1992L0109 — EN — 25.06.1993 — 001.001 — 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
No page date
►M1Commission Directive 93/46/EEC of 22 June 1993 L159 134 1.7.1993
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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),
HavingregardtotheopinionoftheEconomicandSocialCommittee(3),
Whereas some Member States have adopted measures to monitor the
manufacture and the placing on the market of certain substancesfrequentlyusedintheillicitmanufactureofnarcoticdrugsandpsycho-tropic substances; whereas other Member States are about to adoptmeasures of this kind; whereas it is therefore necessary to establishcommun rules at Community level in anticipation of the completedinternal market in order to avoid distortion of competition in lawfultrading 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 asthe ‘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 itscompetences;
WhereastherequirementsofArticle12oftheUnitedNationsConven-
tion,inrespectoftradeinprecursors,(i.e.substancesfrequentlyusedintheillicitmanufactureofnarcoticdrugsorpsychotropicsubstances,areimplementedasfarastradebetweentheCommunityandthirdcountriesisconcernedbyCouncilRegulation(EEC)No3677/90of13December1990 laying down measures to be taken to discourage the diversion ofcertain substances to the illicit manufacture of narcotic drugs andpsychotropic substances(
4);
Whereas Article 12 of the United Nations Convention envisages adop-
tionofappropriatemeasurestomonitormanufactureanddistributionofprecursors; whereas, by decisions taken at its 35th session, the UnitedNations Commission on Narcotic Drugs included additional substancesin the tables of the Annex to the Convention; whereas correspondingprovisions should be laid down in this Directive in order to detectpossible cases of illicit diversion of drugs in the Community or tocounter fraudulent imports into the Community and to ensure thatcommon monitoring rules are applied in the Community market;
WhereastheprovisionsofArticle12oftheUnitedNationsConvention
arebasedonasystemofmonitoringtradeinthesubstancesinquestion;whereasmosttradeinthesesubstancesisfullylicit;whereasthedocu-mentation and labelling of consignments of these substances must besufficiently explicit; whereas it is furthermore important, whilstproviding competent authorities with the necessary means of action, todevelopwithinthespiritoftheUnitedNationsConventionmechanisms
(1) OJ No C 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 No C 159, 17. 6. 1991, p. 58.
(4) OJ No L 357, 20. 12. 1990, p. 1. Regulation as last amended by Regula-
tion (EEC) No 900/92 (OJ No L 96, 10. 4. 1992, p. 1).
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based on close cooperation with the operators concerned and on the
development of intelligence gathering, exchange and exploitation;
Whereas,sincediversionpatternsareconstantlychanging,itisconsid-
eredatinternationallevelthattheproceduresprovidedforinArticle12of the United National Convention should be strenghtened to combateffectively 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 effectiveprocedurestopreventdiversionofprecursorandessentialchemicalstoillicit 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 Conven-
tion as the basic instrument of internation cooperation in chemicaldiversion matters, contains a number of recommendations for rein-forcingnationalandinternationalmeasuresonthebasisofthatConven-tion;
Whereas it must be ensured that the manufacture or use of the sched-
uledsubstancesincategory1ofAnnexItothisDirectiveissubjecttopossessionofalicence;whereasthesupplyofsuchsubstancesmustinaddition be authorized only where the persons to whom they are to besupplied are specifically authorized, either generally or individually, tobe supplied with, possess or handle such substances;
Whereas measures should be adopted to establish close cooperation
withtheoperatorsconcernedsothatthelatternotifysuspicioustransac-tions to the competent authorities;
Whereas it is important to establish machinery for administrative
cooperation; whereas it is desirable in this connection that thecompetent authorities in the Community base their actions on CouncilRegulation (EEC) No 1468/81 of 19 May 1981 on mutual assistancebetween the administrative authorities of the Member States andcooperationbetweenthelatterandtheCommissiontoensurethecorrectapplication of the law on customs and agricultural matters(
1); whereas
particular attention must be paid to the confidentiality of the informa-tion received and exchanged;
Whereas each Member State should introduce penalties sufficiently
dissuasivetoforestallinfringementsoftheprovisionsadoptedinimple-mentation of this Directive,
HAS ADOPTED THIS DIRECTIVE:
TITLE I
General
Article 1
1. The purpose of this Directive is to establish intra-Community
monitoringofcertainsubstancesfrequentlyusedfortheillicitmanufac-ture of narcotic drugs and psychotropic substances with a view topreventing the diversion of such substances.
2. For the purposes of this Directive:
(a) ‘scheduled substance'means any substance specified in Annex I,
includingmixturescontainingsuchsubstances.Thisexcludesmedi-cinal products or other preparations containing scheduled
(1) OJ No L 144, 2. 6. 1981, p. 1. Regulation as amended by Regulation
(EEC) No 945/87 (OJ No L 90, 2. 4. 1987, p. 3).
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substancesthatarecompoundedinsuchawaythatsuchsubstances
cannot be easily used or recovered by readily applicable means;
(b) ‘placing on the market'means any supply against payment or free
of charge to third parties of scheduled substances manufactured inthe Community or put into free circulation in the Community;
(c) ‘operator'means any natural or legal person engaged in the manu-
facture,processing,tradeordistributionofscheduledsubstancesinthe Community or involved in other related activities such as thebrokering and storage of scheduled substances;
(d) ‘InternationalNarcoticsControlBoard'meanstheBoardestablished
bytheSingleConventiononNarcoticDrugs,1961,asamendedbythe 1972 Protocol.
TITLE II
MONITORING OF PLACING ON THE MARKET
Article 2
Documentation and labelling
EachMemberStateshalltakeallthemeasuresnecessarytoensurethat
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 ship-pingdocumentsshallcertainsufficientinformationpositivelytoidentify:
— thenameofthescheduledsubstanceasgivenincategories1
and 2 of Annex I,
— the quantity and weight of the scheduled substance and,
whereitconsistsofamixture,thequantityandweightofthemixtureaswellasthequantityandweightorthepercentageof any substance or substances specified in categories 1 and2 of Annex 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.Thedetailedrulesforimplementingthisprovisionwillbedeter-minedinaccordancewiththeprocedurelaiddowninArticle10(2). When these detailed rules are examined, due account shallbetakenofthepossibilityforaregularcustomerobtainingfroma supplier a scheduled substance specified in category 2 ofAnnexItoprovideasingledeclarationcoveringalltransactionsinvolving that substance over a period of one year;
2. however,theobligationsunderparagraph1shallnotapplytotrans-
actions concerning scheduled substances in category 2 of Annex Iwhere the quantities involved do not exceed those indicated inAnnex II;
3. operatorsshallensurethatlabelsareaffixedtoscheduledsubstances
in categories 1 and 2 of Annex I before they are placed on themarket.Suchlabelsmustshowthenamesofthesubstancesasgivenin Annex I. 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. thedocumentationreferredtoinparagraphs1and4shallbekeptfor
a period of not less than three years from the end of the calendaryear in which the operation referred to in paragraph 1 took place,andmustbereadilyavailableforinspectionbythecompetentauthor-ities upon request.
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Article 3
Each Member State shall designate the competent authority or authori-
ties responsible for ensuring the application of this Directive.
ItshallinformtheCommissionofthecompetentauthorityorauthorities
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 sched-uled substances in category 1 of Annex I is subject to possession of alicence issued by the competent authorities.
2. In considering whether to grant a licence, the competent authori-
tiesshalltakeintoaccountinparticularthecompetenceandintegrityofthe applicant.
Thelicencemaybesuspendedorrevokedbythecompetentauthorities
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 no longer fulfilled.
3. Member States shall take all appropriate measures to ensure that
anyoperatorholdingthelicencereferredtoinparagraph1shallsupplyscheduledsubstancesspecifiedincategory1ofAnnexIonlytopersonsspecifically authorized, either generally or individually, to be suppliedwith, possess or handle such substances.
4. Operatorsengagedinthemanufactureorplacingonthemarketof
scheduled substances in category 2 of Annex I shall be required toregister and update with the competent authorities the addresses of thepremises from which they manufacture or trade in these substances.
Article 5
Cooperation
Member States shall take the necessary measures to establish close
cooperation between the competent authorities and operators, so thatoperators:
— notify the competent authorities immediately of any circumstances,
such as unusual orders or transactions involving scheduledsubstances, which suggest that such substances to be placed on themarketormanufactured,asthecasemaybe,maybedivertedfortheillicit manufacture of narcotic drugs or psychotropic substances,
— providethecompetentauthoritiesinsummaryformwithsuchinfor-
mation about their transactions involving scheduled substances asthe competent authorities may require.
TITLE III
CONTROL MEASURES
Article 6
Powers of competent authorities
1. InordertoensurethecorrectapplicationofArticles2and4,each
MemberStateshalladopt,withintheframeworkofitsnationallaw,themeasures necessary to enable the competent authorities:
(a) to obtain information on any orders for scheduled substances or
operations involving scheduled substances;
(b) toenteroperators’businesspremisesinordertoobtainevidenceof
irregularities.
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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
MemberStateshallcommunicatetotheotherMemberStatesandtotheCommissionthenamesofthecompetentauthoritiesappointedtoactascorrespondents in accordance with Article 2 (2) of that Regulation.
TITLE V
FINAL PROVISIONS
Article 8
Each Member State shall determine the penalties to be applied for
infringement of the provisions adopted in implementation of thisDirective.Thepenaltiesshallbesufficienttopromotecompliancewiththose provisions.
Article 9
1. To permit any necessary adjustments to the arrangements for
monitoring scheduled substances, the competent authorities in eachMember State shall each year communicate to the Commission allrelevantinformationontheimplementationofthemonitoringmeasureslaiddowninthisDirective,inparticularasregardssubstancesusedfortheillicitmanufactureofnarcoticdrugsorpsychotropicsubstancesandmethods of diversion and illicit manufacture.
2. Onthebasisofthecommunicationsmadepursuanttoparagraph1,
theCommissionshall,inaccordancewithArticle12(12)oftheUnitedNations 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
pursuanttoArticle10ofRegulation(EEC)No3677/90.TheCommitteeshall examine any matter concerning the application of this Directiveraisedbyitschairmaneitheronhisowninitiativeorattherequestofarepresentative 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 chairmanmaylaydownaccordingtotheurgencyofthematter.TheopinionshallbedeliveredbythemajoritylaiddowninArticle148(2)oftheTreatyin the case of decisions which the Council is required to adopt on aproposalfromtheCommission.ThevotesoftheMemberStateswithinthe 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 ofthe Committee, they shall be communicated by the Commission to theCouncilforthwith.InthateventtheCommissionshalldeferapplicationofthemeasureswhichithasdecidedforthreemonthsfromthedateofcommunication.
The Council, acting by a qualified majority, may take a different
decision within the period referred to in the previous subparagraph.
3. The procedure laid down in paragraph 2 shall be followed in
particular for:
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(a) the determination, where appropriate, of the conditions relating to
the documentation and labelling of mixtures and preparations ofsubstances in category 2 of Annex I as provided for in Article 2;
(b) theamendmentoftheAnnexestothisDirective,incaseswherethe
tablesoftheAnnextotheUnitedNationsConventionareamended;
(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 refer-
encetothisDirectiveorshallbeaccompaniedbysuchreferenceontheoccasion of their official publication. The methods of making such areference 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 bythis Directive. The Commission shall inform the other Member Statesthereof.
Article 12
This Directive is addressed to the Member States.
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ANNEX I
CATEGORY 1
SubstanceCNdenomination
(ifdifferent)CNcode
Ephedrine 29394010
Ergometrine 29396010
Ergotamine 29396030
Lysergic acid 29396050
1-Phenyl-2-propanone Phenylacetone 29143010
Pseudoephedrine 29394030
Acetylanthranilic acid 2-Acetamidobenzoic acid 29242950
3,4-Methylenedioxyphenylpropan-2-one 29329077
Isosafrole (cis + trans) 29329073
Piperanol 29329075
Safrole 29329071
The salts of the substances listed in this Category whenever the existence of such salts is possible.
CATEGORY 2
SubstanceCNdenomination
(ifdifferent)CNcode
Acetic anhydride 29152400
Anthranilic acid 29224950
Phenylacetic acid 29163300
Piperidine 29333930
The salts of the substances listed in this Category whenever the existence of such salts is possible.
CATEGORY 3
SubstanceCNdenomination
(ifdifferent)CNcode
Acetone(*) 29141100
Ethyl ether(*) Diethyl ether 29091100
Methylethylketone (MEK)(*) Butanone 29141200
Taluene(*) 29023010(90)
Potassium permanganate(*) 28416010
Sulphuric acid 28070010
Hydrochloric acid Hydrogen chloride 28061000
(*) The salts of these substances whenever the existence of such salts is possible.
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ANNEX II
Substance Threshold
Acetic anhydride 20l
Anthranilic and its salts 1kg
Phenylacetic acid and its salts 1kg
Piperidine and its salts 0,5kg