Safety evaluation of certain food additives - ipcs inchem

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ALIPHATIC LINEAR ,-UNSATURATED ALDEHYDES 343 Table 2 (contd) Flavouring agent (No.) Most recent annual volume (kg) a Methyl trans-2octenoate (1811) Intake b Annual μg/day μg/kg bw per day volume from natural occurrence in foods (kg) c Europe 2 0.2 0.003 USA 3 0.3 0.01 + NA Japan Ethyl trans-2octenoate (1812) 0.1 0.03 0.0004 Europe 93 10 0.2 USA 0.7 0.08 0.001 2 3 Japan (E,Z)-Methyl 2nonenoate (1813) 0.1 0.03 0.0004 Europe 68 7 0.1 USA 1159 142 2 NA Japan Ethyl trans-2decenoate (1814) 3 1 0.01 Europe 53 6 0.1 USA 0.1 0.02 0.0003 + NA Japan Total 98 26 0.4 Europe 532 USA 1541 Japan 682 Consumption ratio d bw, body weight ; ND, no intake data reported; NA, not applicable; +, reported to occur naturally in foods (Nijssen et al., 2007), but no quantitative data; , not reported to occur naturally in foods. a From European Flavour and Fragrance Association (2005), Gavin et al. (2007) and Japan Flavor & Fragrance Materials Association (2002). Total poundage values of
344 ALIPHATIC LINEAR ,-UNSATURATED ALDEHYDES Table 2 (contd) b Intake (μg/person per day) calculated as follows: [(annual volume, kg) × (1 × 10 9 μg/kg)/ (population × survey correction factor × 365 days)], where population (10%, “consumers only”) = 32 × 10 6 for Europe, 28 × 10 6 for the USA and 13 × 10 6 for Japan; and where survey correction factor = 0.8 for the surveys by the USA, Europe and Japan, representing the assumption that only 80% of the annual flavour volume was reported in the poundage surveys (Japan Flavor & Fragrance Materials Association, 2002; European Flavour and Fragrance Association, 2005; Gavin et al., 2007). Intake (μg/kg bw per day) calculated as follows: (μg/person per day)/body weight, where body weight = 60 kg. Slight variations may occur from rounding. c Quantitative data for the USA reported by Stofberg & Grundschober (1987). d The consumption ratio is calculated as follows: (annual consumption from food, kg)/(most recent reported volume as a flavouring substance, kg). e Annual consumption for the USA was calculated as described by Stofberg & Grundschober (1987), based on quantitative data reported in Nijssen et al. (2007). 1.3 Absorption, distribution, metabolism and elimination Information on the hydrolysis, absorption, distribution, metabolism and elimination of flavouring agents belonging to the group of aliphatic linear ,-unsaturated aldehydes, acids and related alcohols, acetals and esters has previously been described in the report of the sixty-third meeting (Annex 1, reference 173). No relevant additional data have been reported since that meeting. 1.4 Application of the Procedure for the Safety Evaluation of Flavouring Agents Step A1. In applying the Procedure for the Safety Evaluation of Flavouring Agents to the 22 flavouring agents in this group of aliphatic linear ,-unsaturated aldehydes, acids and related alcohols, acetals and esters, the Committee assigned all 22 (Nos 1793–1814) to structural class I (Cramer et al., 1978). Step A2. All flavouring agents in this group are expected to be metabolized to innocuous products. The evaluation of all flavouring agents in this group therefore proceeded via the A-side of the Procedure. Step A3. The estimated daily per capita intakes of all 22 flavouring agents in structural class I are below the threshold of concern (i.e. 1800 μg/person per day for class I). According to the Procedure, the safety of these 22 flavouring agents raises no concern when they are used at their current estimated levels of intake. Table 1 summarizes the evaluations of the 22 aliphatic linear ,unsaturated aldehydes, acids and related alcohols, acetals and esters (Nos 1793– 1814) in this group. 1.5 Consideration of combined intakes from use as flavouring agents The flavouring agents in this group of aliphatic linear ,-unsaturated aldehydes, acids and related alcohols, acetals and esters are predicted to be metabolized by hydrolysis and/or oxidative metabolism, followed by complete
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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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Page 299 and 300: 292 ALIPHATIC BRANCHED-CHAIN SATURA
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ALKOXY-SUBSTITUTED ALLYLBENZENES 39
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FURAN-SUBSTITUTED ALIPHATIC HYDROCA
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HYDROXY- AND ALKOXY-SUBSTITUTED BEN
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MISCELLANEOUS NITROGEN-CONTAINING S
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580 SUBSTANCES STRUCTURALLY RELATED
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ANNEXES
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598 ANNEX 1 10. Specifications for
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600 ANNEX 1 No. 54, 1974; WHO Techn
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602 ANNEX 1 70. Evaluation of certa
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604 ANNEX 1 108. Toxicological eval
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606 ANNEX 1 148. Residues of some v
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608 ANNEX 1 188. Safety evaluation
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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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