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    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION



    TOXICOLOGICAL EVALUATION OF CERTAIN
    FOOD ADDITIVES AND CONTAMINANTS



    WHO FOOD ADDITIVES SERIES 32





    Prepared by:
      The forty-first meeting of the Joint FAO/WHO Expert
      Committee on Food Additives (JECFA)



    World Health Organization, Geneva 1993


         The International Programme on Chemical Safety (IPCS) is a
    joint venture of the United Nations Environment Programme, the
    International Labour Organisation, and the World Health Organization. 
    The main objective of the IPCS is to carry out and disseminate
    evaluations of the effects of chemicals on human health and the
    quality of the environment.  Supporting activities include the
    development of epidemiological, experimental laboratory, and risk-
    assessment methods that could produce internationally comparable
    results, and the development of manpower in the field of toxicology. 
    Other activities carried out by the IPCS include the development of
    know-how for coping with chemical accidents, coordination of
    laboratory testing and epidemiological studies, and promotion of
    research on the mechanisms of the biological action of chemicals.

    ISBN 92 4 166032 5

    CONTENTS

    INTRODUCTION
         PREFACE
         MONOGRAPH FORMAT

    ANTIOXIDANTS
         GALLATES

    FLAVOURING SUBSTANCES
         BENZYL ACETATE
         2-ETHYL-1-HEXANOL
         ALPHA-METHYLBENZYL ALCOHOL

    FLAVOUR ENHANCERS
         DISODIUM 5'-GUANYLATE AND DISODIUM 5'-INOSINATE

    FOOD COLOURS
         CAROTENES FROM NATURAL SOURCES (ALGAL AND VEGETABLE)

    SWEETENING AGENTS
         MALTITOL AND MALTITOL SYRUP
         SACCHARIN AND ITS SALTS

    THICKENING AGENTS
         KONJAC FLOUR
         PROCESSED  EUCHEUMA SEAWEED
         PROPYLENE GLYCOL ALGINATE

    MISCELLANEOUS SUBSTANCES
         -CYCLODEXTRIN
         SODIUM IRON EDTA
         SUCROSE ACETATE ISOBUTYRATE
         UREA

    CONTAMINANT
         CHLOROPROPANOLS

    ANNEXES
         ANNEX 1
         ANNEX 2
         ANNEX 3
         ANNEX 4
         
    
    PREFACE

         The monographs contained in this volume were prepared by the
    forty-first Joint FAO/WHO Expert Committee on Food Additives (JECFA),
    which met in Geneva, Switzerland, from 9 to 18 February 1993.  These
    monographs summarize the safety data on selected food additives and
    contaminants reviewed by the Committee.  The data reviewed in these
    monographs form the basis for acceptable daily intakes (ADIs)
    established by the Committee.

         The forty-first report of JECFA will be published by the World
    Health Organization in the WHO Technical Report Series.  The
    participants in the meeting are listed in Annex 3 of the present
    publication and a summary of the conclusions of the Committee is
    included as Annex 4.

         Specifications established at the forty-first meeting of JECFA
    will be published in the FAO Food and Nutrition Paper series.  These
    toxicological monographs should be read in conjunction with the
    specifications and the report.

         Reports and other documents resulting from previous meetings of
    the Joint FAO/WHO Expert Committee on Food Additives are listed in
    Annex 1.

         JECFA serves as a scientific advisory body to FAO, WHO, their
    Member States, and the Codex Alimentarius Commission, primarily
    through the Codex Committee on Food Additives and Contaminants and the
    Codex Committee on Residues of Veterinary Drugs in Foods, regarding
    the safety of food additives, residues of veterinary drugs, naturally
    occurring toxicants, and contaminants in food.  Committees serve this
    function by preparing reports of their meetings and publishing
    specifications or residues monographs and toxicological monographs,
    such as those contained in this volume, on substances that they have
    considered.

         Many proprietary unpublished reports are referenced in this
    volume.  These were voluntarily submitted to the Committee, generally
    by producers of the food additives under review, and in many cases
    these reports represent the only safety data available on these
    substances.  The working papers used by the Committee to develop the
    monographs in this volume were developed by Temporary Advisers based
    on all the data that had been submitted, and all these studies were
    available to the Committee as it made its evaluations and finalized
    the monographs.

         From 1972 to 1975 the toxicology monographs prepared by Joint
    FAO/WHO Expert Committees on Food Additives were published in the WHO
    Food Additives Series; between 1975 and 1985 this series was available
    in the form of unpublished WHO documents provided by the Organization
    upon request.  WHO Food Additives Series Volume No. 20, prepared by

    the twenty-ninth Committee in 1985, through WHO Food Additives Series
    Volume No. 24, prepared by the thirty-third Committee in 1988, were
    published by the Cambridge University Press.  Beginning with WHO Food
    Additives Series No. 25, prepared by the thirty-fourth Committee, WHO
    has produced these volumes as priced documents.

         The preparation and editing of the monographs included in this
    volume have been made possible through the technical and financial
    contributions of the Participating Institutions of the International
    Programme on Chemical Safety (IPCS), which support the activities of
    JECFA.  IPCS is a joint venture of the United Nations Environment
    Programme, the International Labour Organisation, and the World Health
    Organization, which is the executing agency.  One of the main
    objectives of the IPCS is to carry out and disseminate evaluations of
    the effects of chemicals on human health and the quality of the
    environment.

         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 organizations participating in the IPCS concerning
    the legal status of any country, territory, city, or area or its
    authorities, nor concerning the delimitation of its frontiers or
    boundaries.  The mention of specific companies or of certain
    manufacturers' products implies neither that they are endorsed nor
    recommended by those organizations in preference to others of a
    similar nature that are not mentioned.

         Any comments or new information on the biological or
    toxicological data on the compounds reported in this document should
    be addressed to: Joint WHO Secretary of the Joint FAO/WHO Expert
    Committee on Food Additives, International Programme on Chemical
    Safety, World Health Organization, Avenue Appia, 1211 Geneva 27,
    Switzerland.

    MONOGRAPH FORMAT

         Note: Monographs in this document generally follow the format
    presented below.  All monographs may not, however, require the use of
    each heading, and in some monographs the format has been modified to
    better present data about several substances.

    1.   EXPLANATION

    2.   BIOLOGICAL DATA
         2.1   Biochemical aspects
               2.1.1    Absorption, distribution and excretion.
               2.1.2    Biotransformation
               2.1.3    Effects on enzymes and other biochemical 
                        parameters
         2.2   Toxicological studies
               2.2.1    Acute toxicity studies
               2.2.2    Short-term toxicity studies
               2.2.2.1-2.2.2.X    Species tested
               2.2.3    Long-term/carcinogenicity studies
               2.2.4    Reproduction studies
               2.2.5-2.2.X    Special studies
         2.3   Observations in humans

    3.   COMMENTS

    4.   EVALUATION

    5.   REFERENCES





















    See Also:
       Toxicological Abbreviations