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Evaluation of Certain Food Additives 952 Food Additives WHO Technical Report Series WHO Technical Sixty-ninth report of the FOOD ADDITIVES Joint FAO/WHO Expert Committee on Food and Agriculture Organization of the United Nations S I N A P T A F I EVALUATION OF CERTAIN EVALUATION OF CERTAIN FOOD ADDITIVES WHO Technical Report Series 952 ISBN 978 92 4 120952 6 2,3-trimethylbutyramide (No. 1595) and N, , phytosterols, phytostanols and their esters, , calcium lignosulfonate (40–65), ethyl lauroyl arginate, paprika Pichia pastoris A. niger -unsaturated aldehydes, acids and related alcohols, acetals and esters; β , α expressed in niger Aspergillus L-monomenthyl glutarate (No. 1414). recommendations for intakes and Annexed to the report are tables summarizing the Committee’s toxicological evaluations of the food additives considered. aliphatic secondary alcohols, ketones and related esters; alkoxy-substituted allylbenzenes present in foods and essential oils and used as flavouring agents; esters of aliphatic acyclic primary alcohols with aliphatic linear saturated carboxylic acids; furan-substituted aliphatic hydrocarbons, alcohols, aldehydes, ketones, carboxylic acids and related esters, sulfides, disulfides and ethers; miscellaneous nitrogen-containing substances; monocyclic and bicyclic secondary alcohols, ketones and related esters; hydroxy- and alkoxy-substituted benzyl derivatives; and substances structurally related to menthol). Specifications for the following food additives were revised: canthaxanthin; carob bean gum and carob bean gum (clarified); chlorophyllin copper complexes, sodium and potassium salts; Fast Green FCF; guar gum and FCF; and Sunset Yellow guar gum (clarified); iron oxides; isomalt; monomagnesium phosphate; Patent Blue V; trisodium diphosphate. Re-evaluation of flavouring agents for which estimated intake was based on anticipated poundage data was carried out for 2-isopropyl- This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety This report represents the conclusions of a Joint FAO/WHO of various food additives, including flavouring agents, with a view to recommending acceptable daily intakes (ADIs) and to preparing specifications for identity and purity. The first part of the report contains a general discussion of the principles governing the toxicological evaluation flavouring agents). A summary follows of the and assessment of intake of food additives (in particular, evaluations of technical, toxicological and intake data for certain food additives (asparaginase Committee’s from extract, phospholipase C expressed in polydimethylsiloxane, steviol glycosides and sulfites [assessment of dietary exposure]) and 10 groups of related flavouring agents (aliphatic branched-chain saturated and unsaturated alcohols, aldehydes, acids and related esters; aliphatic linear WHO Technical Report Series 952 EVALUATION OF CERTAIN FOOD ADDITIVES Sixty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives Food and Agriculture Organization of the United Nations World Health Organization WHO Library Cataloguing-in-Publication Data Evaluation of certain food additives : sixty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives. (WHO technical report series ; no. 952) 1.Food additives - analysis. 2.Food additives - toxicity. 3.Flavoring agents - analysis. 4.Flavoring agents - toxicity. 5.Food contamination - analysis. 6.Risk assessment. I.World Health Organization. II.Food and Agriculture Organization of the United Nations. III.Joint FAO/WHO Expert Committee on Food Additives. Meeting (69th: 2008, Rome, Italy). IV.Series. ISBN 978 92 4 120952 6 (NLM classification: WA 701) ISSN 0512-3054 © World Health Organization 2009 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication contains the collective views of an international group of experts on food additives and does not necessarily represent the decisions or the policies of the World Health Organization. Typeset in India Printed in India Contents 1. Introduction 1 1.1 Declarations of interests 1 2. General considerations 3 2.1 Modification of the agenda 3 2.2 Report from the Fortieth Session of the Codex Committee on Food Additives (CCFA) and the Second Session of the Codex Committee on Contaminants in Food (CCCF) 4 2.3 Principles governing the toxicological evaluation of compounds on the agenda 5 2.4 The safety evaluation of flavouring agents 5 2.4.1 Dietary exposure assessment of flavouring agents: Incorporation of the single portion exposure technique (SPET) into the Procedure for the Safety Evaluation of Flavouring Agents 5 2.4.2 Considerations on the thresholds of toxicological concern used in the Procedure 14 2.5 Food additive specifications 15 2.5.1 Withdrawal of specifications 15 2.5.1.1 Carbohydrase from Aspergillus niger varieties 15 2.5.1.2 Estragole 16 2.5.2 Method for determination of nickel in polyols 16 2.6 Relationship between the ADI and specifications 16 3. Specific food additives (other than flavouring agents) 19 3.1 Safety evaluations 19 3.1.1 Asparaginase from Aspergillus niger expressed in A. niger 19 3.1.2 Calcium lignosulfonate (40–65) 22 3.1.3 Ethyl lauroyl arginate 27 3.1.4 Paprika extract 32 3.1.5 Phospholipase C expressed in Pichia pastoris 36 3.1.6 Phytosterols, phytostanols and their esters 39 3.1.7 Polydimethylsiloxane 46 3.1.8 Steviol glycosides 50 3.1.9 Sulfites: assessment of dietary exposure 55 3.2 Revision of specifications 66 3.2.1 Canthaxanthin 66 3.2.2 Carob bean gum and carob bean gum (clarified) 66 3.2.3 Chlorophyllin copper complexes, sodium and potassium salts 67 3.2.4 Fast Green FCF 67 3.2.5 Guar gum and guar gum (clarified) 67 3.2.6 Iron oxides 67 3.2.7 Isomalt 68 3.2.8 Monomagnesium phosphate 68 3.2.9 Patent Blue V 68 iii 3.2.10 Sunset Yellow FCF 68 3.2.11 Trisodium diphosphate 69 4. Flavouring agents 71 4.1 Flavouring agents evaluated by the Procedure for the Safety Evaluation of Flavouring Agents 71 4.1.1 Aliphatic branched-chain saturated and unsaturated alcohols, aldehydes, acids and related esters: additional compounds 73 4.1.2 Aliphatic linear Į, ȕ-unsaturated aldehydes, acids and related alcohols, acetals and esters: additional compounds 84 4.1.3 Aliphatic secondary alcohols, ketones and related esters: additional compounds 92 4.1.4 Alkoxy-substituted allylbenzenes present in foods and essential oils and used as flavouring agents 103 4.1.5 Esters of aliphatic acyclic primary alcohols with aliphatic linear saturated carboxylic acids: additional compounds 106 4.1.6 Furan-substituted aliphatic hydrocarbons, alcohols, aldehydes, ketones, carboxylic acids and related esters, sulfides, disulfides and ethers 112 4.1.7 Hydroxy- and alkoxy-substituted benzyl derivatives: additional compounds 114 4.1.8 Miscellaneous nitrogen-containing substances: additional compounds 121 4.1.9 Monocyclic and bicyclic secondary alcohols, ketones and related esters: additional compounds 130 4.1.10 Substances structurally related to menthol: additional compounds 139 4.2 Re-evaluation of flavouring agents for which estimated intake was based on anticipated poundage data 145 4.2.1 2-Isopropyl-N,2,3-trimethylbutyramide (No. 1595) 157 4.2.2 L-Monomenthyl glutarate (No. 1414) 158 4.3 Specifications of identify and purity of flavouring agents 164 5. Future work 165 6. Recommendations 167 Acknowledgements 169 References 171 Annex 1 Reports and other documents resulting from previous meetings of the Joint FAO/WHO Expert Committee on Food Additives 175 iv Annex 2 Acceptable daily intakes, other toxicological information and information on specifications 187 Annex 3 Further information required or desired 203 Annex 4 Summary of the safety evaluation of secondary components for flavouring agents with minimum assay values of less than 95% 205 v Sixty-ninth meeting of the Joint FAO/WHO Expert Committee on Food Additives Rome, 17–26 June 2008 Members Professor J. Bend, Department of Pathology, Siebens-Drake
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