IPCS INCHEM Home


    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION



    TOXICOLOGICAL EVALUATION OF CERTAIN
    FOOD ADDITIVES AND CONTAMINANTS



    WHO FOOD ADDITIVES SERIES 28





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



    World Health Organization, Geneva 1991


         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.

         IPCS gratefully acknowledges the assistance provided by the
    International Life Sciences Institute (ILSI) in the form of editing of
    the toxicological monographs by Dr L. Fishbein and by providing a
    typist and typing facilities for their production.


    CONTENTS

    Preface

    Monograph Format

    Antioxidants

    Butylated hydroxytoluene (BHT)
    Erythorbic acid and its sodium salt

    Enzyme Preparations

    alpha-Amylase from  Bacillus stearothermophilus
    alpha-Amylase from  Bacillus subtilis
    alpha-Amylase from  Bacillus stearothermophilus expressed in
          Bacillus subtilis
    alpha-Amylase from  Bacillus megaterium expressed in
          Bacillus subtilis
    Chymosin A produced from  Escherichia coli K-12 containing
         calf prochymosin A gene
    Chymosin B produced from  Kluyveromyces lactis containing
         calf prochymosin B gene
    Chymosin produced from  Aspergillus niger var. awamori
         containing calf prochymosin B gene

    Flavouring agents

    Allyl esters (allyl hexanoate, allyl heptanoate, and
         allyl isovalerate)
    Trans-anethole
    (+)-Carvone and (-)-carvone

    Food Colour

    Erythrosine

    Sweetening agents

    Acesulfame potassium
    Trichlorogalactosucrose (TGS)

    Miscellaneous food additives

    Dimethyldicarbonate (DMDC)
    Dioctyl sodium sulfosuccinate (DSS)
    Gellan gum

    Contaminants

    Benzo[a]pyrene
    Ochratoxin A

    Annexes

         Annex 1   Reports and other documents resulting
                   from meeting of the Joint FAO/WHO Expert 
                   Committee on Food Additives

         Annex 2   Abbreviations used in the monographs

         Annex 3   Participants at thirty-seventh meeting
                   of the Joint FAO/WHO Expert Committee 
                   on Food Additives 

         Annex 4   Acceptable daily intakes, other
                   toxicological recommendations and 
                   information on specifications

         Annex 5   Corrigenda to Food Additives Series 
                   No. 26

    PREFACE

         The monographs contained in this volume were prepared by the
    thirty-seventh Joint FAO/WHO Expert Committee on Food Additives
    (JECFA), which met in Geneva, Switzerland, 5-14 June 1990.  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 thirty-seventh report of JECFA has been published by the
    World Health Organization as WHO Technical Report Series No. 806.  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-seventh meeting of JECFA
    will be issued separately by FAO.  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, 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.

         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 submitted, and all these studies were available to the
    Committee when it made its evaluations.

         From 1972 to 1975 the toxicology monographs prepared by Joint/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. 
    WHO Food Additives Series Volume No. 20, which was

    prepared by the twenty-ninth Committee in 1985, through  WHO Food
    Additives Series Volume No. 24, which was prepared by the thirty-third
    Committee in 1988, 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 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