RESTRICTED
WORLD TRADE G/TBT/Notif.95.85
28March 1995
ORGANIZATION(95-0717)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: CANADA
Ifapplicable, name oflocal government involved (Articles 3.2and7.2):
2. Agency responsible: Department ofNational Health andWelfare
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): Colouring agents
5. Title andnumber ofpages ofthenotified document: Proposed Amendment totheFood andDrug
Regulations (pages 708-711)
6. Description ofcontent:
ThisAmendment addsanthocyanin pigments derived from thejuice expressed from fresh
edible fruitorvegetables toparagraph C.01.040.2(3)(a) tothelistofcolouring agents permitted
indrugs forinternal andexternal use. Thisaddition isconsistent withPartB,Division 16,Table
IIIoftheFood andDrug Regulations which includes anthocyanins asfood additives thatmaybe
used ascolouring agents. Additionally, fruitandvegetable juices arealsopermitted foruseas
food colorants intheUnited States.
Inview ofthese permitted uses, andthefactthatingestion ofthecolouring agent from
drugs would benegligible incomparison tofoods, theWorking Party onDrugs andCosmetic
Colours hasrecommended thatanthocyanin pigments derived from juice expressed from fresh
edible fruit orvegetables beadded tothelistofpermitted colorants indrugs forinternal or
external use.
This amendment also adds thefollowing colorants tothelistofcolouring agents
permitted indrugs forexternal useonly:
Annatto (C.I. No.75120)
Bismuth Oxychloride (C.I. No.77163)
Chromium Hydroxide Green (Pigment Green 18(C.I. No.77289))
Dibromofluorescein (Solvent Red72(C.I. No.45370:1); Orange No.5
(D&COrange No.5))
Guanine (C.I. No.75170)
Manganese Violet (C.I. No.77742)
Mica (C.I. No.77019)
Zinc Oxide (C.I. No.77947)
./.G/TBT/Notif.95.85
Page2
7. Objective andrationale: Protection ofhealth
8. Relevant documents: Canada Gazette, PartI,11March 1995
9. Proposed dateofadoption andentry intoforce: Notstated
10. Final dateforcomments: 10April 1995
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother body: