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        INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

        WORLD HEALTH ORGANIZATION



        SAFETY EVALUATION OF CERTAIN
        FOOD ADDITIVES AND CONTAMINANTS



        WHO FOOD ADDITIVES SERIES 40





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



        World Health Organization, Geneva 1998



        The International Programme on Chemical Safety (IPCS), established
    in 1980, is a joint venture of the United Nations Environment
    Programme (UNEP),  the  International  Labour  Organisation (ILO), 
    and  the World Health Organization (WHO). The overall objectives of
    the IPCS are to establish the scientific basis for assessment of the
    risk to human health and the environment from exposure to chemicals,
    through international peer-review processes, as a prerequisite for the
    promotion of chemical safety, and to provide technical assistance in
    strengthening national capacities for the sound management of
    chemicals.

        The Inter-Organization Programme for the Sound Management of
    Chemicals (IOMC) was established in 1995 by UNEP, ILO, the Food and
    Agriculture Organization of the United Nations, WHO, the United
    Nations Industrial Development Organization and the Organisation for
    Economic Co-operation and Development (Participating Organizations),
    following recommendations made by the 1992 UN Conference on
    Environment and Development to strengthen cooperation and increase
    coordination in the field of chemical safety.  The purpose of the IOMC
    is to promote coordination of the policies and activities pursued by
    the Participating Organizations, jointly or separately, to achieve the
    sound management of chemicals in relation to human health and the
    environment.

    Health & Environment International, Ltd., by agreement with WHO,
    performed independent literature searches on some of the substances on
    which data are summarized in this document in order to ensure that all
    relevant toxicological and related information was reviewed.

    ISBN 92 4 166040 6

    CONTENTS

    Preface

    Antioxidant
        tert-Butylhydroquinone (TBHQ)

    Emulsifiers
        Microcrystalline cellulose
       Sucrose esters of fatty acids and sucroglycerides

    Enzyme preparations
        alpha-Acetolactate decarboxylase
       Maltogenic amylase

    Sweetening agent
       Maltitol syrup

    Miscellaneous substance
       Salatrim (short- and long-chain acyltriglyceride molecules)

    Substances evaluated using the Procedure for the Safety Evaluation
    of Flavouring Agents
        Introduction
      Saturated aliphatic acyclic linear primary alcohols, 
            aldehydes and acids
      Saturated aliphatic acyclic branched-chain primary alcohols, 
            aldehydes and acids
      Aliphatic lactones
      Esters of aliphatic acyclic primary alcohols with branched-chain 
            aliphatic acyclic acids
      Esters of aliphatic acyclic primary alcohols with aliphatic 
            linear saturated carboxylic acids
      Esters derived from branched-chain terpenoid alcohols and 
            aliphatic acyclic linear and branched-chain
            carboxylic acids

    Contaminants
      Aflatoxins

    Annexes

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

        Annex 2 Abbreviations

        Annex 3 Participants in the forty-ninth meeting
                of the Joint FAO/WHO Expert Committee
                on Food Additives

        Annex 4 Acceptable Daily Intakes, other toxico-
                logical information and information
                on specifications

        Annex 5 Application of a threshold of toxicological
                concern in the safety evaluation of certain
                flavouring agents
     

    PREFACE

        The monographs contained in this volume were prepared at the
    forty-ninth meeting of the Joint FAO/WHO Expert Committee on Food
    Additives (JECFA), which met in Rome, Italy, 17-26 June 1997. 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-ninth report of JECFA will be published by the World
    Health Organization in the WHO Technical Report Series. Terms
    abbreviated in the monographs are listed in Annex 2. 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.
    Some of the substances listed in this annex were evaluated at the
    present meeting for residues only.

        Specifications established at the forty-ninth meeting of JECFA
    have been issued separately by FAO as Food and Nutrition Paper No. 52,
    Add. 5. 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 cited. 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. Special acknowledgement is made to these
    advisers. The monographs were edited by Dr P.G. Jenkins, International
    Programme on Chemical Safety.

        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 to
    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 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.

        This volume contains monographs prepared at the forty-ninth
    meeting of the Joint FAO/WHO Expert Committee on Food Additives
    (JECFA), which met in Rome, Italy, from 17 to 26 June 1997.
        The toxicological monographs in this volume summarize the safety
    data on a number of food additives, including the antioxidant  tert-
    butylhydroquinone, the emulsifiers microcrystalline cellulose and
    sucrose esters of fatty acids and sucroglycerides, the enzyme
    preparations  alpha-acetolactate decarboxylase and maltogenic
    amylase, the sweetening agent maltitol syrup, the low-caloried fat
    salatrim, a large number of flavouring agents, and aflatoxins. The
    data summarized in these monographs served as the basis for the
    evaluations performed by the Committee.
        This volume and others in the WHO Food Additives Series contain
    information that is useful to those who produce and use veterinary
    drugs and food additives, government and food regulatory officers,
    industrial testing laboratories, toxicological laboratories, and
    universities.





















    See Also:
       Toxicological Abbreviations