RESTRICTED
WORLD TRADE WT/CTE/W/29
14May1996
ORGANIZATION(96-1879)
Committee onTrade andEnvironment
ITEM 7:DOMESTICALLY PROHIBITED GOODS
ASSESSMENT OFTHE PRODUCT COVERAGE INSPECIFIC
INTERNATIONAL INSTRUMENTS
Note bytheSecretariat
I. INTRODUCTION
ThisNote hasbeenprepared inresponse torequests from delegations foradditional
information regarding existing international instruments relevant inthefieldofdomestically
prohibited goods (DPGs), withaviewtofacilitating identification ofpossible gapsintheproduct
coverage.
TheNote provides asurvey oftheproduct coverage andinformation exchange systems of
themain international instruments relating toDPGs. Thefollowing international instruments are
examined inthisNote:
1. Amended London Guidelines fortheExchange ofInformation onChemicals in
International Trade, UNEP, adopted 1989.
2. International Code ofConduct ontheDistribution andUseofPesticides, FAO, adopted
1985.
3. International Register ofPotentially Toxic Chemicals (IRPTC), UNEP, established 1976.
4. United Nations Consolidated ListofProducts Whose Consumption and/or SaleHave Been
Banned, Withdrawn, Severely Restricted ornotApproved byGovernments, fifthissue,
1994.
5. Code ofEthics onInternational Trade inChemicals, UNEP, adopted 1984.
6. Montreal Protocol onSubstances ThatDeplete theOzone Layer, UNEP, 19891.
7. Convention Concerning Safety intheUseofChemicals atWork, ILO, 1990.
8. Basel Convention ontheControl ofTransboundary Movements ofHazardous Wastes and
Their Disposal, UNEP, 1992.
9. Certification Scheme ontheQuality ofPharmaceutical Products Moving inInternational
Commerce, WHO, adopted 1975.
10. 1988 Convention Against Illicit Traffics inNarcotic Drugs andPsychotropic Substances,
UN,1990.
11. 1971 Convention onPsychotropic Substances, UN,1976.
12. 1961 Single Convention onNarcotics, UN,1964, asamended by1972 Protocol, 1975.
13. Codex Alimentarius, established 1962.
14. Agreement onTechnical Barriers toTrade, WTO, 1995.
15. Agreement onSanitary andPhytosanitary Measures, WTO, 1995.
1Unless otherwise indicated, thedateisthatatwhich theagreement came intoforce.WT/CTE/W/29
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Four broad categories ofpotential DPGs canbeidentified: chemicals (including pesticides
andfertilizers), pharmaceutical products, consumer products andhazardous wastes. They are
currently covered, toatleastsome extent, byinternational instruments operated byspecialized UN
agencies. Several ofthemost comprehensive ofthese instruments havecome intoforce since the
issue ofDPGs wasraised intheGATT in1982. Work iscontinuing onsome oftheinstruments
listed above, including expansion andclarification ofproduct coverage, exchange ofinformation,
andtechnical assistance.
Theproduct coverage appears tobemost extensive inthefieldofchemicals,
pharmaceuticals andhazardous wastes. Although relative gapsmayexistinterms ofspecific
categories ofproducts orwastes, identifying suchgapsliesoutside thetechnical competence and
mandate oftheWTO Secretariat. Inmeetings oftheGATT Working Group onDPGs andofthe
CTE, certain delegations expressed theconcern thatinparticular consumer products, certain
pharmaceuticals, cosmetics andfoodstuff, suchasfoodadditives, mayrepresent gapsincoverage.
Residual gapsintheflows ofinformation could stemfrom differences between
membership oftheWTO andthose international instruments dealing withtheproducts concerned.
However, information andassistance areinprinciple made available upon request alsotocountries
which arenotsignatories toorparticipants inthose instruments.
Product coverage regarding consumer products appears tobelesscomprehensive. The
UNConsolidated Listprovides relevant information inthisregard, butislimited tothehazards
embodied insome consumer products onaccount oftheirchemical composition. Consumer
products mayshow other potentially dangerous characteristics which arethesubject ofgovernment
regulation, suchasriskassessment ofthehazards stemming from theuseofaproduct. While
some information canbedrawn from TBTnotifications, noestablished multilateral framework
provides systematic information inthisregard. Thiscanbeexplained bythedifficulty ofdefining
andmonitoring therequired information inafieldwhich ispotentially unlimited. Whereas the
hazards presented byachemical onaccount ofitscomposition, forinstance, caninprinciple be
objectively defined -andnearly universally recognized -theriskstemming, forinstance, from the
useofapotentially dangerous toyismore subjective. National sensitivities regarding thepotential
hazards ofconsumer products canvaryfrom onecountry toanother, asaresult ofdifferences in
habits, lifestyle, culture, priorities, etc.
II. CHEMICALS AND PESTICIDES
(a) TheAmended London Guidelines fortheExchange ofInformation onChemicals
inInternational Trade andtheInternational Code ofConduct ontheDistribution
andUseofPesticides
TheAmended London Guidelines fortheExchange ofInformation onChemicals in
International Trade2provide avoluntary instrument toassist governments inregulating trade in
chemicals through theexchange ofscientific, technical, economic andlegalinformation on
chemicals which arebanned orseverely restricted. Thisinstrument isoperated jointly withthe
FAO International Code ofConduct ontheDistribution andUseofPesticides3which hasthe
objective toestablish voluntary standards ofconduct andincrease confidence between importing
2TheLondon Guidelines were adopted in1987 bytheUNEP Governing Council, andamended in1989.
3Adopted in1985.WT/CTE/W/29
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andexporting countries intheavailability, regulation, marketing anduseofpesticides. Both
instruments include mechanisms aimed atmaking existing information about hazardous chemicals
more freely available, inorder topermit competent authorities incountries toassess therisks
associated withtheuseofthese substances. Thefirstmechanism istheprior informed consent
(PIC) procedure, which wasadded in1989 tohelpcontrol imports ofunwanted chemicals that
havebeenbanned orseverely restricted. ThePICprocedure isimplemented through the
FAO/UNEP Joint Programme onOperation ofPrior Informed Consent4.Thesecond mechanism
concerns information exchange onchemicals ininternational trade.
AsofMarch 1996, 145countries were participating inthePICandinformation exchange
procedures.
(i) ThePICProcedure
ThePICprocedure isvoluntary andaimsatassisting countries withlimited resources to
make decisions regarding theimport ofcertain chemicals. TheaimofthePICprocedure isto
promote ashared responsibility between exporting andimporting countries inprotecting human
health andtheenvironment from theharmful effects ofcertain hazardous chemicals which are
traded internationally. ThePICprocedure isnotmeant toprovide alegalframework for
decision-making since theresponsibility formaking andenforcing thedecisions required under the
procedure remains witheachcountry.
Chemicals eligible forthePICprocedure
ThePICprocedure distinguishes three major usecategories ofchemicals, namely
pesticides5,industrial chemicals andconsumer chemicals6.Anychemical banned7orseverely
restricted8forhealth orenvironmental reasons inatleastonecountry after1January 1992 is
eligible forinclusion inthePICprocedure. Inthecaseofchemicals banned orseverely restricted
prior tothatdate, those forwhich control actions havebeentaken infiveormore countries are
alsoeligible. Theprocedure applies tochemicals assuchandnottoproducts/articles which may
contain residual elements ofsuchchemicals.
4InUNEP, theInternational Register ofPotentially Toxic Chemicals (IRPTC) istheleadoffice forindustrial andconsumer chemicals.
InFAO, thePlant Production Division oftheleadagency forpesticides.
5Article 2oftheFAOCode ofConduct defines apesticides as"anysubstance ormixture ofsubstances intended forpreventing, destroying
orcontrolling anypest,including vectors ofhuman oranimal disease, unwanted species ofplants oranimals causing harms during orotherwise
interfering withtheproduction, processing, storage, transport, ormarketing offood, agricultural commodities, wood andwood products
oranimal feedstuffs, orwhich maybeadministered toanimals forthecontrol ofinsects, arachnids orother pests inorontheirbodies.
Thetermincludes substances intended foruseasaplant growth regulator, defoliant, desiccant, oragent forthinning fruitorpreventing
thepremature falloffruit, andsubstances applied tocrops whether before orafterharvest toprotect thecommodity fromdeterioration during
storage andtransport".
6Article 1oftheLondon Guidelines defines achemical as"aharmful substance whether byitselforinamixture orpreparation, whether
manufactured orobtained from nature andincludes suchsubstances usedasindustrial chemicals andpesticides".
Industrial chemicals arechemicals usedinindustrial activities.
Consumer chemicals arechemicals which arecustomarily produced forprivate, non-occupational use.
7A"Bannedchemical"meansachemicalwhichhas,forhealthorenvironmentalreasons,beenprohibitedforallusesbyfinalgovernmental
regulatory action (Article 1(a)oftheLondon Guidelines).
8"A"severely restricted chemical" means achemical forwhich, forhealth orenvironmental reasons, virtually alluseshavebeenprohibited
nationally byfinalgovernment regulatory action, butforwhich certain specific usesremain authorized" /Article 1(b)oftheLondon Guidelines).WT/CTE/W/29
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Inaddition, acutely toxic pesticide formulations which havenotbeenbanned orseverely
restricted inanycountry forhealth andenvironmental reasons, butwhich arecausing problems
under conditions ofusefound indeveloping countries mayalsobeincluded. Anexpert group is
mandated toconsider whether there exists aneedforalistofsuchproducts tosupplement the
chemicals which arealready subject tothePICprocedure. Consistent withthephilosophy of
informed consent, participating countries would beprovided withinformation onthese pesticide
formulations toenable them tomake informed decisions, based onanevaluation ofthepotential
risks, concerning whether theywishtoreceive shipments. TheFAO/UNEP Joint Expert Group
ofExperts onPICisconsidering various criteria toidentify pesticides which would fallunder this
category.
Theamended London Guidelines donotapply topharmaceuticals, including narcotics,
drugs andpsychotropic substances, radioactive materials, chemicals imported forthepurposes of
research oranalysis inquantities notlikely toaffect theenvironment orhuman health, chemicals
imported aspersonal orhousehold effects, inquantities reasonable forthese uses, foodadditives9.
There isalsoanexclusion forsmall quantities ofchemicals usedforresearch purposes andsome
other small-volume uses.
AsofDecember 1995, twelve pesticides andfiveindustrial chemicals were subject tothe
PICprocedure. InMarch 1995, theFAO/UNEP Joint Group ofExperts onPICrecommended
theinclusion ofafurther seventeen chemicals intothePICprocedure, forwhich theDGDs10will
becirculated in1996. Twelve were selected onthebasis ofcontrol actions incountries and
formulations offivepesticides were selected onthebasis ofpotential problems under conditions of
useindeveloping countries.
Procedure forincluding achemical intothePICsystem
Inorder toparticipate inthePICprocedure, eachcountry must nominate aDesignated
National Authority (DNA) which willactasanational focal point. TheDNA isresponsible for
collecting andproviding national information onthesubstances concerned toFAO, UNEP and
other countries, andensuring thattheinformation received istransmitted toallrelevant authorities
andorganizations within thecountry.
TheFAO andUNEP Secretariats arejointly responsible fortheoperation oftheJoint
Programme operated bytheFAO/UNEP Joint Group ofExperts onPIC. TheFAO/UNEP
Secretariat receives notifications ofbanned andseverely restricted chemicals which arecandidates
forinclusion inthePICprocedure. Onthebasis ofthenotifications received, theFAO/UNEP
Joint Group identifies thechemicals which willbeincluded inthePICprocedure. Foranysuch
product, theFAO/UNEP Secretariat willestablish aDGD. TheDGDs willthenbeforwarded to
allDNAs which willhavetoprepare, within 90days, anImporting Country Response (ICR) on
thebasis oftheinformation provided. IntheICR, countries report whether ornottheyaccept
future import, orallow import onlyunder certain conditions. Import decisions must apply
uniformly toimports from allexporting countries andtoanydomestic manufacture ofthe
chemicals. These import decisions arecompiled byFAO/UNEP Secretariat anddistributed toall
DNAs inparticipating countries every sixmonths. Exporting countries should thenensure that
PICdecisions made byparticipating importing countries arecommunicated totheirexporter,
9Itisleftopen toGovernments toapply theguidelines topharmaceuticals andfoodadditives iftheyshould wishtodoso.Sofar,
noGovernments haveprovided information onregulatory actions onthese types ofchemicals.
10ADecision Guidance Document (DGD) sumsupthemostimportant characteristics oftheproduct (itschemical andphysical properties,
theriskslinked withitsuse,itseffects ontheenvironment, etc).WT/CTE/W/29
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industry andanyother relevant authorities, andthatnoexport occurs contrary tothedecision of
participating importing countries. Iftheimporting country hasnotprovided ananswer under the
PICprocedure, thestatus quoshould apply, i.e.export should notproceed without theconsent of
theimporting country unless thechemical hasbeenshipped foruseinthecountry orhasbeen
officially requested bythecountry.
Itisimportant tonotethattheexport notification isnotanobligation tiedtotheexport of
anychemical subject tothePICprocedure. Theobligation toprovide anexport notification
applies onlytothose countries which haveactually banned orseverely restricted achemical,
whether included inthePICprocedure ornot.Therefore, anychemical, whether included inthe
PICprocedure ornot,canbeexported without theneedforanexport notification, from any
country which hasnottaken regulatory action tobanorseverely restrict thatchemical.
Based onmandates from theFAO andUNEP Governing Bodies, twoparallel processes
havebeeninitiated in1995 which aremonitored jointly bythetwoorganizations. First, the
Intergovernmental Negotiating Committee (INC) iscurrently working todevelop aninternational
legally binding instrument fortheapplication ofthePICprocedure forcertain hazardous
chemicals andpesticides ininternational trade; itisexpected tocomplete itswork by1997. One
partofitswork istheidentification ofcandidate chemicals forinclusion inthePICprocedure;
theINCestablished aworking group onthisissue. Preliminary discussions haveindicated that
suchchemicals should include chemicals notified asbanned orseverely restricted forhealth or
environmental reasons byatleastonparty, aswellashazardous pesticides formulations which
maybecausing problems under conditions ofuseindeveloping countries. Thesecond process is
theGovernment Designated Expert Group whose mandate istoconsider theneedforadditional
measures tofurther reduce therisksofcertain hazardous chemicals ininternational trade.
(ii) TheInformation Exchange Procedure forChemicals inInternational Trade
TheLondon Guidelines andtheFAO Code ofConduct contain provisions which aimat
facilitating theexchange ofinformation between countries onchemicals moving ininternational
trade, especially those chemicals which havebeenbanned orseverely restricted forhealth or
environmental reasons. First, agovernment should notify UNEP andFAO assoonaspossible of
theaction ittakes tobanorseverely restrict achemical inorder toprotect health orthe
environment. Thisinformation isthencompiled byFAO/UNEP Secretariat andsenttoDNAs in
participating countries. These notifications alsorepresent theprimary information foridentifying
chemicals andpesticides which maybeincluded inthePICprocedure.
Secondly, theinformation exchange procedure foresees thattheDNA ofacountry
exporting achemical which isbanned orseverely restricted fordomestic useshould ensure that
theDNA oftheimporting country isaware thattheexport ofsuchachemical istobeexpected or
isabout tooccur. Exporting countries areencouraged toprovide importing countries with
information, advice andassistance, including appropriate precautionary information, regarding the
chemicals theyareexporting. TheDNA intheimporting country should alsobeinformed bythe
DNA oftheexporting country ofthedevelopment ofanysignificant newinformation relevant to
theinitial control action intheexporting country.
Information regarding classification, packaging andlabelling ofchemicals forexports is
alsoprovided forintheinformation exchange procedure. Exporting countries should ensure that
exported chemicals aresubject tothesame stringent requirements forclassification, packaging and
labelling ascomparable products intended fordomestic use. Intheabsence ofstandards or
requirements inthecountry ofimport, theexporting country should alsoensure thattheWT/CTE/W/29
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classification, packaging andlabelling ofthechemical exported conform torecognized
international standards.
(b) TheInternational Register ofPotentially Toxic Chemicals (IRPTC)
TheIRPTC wassetupbyUNEP in1976, withtheobjective ofidentifying potential
hazards associated withchemical use,assembling information onexisting policies forcontrol and
regulation ofhazardous chemicals atnational andinternational levels, andmaking dataon
chemicals available. Theinformation provided togovernments isconsidered tobeessential for
developing andenhancing thechemical management capabilities ofcountries.
IRPTC includes information onalltypes ofchemical substances, except pharmaceuticals
andradioactive material. Thedatabankonchemicals contains aseries offilesonallaspects of
some 100'000chemical thataredeemed important toconducting ahazard assessment (identity,
properties, environmental behaviour andeffects, toxicity ofsubstances, etc). Belonging tothis
databank, theIRPTC Legal Filecontains summary information onnational regulations in13
countries andinternational guidelines andrecommendations of6international organizations related
tocontrol ofsubstances invarious media suchasair,water, drinking water, wastes, soil,food
andbeverages, consumer goods (including cosmetics andtoiletries), aswellastheiruseand
transport; itcontains about 50'000files. Finally, IRPTC keeps some 7000 Special fileson
substances ofspecial international importance.
(c) TheUnited Nations Consolidated ListofProducts Whose Consumption and/or
SaleHave Been Banned, Withdrawn, Severely Restricted ornotApproved by
Governments
TheUNConsolidated ListofProducts Whose Consumption and/or SaleHave Been
Banned, Withdrawn, Severely Restricted ornotApproved byGovernments isprepared jointly by
theUnited Nations Secretariat, WHO andUNEP, andisperiodically up-dated (thefifthandlast
issue waspublished in1994). Itpresents information onregulatory action taken bygovernments
onpharmaceuticals, agricultural andindustrial chemicals, andconsumer products. Itisdivided
intotwoparts containing regulatory andcommercial information respectively. Theinformation
provided isnotconsidered tobeexhaustive, neither interms ofproducts, norinterms of
regulatory measures, itcovers nevertheless regulatory action taken by93governments onsome
700products. TheListismeant tocomplement andconsolidate theinformation produced within
theUNsystem.
Regarding chemicals, theConsolidated Listcontains information onnational control
actions forabout 370agricultural andindustrial chemicals. Thisinformation isbased on
notifications received byIRPTC from governments.
(d) Code ofEthics onInternational Trade inChemicals
Thisinstrument wasimplemented in1994 under theauspices ofUNEP andisintended to
complement theAmended London Guidelines bysetting forth voluntary standards ofconduct for
private sector industry.
TheCode covers "theproduction andmanagement ofchemicals ininternational trade,
taking intoaccount theirentire lifecycle". TheCode doesnotapply topharmaceuticals,
radioactive materials, small quantities ofchemicals imported forresearch, chemicals imported as
personal household orfoodadditives.WT/CTE/W/29
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Bysigning ontotheCode, participants undertake toincrease asound production andsafe
management ofchemicals byproviding government authorities andinterested private sector
participants withrelevant information regarding chemicals indomestic andinternational trade, and
bycomplying withtherelevant aspects ofthePICprocedure carried outbyUNEP andFAO.
Producers areurged toprovide sufficient information toimporters, through labelling orother
means, toensure safe,environmentally sound management ofwastes intrade.
(e) TheMontreal Protocol onSubstances ThatDeplete theOzone Layer11
TheMontreal Protocol isalegally binding instrument aiming atthereduction andphase-
outofconsumption andproduction ofspecified substances thatdeplete theozone layer. Asof
31December 1995, 151countries hadratified it.
Thesubstances controlled inAnnex Aoftheoriginal Protocol, whether existing alone or
inamixture, are5chlorofluorocarbons (CFCs) and3halons. Twosubsequent amendments tothe
Protocol added more substances: the1990 London Amendment covers carbon tetrachloride and
methyl chloroform (Annex B)andthe1992 Copenhagen Amendment listshydrobromo-
fluorocarbons (HBFCs), hydrochlorofluorocarbons (HCFCs) andmethyl bromide (Annex C).
Thebasic obligation istoprogressively eliminate production andconsumption of
controlled substances. TheProtocol laysdown foreachgroup ofcontrolled substance aschedule
forreduction andeventual phase-out ofproduction andconsumption. Thisimplies agradual
reduction andelimination oftrade among Parties, whose implementation islefttoeachParty to
determine. TheProtocol imposes ageneral obligation tobanexports ofcontrolled substances to
non-Parties. However, exports ofcontrolled substances areallowed tonon-Parties which fully
comply withtheProtocol control measures.
TheLondon amendment introduced anobligation fortheParties toprovide theSecretariat
withstatistical dataontheirannual production ofcontrolled substances, aswellasontheirimports
andexports toParties andnon-Parties respectively. Moreover, Decision VII/9 (Basic Domestic
Needs) foresees that"(...) exporting Parties should report totheOzone Secretariat by30
September eachyearonthetypes, quantities anddestinations oftheirexports ofozone-depleting
substances during theprevious year".12
(f) 1990 Convention Concerning Safety intheUseofChemicals atWork
ThisConvention entered intoforce in1993 andisimplemented under theauspices of
ILO13.Itcovers chemical elements andcompounds, andmixtures thereof, whether natural or
synthetic. "Use ofchemicals atwork" means anywork activity which mayexpose aworker toa
chemical, suchastheproduction, handling, storage andtransport ofchemicals, thedisposal and
treatment ofwaste chemicals, therelease ofchemicals resulting from work activities, the
maintenance, repair andcleaning ofequipment andcontainers forchemicals.
Theobjective oftheConvention istoensure thatallchemicals areevaluated bya
competent national authority todetermine theirhazards, provide information toemployers and
11UNEP, entered intoforce in1989.
12Seedoc.WT/CTE/W/19 (23January 1996).
13Theprovisions ofthisConvention aretobeapplied inconjunction withtheRecommendation concerning Safety intheUseofChemicals
atWork, No.177,ILO, 25June1990.WT/CTE/W/29
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workers concerning chemicals usedatwork andtoestablish principles forprogrammes toensure
thatthese chemicals areusedsafely. Forthatpurpose, allchemicals shallbeclassified.
Hazardous chemicals shallbelabelled andachemical safety datasheet, containing detailed
essential information regarding theiridentity, supplier, classification, hazards, safety precautions
andemergency procedures shallbeprovided toemployers. Requirements formarking and
labelling chemicals, andforchemical safety datasheets, areestablished bythecompetent national
authority, inaccordance withnational orinternational standards.
Pursuant totheConvention, exporting member States shallcommunicate toanyimporting
country hazardous chemicals domestically prohibited forreasons ofsafety andhealth atwork, as
wellasthegrounds forsuchprohibition. Suppliers (manufacturers, importers ordistributors) are
toensure thatchemicals havebeenclassified, marked orlabelled ashazardous inaccordance with
theConvention, andthatchemical safety datasheets areprepared forhazardous chemicals.
Workers havearighttoaccess toanyinformation required tobekeptpursuant totheConvention.
III. HAZARDOUS WASTES
(a) Basel Convention ontheControl ofTransboundary Movements ofHazardous
Wastes andTheir Disposal
TheBasel Convention wasadopted in1989 by116states, andentered intoforce in
May1992. AsofJanuary 1996, 97countries hadratified it.TheConvention aimsatreducing the
generation ofhazardous wastes, andatminimizing theirtransboundary movement.
(i) Coverage
TheConvention defines wastes as"substances orobjects which aredisposed oforare
intended tobedisposed oforarerequired tobedisposed ofbytheprovisions ofnational law"14.
"Disposal" includes operations leading tofinaldisposal (such aslandfill, incineration onlandorat
sea,release ontocontinental waterbodies, release ontotheocean including sea-bed insertion), as
wellasthose leading torecycling, resource recovery, reclamation, direct re-use oralternative
uses. Wastes areconsidered as"hazardous" iftheybelong toanyofthecategories listed in
Annex Iandhaveanyofthehazardous characteristics listed inAnnex III15oftheConvention. In
addition, wastes which are"defined as,orareconsidered tobe,hazardous wastes bythedomestic
legislation oftheParty ofexport, import ortransit"16alsofallunder thescope oftheConvention;
inthiscase, therelevant wastes shallbetreated ashazardous wastes byother parties when dealing
withthestateinquestion. Household wastes aswellasresidues from theirincineration (defines
as"other wastes", Annex II)alsofallunder thescope oftheConvention17.
TheBasel Convention excludes radioactive wastes which arecovered bypertinent
international control system (namely those developed bytheInternational Atomic Energy Agency),
orwastes thatresult from normal operations ofaship, which aresubject to1973/1978 MARPOL
Convention adopted under theauspices oftheInternational Maritime Organization rules.
14Article 2.1.
15Annex Ilists45categories ofwastes tobecontrolled. Annex IIIenumerates alistof9hazardous characteristics.
16Article 1.1(b).
17Article 1.2.WT/CTE/W/29
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(ii) Obligations
Under theoriginal Convention, transboundary movements ofhazardous wastes areallowed
onlyiftheexporting country doesnothaveappropriate facilities fortreating thewastes inan
environmentally sound andefficient manner, orifthewastes arerequired asrawmaterials for
recycling orrecovery industries intheimporting country. TheConvention prohibits theexport of
wastes under certain circumstances, inparticular when there is"reason tobelieve" that
environmentally sound management ordisposal options arenotavailable intheimporting country,
iftheimporting country hasprohibited suchimports, ortocountries thatarenotparties tothe
Convention.
Theprior informed consent (PIC) principle applies when atransboundary movement of
hazardous wastes takes place, namely thetransboundary movement cantakeplace onlyafterthe
states ofexport andtransit havegiven theirexpress written consent tothestateofexport, onthe
basis ofinformation provided bythelatter. Under theBasel Convention, Parties must exchange
information through theSecretariat ontheirwaste-related activities. Thisinformation includes,
interalia,thechanges innational definition ofhazardous wastes, decisions related totheimport or
export ofhazardous wastes.
Inaddition, Decision II/1218prohibits theexports ofhazardous wastes (i)from OECD
member states tonon-OECD member states forthepurpose offinaldisposal, and(ii)asof31
December 1997, from OECD member states tonon-OECD member states forthepurpose of
recycling orresource recovery. Atthethirdmeeting oftheConference oftheParties in
September 1995, Parties decided byconsensus toinclude Decision II/12 asanamendment tothe
Basel Convention19.Thisamendment willenter intoforce between theParties having accepted it
onceatleastthree-fourths oftheParties haveratified it.
InDecision III/1, Parties further requested theTechnical Working Group (TWG) to
accelerate itscurrent work onthedefinition ofhazardous wastes characteristics. TheTWG is
developing alistofwastes which arehazardous andthusfallwithin thescope oftheConvention
(listA),andalistofnon-hazardous wastes which normally would notbesubject tothe
Convention (listB).TheTWG isalsodeveloping alistCcontaining wastes forwhich further
clarification isneeded. Thepurpose ofthose listsistoprovide guidance toParties indetermining
ifawaste ishazardous ornotwithin theframework oftheBasel Convention considering thefact
thatsome categories ofwastes listed intheConvention maycontain specific wastes which are
always hazardous andwastes which maybesometimes hazardous. Itshould benoted thatat
present theclassification ofwastes intheConvention isparticularly difficult forwastes which
possess hazardous constituents andwhere there isaneedtodetermine atwhatlevelsuch
constituents willcause thatwaste toexhibit hazardous characteristics. TheTWG isexpected to
present itsrecommendation totheConference oftheParties atitsfourth meeting in1997 for
decision-making.
18Adopted byconsensus attheSecond Meeting oftheConference oftheParties, inMarch 1994.
19Decision III/1, Amendment totheBasel Convention, seedoc.WT/CTE/W/12, 10October 1995.WT/CTE/W/29
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IV. PHARMACEUTICALS, INCLUDING NARCOTIC AND PSYCHOTROPIC
SUBSTANCES
(a) Certification Scheme ontheQuality ofPharmaceutical Products Moving in
International Commerce
Thisinstrument wasadopted in1975 under theauspices oftheWHO. AsofMarch 1996,
139countries participated intheCertification Scheme.
Forthepurpose oftheCertification Scheme, "pharmaceutical products" means any
medicine intended forhuman use,oraveterinary product administered tofood-producing animals,
presented initsfinished dosage orasastarting material foruseinsuchadosage form, when itis
subject tocontrol bylegislation intheexporting Member country andintheimporting Member
country.
TheCertification Scheme islinked totheWHO standards onGood Manufacturing Practice
(GMP)20andprovides asimple administrative mechanism which allows animporting country to
gainimportant information about theregulatory status ofaspecific product intheexporting
country.
Countries participating intheScheme must communicate totheDirector General ofWHO
information concerning thecompetent authority responsible forthecertification oftheirexports of
pharmaceutical products. Attherequest ofacommercially interested party, thecompetent
authority shallcertify thatthepharmaceutical product isauthorized forsaleordistribution within
thejurisdiction oftheexporting country, or,ifitisnotauthorized, thereason whythat
authorization hasnotbeenaccorded. Thecompetent authority oftheexporting country must also
submit information relating totheplant inwhich itsexported pharmaceutical products are
manufactured andmust attest thatallproduct information, including labelling, iscurrently
authorized inthecertifying country. Thecompetent authority oftheimporting country must
decide upon receipt ofthecertificate whether togrant orrefuse theauthorization forsaleor
distribution ofthepharmaceutical product ortomake authorization conditional onthesubmission
ofsupplementary data. Acountry mayopttoparticipate solely tocontrol theimport of
pharmaceutical products andactive substances. Inthecaseimported products show quality defects
thatareconsidered tobeofaserious nature bytheimporting country, thecompetent authority of
thatcountry should notify thecompetent authority oftheexporting country witharequest to
institute enquiries. Conversely, ifthecompetent authority oftheexporting country ascertains
serious quality defects, thatcompetent authority should notify thecompetent authority ofthe
importing country.
Inaddition totheScheme, WHO monitors various instruments providing information
about pharmaceuticals. Among them, theWHO Drug Monitoring Programme focuses onthe
exchange ofinformation about safety andefficacy ofpharmaceutical preparations, aswellasnew
information regarding theirserious side-effects. Thisprogramme provides achannel through
which countries areinformed ofdecisions toprohibit orlimittheavailability ofdrugs already in
use. WHO makes available evaluated information regarding safety andefficacy ofdrugs intwo
widely disseminated publications, themonthly WHO pharmaceutical Newsletter andthequarterly
WHO Drug Information ,which cover inparticular general policy topics, reports inindividual
drugs andrecent regulatory decisions, listsofnewly approved pharmaceutical products.
20TheGMPtextprovidescomprehensiveguidancetogovernmentsandmanufacturersonimportantaspectsofdrugmanufacturer,including
personnel, premises, equipment, sanitation, starting materials, manufacturing operations, labelling andpackaging, quality control system,
self-inspection, distribution records, complaints andreports ofadverse reactions, expiry dates.WT/CTE/W/29
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(b) 1988 Convention Against Illicit Traffics inNarcotic Drugs andPsychotropic
Substances21,1971 Convention onPsychotropic Substances22and1961 Single
Convention onNarcotics23
The1961 and1971 Conventions were primarily designed forthecontrol oflicitsupply of
narcotic drugs andpsychotropic substances respectively. Narcotic drugs include opium andits
derivatives (morphine, codeine andheroine), other narcotic drugs ofman-made origin (such as
methadone andpethidine), aswellascannabis andcocaine. Psychotropic substances include
mainly hallucinogens, stimulants anddepressants. Based onWHO recommendations, theUN
Commission onNarcotic Drugs determines which substances should besubject tocontrol: asof
August 1995, the1961 Convention covered some 115substances andsome 105substances were
included inthe1971 Convention. TheConventions categorizes drugs according totheiraddictive
properties, theirtherapeutic value andtherisksarising from theirabuse inschedules annexed to
therespective instruments. Forexample, theprovisions governing Schedule IVsubstances, which
aretheleaststringent, include interalia,therequirement toissue licenses formanufacture, trade,
distribution, import andexport, andtherightforcountries, Parties totheConvention, tonotify
other Parties thattheyintend toprohibit orrestrict theimport ofspecified substances, which
obliges thenother Parties tobanorcontrol exports tothatcountry, accordingly.
The1988 Convention complements thetwoprevious instruments. Itsobjective isto
prevent andcombat drugabuse through controlling theillicit supply ofnarcotic drugs and
psychotropic substances andtoprevent trade inandthediversion ofmaterials andequipment for
theirillicit production ormanufacture.
(c) UNConsolidated ListofProducts Whose Consumption and/or SaleHave Been
Banned, Withdrawn, Severely Restricted ornotApproved byGovernments
Thedrugsection oftheConsolidated Lististheresult ofacollaboration between WHO
andUNEP/IRPTC. Thelastissue, published in1994, contains information onmore than
300products bynotified 99governments. Inorder toputthenational decision intoan
international perspective, WHO hasprepared acomment which appears attheendofeachproduct
entry; thiscomment iscleared byallnational regulatory authorities whose decisions havebeen
reported.
V. CONSUMER PRODUCTS
(a) UNConsolidated ListofProducts Whose Consumption and/or SaleHave Been
Banned, Withdrawn, Severely Restricted ornotApproved byGovernments
Incollaboration withIRPTC, theUNConsolidated Listprovides information on
regulatory measures taken bygovernments inrelation withconsumer products, including a
description ofandthegrounds fortheaction taken. Theinformation covers onlyconsumer
products which arehazardous onaccount oftheirchemical composition. TheListcontains
information regarding action taken onsome 106substances which areprohibited orrestricted in
21Adopted in1988, entered intoforce in1990.
22Adopted in1971, entered intoforce in1976.
23Adopted in1961, entered intoforce in1964, amended by1972 Protocol which entered intoforce in1975.WT/CTE/W/29
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consumer products, suchaschildren 'sarticles, household products, automotive, cosmetics,
cleaning fluids, paints, personal products, textiles andclothing.
(b) Codex Alimentarius24
TheCodex Alimentarius isacollection ofinternational foodstandards adopted bythe
Codex Alimentarius Commission, which istheinternational body responsible fortheexecution of
theJoint FAO/WHO Food Standards Programme. More than150countries currently participate
intheProgramme, which wascreated in1962 withthepurpose ofprotecting thehealth of
consumers andfacilitating international trade infoods. TheCodex Alimentarius includes
standards foralltheprincipal foods, whether processed orsemi-processed orraw. Itincludes
provisions inrespect ofthehygienic andnutritional quality offood, including microbiological
norms, provisions forfoodadditives25,pesticides residues, contaminants26,labelling and
presentations, andmethods ofanalysis andsampling.
Thestandards andmaximum limits forpesticides residues areestablished bytheCodex
Alimentarius Commission. Governments must thennotify theCodex Secretariat whether they
accept theneworamended standards. When agovernment cannot accept astandard, orwhen it
accepts thestandard conditionally, itmust alsonotify thereasons therefor. Thisnotification
system ensures thatCodex Alimentarius canbeusedasareference forgovernments andtraders.
Regarding foodadditives, forinstance, theCodex Alimentarius contains General
Principles fortheUseofFood Additives, andanInternational Numbering System forFood
Additives (INS) whose purpose istofacilitate theidentification offoodadditives iningredient
lists. Further provisions relate tothecarry-over offoodadditives intofoods, thelabelling offood
additives when soldassuch, etc.
VI. WTO INSTRUMENTS RELATED TODPGs
(a) TheAgreement onTechnical Barriers toTrade
TheTBTAgreement recognizes therightofMembers toadopt measures suchastechnical
regulations, standards, testing andcertification procedures totheextent theyconsider appropriate
fortheprotection ofhuman, animal orplant lifeorhealth, ortheenvironment, ortomeetother
consumer interests. Atechnical regulation amounts alsotoabanonthedomestic saleoruseof
theproduct concerned which doesnotmeetthestandard setinthatregulation.
TheAgreement increases transparency byrequiring prior notification, affording other
Members opportunities forcomments, andestablishing enquiry points toanswer enquiries from
24Latin expression, meaning Food LaworCode.
25According totheCodex, foodadditive means "anysubstance notnormally consumed asafoodbyitselfandnotnormally usedas
atypical ingredient ofthefood, whether ornotithasnutritive value, theintentional addition ofwhich tofoodforatechnological (including
organoleptic) purpose inthemanufacture, processing, preparation, treatment, packing, packaging, transport orholding ofsuchfoodresults,
ormaybereasonably expected toresult, (directly orindirectly) initoritsby-products becoming acomponent oforotherwise affecting
thecharacteristics ofsuchfoods. Thetermdoesnotinclude "contaminants" orsubstances added tofoodformaintaining orimproving nutritional
qualities.
26According totheCodex, contaminant means "anysubstance notintentionally added tofood, which ispresent insuchfoodasaresult
oftheproduction (including operations carried outincrophusbandry, animal husbandry andveterinary medicine), manufacture, processing,
preparation, treatment, packing, packaging, transport orholding ofsuchfoodorasaresult ofenvironmental contamination. (...).WT/CTE/W/29
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other Members. Notifications under theTBTAgreement contain information ontechnical
regulations administered atthenational levelwhich isofrelevance tothediscussions onDPGs.
Forexample, under thecategory ofwastes andchemicals, TBTnotifications included in1995
information onabanonexport ofmercury andmercury compounds (G/TBT/Notif.95.300); and
abanontheimport andexport ofthechemicals methylene chloride andtrichloroethylene.
Although notifications dealing withfoodandfoodadditive andother requirements areprimarily
addressed under theSPSAgreement, some 49TBTnotifications dealtwitharange oftechnical
regulations related tofoodin1995. These included labelling requirements forexpiration dates of
food(G/TBT/Notif. 95.152); regulations related tofoodstuffs (G/TBT/95.113); andregulations
related totheallowable useofcertain foodadditives (forexample, theallowable useofsweeteners
(G/TBT/Notif. 95.117) andmaximum allowable useoferythosine infishandother foodproducts
(G/TBT/Notif. 95.187). Notifications havealsobeenreceived under theTBTAgreement on
regulations related totheimport andhandling ofradioactive wastes (G/TBT/Notif. 95.185).
(b) TheAgreement onSanitary andPhytosanitary Measures
Before theentry intoforce oftheWTO, regulations regarding sanitary andphytosanitary
measures, including foodsafety standards, were subject totheTBTAgreement forthose countries
which were signatories.
TheSanitary andPhytosanitary (SPS) Agreement27recognizes therightofMembers to
adopt andenforce "measures necessary toprotect human, animal orplant lifeorhealth" but
requires thatthese measures arenotapplied inadiscriminatory orarbitrary manner norrepresent
adisguised restriction oninternational trade. TheSPSAgreement encourages countries to
harmonize theirSPSrequirements bybasing them, whenever possible, oninternational
standards28.Countries cantakemore stringent SPSmeasures iftheyhaveascientific justification,
oriftheycandemonstrate thattheinternational standard would notprovide whattheyconsider to
betheacceptable levelofrisk.
Transparency procedures contained intheSPSAgreement aresimilar tothose oftheTBT
Agreement. Members shallalsoestablish enquiry points responsible foranswering questions
relating toSPSmeasures. When aSPSmeasure differs from international standard, guideline or
recommendation, Members shalladditionally notify them toother Members through theWTO
Secretariat. Some 277SPSregulations havebeennotified since theentry intoforce ofthe
Agreement. They address requirements regarding, interalia,foodquality standards (limits for
pesticides, antibiotics, preservatives andother residues infood), foodadditives, labelling
requirements forfood.
Thus, theSPSAgreement, through itsnotification andenquiry point system, provides a
valuable source ofinformation regarding foodsafety andfoodadditive regulations implemented in
WTO Member countries. Moreover, anyquestion relating totheimplementation oftheSPS
Agreement canberaised intheSPSCommittee.
27Sanitary andPhytosanitary measures are"[A]ny measure applied (...)toprotect human, oranimal lifeorhealth within theterritory
oftheMember from risksarising from additives, contaminants, toxins ordisease-causing organisms infoods, beverages orfeedstuffs;"
(emphasis added). Foracomplete definition, seeAnnex AoftheAgreement.
28Theinternational standards referred tointheSPSAgreement aretheCodex Alimentarius Commission, theInternational Office of
Epizootics, andtherelevant international andregional organizations operating within theframework oftheInternational Plant Protection
Convention.WT/CTE/W/29
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VII. GATT WORKING GROUP ONDOMESTICALLY PROHIBITED GOODS
Under theGATT Working Group onDomestically Prohibited Goods, select Contracting
Parties submitted DPG notifications which provided specific information related toproduct
coverage. Between 1989 and1990, 6DPG notifications were received bytheContracting Parties.
Product coverage wasbroad, andnotifications alsocontained information onrelated export
notification procedures, compulsory licensing, inspection procedures andother measures related to
products withdrawn orrestricted from domestic marketing. DPG/Notif.89.1 provided information
onnational export certification schemes related topharmaceutical products which hadbeen
withdrawn orrestricted from domestic marketing. Under thesame DPG notification, information
wasprovided onexport licensing andexport permit schemes covering hazardous wastes andozone
depleting substances. InDPG/Notif. 90.1, information wasprovided concerning mandatory
export licensing procedures covering thefollowing products: foodstuffs, consumer goods,
agricultural products, medicines, chemicals, wastes, woods preservatives, medicines and
pharmaceutical, pesticides. Under DPG/Notif. 90.4, notification wasprovided ofexport permits,
export bansorexport notification systems covering thefollowing products: animals andanimal
products subject tomandatory inspection procedures; foodstuffs; atomic energy andrelated
equipment; toxic chemicals (PCBs) andCFCs; hazardous wastes; PCBwaste; fishandfish
containers; meatproducts; illegal drugs; fertilizers.