CELEX: 51990PC0597
Language: en
Date: 1990-12-18
Title: 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

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