Safety evaluation of certain food additives - ipcs inchem

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MISCELLANEOUS NITROGEN-CONTAINING SUBSTANCES (addendum) 559 Table 2 (contd) bw, body weight; ND, no intake data reported. a From European Flavour and Fragrance Association (2005), Gavin et al. (2007) and Japan Flavor & Fragrance Materials Association (2002). Total poundage values of
560 MISCELLANEOUS NITROGEN-CONTAINING SUBSTANCES (addendum) gavage (National Toxicology Program, 1982) is appropriate because they are all alkyl isothiocyanates and will be metabolized via similar metabolic pathways. The NOEL of 12 mg/kg bw per day for allyl isothiocyanate (No. 1560) provides margins of safety in the range of 5400–24 000 000 in relation to their estimated levels of intake. For 4-(methylthio)butyl isothiocyanate (No. 1892), 5-(methylthio)pentyl isothiocyanate (No. 1896) and 6-(methylthio)hexyl isothiocyanate (No. 1897), the NOEL of 30 mg/kg bw per day for the structurally related flavouring agent 3-(methylthio)propyl isothiocyanate (No. 1564) from an 84-day feeding study in rats (Harper et al., 1961) is appropriate because they are all linear mercaptoisothiocyanates and will be metabolized via similar metabolic pathways. The NOEL of 30 mg/kg bw per day for 3-(methylthio)propyl isothiocyanate (No. 1564) provides margins of safety in the range of 600 000–15 000 000 in relation to their estimated levels of intake. Table 1 summarizes the evaluations of the 14 miscellaneous nitrogencontaining substances in this group. 1.5 Consideration of combined intakes from use as flavouring agents In the unlikely event that the flavouring agents in a homologous series of linear saturated isothiocyanates in structural classes II and III, of which the highest intakes correspond to Nos 1561, 1884, 1885, 1891 and 1895 in Europe and Japan, were to be consumed concurrently on a daily basis, the estimated combined intakes of 2 and 0.89 μg/person per day in Europe and Japan, respectively, would not exceed the thresholds of concern (i.e. 540 μg/person per day for class II and 90 μg/person per day for class III). In the unlikely event that the flavouring agents in a homologous series of branched-chain saturated isothiocyanates in structural class II, of which the highest intakes correspond to Nos 1886, 1887, 1888 and 1890 in Japan, were to be consumed concurrently on a daily basis, the estimated combined intake of 16 μg/ person per day in Japan would not exceed the threshold of concern (i.e. 540 μg/ person per day for class II). In the unlikely event that the flavouring agents in a homologous series of linear saturated mercapto-isothiocyanates in structural class II, of which the highest intakes correspond to Nos 1564, 1892, 1896 and 1897 in Europe, the USA and Japan, were to be consumed concurrently on a daily basis, the estimated combined intakes of 13, 52 and 3.2 μg/person per day in Europe, the USA and Japan, respectively, would not exceed the threshold of concern (i.e. 540 μg/person per day for class II). In the unlikely event that the flavouring agents in a homologous series of linear unsaturated isothiocyanates in structural class II, of which the highest intakes correspond to Nos 1560, 1889, 1893 and 1894 in Europe, the USA and Japan, were to be consumed concurrently on a daily basis, the estimated combined intakes would be 1502, 133 and 222 μg/person per day in Europe, the USA and Japan, respectively. The estimated combined intake would exceed the threshold of concern in Europe (i.e. 540 μg/person per day for class II). The intake in Europe, however, is due mainly to allyl isothiocyanate (No. 1560). Allyl isothiocyanate has a NOEL of
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WHO FOOD ADDITIVES SERIES: 60 Safet
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CONTENTS Preface ..................
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PREFACE The monographs contained in
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ASPARAGINASE FROM ASPERGILLUS NIGER
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16 CALCIUM LIGNOSULFONATE (40-65) 1
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18 CALCIUM LIGNOSULFONATE (40-65) ~
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20 CALCIUM LIGNOSULFONATE (40-65) A
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22 CALCIUM LIGNOSULFONATE (40-65) c
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24 CALCIUM LIGNOSULFONATE (40-65) T
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28 CALCIUM LIGNOSULFONATE (40-65) i
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ETHYL LAUROYL ARGINATE First draft
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ETHYL LAUROYL ARGINATE 41 and Devel
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ETHYL LAUROYL ARGINATE 43 lauroyl a
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ETHYL LAUROYL ARGINATE 45 arginine.
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ETHYL LAUROYL ARGINATE 47 resulting
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ETHYL LAUROYL ARGINATE 49 Table 4.
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ETHYL LAUROYL ARGINATE 51 weight ch
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ETHYL LAUROYL ARGINATE 53 stomach l
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ETHYL LAUROYL ARGINATE 55 fibrosis
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ETHYL LAUROYL ARGINATE 57 Table 5 (
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ETHYL LAUROYL ARGINATE 59 first 4 d
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ETHYL LAUROYL ARGINATE 61 The gener
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ETHYL LAUROYL ARGINATE 63 treatment
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ETHYL LAUROYL ARGINATE 65 gestation
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ETHYL LAUROYL ARGINATE 67 Body weig
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ETHYL LAUROYL ARGINATE 69 Table 6.
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ETHYL LAUROYL ARGINATE 77 About 99%
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ETHYL LAUROYL ARGINATE 79 concentra
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ETHYL LAUROYL ARGINATE 81 theoretic
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ETHYL LAUROYL ARGINATE 83 Huntingdo
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PAPRIKA EXTRACT First draft prepare
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PAPRIKA EXTRACT 87 of capsanthin ra
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PAPRIKA EXTRACT 89 biochemical para
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PAPRIKA EXTRACT 91 Table 1. Sales o
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PAPRIKA EXTRACT 93 Table 2. Estimat
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PAPRIKA EXTRACT 95 The European Sci
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PAPRIKA EXTRACT 97 The potential di
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PAPRIKA EXTRACT 99 Hornero-Mendez,
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PAPRIKA EXTRACT 101 Appendix 1. Res
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PAPRIKA EXTRACT 103 Appendix 1. (co
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PAPRIKA EXTRACT 105 Appendix 1. (co
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108 PHOSPHOLIPASE C EXPRESSED IN PI
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PHYTOSTEROLS, PHYTOSTANOLS AND THEI
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166 POLYDIMETHYLSILOXANE (addendum)
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STEVIOL GLYCOSIDES (addendum) First
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STEVIOL GLYCOSIDES (addendum) 185 r
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STEVIOL GLYCOSIDES (addendum) 187 c
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STEVIOL GLYCOSIDES (addendum) 189 a
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STEVIOL GLYCOSIDES (addendum) 191 N
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STEVIOL GLYCOSIDES (addendum) 193 2
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STEVIOL GLYCOSIDES (addendum) 195 T
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STEVIOL GLYCOSIDES (addendum) 197 a
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STEVIOL GLYCOSIDES (addendum) 199 r
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STEVIOL GLYCOSIDES (addendum) 201 l
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STEVIOL GLYCOSIDES (addendum) 203 g
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STEVIOL GLYCOSIDES (addendum) 209 t
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STEVIOL GLYCOSIDES (addendum) 211 t
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STEVIOL GLYCOSIDES (addendum) 213 s
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STEVIOL GLYCOSIDES (addendum) 215 C
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STEVIOL GLYCOSIDES (addendum) 217 L
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STEVIOL GLYCOSIDES (addendum) 219 W
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222 SULFITES: ASSESSMENT OF DIETARY
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SAFETY EVALUATIONS OF GROUPS OF REL
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264 INTRODUCTION Figure 1. Procedur
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DIETARY EXPOSURE ASSESSMENT OF FLAV
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292 ALIPHATIC BRANCHED-CHAIN SATURA
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332 ALIPHATIC LINEAR ,-UNSATURATED
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ALKOXY-SUBSTITUTED ALLYLBENZENES PR
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ALKOXY-SUBSTITUTED ALLYLBENZENES 35
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FURAN-SUBSTITUTED ALIPHATIC HYDROCA
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Page 516 and 517: FURAN-SUBSTITUTED ALIPHATIC HYDROCA
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Page 587 and 588: 580 SUBSTANCES STRUCTURALLY RELATED
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610 ANNEX 2 ECG electrocardiogram E
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612 ANNEX 2 SI stimulation index SU
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614 ANNEX 3 Ms J. Baines, Food Stan
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ANNEX 4 ACCEPTABLE DAILY INTAKES, O
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ANNEX 4 619 Food additive Specifica
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ANNEX 4 621 3. FLAVOURING AGENTS 3.
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ANNEX 4 623 Flavouring agent No. Sp
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ANNEX 4 625 Flavouring agent JECFA
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ANNEX 4 627 Actual production volum
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ANNEX 4 629 Flavouring agent No. Sp
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ANNEX 5 SUMMARY OF THE SAFETY EVALU
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ANNEX 5 633 Secondary components Co
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