Safety evaluation of certain food additives - ipcs inchem

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DIETARY EXPOSURE ASSESSMENT OF FLAVOURING AGENTS: INCORPORATION OF THE SINGLE PORTION EXPOSURE TECHNIQUE (SPET) INTO THE PROCEDURE FOR THE SAFETY EVALUATION OF FLAVOURING AGENTS First draft prepared by Dr C. Leclercq, 1 Ms U.R. Charrondière, 2 Dr M. DiNovi, 3 Ms J. Baines, 4 Dr J.C. Leblanc, 5 Dr P. Verger, 6 Dr A. Renwick, 7 Dr P. Abbott 8 and Dr G. Sipes 9 1 National Research Institute for Food and Nutrition (INRAN), Rome, Italy 2 Food and Agriculture Organization of the United Nations, Rome, Italy 3 Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD, United States of America (USA) 4 Food Standards Australia New Zealand, Canberra, ACT, Australia 5 French Food Safety Agency (AFSSA), Maisons Alfort, France 6 National Institute for Agricultural Research (INRA) – Met@risk, Paris, France 7 School of Medicine, University of Southampton, Southampton, England 8 Consultant, Canberra, ACT, Australia 9 College of Medicine, University of Arizona, Tucson, AZ, USA Introduction................................................................................. Investigation to develop criteria for the identification of flavouring agents requiring additional consideration.............................. Analysis of data for 57 flavouring agents considered at the sixty-eighth meeting......................................................... Analysis of data for 40 flavouring agents considered at the current meeting................................................................ Analysis of a larger data set of flavouring agents................ IOFI use level data, 2007–2008..................................... Use level data from an industry survey conducted in the USA in 1977.............................................................. FEMA GRAS use level data, 1965–2007...................... Conclusion of the analysis............................................. Comparison of the magnitude of MSDI and SPET estimates......................................................................... Consideration of the incorporation of the SPET estimate into the Procedure.............................................................................. Hydroxy- and alkoxy-substituted benzyl derivatives............ Miscellaneous nitrogen-containing substances................... Conclusion........................................................................... Updated portion sizes................................................................. Combined dietary exposure....................................................... Conclusion.................................................................................. Acknowledgement...................................................................... References................................................................................. Appendix 1: Updated portion sizes to be used for the calculation of SPET estimates................................................................. - 267 - 268 269 269 269 270 270 271 271 275 276 276 277 277 278 278 278 279 279 279 281
268 DIETARY EXPOSURE ASSESSMENT OF FLAVOURING AGENTS 1. INTRODUCTION The Joint FAO/WHO Expert Committee on Food Additives (JECFA) employs the maximized survey-derived intake (MSDI) method as a measure of the dietary exposure to flavouring agents for use in the Procedure for the Safety Evaluation of Flavouring Agents (the Procedure). The MSDI provides a per capita estimate of the dietary exposure to a flavouring agent that is compared with the relevant threshold of toxicological concern (TTC) for each structural class in a decision tree approach according to the Procedure. The TTCs for flavouring agents of class I, class II and class III are, respectively, 1800, 540 and 90 μg/day. The MSDI is based on the reported amount of the flavouring agent introduced into the food supply per year in specific regions, currently Europe, the USA and Japan, corrected for possible underreporting, and assuming that 10% of the relevant population would consume the foods containing the flavouring agent. The Committee considered issues related to the dietary exposure to flavouring agents at its forty-fourth, forty-sixth, forty-ninth, fifty-fifth, sixty-third, sixtyfifth, sixty-seventh and sixty-eighth meetings (Annex 1, references 116, 122, 131, 149, 173, 178, 184 and 187). The main concern expressed by the Committee was that the MSDI may significantly underestimate the dietary exposure to some flavouring agents. This could be the case for flavouring agents consumed by less than 10% of the population, especially where they might be used in a few food categories, and for flavouring agents with an uneven distribution of dietary exposure among consumers. The uneven distribution might be due to a combination of factors, including different use levels across and within food categories, restriction to use in a few foods or food categories and different levels of consumption for different foods. Exposure estimates for many flavouring agents calculated based on reported use levels have been shown to be considerably higher than the corresponding MSDI values, indicating the need for additional exposure estimates based on use levels. The single portion exposure technique (SPET) was developed at the sixtyseventh meeting of the Committee (Annex 1, reference 184) to account for presumed consumer patterns of behaviour with respect to food consumption and the possible uneven distribution of dietary exposure for consumers of foods containing flavouring agents. The SPET provides an estimate of the dietary exposure for an individual who consumes a specific food product containing the flavouring agent every day. The SPET combines an average (or usual) added use level with a standard portion size for a food category. Among all the food categories with a reported use level, the dietary exposure from the single food category leading to the highest dietary exposure from one portion is taken as the SPET estimate. The standard portion does not reflect high food consumption amounts reported in national dietary surveys. At its sixty-eighth meeting and its present meeting, the Committee performed a number of SPET and MSDI calculations with the aim of: • determining if a set of criteria could be identified for future selection of flavouring agents for which the MSDI could underestimate dietary exposure. In these cases, extra information on added use levels recommended by the industry would be required to calculate a SPET estimate;
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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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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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316 ALIPHATIC BRANCHED-CHAIN SATURA
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332 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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