JECFA COMPENDIUM OF FOOD ADDITIVE SPECIFICATIONS VOWME 2 Joint FAO/WHO Expert Committee on Food Additives (JECFA) Combined Specifications from 1st through the 37th Meetings 1956 - 1990 Food and Agriculture Organization of the United Nations Rome, 1992 CORRIGENDUM Compendium of food additive specifications, Volume 2 Joint FAO./WHO Expert Committee on Food Additives (JECFA) This publication is FAO Food and Nutrition Paper No. 52, Volume 2 M-84fT0814E/1 /9.93/11 00 ISBN 92-5-1 03376-5 ISSN 0254-4 725 Food and Agriculture Organization of the United Nations Rome, 1993 COMPENDIUM OF FOOD ADDITIVE SPECIFICATIONS VOWME 2 Joint FAO/WHO Expert Committee on Food Additives (JECFA) Combined Specifications from 1st through the 37th Meetings 1956- 1990 Food and Agriculture Organization of the United Nations Rome, 1992 The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmined in any form or by any means, electromc, mechani cal, photocopying or otherwise, without the prior permission otthe copyright owner. Applications for such permission, with a statement of the purpose and extent of the reproduction, should be addressed to the Director, Publications Division, Food and Agriculture Organization otthe United Nations, Via delle Terme di Caracalla, 00100 Rome, Italy. (Q FAO iii INTRODUCTION A Joint FAO/WHO Conference on Food Additives met in Geneva, Switzerland, in September 1955 and recommended that the two international organizations collect and disseminate information on food additives. Since that time, over 500 substances have been evaluated and provided with specifications for purity and identity by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). JECF A specifications of food additives are intended to serve as a guide for manufacturers and users of the additives, as well as the basis for new or revised national legislation or regulations of member countries of FAO and WHO. The specifications were published variously in FAO Nutrition Meetings Reports Series (NMRS), within WHO Technical Report Series (TRS) or as FAO Food and Nutrition Papers (FNP) comprising 35 separate volumes, published over many years and most of them now out of print. During its more than 30 years of activity, the Committee has reevaluated many food additives in light of changing requirements or new technical and scientific information. Some have been reevaluated more than once. As a result, the specifications for 50 substances were withdrawn over the years because the use of these additives was no longer technically justified or because of safety considerations based on newer scientific information. This present Compendium was prepared in order to consolidate in one reference source, all of the JECFA food additive specifications which are currently applicable. This includes specifications from all JECFA meetings dealing with food additives up to and including the 37th meeting in 1990.' The Compendium consists of general notices; remarks applying to the standards, tests and assays; individual specifications listed in alphabetical order by substance title; and seven annexes plus an index. There are many general tests for identity and purity which are applicable to a wide range of substances in the Compendium. In 1978, these were assembled along with other general reference material and were published as FNP number 5, "Guide to Specifications -JECFA ". FNP 5 was revised in 1983 and a second revision was published in 1991 to coincide with and complement this Compendium. The test procedures and other information from FNP 5, revision 2, are referenced in the specifications throughout the Compendium. Users of this Compendium are encouraged to submit their comments or suggestions to the Chief, Food Quality and Standards Service, Food Policy and Nutrition Division, FAO, via delle Terme di Caracalla, 00100 Rome, Italy. iv ACKNOWLEDGEMENTS This Compendium was prepared by Dr. Kenji Ishii of the Japan Food Additives Association (JFAA) over a period of 18 months at the FAO Headquarters in Rome, Italy. Dr. Ishii was assisted in this massive undertaking by several colleagues in Japan. These were Dr. Kunitoshi Yoshihira and Dr. Toshio Itoh, both of the National Institute of Hygienic Science, as well as the following scientists from the JFAA: Mr. Koh Murai, Dr. Takashi Akiyama, Mr. Rikio Goto, Mr. Nobuyoshi Nosaka, Dr. Tetsuya Kato and Dr. Izumi Kumashiro. FAO gratefully acknowledges the considerable effort of all these experts and especially the outstanding work done by Dr. Ishii. FAO further expresses its appreciation to Mr. Saburosuke Suzuki, Chairman, and Dr. Teruo Shiro, Senior Managing Director, of the Japan Food Additives Association and to the National Instititute of Hygienic Science of Japan, for their generous support in providing the services of Dr. Ishii and of the other experts to prepare this document. The final draft of this Compendium was reviewed and edited by Mr. D .F. Dodgen, Review Chemist, Division of Food Chemistry and Technology, Centre for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, D.C., USA, and Dr. Juhani Paakkanen, Senior Advisor, Ministry of Trade and Industry, Division for Food Affairs, Helsinki, Finland. Their review was invaluable. FAO acknowledges with gratitude the generous contribution of the International Life Sciences Institute, Washington, D.C., USA, to the publication of this Compendium. V SCOPE OF THIS COMPENDIUM This Compendium presents in a consolidated and up-dated form, all of the specifications for identity and purity of over 500 food additives, prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and published in about 35 separate volumes since the first session of the Committee in 1956. Each volume previously published represented the results of a given meeting. The format of individual additive specifications varied from meeting to meeting and ranged from relatively uncomplicated earlier specifications to the more complex recent issuances. The consolidation and up-dating for this Compendium necessitated a uniform format of presentation for the specifications. This format was agreed to by JECFA experts after being proposed by the consultant preparing the draft Compendium (Dr. Kenji Ishii - see Acknowledgements). Early specifications tended to be quite simple in presentation. These were edited to generally conform to the agreed format without changing the substance or meaning of the specification requirements. Typographical errors were also corrected where found. Many of the older specifications do not meet modern requirements for identity and purity. These specifications will be reviewed at future JECFA meetings and revised accordingly. The user of this Compendium will need to become acquainted with both the index and the various annexes. To assist in this, the following summary and explanation of each is offered: -Annex 1 details the General Specifications for Enzyme Preparations Used in Food Processing, with two appendices. Appendix A is "Determination of Antibiotic Activity" and Appendix B is "General Considerations and Specifications for Enzymes from Genetically Manipulated Microorganisms". All enzyme substances must meet the requirements detailed in Annex 1, in addition to the individual specification for the enzyme. Enzymes from microbial sources must also meet the requirements regarding antibiotic activity in Appendix A. Lastly, any enzyme from a genetically manipulated microorganism should further include specification requirements as summarized in Appendix B. - Annex 2 was included to provide general guidance on specifications for colour lakes prepared by the reaction of alumina and appropriate colouring agents. - Annex 3 is designed to clarify the nomenclature to be used in describing chlorophyll and its · derivatives. - Annex 4 provides a listing of former titles of specifications which have been changed in the present Compendium, along with a listing of their current titles. This permits cross-checking of older JECFA references, if desired. - Annex 5 is a cross-index of Codex functional classes and JECFA defined functional uses. - Annex 6 represents a listing of the individual substances by JECF A functional uses. - Annex 7 identifies those substances which previously had specifications, but which are not included in this Compendium, for reasons stated in the Annex. - The Index at the end of this Compendium will assist the user in finding specifications as it cross references the various synonyms used for each substance. vi SPECIAL NOTE The methods and analytical procedures described in this Compendium are designed to be carried out by properly trained personnel in a suitably equipped laboratory. In common with many laboratory procedures, the methods quoted frequently involve hazardous materials. For the correct and safe execution of these methods it is essential that laboratory personnel follow standard safety procedures for the handling of hazardous materials. While the greatest care has been exercised in the preparation of this information, FAO expressly disclaims any liability to users of these procedures for consequential damages of any kind arising out of, or connected with their use. vii CONTENTS Page NOTICES General Notices applying to the Standards, Tests and Assays of the Specifications prepared by JECFA 1 Remarks on Specifications 5 Remarks on Test Methods 6 SPECIFICATIONS -A- Acesulfame Potassium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Acetic Acid, Glacial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Acetic and Fatty Acid Esters of Glycerol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Acetone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Acetone Peroxides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Activated Carbon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Adipic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Agar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Alginic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Allura Red AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Allyl 3-Cyclohexylpropionate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Allyl Heptanoate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Allyl Hexanoate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Allyl lsovalerate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Allyl Tiglate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Allyl-a-ionone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Aluminium Ammonium Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Aluminium Potassium Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Aluminium Powder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Aluminium Silicate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Aluminium Sodium Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Aluminium Sulfate (anhydrous) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Amaranth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Ammonium Alginate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Ammonium Carbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Ammonium Chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Ammonium Dihydrogen Phosphate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Ammonium Hydrogen Carbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Ammonium Hydroxide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Ammonium Persulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Ammonium Polyphosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 Ammonium Salts of Phosphatidic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 Amyl Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 vm a-Amyl Cinnamic Aldehyde . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 a-Amyl Cinnamic Aldehyde Dimethyl Acetal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 a-Amyl Cinnamyl Alcohol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 a-Amylase and Glucoamylase from Aspergillus oryzae . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 a-Amylase from Aspergillus oryzae var. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 a-Amylase from Bacillus megaterium Expressed in Bacillus subtilis . . . . . . . . . . . . . . . . . . . . 107 a-Amylase from Bacillus stearothermophilus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 a-Amylase from Bacillus stearothermophilus Expressed in Bacillus subtilis . . . . . . . . . . . . . . . . 111 a-Amylase from Bacillus subtilis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Amyloglucosidase from Aspergillus niger var. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 trans-Anethole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 Anisyl Acetone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Annatto Extracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121 Anoxomer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127 /3-Apo-8' -carotenal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 /3-Apo-8'-carotenoic Acid Ethyl Ester . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 Ascorbic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155 Ascorbyl Palmitate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 Ascorbyl Stearate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 Aspartame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 Avian Pepsin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Azodicarbonamide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171 Azorubine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175 - B- Beet Red 177 Benzaldehyde ..................................................... . 181 Benzoic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183 Benzoin Gum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... . 187 Benzoyl Peroxide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . 189 Benzyl Acetate .................................................... . 191 Benzyl Alcohol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . 193 Benzyl Benzoate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195 Benzyl Butyl Ether . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... 197 Benzyl Isobutyl Carbinol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199 Benzyl Isoeugenyl Ether . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201 Blackcurrant Extract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... 203 Bone Phosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207 Brilliant Black BN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213 Brilliant Blue FCF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 217 Bromelain ....................................................... . 221 Brominated Vegetable Oils ............................................ . 223 Brown FK ....................................................... . 225 Brown HT ...................................................... . 233 Butan-1-ol ....................................................... . 237 Butan-2-ol ....................................................... . 239 Butane-1 ,3-diol .................................................... . 241 Butyl Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . 243 Butyl p-Hydroxybenzoate ............................................. . 245 Butylated Hydroxyanisole ............................................. . 249 Butylated Hydroxytoluene ............................................. . 253
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