Safety evaluation of certain food additives - ipcs inchem

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DIETARY EXPOSURE ASSESSMENT OF FLAVOURING AGENTS 269 • evaluating the possible impact of using both the MSDI and SPET dietary exposure estimates in the Procedure for different flavour groups. 2. INVESTIGATION TO DEVELOP CRITERIA FOR THE IDENTIFICATION OF FLAVOURING AGENTS REQUIRING ADDITIONAL CONSIDERATION 2.1 Analysis of data for 57 flavouring agents considered at the sixty-eighth meeting At its sixty-eighth meeting, the Committee calculated SPET estimates for 57 flavouring agents based on use levels provided by the International Organization of the Flavour Industry (IOFI), 1 44 with low production volumes (
270 DIETARY EXPOSURE ASSESSMENT OF FLAVOURING AGENTS flavour groups, a similar finding to that for the 57 flavouring agents considered at the sixty-eighth meeting. 2.3 Analysis of a larger data set of flavouring agents Because the analyses of flavouring agents considered at the sixty-eighth meeting and the present meeting were inconclusive, the Committee collected use level data from other sources to determine if suitable criteria for predicting when the MSDI might underestimate dietary exposure could be developed based on a larger group of flavouring agents. Additionally, an analysis was carried out to determine the difference between the SPET estimates and MSDI in relation to the relevant TTCs. Overall, SPET estimates for 549 flavouring agents were calculated, based on use levels derived from three main data sets: • for 225 flavouring agents: recent and refined 1 use level data provided by IOFI to the Committee or to the European Commission (Directorate General for Health and Consumer Affairs [DG SANCO]) in 2007 and 2008; • for 198 flavouring agents: refined 1 use level data collected in an industry survey (National Academy of Sciences/National Research Council [NAS/NRC]) conducted in the USA in 1977 2 ; • for 268 flavouring agents: use levels proposed by industry for flavouring agents registered as Flavor and Extract Manufacturers Association (FEMA) Generally Recognized as Safe (GRAS) 3 and published between 1965 and 2007. Some flavouring agents were assessed using more than one source of use levels, resulting in a total of 691 SPET estimates. 2.3.1 IOFI use level data, 2007–2008 MSDI and SPET estimates were compared for 225 flavouring agents with updated and refined use level data from IOFI; for 128 flavouring agents, data had been provided to DG SANCO (International Organization of the Flavour Industry/ Directorate General for Health and Consumer Affairs, 2008), for 40 flavouring agents, data were provided to the present meeting of the Committee (International Organization of the Flavour Industry/Joint FAO/WHO Expert Committee on Food Additives, 2008), and for 57 flavouring agents, data were provided to the sixty-eighth meeting of the Committee (International Organization of the Flavour Industry/Joint FAO/WHO Expert Committee on Food Additives, 2007) (see Figures 1a, 1b and 1 In this context, “refined” means that the information is derived from typical use levels in specific foods or food types, rather than broad food categories (e.g. “fruit-flavoured yogurt” as opposed to “dairy products”). 2 The use level data from this survey are those used in the paper by Young et al. (2006). 3 GRAS is a regulatory concept specific to the United States Federal Food, Drug, and Cosmetic Act. Any substance added to food requires a food additive regulation for its use, unless its intended use is GRAS. Food ingredients whose use is GRAS are not required by law to receive Food and Drug Administration approval before marketing. FEMA has been publishing lists of flavouring substances, and associated use levels at or below which they have deemed their use to be GRAS, for over 30 years.
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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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Page 229 and 230: 222 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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Page 299 and 300: 292 ALIPHATIC BRANCHED-CHAIN SATURA
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320 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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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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