Safety evaluation of certain food additives - ipcs inchem

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PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS First draft prepared by Dr K. Schneider, 1 Dr M. DiNovi, 2 Dr J. Baines 3 and Dr J. Schlatter 4 1 Research and Advisory Institute for Hazardous Substances (FoBiG), Freiburg, Germany 2 Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD, United States of America (USA) 3 Food Standards Australia New Zealand, Canberra, ACT, Australia 4 Nutritional and Toxicological Risks Section, Federal Office of Public Health, Zurich, Switzerland Explanation ................................................................................ Chemical and technical considerations ............................... Biological data............................................................................ Biochemical aspects ........................................................... Absorption, distribution and excretion............................ Rats ........................................................................ Humans .................................................................. Biotransformation .......................................................... Effects on enzymes and other biochemical parameters in vitro ................................................... Toxicological studies: Phytosterol esters ............................ Short-term studies of toxicity ........................................ Rats ........................................................................ Genotoxicity................................................................... Reproductive toxicity ..................................................... Rats ........................................................................ Minks ...................................................................... Special studies on estrogenic activity ........................... Toxicological studies: Phytostanol–phytosterol mixtures........................................................................... Short-term studies of toxicity ........................................ Genotoxicity................................................................... Reproductive toxicity ..................................................... Mice ........................................................................ Special studies on estrogenic activity ........................... Toxicological studies: Phytostanol esters............................ Acute toxicity ................................................................. Acute oral and dermal toxicity ................................ Skin irritation and corrosion..................................... Eye irritation ........................................................... Skin sensitization .................................................... Short-term studies of toxicity ........................................ Rats ........................................................................ Genotoxicity................................................................... - 117 - 118 119 120 120 120 121 121 122 122 123 123 123 125 127 127 128 128 129 129 130 131 131 132 132 132 132 133 133 133 133 133 135
118 PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS Reproductive toxicity ..................................................... Rats ........................................................................ Special studies on estrogenic activity ........................... Observations in humans ..................................................... Lipid-lowering effect....................................................... Effects on vitamins and carotenoids ............................. Association with atherosclerosis.................................... Other effects.................................................................. Dietary exposure ....................................................................... Introduction.......................................................................... Use in foods......................................................................... International estimates of dietary exposure......................... National estimates of dietary exposure ............................... Background exposure from food.................................... “Directed” exposure from food ...................................... Potential overconsumption of phytosterols/ phytostanols.............................................................. Summary ............................................................................. Comments ................................................................................. Toxicological data ............................................................... Short-term studies of toxicity with phytosterol ester mixtures .................................................................... Short-term studies of toxicity with mixtures of phytosterols and phytostanols................................... Short-term studies of toxicity with phytostanol ester mixtures .................................................................... Studies of reproductive toxicity with phytosterol ester mixtures .................................................................... Studies of reproductive toxicity with phytostanol ester mixtures .................................................................... Genotoxicity................................................................... Estrogenicity.................................................................. Human studies..................................................................... Assessment of dietary exposure ......................................... Evaluation .................................................................................. References ................................................................................ 1. EXPLANATION 136 136 138 139 139 139 145 147 148 148 148 149 149 149 149 150 151 151 151 Phytosterols, phytostanols and their esters were evaluated by the Committee at its present meeting at the request of the Codex Committee on Food Additives at its Thirty-ninth Session (Codex Alimentarius Commission, 2007a). Phytosterols and phytostanols are substances that are similar in structure to cholesterol and are formed exclusively in plants. They are added to food for their blood cholesterol–lowering properties. Phytosterols, phytostanols and their esters have not been evaluated previously by the Committee. In 2000 (Scientific Committee on Food, 2000) and again in 2002 (Scientific Committee on Food, 2002), the former Scientific Committee on Food (SCF) of the European Commission assessed the safety of phytosterols in food. The United States Food and Drug Administration (USFDA) 151 152 152 153 153 154 154 154 155 156 157
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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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Page 96 and 97: PAPRIKA EXTRACT 89 biochemical para
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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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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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