WORLD TRADE G/SPS/GEN/20
23June1997
ORGANIZATION(97-2596)
Original: English Committee onSanitary andPhytosanitary Measures
ECDIRECTIVE ONTHE MARKETING OFCOSMETIC PRODUCTS
Submission bytheUnited States fortheMeeting of1-2July1997
Introduction
1. InJanuary 1997, theEuropean Community published Commission Directive 97/1/EC, which
prohibits themarketing ofcosmetic products containing bovine, ovine, andcaprine tissues andfluids
from thebrain, spinal cord, eyes, oringredients derived therefrom. ThisDirective goesintoeffect
on1July1997.
2. Thebasis given forthisDirective istoensure thehealth andsafety ofconsumers against the
possible riskofbovine spongiform encephalopathy (BSE) orvariant Creutzfeldt-Jakob Disease (CJD).
Asof18June1997, theECDirectorate General XXIV (Consumer Affairs andRelations) hasinformed
usthatthisdirective applies totallow anditsderivatives, many ofwhich areexported fromtheUnited
States totheCommunity formanufacturers ofsoapandother cosmetics.
3. Thislegislation would essentially stopallUSexports oftallow andtallow derivatives because
theriskmaterials referenced inthedirective -brain, spinal cord, andeyes-arenotexcluded from
therawmaterials fromwhich tallow ismade. Itwould alsoimpact USexports offinished cosmetics
andsoaps made from UStallow, andcould alsoimpact trade tothirdcountries which import tallow
formanufacture ofcosmetics intended forfinalexport totheEuropean Community.
4. BSEisnotknown tooccur intheUnited States. TheUnited States hashadandcontinues to
maintainanaggressiveandactivesurveillanceprogrammeforBSE.TheUnitedStatesraiseditsconcerns
about theECDirective inameeting withtheEuropean Community inBrussels inFebruary 1997.
Thismeeting wasalsoattended byrepresentatives from Canada, Australia, andNewZealand, who
hadsimilar concerns.
5. TheEuropean Community notified thisDirective totheWTO inMarch. TheUnited States
submitted comments through normal procedures. TheCommission hasreceived comments onthis
issuefromtheUnited States, Australia, NewZealand, anditsowncosmetic andrendering industries.
6. TheEuropean Community itself isreviewing whether toexempt tallow from theDirective.
Weunderstand thattheECscientific Committee onCosmetics willmeeton24and25Junetoexamine
whether tallow could beconsidered safeunder certain rendering processes. IftheScientific Committee
recommends exempting tallow fromtheDirective, there willnotbesufficient timefortheEuropean
Community toamend theDirective prior tothe1Julyimplementation date. Inanticipation ofthis
outcome, itisunderstood thattheEuropean Community maybedeveloping strategies toexpedite the
amendment oftheDirective. Toprevent unnecessary disruptions intradeintallow products, theUnited
States encourages temporary flexibility intheimplementation ofthisDirective and,inthelongterm,
apermanent exemption forthese products.G/SPS/GEN/20
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Available Scientific Evidence /Relevant International Standards
7. TheUnited States questions thescientific basis ofthisDirective. Studies performed onBSE
haveshown thattallow doesnotcontain anydetectable levelofinfectivity (refer toVeterinary Record
137:605; 1995; Taylor, Woodgate, andAtkinson).
8. TheOffice international desépizooties (OIE) Zoosanitary Code Chapter onBSErecognizes
thefactthattallowdoesnotpresentariskoftransmission.Specifically,Chapter3.2.13,Article3.2.13.2
states thefollowing: "Veterinary Administrations canauthorize without restriction theimport ortransit
through theirterritory, directly orindirectly, ofmilk, milkproducts, tallow, hides andskinsoriginating
from healthy animals from countries where BSEhasbeenreported". Bytheinclusion oftallow in
thisstatement, theOIErecognizes thatthere isnoevidence thattallow presents ariskoftransmission
ofBSE. Inaddition totherelevant OIEguidelines, theWorld Health Organization hasalsoconcluded
thattallow issafe.
9. Another important factor toconsider isthemanufacturing process towhich thistallow is
subjected. Thecosmetics andsoapindustries useprocessing procedures andtemperatures which are
generallyfaraboveallknowntransmissiblespongiformencephalopathy(TSE)inactivationrequirements.
Forexample, thefirststepintheproduction process offattyacidsisthehydrolysis oftallow toproduce
acrude fattyacidanddilute crude glycerine. Thehydrolysis requires temperatures ofabout 250oC,
with40barsofpressure forover2hours. Thisstepalone iswellabove anypublished parameters
forTSE inactivation, andthese compounds maythenbesubjected tofurther treatment inthe
manufacturing process. Products which havegonethrough these rigorous procedures maygenerally
beassumed tobesafeinreference toTSEtransmission, especially ifoneassumes thattallow issafe
evenbefore themanufacturing process begins.
10. TheECDirectivealsoappearstobeinconsistentwithotherCommunitylegislation.Specifically,
itseems toconflict withCommission Decision 94/382/EEC andthesubsequent Commission Decision
96/449/EEC. These decisions laiddown therequirements forprocessing animal waste withaview
totheinactivationofspongiformencephalopathyagents.Decision96/449/EECrequiresthatmammalian
waste betreated within specific parameters, butitexempts certain products which supposedly donot
present ariskofTSEtransmission fromtheserequirements--these products hadalsobeenexempt from
Decision 94/382/EEC. Rendered fatsareonesuchproduct which havebeenexempt. Thislegislation,
which isbased ontheassumption thatrendered fatsdonotpresent ariskofBSEtransmission, appears
tobecontradictory toDirective 97/1/EC, which assumes thatrendered fatsdopresent arisk.
11. TheECDirective alsoisinconsistent withother EClegislation which allows theimport of
lardandrendered fats,suchastallow, forhuman consumption. Currently, there arenorestrictions
related toBSEonsuchproducts imported intotheCommunity. However, Directive 97/1/EC proposes
tolimitthese products foruseincosmetics, whose usewould provide indirect exposure, ifany,to
suchagents.
12. Directive 97/1/EC alsodoesnotallow forrecognition ofdifferences inanimal disease status.
These differences arethefirststepinassessing theriskoftransmission ofsuchagents. Iftherisk
agent, suchasBSE, isnotpresent inthecountry oforigin oftheproduct, (i.e.,theUnited States)
thentheproduct canbeassumed tobesafe.
13. BSEisnotknown tooccur intheUnited States. TheUnited States hashadandcontinues to
maintain anaggressive andactive surveillance programme forBSE. There aremore than250federal
andstateregulatory veterinarians specially trained todiagnose foreign animal diseases, including BSE.
There areseveral agencies involved inthesurveillance programme, including theFood Safety and
Inspection Service (FSIS) andtheCenters forDisease Control (CDC), andtheAnimal andPlantHealthG/SPS/GEN/20
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Inspection Service (APHIS), which leads thisinteragency effort. Thesurveillance samples include
field cases ofcattle exhibiting signs ofneurological disease, cattle condemned atslaughter for
neurological reasons, rabies-negative cattle submitted topublic health laboratories, neurological cases
submitted toveterinary diagnostic laboratories andteaching hospitals, andrandom sampling ofcattle
which arenon-ambulatory atslaughter. AsofMarch 1997, atotalofatleast5,544 brains hadbeen
examined forBSEoranother formofatransmissible spongiform encephalopathy incattle. Noevidence
ofeitherconditionhasbeenfound.Thissurveillanceprogrammemeetsandexceedsthestandardsrecently
adopted bytheOIE(Chapter 3.2.1.3.1). Withthepossible exception oftheUnited Kingdom, webelieve
thatmostECmember States donothaveactive surveillance programmes which meetOIEstandards.
Conclusion
14. TheECCosmetics Directive failstoaccount forscientific evidence regarding animal disease
status intheUnited States andtheriskofBSEtransmission intallow. Furthermore, themeasure is
notbased onrelevant OIEstandards, particularly OIEguidelines related toBSE. Intheabsence of
using arelevant OIEstandard, theEuropean Community hasnotprovided thescientific riskassessment
which would support thisdifference.
15. Asaresult, theCosmetics Directive, initscurrent form, raises anumber ofconcerns with
respect toWTO requirements, including those setoutintheSPSAgreement. Anticipating thatthe
ECScientific Committee onCosmetology willtakeintoaccount theavailable scientific evidence and
make appropriate recommendations forrevising theDirective toallow fortrade intallow andtallow
products, weencourage theCommission toensure thatitsimplementation oftheDirective doesnot
unnecessarily disrupt trade inthese products.