IPCS INCHEM Home


       INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

       WORLD HEALTH ORGANIZATION



       TOXICOLOGICAL EVALUATION OF CERTAIN
       FOOD ADDITIVES AND CONTAMINANTS



       WHO FOOD ADDITIVES SERIES 35





       Prepared by:
       The 44th meeting of the Joint FAO/WHO Expert
       Committee on Food Additives (JECFA)



       World Health Organization, Geneva 1996


        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 166035 X

    CONTENTS

    Preface

    Antioxidants
         Butylated hydroxytoluene (BHT)
         tert-Butyllhydroquinone (TBHQ)

    Colour stabilizer
         4-Hexylresorcinol

    Emulsifiers
         Glycerol ester of wood rosin
         Sucrose esters of fatty acids and sucroglycerides

    Flavouring agent
         Ethyl vanillin

    Food colours
         Canthaxanthin
         Curcumin

    Glazing agents
         Mineral oils and waxes

    Sweetening agent
         Alitame

    Miscellaneous substances
         -Cyclodextrin
         Nitrite
         Nitrate

    Contaminants
         Ochrotaxin A
         Patulin

    Annexes
         Annex 1   Reports and other documents resulting from
                   previous meetings of the Joint FAO/WHO Expert
                   Committee on Food Additives
         Annex 2   Abbreviations used in the Monographs
         Annex 3   Joint FAO/WHO Expert Committee on Food Additives,
                   Rome, 14-23 February 1995

         Annex 4   Acceptable Daily Intakes, other toxicological
                   information, and information on specifications
         Annex 5   A procedure for the safety evaluation of
                   flavouring substances (Paper by Dr I.C. Munro,
                   CanTox Inc., Mississauga, Ontario, Canada)
    

    PREFACE

         The monographs contained in this volume were prepared by the
    forty-fourth Joint FAO/WHO Expert Committee on Food Additives (JECFA),
    which met in Rome, Italy, 14-23 February 1995. 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-fourth report of JECFA has been published by the World
    Health Organization as WHO Technical Report Series No. 859. 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-fourth meeting of JECFA
    has been published by FAO as FAO Food and Nutrition Paper 52, Add. 3.
    These toxicological monographs should be read in conjunction with the
    specifications and the report.

         Reports and other documents resulting from previous meetings of
    JECFA 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 accomplish
    this task by preparing reports of their meetings and publishing
    specifications or residue monographs 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 by Temporary Advisers. A
    special acknowledgement is given at the beginning of each monograph to
    those who prepared these working papers.

         Many proprietary unpublished reports are referenced. These were
    voluntarily submitted to the Committee by various producers of the
    food additives 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. The monographs were edited by Dr H.
    Galal-Gorchev, Geneva, Switzerland.

         From 1972 to 1975 the toxicological monographs prepared by JECFA
    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 No. 20, which was prepared by the
    twenty-ninth Committee in 1985, through WHO Food Additives Series
    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 has been 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 supports 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.





















    See Also:
       Toxicological Abbreviations