Safety evaluation of certain food additives - ipcs inchem

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ALIPHATIC BRANCHED-CHAIN SATURATED AND UNSATURATED ALCOHOLS, ALDEHYDES, ACIDS AND RELATED ESTERS (addendum) First draft prepared by Mrs M.E.J. Pronk 1 and Professor J.R. Bend 2 1 Centre for Substances and Integrated Risk Assessment, National Institute for Public Health and the Environment (RIVM), Bilthoven, Netherlands 2 Department of Pathology, Siebens-Drake Medical Research Institute, Schulich School of Medicine & Dentistry, University of Western Ontario, London, Ontario, Canada Evaluation .................................................................................. Introduction ......................................................................... Assessment of dietary exposure ......................................... Absorption, distribution, metabolism and elimination .......... Application of the Procedure for the Safety Evaluation of Flavouring Agents ....................................................... Consideration of combined intakes from use as flavouring agents ............................................................ Consideration of secondary components ............................ Conclusion .......................................................................... Relevant background information .............................................. Explanation ......................................................................... Additional considerations on intake .................................... Biological data ..................................................................... Biochemical data .......................................................... Hydrolysis, absorption, distribution and excretion ............................................................ Metabolism .............................................................. Toxicological studies ..................................................... Acute toxicity ........................................................... Short-term and long-term studies of toxicity ........... Genotoxicity ............................................................ References ................................................................................ 1. EVALUATION 291 291 292 293 1.1 Introduction The Committee evaluated a group of flavouring agents consisting of 20 aliphatic branched-chain saturated and unsaturated alcohols, aldehydes, acids and related esters. This group included 2 alcohols (Nos 1830 and 1832), 2 aldehydes (Nos 1817 and 1819), 2 acids (Nos 1818 and 1825) and 14 related esters (Nos 1815, 1816, 1820–1824, 1826–1829, 1831, 1833 and 1834). The evaluations were conducted according to the Procedure for the Safety Evaluation of - 291 - 293 305 306 306 306 306 306 307 307 307 308 311 311 313 317 325
292 ALIPHATIC BRANCHED-CHAIN SATURATED AND UNSATURATED ALCOHOLS Flavouring Agents (see Figure 1, Introduction) (Annex 1, reference 131). None of these flavouring agents has previously been evaluated by the Committee. The Committee previously evaluated 32 other members of this group of flavouring agents at its sixty-first meeting (Annex 1, reference 166). All 32 flavouring agents in that group were concluded to be of no safety concern at the current estimated levels of intake, and the Committee maintained the previously established group acceptable daily intake (ADI) of 0–0.5 mg/kg body weight (bw), expressed as citral, for citral (No. 1225), citronellol (No. 1219), geranyl acetate (No. 58), linalool (No. 356) and linalyl acetate (No. 359). Citral and citronellol had already been evaluated by the Committee at its eleventh meeting (Annex 1, reference 14), at which conditional ADIs 1 of 0–0.25 mg/kg bw and 0–1 mg/kg bw, respectively, were allocated. At the twenty-third meeting of the Committee (Annex 1, reference 50), citronellol and citral were re-evaluated as part of a group of terpenoid flavouring agents, including geranyl acetate, linalool and linalyl acetate. A group ADI of 0–0.5 mg/kg bw, expressed as citral, was established for citral, geranyl acetate, citronellol, linalool and linalyl acetate on the basis of their clearly defined metabolism, rapid excretion and low toxicity in short-term studies. The Committee maintained, however, that a long-term study was required for at least one member of this group. At its forty-ninth meeting (Annex 1, reference 131), the Committee evaluated a group of 26 geranyl, neryl, citronellyl and rhodinyl esters derived from branchedchain terpenoid alcohols and aliphatic acyclic carboxylic acids by the Procedure. Two-year studies of carcinogenicity had been conducted for a mixture of two of these esters, geranyl acetate and citronellyl acetate. The Committee concluded that there were no safety concerns for any of the 26 substances at the low levels of intake arising from their use as flavouring agents and maintained the group ADI for citral, geranyl acetate, citronellol, linalool and linalyl acetate. Likewise, at its fifty-fifth meeting (Annex 1, reference 137), when the Committee re-evaluated linalool and linalyl acetate as part of a group of 23 aliphatic acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances by the Procedure, the group ADI was maintained. The findings from all previous evaluations were considered in the present evaluation. Twelve of the 20 flavouring agents in this group have been reported to occur naturally in foods (Nos 1815, 1818, 1820, 1822, 1824–1827, 1830–1832 and 1834). They have been detected in bread, animal fat, a variety of fruits, cinnamon, citrus peel oils, peppermint oil, cheddar cheese, black tea, coffee, white wine, carrot, honey and kelp, for example (Nijssen et al., 2007). 1.2 Assessment of dietary exposure The total annual volume of production of the 20 flavouring agents in this group is approximately 270 kg in Europe (European Flavour and Fragrance Association, 2005), 2200 kg in the USA (Gavin et al., 2007) and 40 kg in Japan (Japan Flavor & Fragrance Materials Association, 2002). In Europe, the USA as well as Japan, prenyl acetate (No. 1827) makes the biggest contribution to the total annual production volume (67%, 59% and 58%, respectively). The estimated 1 “Conditional ADI”, which signifies an ADI with special considerations, is a term no longer used by the Joint FAO/WHO Expert Committee on Food Additives.
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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 247 and 248: 240 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 301 and 302: 294 ALIPHATIC BRANCHED-CHAIN SATURA
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340 ALIPHATIC LINEAR ,-UNSATURATED
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ALKOXY-SUBSTITUTED ALLYLBENZENES PR
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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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