FDA CFSANOFAS

Office of Food Additive Safety Food and Drug Administration 5100 Paint Branch Parkway College Park, Maryland 20740 301-436-1200 http://www.cfsan.fda.gov/guidance.html

U. S. Department of Health and Human Services Food and Drug Administration ( Center for Food Safety and Applied Nutrition) 2002 4 2007 12

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FCSFCN FAP 2002 2002 , 409 h6 21 CFR Parts 173-178 TOR 21 CFR 170.39 409 h 409 a3 409 h1 409 b 21 CFR 170.39 409(b) 123 4 Should sponsor

FDA 3480 Notification for New Use of a Food Contact Substance( FDA 3480 Notification for New Use of a Food Contact Substance) 0.5 ppb 21 CFR 170.39 21 CFR 170.39 (c)(1)(2) 21 CFR 170.39(c)(1) 21 CFR 170.39(c)(2) / 21 CFR 170.39

FDA 3480PDF Word-A C

1. 2. 3. 4. Chemical AbstractsIUPAC CASRegistry Number(2) Mw Mn 1 2 CAS 3 4 5 IR NMR 5. / Tg 2 .3

6.

FDA 3480-D.1 D.2

FDA / (3) FDA 3480-D.3 Technical effect

FDA 3480-F . 100% / 100% 1 mg/kg 50 /3000 ft2 50 mg/in2 1 x 10-6 g /g x 50 mg/in2 = 0.000050 mg/in2(4)

10 1 5 g/kg 100% 100% 10 mil 0.01 1. FDA 3480-F 1 1 SnyderBrederSnyder Breder1985 1 ..1.2 2 2 1 2 mg/in2 0.05 cm 20 mil 0.020 1 mil =

3 21 CFR 177 3 21 CFR 176.170(c) 1

IIIIV BVI 10% (a) B VII B

VI A 10 50% (b) VIC

IIIIV AVVII AIX HB307, Miglyol 812, (c)

a b

c HB307 C10C12 C14 Miglyol 812 10% 3%10%(5) 10%10% 10%15 % Miglyol 812240270C C8 (50-65%)C10 (30-45%) (6) HB 307C10C12C14 (7) ,

10 mL/in2 - 4 40C (104F) 10 20C (68F) 6 12 (8) 20C (68F) 10 PETPS 40C/10 40C/10 30 30 / , 22496 240 5 21 CFR 175.30021 CFR 176.17021 CFR 2. FDA 3480 F 1

TNEs NMRUV-AAS MSGC LCLOQ (9) -- / 120C / (mg/dm2)/mg/in2 0.01 / 1 / 10 3. FDA 3480 F 1

1 (LOQ)(LOD) (10) / 2 101520/1/

Y 3 4 5 1 2 100ab c: (b-a)/c x 100 240 D 2 3 3 / 0.5 1 2 LOD (a) 0.1 mg/kg(a)