Amendment to the proposal for a COUNCIL DIRECTIVE on the manufacture and the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances
Date: 1992-05-25
Institutions: European Commission
Subjects: administrative cooperation, chemical product, customs document, customs inspection, marketing, narcotic

COMMISSION  OF  THE  EUROPEAN  COMMUNITIES 

C0M(92) 218  final-SYN316 

Brussels, 25  May  1992 

J 

Amendment  to the proposal  for a 

COUNCIL DIRECTIVE 

on  the manufacture  and  the placing on  the market  of 

certain substances used  In the  Illicit  manufacture 

of narcotic drugs and psychotropic  substances 

(presented  by  the Commission pursuant  to Article  149(3) 
of  the  EEC-Treaty) 

EXPLANATORY  MEMORANDUM 

At  its meeting  In April  1992  the  European  Parliament  delivered  an  opinion 

on  the  Commission  proposal  set  out  In  C0M(90)  597  final  of  18 December 

1990. 

This  proposal  takes  account  of  the  amendments  desired  by  the  European 

Parliament,  Insofar  as  the Commission  has been  able  to accept  them. 

<1« 

-  1 -

AMENDMENT  TO THE PROPOSAL  FOR A 

COUNCIL  DIRECTIVE 

on  the manufacture  and  the placing on  the market  of 

certain  substances used  in the  illicit  manufacture 

of  narcotic drugs and psychotropic  substances 

Pursuant  to  the  opinion  delivered  on  a  first  reading  by  the  European 

Parliament1^  in the  framework  of  the cooperation  procedure on  the proposal 

for a Council  Directive on  the manufacture  and  the placing on  the market  of 

certain  substances  used  In  the  Illicit  manufacture  of  narcotic  drugs  and 

psychotropic  substances,  transmitted  to  the Council  by  the Commission,  the 

Commission  has decided  the amend  the abovementioned  proposal  as follows: 

1.  The  following  Is added  to recital  3: 

"(In  consequence  of  the  adoption  of  Council  Regulation  (EEC)) 

No  3677/90  of  13  December  1990  laving  down  measures  to  be  taken  to 

discourage  ins  diversion  of  certain  substances  to  ilis  ) 11 »clt 

manufacture  of  narcotic  drugs  and psychotropic  substances"(2) 

(2) OJ No L 357, 20.12.1990. p. 1. 

1)  OJ No 

/l*> 

-  2  -

2.  Recital  5  is amended  as  follows: 

"Whereas  the  provisions  of  Article  12 of  the  Convention  are  based  on  a 
system  of  monitoring  trade  In  the  substances  in  question;  whereas  most 
trade  in  these  substances  Is  fully  legitimate-,  whereas  documentation 
..."  (the  rest  Is  u n c h a n g e d ). 

3.  Recitals  5a,  5b, 5c  and  5d,  with  the  following  wording,  are  added: 

"whereas  the  methods  of  diversion  are  constantly  changing  and  it  Ls. 
level  that  t he  p r o c e d u r es  e s t a b l i s h ed  by 
c o n s i d e r ed  at  I n t e r n a t i o n al 
U  l felt 
Article  12  of  the  1988  United  Nations  Convention  against 
traffic 
be_ 
drugs  and  psychotropic 
strengthened  to  combat  effectively  the  diversion  of  the  substances 
concerned:" 

substances  must 

In  narcotic 

"whereas  the  Commission  and  seven  Member  States  have  participated  In 
the  work  of  the  Action  Group  on  chemical  substances  set  UP fry—the G7 
Houston  Economic  Summit  on  10  July  1990 to  develop  effective  procedures 
JLOi  preventing  the  diversion  of  precursors  and  chemical  substances 
required  for  the  Illicit  manufacture  of  drugs:  and  whereas  throughout 
this  worK  there  has  been  coordination  at  Community  level  and,,close 
consultation  with  representatives  of  trade  and  Industry." 

"whereas  the  final  report  of  the  Action  Group  on  chemical  substances 
was  approved  bv  the G7  London  Economic  Summit  on  15  July  1991:" 

-  3  -

"whereas  the  final  report,  while  recognizing  inaJ, 
Illicit  traffic  LD  narcot lc  drugs  and 
Nations  Convention  against 
psychotropic  substances  is  the  basic  instrument  f_or  International 
cooperation  In  this  area,  contains  a  number  of  recommendations  designed 
infi  baMs 
to  strengthen  national 
thereof;" 

International 

measures  on 

IhQ  1988_  iLn.11 fid. 

and 

4.  Recital  8  Is  amended  as  follows: 

"Whereas  the  licit  trade  in  scheduled  substances  In  Table  I  of  the 
restricted  to  the  manufacture  of  medicinal 
Annex 
products;  whereas  It  Is  necessary  to  ensure  that  the  manufacture  or  use 

is  in  general 

scheduled 

substances 

Ql 
an 
subject 
authorization  granted  by  the  competent  national  authorities:  whereas  it 
is  possible  ..."  (the  rest  unchanged) 

possession 

the 

LS 

to 

of 

5.  The  wording  of  the  Introductory  sentence  to  Article  2(1)  Is  amended  as 

follows: 

"all  transactions  leading  to  the  placing  on  the  market  of  scheduled 
substances  in Tables  I and  11  shall  be  properly  documented." 

6.  Article  2(1)(b)  Is  amended  as  follows: 

(b)  the  documentation  must  furthermore  contain  a  declaration  from  the 
customer  which  shows  the  specific  uses  and  which  confirms  that 
these  substances  are  not  used  for  the  Illicit  manufacture  of 

-  4 -

narcotic  drugs  or  psychotropic  substances;  a  regular  customer  obtaining 

from  a  supplier  a  substance  listed  in  Table  U  may  provide  a  single 

declaration  covering  all  transactions  Involving  that  substance  over  a 

period of one year; 

7.  Article  2(2)  Is amended  as  follows: 

"2. Whenever  operators apply  labels to scheduled  substances  in order  to 

place  them  on  the market  such  labels  shall  mention  the  names  of  these 

substances as stated  In Tables  I and  II of  the Annex.  Operators may  In 

addition  apply  their  customary  labelling." 

8.  A new Article  2(4a)  is created: 

"4a.  As  far  as  compounds  and  mixtures  of  Table  II  substances  are 

concerned,  the  conditions concerning  the  documentation,  record  keeping 

and  labelling  requirements  as  laid  down  in  this  article  shall  be 

adopted,  as  necessary,  by  the  Commission  on  the  basis  of  a  proposal 

submitted  to the committee  provided  for under  Article 9a." 

9.  Article 3, first paragraph,  Is amended  as  follows: 

" —,  Member  States  shall  designate  competent  author Itles."  (the  rest 

unchanged). 

- 5 -

10.  Article 4 Is amended  as follows: 

"Additional  requirements - Substances of Tables  I and II of the Annex 

1. Member  States  shall  take all appropriate  measures  to ensure  that the 
manufacturing  or  putting  Into  free  circulation  In the community  of 
substances  specified  In  Table  I fil the  Annex  Is  subject  to the 
possession  of an  authorization  granted  by the competent  authorities 
designated  under  Article 3. 

2.  Member  States  shall  take all the appropriate  measures  to ensure  that 
an  operator  holding  the authorization  referred  to in paragraph  1 shall 
only  make  available  scheduled  substances  specified  In  Table  I of the 
Annex  to: 

(a)  an operator  who reoulres  a Table  I substance  for the ma.nufacture 
of  a medicinal  product  and who has been  authorized  to manufacture 
that  product  by  an  authorization  granted  In  accordance  with 
Article  16 of Directive  75/319/EEC: or 

(b)  a registered  pharmacist: or 
(c)  a  person  who  Is  In  charge  of  a  laboratory.  the.  r ecogn i sed 
0f 
activities  ol  which  consist  La.  PI  include.  the conduct 
scientific  education  or  research.  and Which 
!_§  attached  to a 
university  or a hospital  or to any other  institution  approved  for 
the  purpose by the competent  authority  designated  under  Article 3;_ 
ox 

(d)  any. other  person, who  has been  authorized  by the competent 

author I ty  UoyJariatotf  undoi... Ar tJelo 
substance  for the purposes  of  the manufacture  of  non-medlclixaJ 
products or other  special  purposes." 

J  to  UVVWJ'J 

a  idMe  I 

6  -

2a.  Operators  involved  In the manufacture  and placing on  the market  of 

scheduled  substances  listed  in  Table  II  shall  be  reouired  to 

notify  the  competent  authorities  of  their  activities  In  this 

trade." 

11.  In Article  5(2)  the  words  "for  example"  are  Inserted  after  the  words 

"persons who suspect, as a result  of  Information  obtained". 

12. Article 6(1), first  paragraph,  Is amended  as  follows: 

1. 

In order  to ensure  the correct  application of Articles  2, 4 and 5, 

each Member  State shall  adopt  within  the framework  of  Its domestic 

law the measures necessary  to enable  the competent  authorities: 

(a)  to  obtain  Information  on  any  orders  for  or  operations  Involving 

scheduled  substances; 

(b)  to enter  operators' business  premises  In order  to obtain  evidence 

of  Irregularities;"  (the rest  unchanged) 

13. Article 9(2)  is amended  as  follows: 

"2.  The  Commission,  on  the  basis  of  the  communications  made  pursuant 

to paragraph  1,  shall,  In consultation  with  Member  States,  draw  up an 

annual  t npor t  to  bo  mitomlUod  to  the  International  Narcotist  Cntiliol 

Board.  ThoCommJssJoa-SliiiLL^rinua-LLy.iicdate  tDe  Annex.lo  this  report," 

-  7 -

14.  An Article 9a with  the following wording  is added: 

"The  Commission  shall  be  assisted  by  a  consultative  committee  made  up 

of  the  representatives  of  the  Member  States  and  chaired  by  the 

representative of  the  Commission. 

The representative of  the Commission  shall  present  the committee  with a 

draft  of  the  measures  to  be  taken.  The  committee  shall  deliver  an 

opinion  on  this  draft  within  a  period  which  the  Chairman  can  set  In 

accordance  with  the  urgency  of  the  matter,  If  necessary  by  taking  a 

vote. 

The  opinion  shall  be  entered  In  the  minutes;  In addition,  each  Member 

State  shall  have  the  right  to  ask  for  Its position  to  be  recorded  In 

the minutes. 

The  Commission  shall  take  account  of  the  opinion  delivered  by  the 

Committee.  It  shall  Inform  the  committee  as  to  how  It  has  taken 

account  of  the opinion." 

15.  Article  10  Is amended  as  follows: 

(D  Member  states  shall  bring  Into  force  the  laws.  regulations and 

administrative  provisions  necessary  to  comply  with  this  Directive 

before  1 July  1992. 

When  Member  States  adopt  these measures,  the  latter  shall  contain 

a  reference  to  this  Directive  or  shall  be  accompanied  by  such 

reference  on  the  occasion  of  their  official  publication.  The 

methods  of  making  such  a  reference  shall  be  laid  down  by  the 

Member  States. 

- 8 -

(2)  Member  States  shall  communicate  to  the  Commission  the  provisions 

of  national  iaw  which  they  adopt  in  the  field  governed  by  this 

Direct ive." 

16. The  text of  the Annex  Is replaced  by  the following 

TABLE I 

Substance 

Ephedr ine 

ErgometrIne 

Ergotamine 

Lysergic  acid 

1-phenyI-2-propanone 

PseudoephedrIne 

AcetYianthranlIic acid N 

MethYlenedloxyphenvl  3. 4-oropanone 2 

SH Code 

2939 4Q 1Q 

2939 60 10 

2939 60 30 

2939 60 50 

2914 30 10 

2939 4Q 30 

2924 29 50 

2932 90 77 

The  salts  of  the  substances  I Isted  La  this  category  whenever  the 

presence of  such  salts  is possible. 

9 -

TABLE  I I 

Acetic anhydride 

AnthranlIic acid 

PhenylacetIc acid 

Piper idlne 

Isosafrole (cls+trans) 
Plperonal 
Safrole 

SH Code 

2915 24 00 

OX 2922 49 90 

2916 33  QO 
2933 39 30 

2932 90 73 

2932 90 75 
2932 90 71 

The  salts  of  the  substances  listed  In  this  category  whenever  the 

existence of such salts  is possible. 

TABLE 11(a) 

Acetone 

Ethyl ether 

Methyl ethvi ketone (MEK) 

Toluene 
Potassium  permanganate 
Sulphuric acid 

Hydrochloric acid 

SH Code 

2914 11 QQ 
2909 11 00 
2914 12 00 

2902 30 10/90 

2841 60 10 

2807 00 10 

28Q6 _10_QJQ 

-  10  -

TABLE  III 

Acetle  anhydrIde 

Anthranilic  acid  and  its  salts 

Phenylacet le acid  and  its  salts 

Piper Idîne  and  its  salts 

Isosafrole  (cls+trans) 

Plperonal 
Safrole 

Threshold 

11 

100  g 

200  g 

0.25  I 

500  ml/g 

soo m i/o 
soo mi/g 

Commission's  position on  the amendments  not  adopted 

ANNEX 

Amendment  No 9:  adds  the  following paragraph  to Article 5(2): 

"The  disclosure  of  such  Information  in  good  faith  to  the  competent 

authorities  shall  not  involve  for  the  persons  concerned  any  civil  or 

criminal  liability of  any  kind." 

Commission's position 

The  Commission  cannot  approve  this  amendment  since  it  lays  down  civil  or 

penal  provisions  which  go beyond  the scope  of  a directive  based  on Article 

100A  and  which,  furthermore,  remain  within  the  competence  of  the  Member 

States. 

The  Commission's  Initial  proposal  is  Justified  on  the  grounds  that  the 

distortion  of  competition  which motivates  this proposal  Is that  which  might 

result  from  the  actual  or  potential  differences  between  national  rules  on 

the  control  of  substances.  The  notification  of  suspicious  circumstances 

forms part  of  these  rules, but  nothing  beyond  that. 

Amendment  No  11: adds  the following provisions  to Article  8: 

"The  Commission  shall  ask  Member  States  to  apply  a  graduated  scale  of 

sanctions  distinguishing  between  oversights  in  registration,  failure  to 

keep  a  register,  fraudulent  registration  of  quantities  and  deliberate 

concealment  of  Important  information. 

Member  States  shall  ensure  that  victims  who  suffer  injury  resulting 

directly  from  a  false declaration  made  In good  faith  are  compensated. 

Commission's  position 

This  amendment  elicits  the  same  comments  as  amendment  No  9,  and  the 

(jomml uu Ion  I r.  t h o r o f o ro  u n a h ln  to  iircnpl  It. 

/!A 

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COM (92) 218 final 

DOCUMENTS 

EN 

05  10 

Catalogue number: CB-CO-92-227-EN-C 

ISBN 92-77-44348-0 

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