Safety evaluation of certain food additives - ipcs inchem

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ALIPHATIC BRANCHED-CHAIN SATURATED AND UNSATURATED ALCOHOLS 293 daily per capita intake is the highest for prenyl acetate in the USA (160 μg). For the other flavouring agents, the estimated daily per capita intakes were in the range of 0.01–68 μg. The estimated daily per capita intake of each agent is reported in Table 1. Annual volumes of production of this group of flavouring agents are summarized in Table 2. 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 branchedchain saturated and unsaturated alcohols, aldehydes, acids and related esters has previously been described in the report of the sixty-first meeting (Annex 1, reference 166). Additional data on the compounds methyl 2-methyl-2-propenoate (No. 1834) and (E,Z)-phytol (No. 1832) have now been submitted and are in line with the information described in the report of the sixty-first 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 20 flavouring agents in this group of aliphatic branched-chain saturated and unsaturated alcohols, aldehydes, acids and related esters, the Committee assigned 19 of these flavouring agents (Nos 1815–1833) to structural class I and the remaining flavouring agent (No. 1834) to structural class II (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 19 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 19 flavouring agents raises no concern when they are used at their current estimated levels of intake. The estimated daily per capita intake of the flavouring agent in structural class II (i.e. methyl 2-methyl-2-propenoate, No. 1834; synonym methyl methacrylate) is below the threshold of concern (i.e. 540 μg/person per day for class II). However, the Committee noted that there is a structural similarity between this flavouring agent and ethyl methacrylate, a substance reported to be neurotoxic. These two chemicals share a common metabolite, methacrylic acid, which is unlikely to be a neurotoxicant because it is more polar and therefore less likely to cross the blood–brain barrier. Because methyl 2-methyl-2-propenoate was shown to have some neurotoxic properties in rats dosed at 500 mg/kg bw per day by gavage for 21 days, the Committee decided to apply the threshold of toxicological concern (TTC) for structural class III (i.e. 90 μg/person per day), which was derived using data that included neurotoxic compounds. Given that the estimated daily per capita intake of methyl 2-methyl-2-propenoate is even well below this lower threshold of concern, the Committee concluded that the safety of this flavouring agent raises no concern when it is used at its current estimated level of intake.
294 ALIPHATIC BRANCHED-CHAIN SATURATED AND UNSATURATED ALCOHOLS Table 1. Summary of the results of safety evaluations of aliphatic branched-chain saturated and unsaturated alcohols, aldehydes, acids and related esters used as flavouring agentsa,b,c Conclusion based on current estimated intake Comments on predicted metabolism Flavouring agent No. CAS No. and structure Step A3d Does the estimated intake exceed the threshold for human intake? Structural class I See note 1 No safety concern No Europe: ND USA: 0.7 Japan: ND Ethyl (E)-2-methyl-2-pentenoate 1815 1617-40-9 O O See note 1 No safety concern No Europe: ND USA: 24 Japan: ND 1816 97890-13-6 2-Methylbutyl 3-methyl-2butenoate O O See note 4 No safety concern No Europe: 0.01 USA: ND Japan: ND 1817 877-60-1 O H (±)(E,Z)-5-(2,2- Dimethylcyclopropyl)-3-methyl-2pentenal
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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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Page 249 and 250: 242 SULFITES: ASSESSMENT OF DIETARY
Page 268: SAFETY EVALUATIONS OF GROUPS OF REL
Page 271 and 272: 264 INTRODUCTION Figure 1. Procedur
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344 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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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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