  confidential  any  trade,  business, 
commercial or professional secret or any trade process referred to therein. 

14 

 
 
  
 
SECTION 5  

EXPORT AUTHORISATION 

Article 13 

1. 

Exports of scheduled substances that require a customs declaration including exports 
of scheduled substances leaving the customs territory form the Community following 
their storage in a free zone or free warehouse during a period of at least 10 days shall 
be subject to an export authorisation.  

However,  exports  of  scheduled  substances  listed  in  Category  3  of  the  Annex  shall 
only  be  subject  to  an  export  authorisation,  where  pre-export-notifications  are 
required or where these substances are exported to certain countries of destination to 
be determined in accordance with the committee procedure.  

Where scheduled substances are re-exported within less than 10 days from the date 
of  their  placing  into  a  suspensive  procedure,  an  export  authorisation  need  not  be 
required,  where  the  operator  can  demonstrate  the  licit  purposes  of  first  export  and 
import in the third country. 

2. 

Export  authorisations  shall  be  issued  by  the  competent  authorities  of  the  Member 
State where the person by whom or on whose behalf the export declaration is made 
and  who  is  the  person  chiefly  responsible  for  the  export  activities  by  virtue  of  his 
own  economic  and  legal  relationship  to  the  scheduled  substances  and  to  the 
consignee (exporter) is established.  

1. 

The  application  for  export  authorisations  referred  to  in  Article  12  shall,  at  least, 
contain the following: 

Article 14 

(a) 

(b) 

(c) 

the names and addresses of the exporter, the importer in the third country, any 
other operator involved in the export operation or shipment, and of the ultimate 
consignee; 

the name of the scheduled substances as stated in the Annex, or in the case of a 
mixture or a natural product, their name and 8 digit CN-code and the name of 
any scheduled substance as stated in the Annex contained therein; 

the quantity and weight of the scheduled substances and, where a mixture or a 
natural  product  is  concerned,  the  quantity,  weight,  and,  if  available,  the 
percentage of any scheduled substance contained therein, and 

(d)  details  of  the  transport  arrangements,  such  as  the  expected  date  of  dispatch, 
method of transport, name of the customs office where the customs declaration 
is to be made and, where available at this stage, identification of the means of 
transport,  itinerary,  expected  point  of  exit  from  Community  customs  territory 
and the point of entry into the importing country;  

15 

 
 
  
 
(e) 

in the cases referred to in Article 19, a copy of the import authorisation issued 
by the country of destination.  

2. 

A  decision  on  the  application  for  an  export  authorisation  shall  be  taken  within  a 
period of 15 working days from the date on which the competent authority considers 
the file to be complete.  

That period shall be extended if, in the cases referred to in Article 19, the competent 
authorities  are  obliged  to  make  further  enquiries  under  the  second  subparagraph  of 
Article 19. 

3. 

The authorisation may be limited to one substance, only.  

Article 15 

1. 

2. 

If  the  details  of  the  itinerary  and  means  of  transport  were  not  provided  in  the 
application,  the  export  authorisation  shall  state  that  the  operator  must  furnish  those 
details to the customs authority or other competent authority at the point of exit from 
the Community customs territory before the physical departure of the consignment. 
In such cases the export authorisation shall be annotated accordingly at the time of 
issue. 

Where the export authorisation is presented to a customs office in another Member 
State than that of the issuing authority, the exporter shall make available any certified 
translation of parts or all information contained on the authorisation, upon request. 

The  export  authorisation  shall  be  presented  in  support  of  the  customs  declaration, 
when the customs declaration is made at the customs office competent to accept that 
declaration. The authorisation shall accompany the consignment to the third country 
of destination.  

The customs office at the point of exit from the Community customs territory shall 
insert  the  details  referred  to  in  Article  13  in  the  authorisation  and  affix  its  stamp 
thereon. 

The  issue  of  an  export  authorisation  shall  not  preclude  any  possible  administrative  or  other 
liability of the holder of the authorisation. 

Article 16 

16 

 
 
  
 
Article 17 

The  export  authorisation  shall  be  refused  if  any  of  the  following  conditions  are 
fulfilled: 

(a) 

details supplied are incomplete;  

(b) 

(c) 

(d) 

there  are  reasonable  grounds  for  suspecting  that  the  information  supplied  is 
false or incorrect;  

in  the  cases  referred  to  in  Article  19,  it  is  established  that  the  import  of  the 
scheduled substances has  not  been  authorised  by  the  competent  authorities of 
the country of destination;  

there are reasonable grounds for suspecting that the substances in question are 
intended  for  the  illicit  manufacture  of  narcotic  drugs  or  psychotropic 
substances. 

Article 18 

The competent authorities may suspend or revoke an export authorisation whenever there are 
reasonable grounds for suspecting that the substances are intended for the illicit manufacture 
of narcotic drugs or psychotropic substances. 

Article 19 

Whenever, under an agreement between the Community and a third country, exports are not 
to be authorised unless an import authorisation has been issued by the competent authorities 
of that third country for the substances in question, the Commission shall communicate to the 
competent authorities of the Member States the name and address of the competent authority 
of the third country, together with any operational information obtained from it. 

The competent authorities in the Member States shall satisfy themselves of the authenticity of 
such  import  authorisation,  if  necessary  by  requesting  confirmation  from  the  competent 
authority of the third country. 

Article 20 

The  period  of  validity  within  which  the  goods  must  have  left  the  Community  Customs 
territory shall not exceed six months from the date of issue of the export authorisation. Under 
exceptional circumstances, the period of validity may be extended, upon request. 

Simplified procedures to grant an export authorisation may be applied. Such procedures shall 
be determined in accordance with the committee procedure.  

Article 21  

17 

 
 
  
 
SECTION 6 

IMPORT AUTHORISATION 

Article 22 

Imports  of  scheduled  substances  listed  in  Category  1  of  the  Annex  that  require  a  licence 
referred to in Article 7 shall be subject to an import authorisation. 

The  import  authorisation  is  issued  by  the  competent  authorities  of  the  Member  State  where 
the  person  by  whom  or  on  whose  behalf  the  customs  declaration  is  made  (importer)  is 
established. 

Further  documented  and  economically  justifiable  cases  and  further  conditions  where  an 
import  authorisation  is  required  may  be  determined  in  accordance  with  the  committee 
procedure.  

1. 

The application for the import authorisations referred to in Article 22 shall, at least, 
contain the following:  

Article 23 

(a) 

(b) 

(c) 

the names and addresses of the importer, the exporter of the third country, any 
other operator involved and of the ultimate consignee; 

the name of the scheduled substances as stated in the Annex, or in the case of a 
mixture or a natural product, their name and the 8 digit CN-code and the name 
of any scheduled substance as stated in the Annex contained therein; 

the quantity and weight of the scheduled substances and, where a mixture or a 
natural  product  is  concerned,  the  quantity,  weight,  and,  if  available,  the 
percentage of any scheduled substance contained therein, and 

(d)  details  of  the  transport  arrangements,  such  as  the  date  and  place  of  the 
envisaged import activities, methods and, if available, means of transport. 

2. 

A  decision  on  the  application  for  an  import  authorisation  shall  be  taken  within  a 
period of 15 working days from the date on which the competent authority considers 
the file to be complete.  

3. 

The import authorisation may be limited to one substance. 

18 

 
 
  
 
Article 24 

The  import  authorisation  shall  accompany  the  consignment  from  the  point  of  entry  into  the 
Community customs territory to the premises of the importer or ultimate consignee.  

The  import  authorisation  shall  be  presented  to  the  customs  office  when  the  scheduled 
substances are declared for a customs procedure. 

Where the import authorisation is presented to a customs office in another Member State than 
that  of  the  issuing  authority,  the  importer  shall  make  available  any  certified  translation  of 
parts or all information contained on the authorisation, upon request. 

Article 25 

The  import  authorisation  shall  be  refused  if  any  of  the  following  conditions  are 
fulfilled: 

(a) 

details supplied are incomplete;  

(b) 

(c) 

there are reasonable grounds for suspecting that the information supplied in the 
application is false or incorrect;  

there  are  reasonable  grounds  for  suspecting  that  the  scheduled  substances  are 
intended  for  the  illicit  manufacture  of  narcotic  drugs  or  psychotropic 
substances. 

Article 26 

The competent authorities may suspend or revoke the import authorisation whenever there are 
reasonable grounds for suspecting that the substances are intended for the illicit manufacture 
of narcotic drugs or psychotropic substances. 

Article 27 

The period of validity within which the scheduled substances must have been introduced into 
the customs territory of the Community shall not exceed six months from the date of issue of 
the  import  authorisation.  Under  exceptional  circumstances,  the  period  of  validity  may  be 
extended, upon request. 

19 

 
 
  
 
CHAPTER III 

POWERS OF COMPETENT AUTHORITIES 

1. 

2. 

3. 

4. 

5. 

Article 28 

Without prejudice to the provisions of Articles 12 to 27 and of paragraphs 2 and 3 of 
this  Article,  the  competent  authorities  of  each  Member  State  shall  prohibit  the 
introduction of scheduled substances into the Community customs territory or their 
departure from it, if there are reasonable grounds for suspecting that the substances 
are intended for the illicit manufacture of narcotic drugs or psychotropic substances. 

The  competent  authorities  shall  detain    or  suspend  release  of  the  scheduled 
substances  for  the  time  necessary  to  verify  the  identification  of  the  scheduled 
substances or the respect of the rules of this Regulation.  

In order to ensure the correct application of this Regulation, each Member State shall 
adopt the measures necessary to enable the competent authorities, in particular:  

(a) 

(b) 

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

to  enter  operators'  business  premises  in  order  to  obtain  evidence  of 
irregularities. 

For the purpose of preventing specific risks of diversion in free zones as well as in 
other sensitive areas such as warehouses, Member States shall ensure that effective 
controls  are  applied  to  operations  carried  out  in  these  areas  at  every  stage  of  these 
operations, and that the controls are no less stringent than those applied in the other 
parts of the customs territory. 

The competent authorities may require the operators to pay a fee  for  the issuing of 
licences,  registrations  and  authorisations.  Such  fees  shall  be  levied  in  a  non-
discriminatory way and shall not exceed the cost of processing the application. 

CHAPTER IV 

ADMINISTRATIVE COOPERATION 

Article 29 

For  the  purposes  of  applying  this  Regulation  and  without  prejudice  to  Article  32,  the 
provisions of Regulation (EC) No 515/97 shall apply mutatis mutandis. Each Member State 
shall  communicate  to  the  other  Member  States  and  to  the  Commission  the  name  of  the 
competent  authorities  appointed  to  act  as  correspondents  in  accordance  with  Article  2(2)  of 
that Regulation. 

20 

 
 
  
 
CHAPTER V  

IMPLEMENTING MEASURES AND AMENDMENTS 

Article 30 

In  addition  to  the  implementing  measures  referred  to  in  this  Regulation,  all  other  measures 
necessary  for  its  implementation,  in  particular  with  regard  to  the  export  and  import 
authorisation forms, and detailed rules for their use, shall be adopted in accordance with the 
committee procedure. 

The Annex to this Regulation shall be adapted, in accordance with the committee procedure to 
take account of any amendments to the Annex to the United Nations Convention.  

Article 31 

Article 32 

1. 

2. 

The  Commission  shall  be  assisted  by  the  Drugs  Precursors  Committee  (hereinafter 
the Committee). 

Where  reference  is  made  to  this  paragraph,  Articles  4  and  7  of  Decision 
1999/468/EC shall apply. 

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at three 
months. 

3. 

The Committee shall adopt its rules of procedure. 

CHAPTER VI 

FINAL PROVISIONS 

Article 33 

The Member  States  shall lay down the rules on penalties  applicable to  infringements  of the 
provisions  of  this  Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are 
implemented. The penalties provided for must be effective, proportionate and dissuasive. The 
Member  States  shall  notify  those  provisions  to  the  Commission  and  shall  notify  it  without 
delay of any subsequent amendment affecting them. 

21 

 
 
  
 
Article 34 

The competent authorities in each Member State shall at least each year communicate to the 
Commission all relevant information on the implementation of the monitoring measures laid 
down  in  this  Regulation,  and  on  scheduled  substances  used  for  the  illicit  manufacture  of 
narcotic  drugs  or  psychotropic  substances  and  methods  of  diversion  and  illicit  manufacture, 
and their licit trade, uses and needs. 

On  the  basis  of  that  information,  the  Commission  shall  in  consultation  with  the  Member 
States  evaluate  the  effectiveness  of  the  rules  of  this  Regulation  and,  in  accordance  with 
Article  12  (12)  of  the  United  Nations  Convention  and  draw  up  an  annual  report  to  be 
submitted to the International Narcotics Control Board. 

The Commission shall, on behalf of the Community, adopt a position regarding amendments 
of Tables I and II of the Annex to the United Nations Convention. 

Article 35 

Regulation (EEC) No 3677/90 is repealed with effect from […]. 

Article 36 

References to the repealed Regulation shall be construed as references to this Regulation. 

Article 37 

This  Regulation  shall  enter  into  force  on  the  twentieth  day  following  its  publication  in  the 
Official Journal of the European Union.  

It shall apply from 1st July 2005. 

This Regulation shall be binding in its entirety and directly applicable in all Member States 

Done at Brussels, […] 

For the Council 
The President 

22 

 
 
  
 
 
 
ANNEX 

Scheduled substances Category 1 

Substance 

CN designation 
(if different) 

CN Code  

CAS No8 

1-Phenyl-2-propanone 

Phenylacetone 

2914 31 00 

103-79-7 

N-acetylanthranilic acid 

2-Acetamidobenzoic acid  2924 23 00 

89-52-1 

Isosafrol (cis + trans) 

2932 91 00 

120-58-1 

3,4-
Methylenedioxyphenylprop
an-2-one 

1-(1,3-Benzodioxol-5-
yl)propan-2-one 

Piperonal 

Safrole 

Ephedrine 

Pseudoephedrine 

Norephedrine 

Ergometrine 

Ergotamine 

Lysergic acid 

2932 92 00 

4676-39-5 

2932 93 00 

120-57-0 

2932 94 00 

94-59-7 

2939 41 00 

299-42-3 

2939 42 00 

90-82-4 

ex 2939 49 
00 

14838-15-4 

2939 61 00 

60-79-7 

2939 62 00 

113-15-5 

2939 63 00 

82-58-6 

The stereoisomeric forms of the substances listed in this Category not being cathine9
whenever the existence of such forms is possible. 

The salts of the substances listed in this Category whenever the existence of such salts 
is possible and not being the salts of cathine. 

8 

9 

The  CAS  No  is  the  "Chemical  Abstracts  Service  Registry  Number",  which  is  a  unique  numeric 
identifier  specific  to  each  substance  and  its  structure.  The  CAS  No  is  specific  to  each  isomer  and  to 
each salt of each isomer. It must be understood that the CAS Nos for the salts of the substances listed 
above will be different to those given. 
Also named (+)-norpseudoephedrine, CN Code 2939 43 00, CAS No 492-39-7. 

23 

 
 
  
 
 
 
 
 
 
 
 
 
 
 
                                                 
Substance 

Acetic anhydride 

Phenylacetic acid 

Anthranilic acid 

Piperidine 

Category 2 

CN designation 
(if different) 

CN code10 

CAS No11 

2915 24 00 

108-24-7 

2916 34 00 

103-82-2 

2922 43 00 

118-92-3 

2933 32 00 

110-89-4 

Potassium permanganate 

2841 61 00 

7722-64-7 

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

Substance 

Category 3 

CN designation 
(if different) 

CN Code1 

CAS No2 

Hydrochloric acid  

Hydrogen chloride 

2806 10 00 

7647-01-0 

Sulphuric acid 

Toluene  

Ethyl ether  

Acetone  

2807 00 10 

7664-93-9 

2902 30 00 

108-88-3 

Diethyl ether 

2909 11 00 

60-29-7 

2914 11 00 

67-64-1 

Methylethylketone  

Butanone 

2914 12 00 

78-93-3 

The salts of the substances listed in this Category whenever the existence of such salts 
is possible and not being the salts of hydrochloric acid and sulphuric acid. 

10 
11 

OJ L 290, 28.10.2002, p. 1. 
The  CAS  No  is  the  "Chemical  Abstracts  Service  Registry  Number",  which  is  a  unique  numeric 
identifier  specific  to  each  substance  and  its  structure.  The  CAS  No  is  specific  to  each  isomer  and  to 
each salt of each isomer. It must be understood that the CAS Nos for the salts of the substances listed 
above will be different to those given. 

24