Safety evaluation of certain food additives - ipcs inchem

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ETHYL LAUROYL ARGINATE 81 theoretical maximum 6 mg/kg bw per day. These data are summarized in Table 8 in section 3.5 above. 5. EVALUATION The majority of effects reported at high dietary concentrations of ethyl lauroyl arginate are considered to be related to its irritant action and not relevant to dietary exposure resulting from use as a food preservative. In two studies of reproductive toxicity in rats, administration of ethyl lauroyl arginate at a dietary concentration of 15 000 mg/kg resulted in delayed vaginal opening among the female offspring. Although this effect was not accompanied by functional changes, the Committee considered it to be adverse and concluded that the NOAEL for this effect was a dietary concentration of 6000 mg/kg, corresponding to 442 mg/kg bw per day expressed as ethyl-N -lauroyl-L-arginate HCl, which should be used as the basis for establishing an ADI. The Committee established an ADI of 0–4 mg/kg bw for ethyl lauroyl arginate, expressed as ethyl-N -lauroyl-L-arginate HCl, based on the NOAEL of 442 mg/kg bw per day identified in studies of reproductive toxicity and a safety factor of 100. The Committee noted that some estimates of high-percentile dietary exposure to ethyl lauroyl arginate exceeded the ADI, but recognized that these estimates were highly conservative and that actual intakes were likely to be within the ADI range. 6. REFERENCES Brown, G. (2008) Review of the white blood cell data on a series of toxicity studies (coded LMA/2, LMA/030, LMA/3, LMA/031 and LMA/050) for Huntingdon Life Sciences. Unpublished report from G. Brown, Comparative Haematology Consultant for Huntingdon Life Sciences Ltd, Huntingdon, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. CentraLabS Clinical Research Ltd (2005a) ELA: an open-label, single-dose study to determine the feasibility of measuring ELA and its breakdown products in plasma after oral administration of ELA to healthy male volunteers. Unpublished report No. LMA 047/033421 from CentraLabS Clinical Research Ltd, Alconbury, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. CentraLabS Clinical Research Ltd (2005b) ELA: an open-label, single-dose study to determine the plasma levels of ELA and its breakdown products after a single oral dose to healthy male volunteers. Unpublished report No. LMA 049/034017 from CentraLabS Clinical Research Ltd, Alconbury, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Cidasal (2003a) Determination of acute toxicity in rats by oral route dose limit test. Unpublished report No. CD02/8399T from Cidasal, Barcelona, Spain. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Cidasal (2003b) Bacterial reverse mutation test. Unpublished report No. CD02/8400T from Cidasal, Barcelona, Spain. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain.
82 ETHYL LAUROYL ARGINATE Cidasal (2003c) Micronucleus test. Unpublished report No. CD02/8401T from Cidasal, Barcelona, Spain. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Codex Alimentarius Commission (2007) Report of the Thirty-ninth Session of the Codex Committee on Food Additives, Beijing, China, 24–28 April. Rome, Italy, Food and Agriculture Organization of the United Nations (ALINORM 07/30/12 Rev.; http:// www.codexalimentarius.net/web/archives.jsp?year=07). European Food Safety Authority (2007) Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of ethyl lauroyl arginate as a food additive. EFSA J., 511, 1–27. Hawkins, D.R. (2005) An overview of the mammalian metabolism of lauric arginate. Unpublished report from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (1995) Mirenat-N: preliminary toxicity to rats by dietary administration for 4 weeks. Unpublished report No. LMA 2/952124 from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (1996) Mirenat-N: toxicity to rats by dietary administration for 13 weeks. Unpublished report No. LMA 3/961342 from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (1998a) ELA: study of tolerance in the rat by oral gavage administration. Unpublished report No. LMA 011/980114 from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (1998b) ELA: preliminary study of embryo-foetal toxicity in the CD rat by oral gavage administration. Unpublished report No. LMA 013/980140 from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (1998c) ELA: study of embryo-foetal toxicity in the CD rat by oral gavage administration. Unpublished report No. LMA 014/984183 from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (1998d) ELA: study of tolerance in the rabbit by oral gavage administration. Unpublished report No. LMA 012/980115 from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (1998e) ELA: preliminary study of embryo-foetal toxicity in the rabbit by oral gavage administration. Unpublished report No. LMA 015/980169 from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (1998f) ELA: study of embryo-foetal toxicity in the rabbit by oral gavage administration. Unpublished report No. LMA 016/992096 from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (1998g) N--Lauroyl-L-arginine ethyl ester monohydrochloride metabolism in the rat. Unpublished report No. LMA 017/983416 from Huntingdon Life Sciences Ltd, Huntingdon, Cambridgeshire, England. Submitted to WHO by Laboratorios Miret S.A., Barcelona, Spain. Huntingdon Life Sciences Ltd (2000a) L.A.E.: acute oral toxicity to the rat (acute toxic class method). Unpublished report No. LMA 018/002881/AC from Huntingdon Life Sciences Ltd,
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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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26 CALCIUM LIGNOSULFONATE (40-65) 2
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28 CALCIUM LIGNOSULFONATE (40-65) i
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Page 72 and 73: ETHYL LAUROYL ARGINATE 65 gestation
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Page 76 and 77: ETHYL LAUROYL ARGINATE 69 Table 6.
Page 84 and 85: ETHYL LAUROYL ARGINATE 77 About 99%
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Page 94 and 95: PAPRIKA EXTRACT 87 of capsanthin ra
Page 96 and 97: PAPRIKA EXTRACT 89 biochemical para
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Page 108 and 109: PAPRIKA EXTRACT 101 Appendix 1. Res
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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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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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