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    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION



    TOXICOLOGICAL EVALUATION OF CERTAIN
    FOOD ADDITIVES AND CONTAMINANTS



    WHO FOOD ADDITIVES SERIES 26





    Prepared by:
      The 35th meeting of the Joint FAO/WHO Expert
      Committee on Food Additives (JECFA)



    World Health Organization, Geneva 1990


         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.



    CONTENTS

    Preface

    Monograph Format

    Emulsifiers

    Sucrose esters of fatty acids sucroglycerides

    Flavouring agents

    Benzyl acetate
    Ethyl vanillin
    Quinine hydrochloride

    Food colours

    Canthaxanthin

    Thickening agents

    Gum arabic
    Modified celluloses

    Miscellaneous food additives

    2-Nitropropane

    Contaminants

    Patulin

     Annexes

    Annex 1   Reports and other documents resulting
              from meetings of the Joint FAO/WHO
              Expert Committee on Food Additives
    Annex 2   Abbreviations used in the monographs
    Annex 3   Thirty-fifth JECFA meeting participants
    Annex 4   Accceptable daily intakes, other
              toxicological recommendations and
              information on specifications

    PREFACE

          The monographs contained in this volume were prepared by the
    thirty-fifth Joint FAO/WHO Expert Committee on Food Additives (JEFCA),
    which met in Rome, Italy, 29 May-7 June 1989.  These monographs
    summarize the safety data on selected food additives and a contaminant
    reviewed by the Committee.  The data reviewed in these monographs form
    the basis for acceptable daily intakes (ADIs) established by the
    Committee.

          The thirty-fifth 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 thirty-fifth meeting of JEFCA
    will be issued separately by FAO under the title, Specifications for
    the identity and purity of certain food additives 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.

          JEFCA 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
    regarding the safety of food additives and contaminants in food. 
    Committees accomplish this task by preparing reports of their meetings
    and publishing specifications and toxicological monographs, such as
    those contained in this volume, on substances that they have
    considered.

          The toxicological monographs contained in this volume are based
    upon working papers that were prepared and/or presented by temporary
    advisers in advance of the 1988 JECFA meeting.  A special
    acknowledgement is given to those who prepared these working papers,
    Dr Ronald Walker, Professor of Biochemistry, University of Surrey,
    Guildford, Surrey, England; Drs D. Benz, I. Chen, C.B. Johnson, M.
    Bleiberg, J. Griffiths, K. Edelman and H. Irausquin, Division of
    Toxicological Review and Evaluation, Center for Food Safety and
    Applied Nutrition, Food and Drug Administration, Washington, DC, USA;
    Dr C.L. Galli, Professor of Toxicology, University of Milan, Italy;
    Drs D.L. Grant, E. Vavasour, S.G. Gilbert, E.M. Kovacs, P. Nawrot and
    T. Kemeny, Bureau of Chemical Safety, Foods Directorate, Health and
    Welfare Canada, Ottawa, Canada; and Dr G.J. van Esch, the Netherlands.

          Many proprietary unpublished reports are referenced.  These were
    voluntarily submitted to the Committee by various producers of the
    veterinary drugs under review and in many cases these reports
    represent the only safety data available on these substances.  The
    temporary advisers based the working papers they developed on all the
    data that were obtained, and all these studies were available to the
    Committee when it made its evaluations.

          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; after 1975 this series was available in the
    form of unpublished WHO documents provided upon request to the
    Organization.   Beginning with WHO Food Additives Series No. 20, which
    was prepared by the twenty-ninth Committee in 1985 until WHO Food
    Additives Series No. 24, which was prepared by the thirty-third
    Committee in 1988, volumes in this series were published by the
    Cambridge University Press.  Beginning with WHO Food Additives Series
    No. 25, which was prepared by the thirty-fourth Committee, WHO is
    producing 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, or concerning the delimitation of its frontiers or
    boundaries.  The mention of specific companies or of certain
    manufacturers' products does not imply that they are endorsed or
    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:  Each monograph in this document follows the general
    format presented below.  Each heading may not, however, be applicable
    to all monographs.

    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 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

               Level causing no toxicological effect

               Estimate of acceptable daily intake

               Further work or information
                       Required for substances given a temporary ADI
                       Desired

    5.   REFERENCES





















    See Also:
       Toxicological Abbreviations