29. 1. 91 Official Journal of the European Communities No C 21/17 
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 
COM(90) 597final— SYN316 
(Submitted by the Commission on 20 December 1990) 
(91/C 21/07) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100a 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas some Member States have adopted measures to 
monitor the manufacture and the placing on the market 
of certain substances frequently used in the illicit manu­
facture of narcotic drugs and psychotropic substances; 
whereas other Member States are about to adopt 
measures of this kind; whereas it is therefore necessary 
to establish common rules at Community level in the 
perspective of the completed internal market in order to 
avoid distortion of competition in the licit trade and to 
ensure homogeneous application of the rules established; 
Whereas on 19 December 1988 the United Nations 
Conference adopted in the effort to combat drugs a 
Convention against Illicit Traffic in Narcotic Drugs and 
Psychotropic Substances; whereas the Community 
participated in the negotiation of this Convention, 
showing its political will to act within the limits of its 
competences; 
Whereas the requirements of Article 12 of the aforemen­
tioned Convention, in respect of trade in precursors, i.e. 
substances frequently used in the illicit manufacture of 
narcotic drugs and psychotropic substances, are 
implemented as far as trade between the Community and 
third countries by Council Regulation (EEC) No . . .; 
Whereas Article 12 of the Convention envisages 
adoption of appropriate measures to monitor manu­
facture and distribution of precursors; whereas in order 
to trace possible illicit diversions of precursors in the 
Community or in view of a fraudulent export from the 
Community and to ensure that common monitoring rules are applied in the Community market, it is necessary to 
complement the aforesaid Regulation; 
Whereas the provisions of Article 12 of the Convention 
are based on a system of monitoring trade in the 
substances in question; whereas documentation and 
labelling as regards consignments of these substances 
have to be sufficiently clear; whereas it is furthermore 
important, whilst providing competent authorities with 
the necessary means of action, to develop, in compliance 
with the spirit of the Convention, mechanisms which are 
based on close cooperation with the economic operators 
concerned as well as on the development of the 
gathering, exchange and exploitation of intelligence; 
Whereas it is also important, in this context, that 
Member States provide for sufficiently dissuasive 
sanctions; 
Whereas, to uncover illicit manufacture and distribution, 
measures have to be taken to encourage vigilance, by the 
various operators, in respect of suspect operations and 
their detection in cooperation with the competent 
authorities; 
Whereas the licit trade in scheduled substances in Table I 
of the Annex is in fact restricted to the manufacture of 
medicinal products; whereas it is therefore possible to 
limit the manufacture and use of these products to 
persons holding an authorization to manufacture 
medicinal products granted in accordance with Article 16 
of Council Directive 75/319/EEC of 20 May 1975 on 
the approximation of provisions laid down by law, regu­
lation or administrative action relating to proprietary 
medicinal products ('), as last amended by Directive 
89/381/EEC (2); 
Whereas it is important to provide mechanisms for 
administrative cooperation; whereas it is suitable in this 
respect, as far as the competent authorities in the 
Community are concerned, to seek inspiration from 
Council Regulation (EEC) No 1468/81 of 19 May 1981 
on mutual assistance between the administrative auth­
orities of the Member States and cooperation between 
the latter and the Commission to ensure the correct 
0) OJ No L 147, 9. 6. 1975, p. 13. 
O OJ No L 181, 28. 6. 1989, p. 44. 
No C 21/18 Official Journal of the European Communities 29. 1.91 
application of the law on customs and agricultural 
matters (*), as amended by Regulation (EEC) No 
945/87 (2); whereas particular attention has to be paid to 
the confidentiality of the information received and 
exchanged, 
HAS ADOPTED THIS DIRECTIVE: 
TITLE I 
GENERAL 
Article 1 
1. This Directive concerns the monitoring, within the 
Community, of certain substances frequently used in the 
illicit manufacture of narcotic drugs and psychotropic 
substances, with a view to preventing diversion of such 
substances. 
2. For the purposes of this Directive: 
(a) scheduled substances means any substance listed in the 
Annex including mixtures containing such 
substances. This excludes pharmaceutical prepa­
rations or other preparations containing scheduled 
substances that are compounded in such a way that 
such substances cannot be easily used or recovered 
by readily applicable means; 
(b) placing on the market means any disposal against 
payment or free of charge to third parties of the 
scheduled substances manufactured in the 
Community or put into free circulation in the 
Community; 
(c) operator means any natural or legal person engaged 
in the manufacture, processing, trade or distribution 
of scheduled substances in the Community, or 
involved in other related activities such as broking or 
holding stock for third parties; 
(d) UN Convention means the United Nations 
Convention against illicit traffic in Narcotic Drugs 
and Psychotropic Substances, adopted in Vienna on 
19 December 1988; 
(e) International Narcotics Control Board means the 
Board established by the Single Convention on 
Narcotic Drugs of 1961, as amended by the 1972 
Protocol. 
TITLE II 
MONITORING OF PLACING ON THE MARKET 
Article 2 
Documentation, records and labelling 
Member States shall take all the measures necessary to 
ensure that the placing on the market of scheduled 
substances is subject to the following requirements: 
(') OJ No L 144, 2. 6. 1981, p. 1. 
(2) OJ No L 90, 2. 4. 1987, p. 3. 1. all transactions leading to the placing on the market 
of scheduled substances shall be properly documented. 
(a) In particular, commercial documents such as 
invoices, cargo manifests, administrative 
documents, transport and other shipping 
documents shall contain sufficient information to 
enable positive identification of the following: 
— the name, the quantity and the weight of the 
scheduled substance(s) as stated in the Annex, 
or in the case of mixtures, the name, the 
quantity and the weight of the substance(s) 
listed in the Annex, 
— the name and address of the supplier(s) and 
the customer(s); 
(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 narcotic drugs or psychotropic substances; 
(c) the obligations under (a) and (b) shall not apply 
to transactions concerning products of Table II of 
the Annex when the quantities involved do not 
exceed those indicated in Table III of the Annex. 
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. 
3. Operators involved in the placing on the market of 
scheduled substances shall keep detailed commercial 
records necessary to fulfil the obligations under point 
1 with regard to these activities. 
4. The documents and records referred to in points 1 
and 3 shall be kept for a period of not less than two 
years from the end of the calendar year in which the 
operation referred to in point 1 took place, and shall 
be made readily available to the competent authorities 
upon request. 
Article 3 
In order to ensure the adoption of appropriate regu­
latory decisions concerning the' manufacture of Table I 
products as set out in the Annex and the placing on the 
market of the scheduled substances, Member States shall 
designate a competent authority. 
Member States shall inform the Commission of the 
competent authority thus designated. 
29. 1.91 Official Journal of the European Communities No C 21/19 
Article 4 
Additional requirements — Substances of Table I 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 scheduled substances of 
Table I of the Annex is subject to possession of an auth­
orization granted in accordance with Article 16 of 
Directive 75/319/EEC. 
2. Member States shall take all appropriate measures 
to ensure that operators holding the authorization 
referred to in paragraph 1 shall only make available / 
scheduled substances of Table I of the Annex to 
operators who are themselves in possession of the auth­
orization referred to in paragraph 1. 
Article 5 
Notification 
1. Member States shall take, consistently with their 
own legal system, appropriate measures including the 
necessary legal protection of interested persons in 
connection with their own responsibility so as to 
encourage operators to notify immediately the competent 
authorities of any circumstances, such as unusual orders 
and transactions of scheduled substances, which indicate 
that such substances to be placed on the market or 
manufactured, as the case may be, are intended to be 
diverted for the illicit manufacture of narcotic drugs or 
psychotropic substances. 
2. In addition to the measures to be taken under 
paragraph 1, Member States shall take, consistently with 
their own legal system, appropriate measures including 
the necessary legal protection of interested persons in 
connection with their own responsibility so as to 
encourage persons who suspect, as a result of infor­
mation obtained by virtue of their professional activities, 
that scheduled substances which have been or are to be 
placed on the market or manufactured, as the case may 
be, are intended to be diverted for the illicit manufacture 
of a narcotic drug or psychotropic substance, to inform 
the competent authorities accordingly. 
TITLE III 
MEASURES OF CONTROL 
Article 6 
Legal powers of competent authorities 
1. In order to ensure the correct application of 
Articles 2, 4 and 5, Member States shall adopt, consis­
tently with their own legal system, the measures 
necessary to allow the competent authorities: 
(a) to obtain information on any orders or transactions 
of scheduled substances; (b) to enter and search professional premises of 
operators and to obtain evidence of irregularities; 
(c) to seize any scheduled substance if there is sufficient 
evidence that such substance, which has been or is to 
be placed on the market or manufactured, as the 
case may be, is intended to be used in the illicit 
manufacture of a narcotic drug or psychotropic 
substance. 
2. Without prejudice to the measures laid down in 
Articles 4 (1) and (2) and 6 (1), the competent authorities 
of Member States may prohibit the placing on the 
market or manufacture, as the case may be, of scheduled 
substances, if there are reasonable grounds for believing 
that these substances are ultimately destined for the illicit 
manufacture of narcotic drugs or psychotropic 
substances. 
TITLE IV 
ADMINISTRATIVE COOPERATION 
Article 7 
For the purpose of applying this Directive, the provisions 
of Regulation (EEC) No 1468/81 shall be applicable 
mutatis mutandis, in particular the provisions on 
confidentiality. Each Member State shall communicate to 
the other Member States and to the Commission 
particulars of the competent authorities appointed to act 
as correspondents within the meaning of Article 2 (2) of 
Regulation (EEC) No 1468/81. 
TITLE V 
FINAL PROVISIONS 
Article 8 
Member States shall determine the sanctions to be 
applied for the infringement of the provisions of this 
Directive. The penalties shall be sufficient to promote 
compliance with those provisions. 
Article 9 
1. The competent authorities of Member States shall 
communicate annually to the Commission: 
— the amounts of scheduled substances seized and, 
when known, their origin, 
— any substance not included in the Annex which is 
identified as having been used in illicit manufacture 
of narcotic drugs or psychotropic substances, and 
which is deemed to be sufficiently significant to be 
brought to the attention of the International 
Narcotics Control Board, 
— methods of diversion and illicit manufacture, 
No C 21/20 Official Journal of the European Communities 29. 1. 91 
— the nature of processing equipment seized and, where 
known, its origin. 
2. The Commission, on the basis of the communi­
cations made pursuant to paragraph 1, shall, in consul­
tation with Member States, draw up an annual report to 
be submitted to the International Narcotics Control 
Board. to comply with this Directive before 1 July 1991. They 
shall forthwith inform the Commission thereof. 
2. When Member States adopt these provisions, they 
shall contain a reference to this Directive or shall be 
accompanied by such reference at the time of their 
official publication. The procedure for such reference 
shall be adopted by Member States. 
Article 10 
1. Member States shall adopt all the provisions necessary Article 11 
This Directive is addressed to the Member States. 
ANNEX 
TABLE I 
Ephedrine 
Ergometrine 
Ergotamine 
Lysergic acid 
1 -phenyl-2-propanone 
Pseudoephedrine CAS No 
299-42-3 
66-79-7 
113-15-5 
82-58-6 
103-79-7 
90-82-4 EINECS No 
206-080-5 
200-485-0 
204-023-9 
201-431-9 
203-144-4 
202-018-6 
TABLE II 
Acetic anhydride 
Acetone 
Anthranilic acid 
Ethyl ether 
Phenylacetic acid 
Piperidine CAS No 
108-24-7 
67-64-1 
118-92-3 
60-29-7 
103-82-2 
110-89-4 EINECS No 
203-564-8 
200-662-2 
204-287-5 
200-467-2 
203-148-6 
203-813-0 
The salts of the substances listed in these tables whenever the existence of such salts is possible. 
TABLE III 
Threshold 
Acetic anhydride 
Acetone 
Anthranilic acid and its salts 
Ethyl ether 
Phenylacetic acid and its salts 
Piperdine and its salts 1 1 
1 1 
100 g 
1 1 
200 g 
0,25 1