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    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION





    SAFETY EVALUATION OF CERTAIN 
    FOOD ADDITIVES



    WHO FOOD ADDITIVES SERIES: 42





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





    World Health Organization, Geneva, 1999
    IPCS - International Programme on Chemical Safety



    This publication is a contribution to the International Programme on
    Chemical Safety.

    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 assessing 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 United Nations 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.

    CONTENTS

    Preface
    Flavouring agents
       trans-Anethole
      Furfural
      Menthol
    Food colour: Riboflavin from genetically modified  Bacillus subtilis 
    Preservative: Sulfur dioxide and sulfites
    Sweetening agent: Stevioside
    Thickening agents
       Carrageenan
       Processed  Eucheuma seaweed
       Sodium carboxymethyl cellulose, enzymatically hydrolysed
    Miscellaneous substances
       gamma-Cyclodextrin
       Glucono-delta-lactone and the calcium, magnesium, potassium, 
          and sodium salts of gluconic acid
       Polyglycitol syrups

    Safety evaluations of groups of related substances 
       evaluated by the Procedure for the Safety Evaluation 
       of Flavouring Agents
       Introduction
          General aspects of metabolism
       Saturated aliphatic acyclic secondary alcohols, ketones, 
          and related saturated and unsaturated esters
       Linear and branched-chain aliphatic unsaturated, unconjugated
          alcohols, aldehydes, acids, and related esters
       Aliphatic acyclic and alicyclic terpenoid tertiary alcohols 
          and structurally related substances
       Carvone and structurally related substances
       Ionones and structurally related substances
       Aliphatic acyclic and alicyclic a-diketones and related 
          alpha-hydroxyketones
       Substances structurally related to menthol

    Assessments of the intake of specific food additives
       Benzoates
       Butylated hydroxyanisole (BHA)
       Butylated hydroxytoluene (BHT)
       Sulfites
        tert-Butylhydroquinone (TBHQ)

    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  Participants in the fifty-first meeting of the 
                Joint FAO/WHO Expert Committee on 
                Food Additives

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

    PREFACE

    The monographs contained in this volume were prepared at the
    fifty-first meeting of the Joint FAO/WHO Expert Committee on Food
    Additives (JECFA), which met at WHO Headquarters in Geneva,
    Switzerland, 9-18 June 1998. These monographs summarize the safety
    data on selected food additives reviewed by the Committee.

    The fifty-first  report of JECFA will be published by the World Health
    Organization in the WHO Technical Report Series. Reports and other
    documents resulting from previous meetings of JECFA are listed in
    Annex 1. The participants in the meeting are listed in Annex 3 of the
    present publication; a summary of the conclusions of the Committee is
    given in Annex 4. Some of the substances listed in Annex 4 were
    evaluated at the meeting only for specifications. 

    Specifications that were developed at the fifty-first meeting of JECFA
    have been issued separately by FAO as Food and Nutrition Paper No. 52
    Add.6. The toxicological monographs in the present publication should
    be read in conjunction with the specifications and the report.

    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 represent the only data
    on safety available on those substances. The Temporary Advisers based
    the working papers they developed on all of the data that were
    submitted, and all of these reports were available to the Committee
    when it made its evaluations. The monographs were edited by E.
    Heseltine, Lajarthe, 24290 St Léon-sur-Vézère, France.

         The preparation and editing of the monographs included in this
    volume were 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.

         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 properties of the compounds evaluated in this
    publication 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