RESTRICTED
WORLD TRADE G/SPS/N/USA/24
18March 1996
ORGANIZATION
(96-0955)
Committee onSanitary andPhytosanitary Measures
NOTIFICATION
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocal government involved:
2. Agency responsible: Food andDrug Administration (24)
3. Products covered (tariff item number(s) asspecified innational schedules deposited with
theWTO. ICSnumbers may beprovided inaddition, where applicable): Colour
additives
4. Title andnumber ofpages ofthenotified document: Permanent Listing ofColour
Additive Lakes (46pages)
5. Description ofcontent: TheFood andDrug Administration isproposing tolistcertain
colour additive lakes permanently assuitable andsafeforuseinfood(notified under
theSPSAgreement), drugs, andcosmetics (notified under theTBTAgreement). The
Agency isproposing topermit theuseofmore thanonestraight colour inthe
preparation ofalake, tomodify thenomenclature forlakes, andsimplify thebatch
certification procedure forlakes. Aspartofthese actions, theAgency isproposing to
amend itsregulations torequire thepreparation oflakes from certified batches of
straight colour; toprovide simplified nomenclature fordeclaring colour additives,
including lakes, oncosmetic products; torequire declaration ofFD&C Yellow No.5
andFD&C Yellow No.6 onallfoods andsome drugproducts containing lakes ofthese
straight colours; andtoterminate thelisting ofcertain straight colours ascomponents
oflakes fordrugs andcosmetic useandthelisting ofcalcium saltsascomponents of
lakes forfooduse.
6. Objective andrationale: Thisproposed ruleisintended tocomplete theAgency 's
disposition oftheprovisions listofcolour additives thatwasestablished under the
transitional provisions ofthecolour additive amendment of1960 andtoestablish
regulations prescribing conditions under which lakes maybeprepared, labelled, and
safely usedinfood, drugs andcosmetics.
./.G/SPS/N/USA/24
Page2
7. Aninternational standard, guideline orrecommendation does notexist [X].
Ifaninternational standard, guideline orrecommendation exists, whenever possible,
identify deviations:
8. Relevant documents: 61FR8372, 4March 1996; 21CFR Parts 70,73,74,80,81,
82,101,178,201and701. Thisproposal wasalsonotified under theAgreement on
Technical Barriers toTrade (TBT).
9. Proposed date ofadoption andentry intoforce: Theeffective datewillbegiven upon
publication ofthefinalroleintheFederal Register.
10. Final date forcomments: Written comments by3June1996, except thatcomments
regarding information collection should besubmitted notlaterthan3May1996.
11. Texts available from: National enquiry point []oraddress andtelefax number ofother
body:
United States SPSEnquiry Point
USDA/FAS/OPSTS
Attn: Carolyn F.Wilson
Room 5545 South Agriculture Building
14thandIndependence
Washington, D.C. 20250
Phone: (202) 720-2239
Fax: (202) 690-0677