食品添加物と国際調和 - nihs.go.jp

1 1 2016 10 7 32 DFA Division of Food Additives NIHS National Institute of Health Sciences 2 DFA Division of Food Additives NIHS National Institute of Health Sciences 3 Joint FAO/WHO Codex Alimentarius Commission, CAC WTO (SPS) SPS TBT 10 12 1 6 4 Codex Committee on Food Additives CCFA 1. * 3. 5.

2 6. 5 CCFA *JECFA FAO/WHO FAO WHO CCFA 3 48 2016 3 14 ( ) 18 ( ) 48 EU 31 CCFA (GSFA) GSFA (INS)* JECFA* 6 CCFA *INS CCFA) ADI JECFA JECFA FAO/WHO JECFA CODEX JECFA JECFA ADI* INS 8 GSFA *ADI Table 1 Table 2 1 Table 3 JECFA ADI ADI Table 3 Table 3 GSFA GSFA GSFA JECFA ADI* INS 9 GSFA *ADI

3 Table 1 Table 2 1 Table 3 JECFA ADI ADI Table 3 Table 3 GSFA GSFA GSFA Codex General Standard for Food Additives (GSFA) Online Database 10 CCFA 80 2015 JECFA JECFA ADI GSFA 600 mg/kg 250 mg/kg( 49 CCFA 11 ( ( * GRAS Generally Recognized As Safe 2002 2002 7 JECFA)))

4 46 41 1 4 54 12 0501001502002503003504004505001945195519 651975198519952005201513 23 31 41 51 61 8 18 28 2016 10 454 28 9 26 14 g /100kcal Aspergillus niger ASP-72 A. oryzae NZYM-SP 28 10 6 HEDP* 15 HEDP *1- -1,1- 16 17 21 11 1 4 1 11 1 34 370 2 18 4 1 19

5 19 9 2010 7 2014 1 2016 6 2016 8 WTO 2017 20 1. 4 5 2. 3. 21 As2O3 As JECFA 22 365 ( 382 ) 8 130 9 217 165 13 62 25 - L- 25 ( ) 23 9 9 ( 62 + 25 )

6 87 14 (2002 ) 2002 5 31 15-30 2002 6 11 * FAO/WHO JECFA * EU 54 18 1.. 2.. selflimiting 3.. 10 mg/kg 1 mg/kg 25 26 JECFA A3. TTC ? A4. ? B4. NOEL ? A5. NOEL ? B5. g/day ? YES NO B3. TTC ? NOEL NOAEL 2. ? 1. TTC a.

7 Cramer I II III I II III b. TTC TTC Class I 1800 g/ / Class II 540 g/ / Class III 90 g/ / MSDI Maximized Survey-Derived Intake JECFA 29 NOAEL* 90 NOAEL 1000 54 JECFA *NOAEL No observed adverse effect level in vivo in vitro

8 1. I II III 2. A3. B3. A4. B4. NOAEL NOAEL A5. NOAEL NOAEL NOAEL 1,000 MSDI Maximized Survey-Derived Intake PCTT Per Capita Intake Times Ten JECFA EFSA* SPET Single Portion Exposure Technique JECFA MSDI 1 10 10% 10% MSDI = 10 365 MSDI 10% JECFA MSDI SPET (JECFA 67 (2006 ) 69 (2008 ) WHO Technical Report Series 940 p3-6, 947 p6-19, 952 p5-15 SPET SPET = * Portion Size GSFA FDA (b))

9 76 1 67 JECFA TRS940 Annex 4) (Portion Size x ) * 1 30 0

10 40