J COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(92) 218 final-SYN316 
Brussels, 25 May 1992 
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« 
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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*> 
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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 unchanged). 
3. Recitals 5a, 5b, 5c and 5d, with the following wording, are added: 
"whereas the methods of diversion are constantly changing and it Ls. 
considered at International level that the procedures established by 
Article 12 of the 1988 United Nations Convention against U l felt 
traffic In narcotic drugs and psychotropic substances must be_ 
strengthened to combat effectively the diversion of the substances 
concerned:" 
"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:" 
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"whereas the final report, while recognizing inaJ, IhQ 1988_ iLn.11 fid. 
Nations Convention against Illicit traffic LD narcot lc drugs and 
psychotropic substances is the basic instrument f_or International 
cooperation In this area, contains a number of recommendations designed 
to strengthen national and International measures on infi baMs 
thereof;" 
4. Recital 8 Is amended as follows: 
"Whereas the licit trade in scheduled substances In Table I of the 
Annex is in general restricted to the manufacture of medicinal 
products; whereas It Is necessary to ensure that the manufacture or use 
Ql scheduled substances LS subject to the possession of an 
authorization granted by the competent national authorities: whereas it 
is possible ..." (the rest unchanged) 
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 
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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). 
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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 
activities ol which consist La. PI include. the conduct 0f 
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 J to UVVWJ'J a idMe I 
substance for the purposes of the manufacture of non-medlclixaJ 
products or other special purposes." 
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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," 
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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. 
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(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 
The salts of the substances I Isted La this category whenever the 
presence of such salts is possible. 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 
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TABLE I I 
SH Code 
2915 24 00 
OX 2922 49 90 
2916 33 QO 
2933 39 30 
2932 90 73 
2932 90 75 
2932 90 71 Acetic anhydride 
AnthranlIic acid 
PhenylacetIc acid 
Piper idlne 
Isosafrole (cls+trans) 
Plperonal 
Safrole 
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 28Q6 _10_QJQ SH Code 
2914 11 QQ 
2909 11 00 
2914 12 00 
2902 30 10/90 
2841 60 10 
2807 00 10 
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TABLE III 
Threshold 
Acetle anhydrIde 11 
Anthranilic acid and its salts 100 g 
Phenylacet le acid and its salts 200 g 
Piper Idîne and its salts 0.25 I 
Isosafrole (cls+trans) 500 ml/g 
Plperonal soo m i/o 
Safrole soo mi/g 
ANNEX 
Commission's position on the amendments not adopted 
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. thoroforo unahln to iircnpl It. 
/!A 

ISSN 0254-1475 
COM (92) 218 final 
DOCUMENTS 
EN 05 10 
Catalogue number: CB-CO-92-227-EN-C 
ISBN 92-77-44348-0 
Office for Official Publications of the European Communities 
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