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    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION



    TOXICOLOGICAL EVALUATION OF CERTAIN
    FOOD ADDITIVES AND FOOD CONTAMINANTS



    WHO FOOD ADDITIVES SERIES 19



    Rome, 19-28 March 1984




         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 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 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.

    WHO Food Additives Series, 1984, No 19

    TOXICOLOGICAL EVALUATION OF CERTAIN FOOD ADDITIVES
    AND CONTAMINANTS

    The evaluations contained in this document

    were prepared by the Joint FAO/WHO

    Expert Committee on Food Additives*

    Rome, 19-28 March 1984

    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    IPCS

              

    *    Twenty-eighth report of the Joint FAO/WHO Expert Committee on
         Food Additives, Geneva, Wld Hlth Org. techn. Rep. Ser., 710,
         1984.

    INTRODUCTION

         The monographs contained in this document have been prepared by
    the Joint FAO/WHO Expert Committee on Food Additives which was held in
    Rome, 19-28 March 1984.

         The printing of this document has been possible through the
    financial contribution of the International Programme on Chemical
    Safety (IPCS) and the editing through the financial assistance of the
    International Life Science Institute (ILSI) which permitted to the
    Central Unit of the IPCS to engage an editor for the purpose.

         Apreciation is expressed to the Directors of the Lead
    Institutions of the IPCS collaborating in supporting the preparatory
    activities of JECFA's WHO side for allowing the experts acting as
    Temporary Advisers time to carry out their duties.

         A special acknowledgment is given to the following experts for
    preparing the drafts of the monographs: Professor C.L. Galli, Istituto
    di Farmacologia e Farmacognosia, UniversitÓ di Milano, Italy; Dr. J.E.
    Long, Food Directorate, Health Protection Branch, Department of Health
    and Welfare, Ottawa, Ontario, Canada; Dr. S.I. Shibko, Director
    Division of Toxicology, Bureau of Food and Drug Administration,
    Washington DC, USA; Dr. R. Walker, Department of Biochemistry,
    University of Surrey, Guildford, U.K.

         Any comment or new information on the biological and
    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 Organisation, Avenue Appia, 1211 Geneva 27,
    Switzerland.

    IPCS 1984

         For rights of reproduction of this document, in part or in
    toto, application should be made to the International Programme on
    Chemical Safety (IPCS), World Health Organisation, Geneva,
    Switzerland.

         The disignations employed and the presentation of the material in
    this publication do not imply the expression of any opinion whatsoever
    on the part of the Central Unit of the International Programme on
    Chemical Safety concerning the legal status of any country, territory,
    city or area or of 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 the
    International Programme on Chemical Safety in preference to others of
    a similar nature that are not mentioned.
    

    JOINT FAO/WHO EXPERT COMMITTEE ON FOOD ADDITIVES

    Rome, 19-28 March 1984.

    Members invited by FAO

    Dr. W.H.B. Denner, Principal Scientific Officer, Food Science
         Division, Ministry of Agriculture, Fisheries and Food, London,
         England.

    Dr. S.W. Gunner, Director, Bureau of Chemical Safety, Food
         Directorate, Health Protection Branch, Department of National
         Health and Welfare, Ottawa, Canada (Chairman).

    Professor K. Kojima, College of Environmental Health, Azabu
         University, Sagamihara-Shi, Kanagawa, Japan.

    Dr. J.P. Modderman, Food Additive and Animal Drug Chemistry,
         Department of Health and Human Sciences, Food and Drug
         Administration, Washington DC, USA.

    Professor F.J. Pellerin, Faculty of Pharmacy, University of Paris XI,
         Centre hospitalier Corentin-Celton, Issy-les-Moulineaux, France.

    Members invited by WHO

    Dr. H. Blumenthal, Director, Division of Toxicology, Bureau of Foods,
         Food and Drug Administration, Washington DC, USA.

    Professor E. Fournier, Professor of Clinical Toxicology,
         H˘pital Fernand-Widal, Paris, France.

    Dr. G. Nazario, Department of Food Standards, National
         Health Council, Rio de Janeiro, Brazil. Sao Paulo, Brazil.

    Dr. P. Pothisiri, Director, Technical Division, Food and Drug
         Administration, Ministry of Public Health, Bangkok, Thailand.

    Professor M.J. Rand, Head, Department of Pharmacology, University of
         Melbourne, Victoria, Australia (Vice-Chairman).

    Dr. A.N. Zaicev, Head, Laboratory of the Hygienic Examination of Food
         Additives, Institute of Nutrition, Academy of Medical Sciences,
         Moscow, USSR.

    Observers invited by FAO

    Mr. A. Feberwee, Chairman, Codex Committee on Food Additives, Ministry
         of Agriculture and Fisheries, The Hague, The Netherlands.

    Dr. R. Mathews, Director, Food Chemicals Codex, National Academy of
         Sciences, Washington DC, USA.

    Secretariat

    Dr. C.L. Galli, Professor of Experimental Toxicology, University of
         Milan, Italy (WHO Temporary Adviser).

    Mr. Y. Hayashi, Director, Division of Pathology, Biological Safety
         Research Centre, National Institute of Hygienic Sciences, Tokyo,
         Japan (WHO Temporary Adviser).

    Dr. J.E. Long, Head, Toxicological Evaluation Division, Health
         Protection Branch, Department of National Health and Welfare,
         Ottawa, Canada (WHO Temporary Adviser).

    Dr. B. MacGibbon, Senior Principal Medical Officer, Division Of
         Toxicology, Environmental Pollution and Prevention, Department of
         Health and Social Security, London, U.K. (rapporteur).

    Professor I. Nir, Department of Pharmacology and Experimental
         Therapeutics, Hadassah Medical School, Hebrew University,
         Jerusalem, Israel (WHO Temporary Adviser).

    Mr. Pearce, Director of Technical Services, Williams (Hounslow)
         Limited, London, England (FAO Consultant).

    Dr. A.W. Randell, Food Policy and Nutrition Division, FAO, Rome, Italy
         (Joint Secretary).

    Dr. N. Rao Maturo, Food Standards Officer, Food Policy and Nutrition
         Division, FAO, Rome, Italy.

    Dr. S.I. Shibko, Associate Director of Regulatory Evaluation, Division
         of Toxicology, Bureau of Food and Drug Administration, Washington
         DC, USA (WHO Temporary Adviser).

    Dr. P. Shubik, Resident Fellow, Green College, University of Oxford,
         England (WHO Temporary Adviser).

    Professor K. Topsy, Beau Bassin, Mauritius (WHO Temporary Adviser)

    Dr. G. Vettorazzi, Toxicologist, International Programme on Chemical
         Safety, Division of Environmental Health, WHO, Geneva,
         Switzerland (Joint Secretary).

    Dr. R. Walker, Department of Biochemistry, University of Surrey,
         Guildford, England (WHO Temporary Adviser).

    Mr. J. Wilbourn, Unit of Carcinogen Identification and Evaluation,
         International Agency for Research on Cancer, Lyons, France.

    ACCEPTABLE DAILY INTAKES AND INFORMATION ON SPECIFICATIONS

                                                   ADI for man (mg/kg
                               Specifications1     of body weight) [and
                                                   other toxicological
                                                   recommendations]

    A. SPECIFIC FOOD ADDITIVES

    Antioxidants

         Anoxomer                    ST            0-8

    Enzyme preparations

         Glucose isomerase
         (isolated from
         Streptomyces
         violaceoniger)              R             ADI not specified2
         Protease (isolated
         from Streptomyces
         fradiae)                    S             ADI withdrawn3

    Flavouring agents

         Trans-anethole              R             0-2.54
         Cinnamaldehyde              R             0-0.74
         Ethyl methylphenyl
         glycidate                   R             0-0.5
         alpha-Ionone                S             0-0.15
         beta-Ionone                 R             0-0.15
         Nonanal                     O             0-0.16
         Octanal                     R             0-0.16

    Food colours

         Amaranth                    R             0-0.5
         Brown HT                    R             0-1.5
         Erythrosine                 R             0-1.254
         Quinoline Yellow            RT            0-10

    Food solvents

         2-Nitropropane              ST            Temporary acceptance7
         Triethyl citrate            R             0-20

    Sweetening agents

         Saccharin                   S             0-2.54/8
         Saccharin, calcium          S             0-2.54/8
         Saccharin, potassium        N             0-2.54/8
         Saccharin, sodium           S             0-2.54/8

    Thickening agents

         Carrageenan and
         furcellaran                 RT            ADI not specified2
         Tara gum                    R             0-12.54

    B. CONTAMINANTS

    Potential migrants from food-contact materials

         Acrylonitrile                             Provisional acceptance9
         Bis(2-ethylhexyl)
           phthalate                               Provisional acceptance9
         Styrene                                   [0.0410]
         Vinyl chloride                            Provisional acceptance9

    Notes

    1    N, new specifications prepared; O, specifications not prepared;
         R, existing specifications revised; S, specifications exist,
         revision not considered or not required; the existing, new, or
         revised specifications are tentative and comments are invited.

    2    The statement "ADI not specified" means that, on the basis of
         the available data (chemical, biochemical, toxicological, and
         other), the total daily intake of the substance, arising from its
         use at the levels necessary to achieve the desired effect and
         from its acceptable background in food, does not, in the opinion
         of the Committee, represent a hazard to health. For that reason,
         and for reasons stated in the individual evaluations, the
         establishment of an acceptable daily intake (ADI) is not deemed
         necessary.

    3    Insufficient toxicological data available.

    4    Temporary acceptance.

    5    Group ADI for alpha-ionone and beta-ionone, singly or in
         combination.

    6    Group ADI for octanal and nonanal, singly or in combination.

    7    The previous recommendation that 2-nitropropane should not be
         used as a solvent in food processing changed to temporary
         acceptance for use as a fractionating solvent for edible fats and
         oils only, with the stipulation that residue levels are kept to
         the lowest technologically attainable, which is understood to be
         lower than the detection limit by current analytical methods.

    8    Group ADI for saccharin, saccharin calcium, saccharin sodium,
         and saccharin potassium, singly or in combination.

    9    The use of food-contact materials from which the substance may
         migrate is provisionally accepted, on condition that the amount
         of the substance migrating into the food is reduced to the lowest
         level technologically attainable.

    10   This figure represents the provisional maximum tolerable daily
         intake (PMTDI) of styrene. It is not an ADI. The MTDI for styrene
         is provisionally accepted under the same conditions as those set
         out in Note 9.

    11   The existing specifications for some salts of fatty acids are
         incorporated in the new specifications.

    12   Replaces the specification for methyl violet, of which the
         colour crystal violet is a purified compound.

    13   The existing specifications incorporated into a single
         specification covering a series of related substances.

    14   No knowledge of the continuing use of the colour in food and no
         information received with regard to the specifications over a
         long period of time.

    15   No ADI allocated because of insufficient data.

    16   The colour is little used and it is understood its use will be
         discontinued.

    17   Specifications withdrawn at previous meetings.

    CONTENTS

    THE MONOGRAPHS

    Food additives

    Amaranth*

    Anoxomer*

    Brown HT*

    Carrageenan and furcellaran

    Erythrosine

    Glucose isomerase (isolated from Streptomyces violaceoniger)

    alpha- and ▀-Ionone

    2-Nitropropane

    Quinoline yellow

    Saccharin, calcium, potassium and sodium salts

    Triethyl citrate*

    Food contaminants

    Acrylonitrile

    Bis (2-ethylhexyl) phtbalate

    Styrene

    Vinyl chloride

              

    *    Monograph addendum
    





















    See Also:
       Toxicological Abbreviations