, Positive List 2004. 10. 28 120Tel : 033-640-233E-mail : leekt@kangnung.ac.kr

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FCS Food-Contact Substances(FCS) = Indirective Food Additives(FFDCA201(S))

1938 Federal Food, Drugs, and Cosmetics Act(FFDCA)

1958 FFDCA

: 21 CFR(Code of Federal Regulation) Part 174 178

1997 Food and Drug Administration Modernization Act(FDAMA) Food-Contact Notification(FCN)

2000 1 18 FCN

FCS CFSAN(Center for Food Safety and Applied Nutrition)FCS PL , , FCS (FDA)

FCS Food-Contact Petition (FCP)1958 CEDI(*) 1 ppm Food-Contact Notofocation (FCN)2000 1 18 CEDI 1 ppm * CEDI : (Cumulative Estimated Daily Intake)

FAP FCS 21 CFR : 21 CFR 171.1 FD&C Act Section 409(b)(2) : : : : 24

FCN FCS : , : http://www.cfsan.fda.gov/~dms/opa2pmna.html : http://www.cfsan.fda.gov/~dms/opa2pmnc.html : http://www.cfsan.fda.gov/~dms/opa2pmnt.html 120

FCN http://www.cfsan.fda.gov/~dms/opa-fcn.html , (identity), ( , ), , 2000 3 1 2004 10 444

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Chemical IdentityCAS registry , (, IUPAC), , , , , , , , , CEDI

Inventory of Effective Premarket Notifications for Food Contact Substance

FCNNo.FCSNotifierIntended useLimitations/Specifi-cationEffective DateEnviron. ReviewManufac. of the FCS4Isophthalic acid or dimethyl isophthalateBP AmocoAs a monomer in the maufacture of ethylene terephthalate- copolymers Limitations/Specifi-cationMar 15, 2000EA/FONSI

FCNNo.Intended UseLimitation / Specifications4As a monomer in the manufacture of ethylene terephthalate-isophthalate copolymers.The finished copolymers must contain from 3 to 17Weight percent ethylene isophthalate units. The finishedCopolymers must also meet specifications in 21 CFR177.1630(f) (j) appropriate to their intended use.

FCS FAP FCN Ramsey Proposal (1969) 20ppb Threshold-of-Regulation (TOR) (1) 0.5 ppb(w/w) (2) 1% (3) http://www.cfsan.fda.gov/~dms/opa-torx.html GRAS (Generally Recognized As Safe) Prior sanctioned

21 CFR PL Part 174Part 175Part 176Part 177Part 178Part 179 , Subpart 4.

PL (21 CFR, Part 177)

PL (21 CFR, Part 178) - - 2 - - / 3 - - 41 Subpart BSubpart CSubpart D* 2

EC directive (), Framework directive 89/109/EEC

, Framework directive Specific directives

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PL directive EC directive 90/128/EEC - PL

92/39/EEC, 93/9/EEC, 95/3/EC, 96/11/EC, 1999/91/EC, 2001/62/EC, 2002/17/EC, 2002/72/EC 2004/19/EC 2004 3 1 ) 9

Specific Directive (89/109/EEC I)

(elastomers)

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EFSA European Food Safety Authority(EFSA)

2002 1 28

FCS 2003 4 29 EFSA Scientific Panel on Food Additives, Flavorings, Processing Aids and Materials in Contact with Food(AFC) ad hoc expert group( )

6

: Note for Guidance

Synoptic Document

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Synoptic Document SCF(*) : 2,000 - - PL - * SCF : Scientific Committee for Food

2004/19/EC Directive

2004/19/EC Directive

Section ASection BSection ASection B 31511385130SMLSML(T)103-70130(mg/kg)ND~30-ND~480.02~45QM, QM(T)3221-(mg/kg)ND~55--QMA,QMA(T)24-4-(mg/6dm2)ND~5-0.05~4.8-

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01PolyethylenePE02PolypropylenePP03PolymethylpentenePMP4--104-1Polybutene-1PB-1-105ButadieneBDR1,4-06 Ethylenetetracyclododecene copolymerE/TD11PolystyrenePS12Acrylonitrile styreneAS, 13Acrylonitrilebutadiene styreneABS, , 14Polyphenylene etherPPE2,6-, 15PolyacrylonitrilePAN16Fluoro resinFR 17PolymethaacrylostyreneMS styrene21Polymethylmethaacrylate resinPMMA22NylonPA, , 23PolyethyleneterephthalatePET,

PL II

24PolycarbonatePC2,2-(4-), , 25PolyvinylalcoholPVA()26PolyacetalPOM27PolybutylenterephthalatePBT1,4- 28PolyyarylsulfonPASF4,4--29PolyarylatePAR, 2,2-(4-)30Hydroxybutyl polyesterHBP, , 40PolyetherimidePEI4,4-[(p-)]2, 41Polycyclohexylenedimethylen-eterephthalatePCT1,4- 42PolyethylenenaphthalatePEN2,6- 43PolyestercarbonatePPC, , 2,2-(4-), 44PolylactidePLA

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1. ()(1) ( 52) Positive list()(2) ( 370)

2. ( 370 ) Positive list ( 9 )

1. (FFDCA)(1) FAP (, GRAS , CFR ) End test Positive list ( , )

(2) FCN FDA homepage ( )1. (EC directive ) Positive list( )

2. (1) CE()(2) BgVV()(3) BGF() Positive list( )

PL 1. 52 2. 1. CFR Part 177 a. Part 178 b. Part 172, 173 c. Part 181 d. Part 182, 184, 186 GRAS 2. FCN , EC Directive Annex 1 Monomer Annex 2 Annex 3

EU EC . SynopticdocumentFDAEU

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