CELEX: 51992PC0218
Language: en
Date: 1992-05-25
Title: 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

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)
 ---pagebreak---                              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«
 ---pagebreak---                                        - 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*>
 ---pagebreak---                                                       - 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.
   c o n s i d e r e d at I n t e r n a t i o n a l level that t h e p r o c e d u r e s e s t a b l i s h e d 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 G 7 London Economic Summit on 15 July 1991:"
 ---pagebreak---                                   - 3 -
   "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
 ---pagebreak---                                        - 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).
 ---pagebreak---                                      - 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
         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."
 ---pagebreak---                                         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,"
 ---pagebreak---                                         - 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.
 ---pagebreak---                                       - 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                                                        SH Code
    Ephedr ine                                                       2939 4Q 1Q
    ErgometrIne                                                      2939 60 10
    Ergotamine                                                       2939 60 30
    Lysergic acid                                                    2939 60 50
    1-phenyI-2-propanone                                             2914 30 10
    PseudoephedrIne                                                  2939 4Q 30
    AcetYianthranlIic acid N                                         2924 29 50
    MethYlenedloxyphenvl 3. 4-oropanone 2                            2932 90 77
    The  salts of   the   substances   I Isted   La  this category  whenever  the
    presence of such salts is possible.
 ---pagebreak---                                  9 -
TABLE I I
                                                          SH Code
Acetic anhydride                                          2915 24 00
AnthranlIic acid                                       OX 2922 49 90
PhenylacetIc acid                                         2916 33 QO
Piper idlne                                               2933 39 30
 Isosafrole (cls+trans)                                   2932 90 73
Plperonal                                                 2932 90 75
Safrole                                                   2932 90 71
The salts of    the substances  listed In this category whenever the
existence of such salts is possible.
TABLE 11(a)                                               SH Code
Acetone                                                   2914 11 QQ
Ethyl ether                                               2909 11 00
Methyl ethvi ketone (MEK)                                 2914 12 00
Toluene                                                2902 30 10/90
Potassium permanganate                                    2841 60 10
Sulphuric acid                                            2807 00 10
Hydrochloric acid                                         28Q6 _10_QJQ
 ---pagebreak---                                 - 10 -
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
 ---pagebreak---                                                         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. t h o r o f o r o u n a h l n  to iircnpl    It.
                                                                                                          /!A
 ---pagebreak---  ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM (92) 218 final
                                                      DOCUMENTS
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