1992L0109 — EN — 01.03.2001 — 002.001 — 1
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►B COUNCIL DIRECTIVE 92/109/EEC
of 14 December 1992
on the manufacture and the placing on the market of certain substances used in the illicit
manufacture of narcotic drugs and psychotropic substances
(OJ L 370, 19.12.1992, p. 76)
Amended by:
Official Journal
Nopage date
►M1Commission Directive 93/46/EEC of 22 June 1993 L 159 134 1.7.1993
►M2Commission Directive 2001/8/EC of 8 February 2001 L 39 31 9.2.2001
▼B
COUNCIL DIRECTIVE 92/109/EEC
of 14 December 1992
on the manufacture and the placing on the market of certain
substances used in the illicit manufacture of narcotic drugs and
psychotropic substances
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European EconomicCommunity, and in particular Article 100a thereof,
Having regard to the proposal from the Commission(
1),
In cooperation with the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas some Member States have adopted measures to monitor the
manufacture and the placing on the market of certain substancesfrequently used in the illicit manufacture of narcotic drugs andpsychotropic substances; whereas other Member States are about toadopt measures of this kind; whereas it is therefore necessary to
establish commun rules at Community level in anticipation of the
completed internal market in order to avoid distortion of competition inlawful trading and to ensure uniform application of the rules adopted;
Whereas on 19 December 1988 a Convention against Illicit Traffic in
Narcotic Drugs and Psychotropic Substances, hereinafter referred to as
the ‘United Nations Convention’, was adopted in Vienna; whereas theUnited Nations Convention is part of the world-wide efforts to combatdrugs; whereas the Community participated in the negotiation of thatConvention, showing its political will to act within the limits of its
competences;
Whereas the requirements of Article 12 of the United Nations
Convention, in respect of trade in precursors, (i.e. substances frequentlyused in the illicit manufacture of narcotic drugs or psychotropicsubstances, are implemented as far as trade between the Community and
third countries is concerned by Council Regulation (EEC) No 3677/90
of 13 December 1990 laying down measures to be taken to discouragethe diversion of certain substances to the illicit manufacture of narcoticdrugs and psychotropic substances(
4);
Whereas Article 12 of the United Nations Convention envisages
adoption of appropriate measures to monitor manufacture and distribu-tion of precursors; whereas, by decisions taken at its 35th session, theUnited Nations Commission on Narcotic Drugs included additionalsubstances in the tables of the Annex to the Convention; whereas
corresponding provisions should be laid down in this Directive in order
to detect possible cases of illicit diversion of drugs in the Community orto counter fraudulent imports into the Community and to ensure thatcommon monitoring rules are applied in the Community market;
Whereas the provisions of Article 12 of the United Nations Convention
are based on a system of monitoring trade in the substances in question;whereas most trade in these substances is fully licit; whereas thedocumentation and labelling of consignments of these substances mustbe sufficiently explicit; whereas it is furthermore important, whilstproviding competent authorities with the necessary means of action, to
develop within the spirit of the United Nations Convention mechanisms
based on close cooperation with the operators concerned and on thedevelopment of intelligence gathering, exchange and exploitation;1992L0109 — EN — 01.03.2001 — 002.001 — 2
(1) OJ NoC 21, 29. 1. 1991, p. 17.
(2) OJ No C 125, 13. 5. 1992, p. 195; and Decision of 18 November 1992 (not
yet published in the Official Journal).
(3) OJ NoC 159, 17. 6. 1991, p. 58.
(4) OJ No L 357, 20. 12. 1990, p. 1. Regulation as last amended by Regulation
(EEC) No900/92 (OJ NoL 96, 10. 4. 1992, p. 1).
▼B
Whereas, since diversion patterns are constantly changing, it is
considered at international level that the procedures provided for inArticle 12 of the United National Convention should be strenghtened to
combat effectively the diversion of the substances concerned;
Whereas the Commission and seven Member States participated in the
work of the Chemical Action Task Force established by the G7Economic Summit in Houston on 10 July 1990 to develop effective
procedures to prevent diversion of precursor and essential chemicals to
illicit drugs manufacture; whereas throughout this work there has beencoordination at Community level and close consultation with represen-tatives of trade and industry;
Whereas the Final Report of the Chemical Action Task Force was
approved by the G7 Economic Summit in London on 15 July 1991;
Whereas this Final Report, in recognizing the United Nations
Convention as the basic instrument of internation cooperation inchemical diversion matters, contains a number of recommendationsfor reinforcing national and international measures on the basis of that
Convention;
Whereas it must be ensured that the manufacture or use of the scheduled
substances in category 1 of Annex I to this Directive is subject topossession of a licence; whereas the supply of such substances must inaddition be authorized only where the persons to whom they are to be
supplied are specifically authorized, either generally or individually, to
be supplied with, possess or handle such substances;
Whereas measures should be adopted to establish close cooperation with
the operators concerned so that the latter notify suspicious transactionsto the competent authorities;
Whereas it is important to establish machinery for administrative
cooperation; whereas it is desirable in this connection that the competentauthorities in the Community base their actions on Council Regulation(EEC) No 1468/81 of 19 May 1981 on mutual assistance between theadministrative 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 matters(
1); whereas particular
attention must be paid to the confidentiality of the information receivedand exchanged;
Whereas each Member State should introduce penalties sufficiently
dissuasive to forestall infringements of the provisions adopted in
implementation of this Directive,
HAS ADOPTED THIS DIRECTIVE:
TITLE I
General
Article 1
1. The purpose of this Directive is to establish intra-Community
monitoring of certain substances frequently used for the illicitmanufacture of narcotic drugs and psychotropic substances with a
view to preventing the diversion of such substances.
2. For the purposes of this Directive:
(a) ‘scheduled substance’ means any substance specified in Annex I,
including mixtures containing such substances. This excludes
medicinal products or other preparations containing scheduled
substances that are compounded in such a way that such substancescannot be easily used or recovered by readily applicable means;1992L0109 — EN — 01.03.2001 — 002.001 — 3
(1) OJ No L 144, 2. 6. 1981, p. 1. Regulation as amended by Regulation (EEC)
No945/87 (OJ NoL 90, 2. 4. 1987, p. 3).
▼B
(b) ‘placing on the market’ means any supply against payment or free of
charge tothird parties o f scheduled substances manufactured in theCommunity 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 the brokering and storage of scheduled substances;
(d) ‘International Narcotics Control Board’ means the Board established
by the Single Convention on Narcotic Drugs, 1961, as amended by
the 1972 Protocol.
TITLE II
MONITORING OF PLACING ON THE MARKET
Article 2
Documentation and labelling
Each Member State shall take all the measures necessary toensure that
the placing on the market of scheduled substances is subject to thefollowing requirements:
1. all transactions leading to the placing on the market of scheduled
substances in categories 1 and 2 of Annex I shall be properlydocumented;
(a) in particular, commercial documents such as invoices, cargo
manifests, administrative documents, transport and other shipping
documents shall certain sufficient information positively to
identify:
— the name of the scheduled substance as given in categories 1
and 2 of Annex I,
— the quantity and weight of the scheduled substance and, where
it consists of a mixture, the quantity and weight of the mixtureas well as the quantity and weight or the percentage of anysubstance or substances specified in categories 1 and 2 ofAnnex I which are contained in the mixture,
— the name and address of the supplier, distributor and of the
consignee;
(b) the documentation must furthermore contain a declaration from
the customer which shows the specific uses of the substances.
The detailed rules for implementing this provision will bedetermined in accordance with the procedure laid down in Article10 (2). When these detailed rules are examined, due account shallbe taken of the possibility for a regular customer obtaining from asupplier a scheduled substance specified in category 2 of Annex I
to provide a single declaration covering all transactions involving
that substance over a period of one year;
2. however, the obligations under paragraph 1 shall not apply to
transactions concerning scheduled substances in category 2 of Annex
I where the quantities involved do not exceed those indicated inAnnex II;
3. operators shall ensure that labels are affixed to scheduled substances
in categories 1 and 2 of Annex I before they are placed on the market.Such labels must show the names of the substances as given in AnnexI. Operators may in addition affix their customary labels;
4. operators shall keep such detailed records of their activities as are
required to comply with their obligations under paragraph 1;
5. the documentation referred to in paragraphs 1 and 4 shall be kept for
a period of not less than three years from the end of the calendar yearin which the operation referred to in paragraph 1 took place, and mustbe readily available for inspection by the competent authorities uponrequest.1992L0109 — EN — 01.03.2001 — 002.001 — 4
▼B
Article 3
Each Member State shall designate the competent authority or
authorities responsible for ensuring the application of this Directive.
It shall inform the Commission of the competent authority or authorities
thus designated.
Article 4
Scheduled substances in Categories 1 and 2of Annex I
1. Member States shall take all appropriate measures to ensure that
the manufacture or placing on the market in the Community of
scheduled substances in category 1 of Annex I is subject to possessionofa licence issued by the competent authorities.
2. In considering whether to grant a licence, the competent authorities
shall take into account in particular the competence and integrity of theapplicant.
The licence may be suspended or revoked by the competent authorities
whenever there are reasonable grounds for belief that the holder is nolonger a fit and proper person to hold a licence, or that the conditionsunder which the licence was issued are nolo nger fulfilled.
3. Member States shall take all appropriate measures to ensure that
any operator holding the licence referred to in paragraph 1 shall supplyscheduled substances specified in category 1 of Annex I only to personsspecifically authorized, either generally or individually, to be suppliedwith, possess or handle such substances.
4. Operators engaged in the manufacture or placing on the market of
scheduled substances in category 2 of Annex I shall be required toregister and update with the competent authorities the addresses of the
premises from which they manufacture or trade in these substances.
Article 5
Cooperation
Member States shall take the necessary measures toestablish clo se
cooperation between the competent authorities and operators, so that
operators:
— notify the competent authorities immediately of any circumstances,
such as unusual orders or transactions involving scheduledsubstances, which suggest that such substances tobe placed o n themarket or manufactured, as the case may be, may be diverted for theillicit manufacture of narcotic drugs or psychotropic substances,
— provide the competent authorities in summary form with such
information about their transactions involving scheduled substancesas the competent authorities may require.
TITLE III
CONTROL MEASURES
Article 6
Powers of competent authorities
1. In order to ensure the correct application of Articles 2 and 4, each
Member State shall adopt, within the framework of its national law, themeasures necessary to enable the competent authorities:
(a) to obtain information on any orders for scheduled substances or
operations involving scheduled substances;
(b) to enter operators' business premises in order to obtain evidence of
irregularities.1992L0109 — EN — 01.03.2001 — 002.001 — 5
▼B
TITLE IV
ADMINISTRATIVE COOPERATION
Article 7
For the purposes of applying this Directive and without prejudice to
Article 10, the provisions of Regulation (EEC) No 1468/81 and inparticular those on confidentiality shall apply mutatis mutandis . Each
Member State shall communicate to the other Member States and to the
Commission the names of the competent authorities appointed to act ascorrespondents in accordance with Article 2 (2) of that Regulation.
TITLE V
FINAL PROVISIONS
Article 8
Each Member State shall determine the penalties tobe applied fo r
infringement of the provisions adopted in implementation of thisDirective. The penalties shall be sufficient to promote compliance with
those provisions.
Article 9
1. Topermit any necessary adjustments tothe arrangements fo r
monitoring scheduled substances, the competent authorities in each
Member State shall each year communicate to the Commission allrelevant information on the implementation of the monitoring measureslaid down in this Directive, in particular as regards substances used forthe illicit manufacture of narcotic drugs or psychotropic substances and
methods of diversion and illicit manufacture.
2. On the basis of the communications made pursuant to paragraph 1,
the Commission shall, in accordance with Article 12 (12) of the UnitedNations Convention and in consultation with the Member States, drawup an annual report to be submitted to the International NarcoticsControl Board.
Article 10
1. The Commission shall be assisted by the Committee set up
pursuant to Article 10 of Regulation (EEC) No 3677/90. The Committee
shall examine any matter concerning the application of this Directive
raised by its chairman either on his own initiative or at the request of arepresentative of a Member State.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliver its opinion on the draft within a time limit which the chairmanmay lay down according to the urgency of the matter. The opinion shall
be delivered by the majority laid down in Article 148 (2) of the Treaty in
the case of decisions which the Council is required to adopt on aproposal from the Commission. The votes of the Member States withinthe Committee shall be weighted in the manner set out in that Article.The chairman shall not vote.
The Commission shall adopt measures which shall apply immediately.
However, if these measures are not in accordance with the opinion of the
Committee, they shall be communicated by the Commission to theCouncil forthwith. In that event the Commission shall defer applicationof the measures which it has decided for three months from the date ofcommunication.
The Council, acting by a qualified majority, may take a different
decision within the period referred to in the previous subparagraph.1992L0109 — EN — 01.03.2001 — 002.001 — 6
▼B
3. The procedure laid down in paragraph 2 shall be followed in
particular for:
(a) the determination, where appropriate, of the conditions relating to
the documentation and labelling of mixtures and preparations of
substances in category 2 of Annex I as provided for in Article 2;
(b) the amendment of the Annexes to this Directive, in cases where the
tables of the Annex to the United Nations Convention are amended;
(c) the amendment of the thresholds specified in Annex II.
Article 11
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with Articles 7 and 10before 1 January 1993 and with the other Articles before 1 July 1993.They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such reference onthe occasion of their official publication. The methods of making such a
reference shall be determined by the Member States.
2. Member States shall communicate to the Commission the main
provisions of national law which they adopt in the field governed by thisDirective. The Commission shall inform the other Member Statesthereof.
Article 12
This Directive is addressed tothe Member States.1992L0109 — EN — 01.03.2001 — 002.001 — 7
▼M2
ANNEX I
CATEGORY 1 (1)
SubstanceCN designation
(if different)CN code (2)
1-Phenyl-2-propanone Phenylacetone 2914 3100
N-acetylanthranilic acid 2-Acetamidobenzoic acid 2924 2200
Isosafrol (cis + trans) 2932 9100
3,4-Methylenedioxyphenylpropane-2-
one1-(1,3-Benzodioxol-5-yl)propan-2-
one2932 9200
Piperonal 2932 9300
Safrole 2932 9400
Ephedrine 2939 4100
Pseudoephedrine 2939 4200
Norephedrine ex 29394900Ergometrine 2939 6100
Ergotamine 2939 6200
Lysergic acid 2939 6300
(1) The salts of the substances listed in this category whenever the existence of such salts is possible.
(2) OJ L 278, 28.10.1999, p. 1.
CATEGORY 2 (1)
SubstanceCN designation
(if different)CN code (2)
Acetic anhydride 2915 2400
Phenylacetic acid 2916 3400
Anthranilic acid 2922 4300
Piperidine 2933 3200
(1) The salts of the substances listed in this category whenever the existence of such salts is possible.
(2) OJ L 278 du 28.10.1999, p. 1.
CATEGORY 3
SubstanceCN designation
(if different)CN code (1)
Hydrochloric acid Hydrogen chloride 2806 1000
Sulphuric acid 2807 0010
Potassium permanganate (*) 2841 6100
Toluene (*) 2902 3010 (90)
Ethyl ether (*) Diethyl ether 2909 1100
Acetone (*) 2914 1100
Methylethylketone (MEK)(*) Butanone 2914 1200
(*) The salts of these substances whenever the existence of such salts is possible.
(1) OJ L 278 du 28.10.1999, p. 1.1992L0109 — EN — 01.03.2001 — 002.001 — 8
▼M1
ANNEX II
Substance Threshold
Acetic anhydride 20 l
Anthranilic and its salts 1 kg
Phenylacetic acid and its salts 1 kg
Piperidine and its salts 0,5 kg1992L0109 — EN — 01.03.2001 — 002.001 — 9