RESTRICTED
WORLD TRADE G/SPS/N/USA/12
11August 1995
ORGANIZATION
(95-2380)
Committee onSanitary andPhytosanitary Measures
NOTIFICATION
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocal government involved:
2. Agency responsible: Food andDrug Administration (12)
3. Products covered (tariff item number(s) asspecified innational schedules deposited with
theWTO. ICSnumbers may beprovided inaddition, where applicable): Food color
additive
4. Title andnumber ofpages ofthenotified document: Labeling declaration forFD&C
Yellow No.6 andFD&C Yellow No.5; amendment ofstandard ofidentity forcheese
product (6pages)
5. Description ofcontent: TheFood andDrug Administration (FDA) isproposing to
require declaration ofFD&C Yellow No.6 intheingredient listonthelabels ofbutter,
cheese, andicecream, andonthelabels ofdrugproducts administered tomucous
membranes, when thecolor additive isusedinthese products. Thisproposed action
willnothaveanyeffect onthepermanent listing ofFD&C Yellow No.6 .Also, FDA
isproposing toamend thestandard ofidentity forcold-pack andclubcheese tomake it
conform totherequirements forlisting FD&C Yellow No.5 andFD&C Yellow No.6
onthelabels offoodthatcontains these additives. Inaddition, FDA isproposing to
amend theregulation forFD&C Yellow No.5 toprovide fortheuseofabbreviated
names forthiscolor additive.
6. Objective andrationale: Health; thisproposal isbased onreports intheliterature of
allergic-type reactions toFD&C Yellow No.6
7. Aninternational standard, guideline orrecommendation does notexist [X].
Ifaninternational standard, guideline orrecommendation exists, whenever possible,
identify deviations:
8. Relevant documents: 60FR37611, 21July1995; 21CFR Part74,133and201.
Willappear intheFederal Register when adopted.
9. Proposed date ofadoption andentry intoforce: Theadministration isproposing thatany
finalruletheymayissue based upon thisproposal become effective 2years afterits
publication inthefederal register
10. Final date forcomments: 4October 1995
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: