WORLD TRADE G/TBT/Notif.96.65
26March 1996
ORGANIZATION
(96-1091)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Food andDrug Administration (44)
Agency orauthority designated tohandle comments regarding thenotification canbe
indicated ifdifferent from above:
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Colour additive lakes
5. Title, number ofpages andlanguage(s) ofthenotified document: Permanent Listing of
Colour Additive Lakes (46pages)
6. Description ofcontent: TheAdministration isproposing tolistcertain colour additive
lakes permanently assuitable and safe foruseinfood (notified under the
SPSAgreement), drugs, andcosmetics (notified under theTBT Agreement). The
Administration isalsoproposing topermit theuseofmore thanonestraight colour in
thepreparation ofalake,tomodify thenomenclature forlakes, andtosimplify thebatch
certification procedure forlakes. Aspartoftheactions, theAdministration isproposing
toamend itsregulations torequire thepreparation oflakes from certified batches of
straight colours; toprovide simplified nomenclature fordeclaring colour additives,
including lakes, oncosmetic products; torequire declaration ofFD&C yellow No.5
andFD&C yellow No.6onallfoods andsome drugproducts containing lakes ofthese
straight colours; andtoterminate thelisting ofcertain straight colours ascomponents of
lakes fordrugandcosmetic useandthelisting ofcalcium saltsascomponents oflakes
forfooduse.
7. Objective andrationale: Tocomplete theAgency 'sdisposition oftheprovisional listof
colour additives thatwasestablished under thetransitional provisions ofthecolour
additive amendments of1960 andtoestablish regulations prescribing conditions under
which lakes maybeprepared, labelled, andsafely usedinfood, drugs, andcosmetics.
./.G/TBT/Notif.96.65
Page2
8. Relevant documents: 61FR8372, 4March 1996; 21CFRParts 70,73,74,80,81,82,
101,178,201,and701. Willappear intheFederal Register when adopted.
9. Proposed dateofadoption: Tobedetermined
Proposed dateofentry intoforce:
10. Final dateforcomments: 3June1996
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: