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    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION





    SAFETY EVALUATION OF CERTAIN FOOD
    ADDITIVES AND CONTAMINANTS



    WHO FOOD ADDITIVES SERIES: 44





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





    World Health Organization, Geneva, 2000
    IPCS - International Programme on Chemical Safety


    EVALUATION OF NATIONAL ASSESSMENTS OF INTAKE OF CANTHAXANTHIN

    First draft prepared by M. DiNovi

    Division of Product Manufacture and Use, Office of Premarket Approval,
    Center for Food Safety and Applied Nutrition, United States Food and
    Drug Administration, Washington DC, United States

    Introduction
    Assessments of intake of canthaxanthin
         Assessments based on data on poundage (disappearance)
         Assessments based on model diets
         Assessments based on individual dietary records
    Evaluation of estimates of intake of canthaxanthin
    Conclusions and recommendations
    Bibliography

    1.  INTRODUCTION

         The Committee evaluated the toxicity of canthaxanthin, a food
    additive used to colour foods both directly and also indirectly
    through its use in animal feeds, at its tenth, eighteenth,
    thirty-first, thirty-fifth, and forty-fourth meetings (Annex 1,
    references  13,  35,  77,  88, and  116). It established an ADI of 0-25
    mg/kg bw at its eighteenth meeting, which it reduced to 0-0.05 mg/kg
    bw and made temporary at its thirty-first meeting. This temporary ADI
    was not extended by the Committee at its thirty-fifth meeting. At its
    forty-fourth meeting, the Committee established an ADI of 0-0.03 mg/kg
    bw. The present Committee assessed the intake of canthaxanthin.
    Maximum limits have been proposed for its use in a variety of solid
    foods and beverages in the draft General Standard for Food Additives
    (GSFA) being established by the Codex Committee on Food Additives and
    Contaminants.

         Four member countries provided information on the intake of
    canthaxanthin: Australia, New Zealand, the United Kingdom, and the
    United States. Information was also provided by a manufacturer of
    canthaxanthin. A joint assessment was submitted by Australia and New
    Zealand. The intake assessments were based on 'poundage' data, model
    diets, and individual dietary records. A summary of the data
    submissions is given in Table 1.

    2.  ASSESSMENTS OF INTAKE OF CANTHAXANTHIN

    2.1  Assessments based on data on poundage (disappearance)

         In the United Kingdom, the recorded poundage for canthaxanthin is
    0, indicating that there is no direct use of the colour as an
    additive. In the United States, disappearance data for 1987 were used
    to estimate a per capita poundage of canthaxanthin of 0.0002 mg/kg bw
    per day and a 'pseudo-90th percentile' intake of 0.0004 mg/kg bw per
    day, representing approximately 1% of the ADI. This estimate is based
    on the assumption that the reported poundage represented only 60% of
    the amount which actually disappeared and was corrected for presumed

    underreporting. An extensive report provided by the producer on the
    poundages of canthaxanthin that disappeared in 1995-97 in 75 countries
    in which canthaxanthin is used directly and indirectly presents
    analyses that take into account the deposition of canthaxanthin in
    foods from its indirect use in feed, primarily in eggs, fish, and
    poultry. The report also describes imports and exports of
    canthaxanthin, where appropriate. In none of the 75 countries does the
    per capita intake estimated on this basis approach the ADI. The
    highest estimated per capita intakes during 1995-97 were in Portugal
    and Norway, representing approximately 7 and 8% of the ADI,
    respectively.

        Table 1. Summary of submissions on canthaxanthin
                                                                                     

    Country or company       Budget    Poundage    FBS/HES/     Model     Individual 
                             method    data        sales data   diets     dietary
                                                                          records
                                                                                     

    Australia-New Zealand                                                 
    F. Hoffman-La Roche                           
    United Kingdom                                                       
    United States                                                       
                                                                                     
    FBS, food balance sheet; HES, household economic survey; sales, retail stores
    
    2.2  Assessments based on model diets

         The United States submitted analysis of canthaxanthin intake
    based on model diets. For proper interpretation of such analyses, the
    assumptions on which they are based must be clearly stated. In this
    case, the model diet was constructed to predict the canthaxanthin
    intake of an average and a 90th percentile consumer and was completed
    by combining food consumption data derived from a 14-day food
    frequency survey made during 1982-88 by the Market Research
    Corporation of America with average portion sizes from a three-day
    national food consumption survey conducted in 1987-88 by the US
    Department of Agriculture. The levels of use of canthaxanthin proposed
    in the draft GSFA were used for all food categories.

         The analysis yielded a mean estimate of intake of canthaxanthin
    of 0.27 mg/kg bw per day, representing 900% of the ADI, and an
    estimated intake at the 90th percentile of 0.54 mg/kg bw per day,
    1800% of the ADI. It should be noted that the conservative assumption
    was made in this analysis that all the canthaxanthin used in animal
    feed indirectly colours food and is transferred to consumed animal
    products.

    2.3  Assessments based on individual dietary records

         Three countries submitted analyses of canthaxanthin intake based
    on individual dietary records (Table 2). The combined Australia-New
    Zealand analysis was based on food intake data from a one-day recall
    survey of 13 858 individuals and proposed GSFA use levels, as there
    are no permitted direct uses for canthaxanthin in Australia. When the
    level of use proposed in the GSFA was reported as that concordant with
    good manufacturing practice, a level of zero was assumed. Further, it
    was assumed that canthaxanthin coloured any food in which it occurred
    and that the average weight of a consumer is 67 kg.

         In the analysis completed in the United Kingdom, 97.5th
    percentile food intakes from two surveys--a survey of adults in 1990
    and one of children in 1995--were combined with the maximum reported
    or theoretically possible concentrations in eggs, poultry, salmon, and
    trout. Actual body weights were used in the calculations.

         The analysis supplied by the United States was based on food
    intakes from a three-day recall survey combined with reported or
    allowable levels of use of canthaxanthin in five broad food
    categories. Actual body weights were used.

         When national measured or regulatory levels of use of
    canthaxanthin are combined with mean food intakes, the estimated
    intake is equal to or below the ADI, but analyses of estimated intakes
    at the 90th, 95th, or 97.5th percentile exceed the ADI. Use of the
    draft GSFA maximum use levels results in estimates of intake that
    greatly exceed the ADI.

    3.  EVALUATION OF ESTIMATES OF INTAKE OF CANTHAXANTHIN

         The data submitted show that canthaxanthin is rarely used
    directly for colouring food anywhere in the world, but is primarily
    used to colour the meat of poultry, salmon, and trout and the yolks of
    eggs indirectly through animal feeds. Therefore, estimates of intake
    that are based on procedures used to determine intake of direct
    additives will necessarily result in overestimation of probable
    intake.

         The submission of the producing company provided a comprehensive
    picture of the actual use of and resulting intake of canthaxanthin. In
    no country does the estimated  per capita intake approach the ADI if
    account is taken of the amount of canthaxanthin that is deposited in
    animal flesh when it is used in animal feed  Additionally, since the
    highly conservative national estimates of intake at mean consumption
    levels do not exceed the ADI, assurance is provided that long-term
    intake of canthaxanthin is unlikely to exceed the ADI. The Committee
    concluded that per capita estimates are appropriate, as the foods that
    are indirectly coloured by canthaxanthin are primary components of
    most diets and would probably be consumed by a large percentage of the
    population.


        Table 2. Estimates of intake of canthaxanthin based on individual dietary records 
                                                                                                                                

    Country        Date       Survey                 Assumptions                         Model                 Intake      % ADIa
                                                                                                               (mg/kg bw
                                                                                                               per day)
                                                                                                                                

    Australia-     1985       National nutrition     - maximum additive levels (GSFA)    Mean intake (all      0.44        1470
    New Zealand               survey; 24-h           - modified GSFA classification      respondents) GSFA     0.46        1530
                              recall; 2- > 70          system                            Mean intake           2.11        7030
                              years; sample,         - maximum additive level within     (consumers) GSFA 
                              13 858                   any one group                     95th percentile 
                                                     - reports 95th percentile           (consumers) GSFA
                                                       consumption
                                                     - intakes adjusted for 
                                                       individual body weight 

    United         1990,      Dietary and            97.5th percentile intake            National adult use    0.01        30
    Kingdom        1995       nutritional survey                                         levels                0.04        130
                              of British adults,                                         National use by 
                              National Diet and                                          children aged 1-4
                              Nutrition Survey,
                              children

    United         1989-      48 states and          - national use levels               Mean                  0.031       100
    States         92         Washington DC;         - eaters only                       90th percentile       0.11        370
                              3-day recall;
                              all age groups;
                              sample, 11 912
                                                                                                                                

    GSFA, General Standard for Food Additives
    a     JECFA ADI, 0-0.3 mg/kg bw
    

    4.  CONCLUSIONS AND RECOMMENDATIONS

         The Committee noted that estimates of the intake of canthaxanthin
    that are based on the assumption that it is used directly in all foods
    at the maximum levels proposed in the draft General Standard for Food
    Additives greatly exceed the ADI, as the General Standard proposes
    much broader use in food than occurs in those countries in which
    canthaxanthin is used. Intake based on national data did not exceed
    the ADI. The data submitted by the manufacturer indicated that
    indirect exposure to canthaxanthin from its use as a feed colourant is
    the major source of intake.

         The Committee concluded that use of canthaxanthin will not result
    in long-term intake that exceeds the ADI.

    5.  BIBLIOGRAPHY

    Baines, J. Estimated intake assessment for canthaxanthin in Australia.
    Personal communication. Australia-New Zealand Food Authority,
    Canberra, to FAO, January 1999.

    Fisher, C.E. Dietary exposure to the four additives referred to JECFA
    by CCFAC. London: Ministry for Agriculture, Fisheries and Food, Joint
    Food Safety and Standards Group. Submitted to FAO, 22 December 1998.

    F. Hoffmann-LaRoche Ltd. Canthaxanthin intake 1995-1997. A poundage
    approach for evaluation by JECFA. April 1999. Submitted to WHO by F.
    Hoffmann-LaRoche Ltd, Basel, Switzerland.

    Rulis, A.M. United State intake data on canthaxanthin. Food and Drug
    Administration, Washington DC, submitted to FAO, 10 December 1998.

    Verger, P. Estimation of the theoretical maximum intake for certain
    food additives in France, Observatory of Food Consumption, Paris.
    Personal communication, submitted to FAO, 1 June 1999.
    


    See Also:
       Toxicological Abbreviations
       Canthaxanthin (WHO Food Additives Series 22)
       Canthaxanthin (WHO Food Additives Series 26)
       Canthaxanthin (WHO Food Additives Series 35)
       CANTHAXANTHIN (JECFA Evaluation)