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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

    ASSESSMENT OF INTAKE OF SPECIFIC FOOD ADDITIVES



    EVALUATION OF NATIONAL ASSESSMENTS OF INTAKE OF ANNATTO EXTRACTS (BIXIN)

    First draft prepared by Philippe Verger

    French Observatory of Food Consumption, National Agricultural Research
    Institute, Paris, France

    Introduction
    Screening of annatto extracts by the budget method
    Assessments of intake of annatto extracts
         Assessments based on data on poundage (disappearance)
         Assessments based on data from household economic surveys
         Assessments based on model diets
         Assessments based on individual dietary records
    Evaluation of estimates of intake of annatto extracts
    Conclusions and recommendations
    Bibliography

    1.  INTRODUCTION

         The Committee last examined the toxicity of annatto extracts,
    which are food additives used to impart a yellow colour to food, at
    its twenty-sixth meeting (Annex 1, reference  59) and allocated an
    ADI of 0-0.065 mg/kg bw expressed as bixin. At its present meeting,
    the Committee assessed the intake of annatto extracts. National
    authorizations are also generally expressed in terms of the primary
    chemical colouring agent in the extracts, bixin, which is assumed to
    be present at a minimum concentration of 0.2% and a maximum of 3.5% of
    the total annatto extracts, with typical concentrations assumed in the
    assessments of different countries of 3-3.5%.

         Annatto extracts are proposed for use in a wide range of solid
    foods in the draft General Standard for Food Additives (GSFA) that is
    being developed by the Codex Committee on Food Additives and
    Contaminants. Information was received from seven countries:
    Australia, Brazil, Canada, France, the Netherlands, the United
    Kingdom, and the United States. The assessments were conducted on the
    basis of a variety of assumptions about the potential concentrations
    of annatto extracts and for various consumption patterns. The
    submissions are summarized in Table 1.

    2.  SCREENING OF ANNATO EXTRACTS BY THE BUDGET METHOD

         The Codex GSFA proposes that annatto extracts be permitted for
    use in a wide range of solid foods. Table 2 summarizes the data from
    the Netherlands, which includes the concentration permitted for use in
    Europe, the proportion of the solid food supply likely to contain
    annatto, the maximum levels of annatto permitted by GSFA, and a
    comparison of these levels to the theoretical maximum level calculated
    by the budget method for European countries.

        Table 1. Summary of submissions on annatto extracts
                                                                              

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

    Australia                                                        
    Brazil                                                          
    Canada                                                           
    France                                                          
    Netherlands                                                     
    United Kingdom                                        
    United States                                                  
                                                                              

    FBS, food balance sheet; HES, household economic survey; sales, retail stores
    
         The theoretical maximum level of use for annatto in solid foods
    was less than the maximum permitted level for the country that
    submitted data (25 mg/kg) and was also less than the GSFA level of
    1000 mg/kg. A detailed assessment of the intake of annatto from its
    use in solid foods is therefore required.

    3.  ASSESSMENTS OF INTAKE OF ANNATTO EXTRACTS

    3.1  Assessments based on data on poundage (disappearance)

         Estimates of the amount of annatto extracts available per capita
    based on poundage data are given in Table 3 for five countries and
    compared with the ADI of 0-0.065 mg/kg bw. The estimated intakes are
    less than the ADI, except in Brazil, and vary from 0.005 to 0.14 mg/kg
    bw per day (7.6-215% of the ADI). The poundage method shows a
    significant increase in the use of this additive in the USA between
    1987 and 1996.

    3.2  Assessments based on data from household economic surveys

         France submitted data from household surveys and data on sales,
    and the estimated intake was based on national maximum levels of use
    (Table 4). The estimates indicate that the potential intake of annatto
    extracts by high consumers (0.034 mg/kg bw per day) represents 52% of
    the ADI. Although it is generally not possible to identify high
    consumers from household economic surveys, in this submission high
    consumption of annatto extracts was estimated by dividing the
    household consumption by the number of members of the household in
    order to derive the intake of individual consumers.

        Table 2. Estimate of a theoretical maximum level for annatto extracts
    by the budget method
                                                                        

    Country         % solid food      National   GSFA       Theoretical
                    containing        maximum    maximum    maximum
                    annato extracts   level      levela     level
                                      (mg/kg)    (mg/kg)    (mg/kg)
                                                                        

    Netherlands     25                25         1000       10.4
                                                                        

    a The draft General Standard for Food Additives (GSFA) proposes a
      maximum use level of 1000 mg/kg for food category 8.1.1.2, mince
      of fresh meat, poultry, and game

    Table 3. Estimates of intake of annatto extracts based on poundage data
                                                                                   

    Country          Date      Consumers      Estimated intake         % ADIa
                               (millions)     of bixin (mg/kg                
                                              bw per day)
                                                                                   

    Brazil           1997      44.6 (28% of   0.14                     215
                               population)

    United Kingdom   1984-86   56             0.0083                   12.8

    United States    1987      244            Mean, 0.005              7.7
                                              90th percentile, 0.01    15.4
                     1996      260            Mean, 0.008              12.3
                                              90th percentile, 0.016   24.6
                                                                                   

    a JECFA ADI, 0-0.065 mg/kg bw
    b Assumes that all persons are consumers and that the 90th percentile
      intake is twice the mean intake.
    
    3.3  Assessments based on model diets

         The USA submitted data based on model diets, details of which are
    summarized in Table 5. The model diet was constructed to predict the
    intake of annatto by a long-term consumer by using food consumption
    data derived from food frequency data for 1982-88 from the Market
    Research Corporation of America and average portion sizes from the
    1987-88 three-day national food consumption survey of the US
    Department of Agriculture. Maximum additive levels were assumed. The
    estimates of intake of annatto extracts do not exceed the ADI.

    3.4  Assessments based on individual dietary records

         Intake estimates for annatto extracts based on individual dietary
    records were submitted by six countries. In each case, the mean and
    specified percentile estimates were derived for individuals adjusted
    for body weight, except in the Canadian assessment. The assumptions
    made and the intake estimates derived are summarized in Table 6.

        Table 4. Estimates of intake of annatto extracts based on household
    economic surveys and sales data
                                                                                  

    Country   Date    Survey   Assumptions             Estimated            % ADIa 
                                                       intake of bixin
                                                       (mg/kg bw per day)
                                                                                  

    France    1995    Sales    Maximum European        0.034                52
                      data     Union levels of use, 
                               with adjustment for
                               catering outside the
                               home (1994)
                                                                                  

    a JECFA ADI, 0-0.065 mg/kg bw
    
         The estimates based on individual dietary records and national
    use levels indicate intakes of bixin lower than the ADI for mean
    consumers in all countries except Australia and Brazil. For Australia,
    the estimates were based on the asumption that annatto is used only in
    all the products in each food class for which permission has been
    granted. For Brazil, the estimate was made for a specific at-risk
    population which consumes annatto extracts in large amounts after
    direct addition to foods as a condiment; the results do not correspond
    to the mean exposure of the total Brazilian population.

         For high consumers, the reported intakes were below the ADI in
    the USA and about twice the ADI in Brazil, Canada, France, and the
    Netherlands. All the countries except Brazil recognized that the
    results are overestimates because they assume maximum additive
    concentrations in all food categories in which annatto is authorized
    for use or might be used. Australia reported intakes that were above
    the ADI but recognized that very conservative assumptions were made.
    Moreover, the Australian survey is based on a one-day food intake
    recall, which would contributes to the overestimate of bixin intake.


        Table 5. Estimates of intake of annatto extracts based on model diets
                                                                                                                             

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

                                                                                                                             

    United     1982-88    14-day menu obtained      Long-term consumer      Long-term consumer
    States                from MRCA food            - maximum additive         Mean               0.028            43
                          frequency data (1982-87)    levels (GSFA)            90th percentile    0.73             86
                          combined with portion     - 90th percentile
                          sizes from USDA/NFCS        high consumption
                          (1987-88); > 2 years        level twice mean
                                                      consumption
                                                    - all respondents
                                                      are consumers
                                                    - GSFA classification
                                                      system
                                                                                                                              

    GSFA, General Standard for Food Additives; MRCA, Market Research Corporation of America; USDA/NFCS,
    US Department of Agriculture/National Food Consumption Survey

    a  JECFA ADI, 0-0.065 mg/kg bw
    

    4.  EVALUATION OF ESTIMATES OF INTAKE OF ANNATTO EXTRACTS

         Screening of additives by the budget method indicated that
    annatto extracts require further assessment for use as an additive.
    Inclusion of national proportions of the food supply that may contain
    annatto extracts did not change this decision.

    5.  CONCLUSIONS AND RECOMMENDATIONS

         The Committee concluded that intake of annatto extracts would
    exceed the ADI for bixin if all foods contained annatto extracts at
    the levels proposed in the draft General Standard for Food Additives.
    Intakes based on national permissions would not exceed the ADI for
    most populations. Since estimates of intake that result from use of
    the general assumption that all foods in a category are coloured by
    the same additive at the maximum level are overestimates, the
    Committee recognized that the ADI for bixin is unlikely to be exceeded
    as a result of use of annatto extracts. However, information from
    Brazil indicated that about 44 million people (28% of the population)
    consume annatto seeds directly as a condiment and have done so for
    many years, at a level of consumption that is approximately 150% of
    the ADI.

         Although the results of studies in humans normally take
    precedence over those in experimental animals, the submitted reports
    were of only limited value. In order to ensure that all of the
    relevant data on annatto extrcts have been reviewed, the Committee
    recommended their re-evaluation in 2001. The Committee also
    recommended that populations with a high intake of annatto extracts
    continue to be monitored.


        Table 6. Estimates of intake of annatto extracts based on individual dietary records
                                                                                                                                       

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

    Australia    1985      National survey;     - maximum additive levels            Mean intake                    0.14         205
                           24-h recall;           (Australia or GSFA)                (population = consumers)
                           adults, > 2 years;   - modified GSFA classification       Australia
                           sample, 13 858         system
                                                - maximum additive level             Mean intake                    0.87         1246
                                                  within any one group               (population = consumers)
                                                - reports 95th percentile            GSFA
                                                  consumption 
                                                - intakes adjusted for
                                                  individual body weight             95th percentile                0.47         672
                                                                                     (consumers) Australia
                                                                                     95th percentile                2.54         3634
                                                                                     (consumers) GSFA

    Brazil       1998      Local; food          All members of household             Mean consumption               0.097-       149-
                           frequency            considered to be consumers                                          0.103        158
                           questionnaires; 
                           one-month recall, 
                           202 households, 
                           849 consumers. 
                           High consumers 
                           of 'Colorifico'

    Canada       1973      National             -  maximum additive levels           Mean intake of                 1.2a         64
                                                -  intakes adjusted for              all persons                    0.042b
                                                   individual body weight
                                                -  reports 95th, 97.5th
                                                   percentile consumption            Mean intake in                 3.0a         161
                                                -  reports by age group              worst case                     0.105b

    Table 6. (continued)
                                                                                                                                       

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

    France       1993-94   National;            - maximum additive levels (EU)       Mean intake (population) EU    0.027        41
                           7-day record;        - adjusted for catering              90th percentile EU             0.052        80
                           5-75 years;            outside the home
                           sample, 1116         - intakes adjusted for
                                                  individual body weight             97.5th percentile EU           0.083        127
                                                - reports 90th, 95th 
                                                  percentile consumption             
                                                - reports by age group               Corrected mean intake EU       0.006        9.2
                                                                                     (population) 
    Netherlands  1992      National; 2-day      - maximum additive levels (EU)       Mean intake (population) EU    0.028        43
                           record; 5-65         - intakes adjusted for individual    95th percentile EU             0.104        160
                           years; sample,         body weight
                           6000                 - reports 95th, 97.5th               97.5th percentile EU           0.158        243
                                                  percentile consumption
                                                - reports by age group               Maximum                        0.669
                                                                                     Corrected mean intake                       < 100
                                                                                     (population) EU
    United       1989-92   48 states and                                             Mean intake (total             0.018        28
    States                 Washington DC;                                            population)                                 29
                           3-day recall;                                             Mean intake (consumers)        0.019
                           all age groups;
                           sample, 11 912                                            90th percentile (total         0.046        70
                                                                                     population)                    0.048        74
                                                                                     90th percentile (consumers)
                                                                                                                                       

    GSFA, General Standard for Food Additives; EU, European Community
    a  JECFA ADI, 0-0.07 mg/kg bw; not corrected for bixin
    b  Assuming 3.5% bixin
    

    6.  BIBLIOGRAPHY

    Australia-New Zealand Food Authority (1997)  Aus-NZ Food Standards
     Code, Canberra.

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

    Codex Committee on Food Additives and Contaminants (1997)  Report of
     the Twenty-ninth Session of the Codex Committee on Food Additives
    and  Contaminants, Rome, Food and Agriculture Organization of the
    United Nations (document ALINORM 97/12A, Appendix V).

    Commission of the European Communities (1979)  Reports of the
     Scientific Committee for Food, Eighth Series, Luxembourg.

    European Commission (1995)  European Union Directive 95/2/CE,
    Brussels

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

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

    Salminen, J.W. Comments about the list of substances scheduled for
    evaluation by the JECFA. Health Protection Branch, Ottawa, submitted
    to FAO, 16 December 1998.

    TNO Nutrition and Food Research Institute (1999) Assessment of the
    intake of selected additives with a screening approach, Zeist.
    Submitted to FAO by the Ministry of Health, Sport and Welfare, The
    Hague, 21 May 1999.

    Toledo, C.F. National intake assessment of the intake of bixin in
    Brazil. Faculty of Food Enginneering, University of Campinas,
    Campinas. Submitted to FAO, 1999.

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


    See Also:
       Toxicological Abbreviations
       Annatto Extracts (WHO Food Additives Series 52)
       Annatto extracts (FAO Nutrition Meetings Report Series 46a)
       Annatto extracts (WHO Food Additives Series 6)
       Annatto extracts (WHO Food Additives Series 17)
       ANNATTO EXTRACTS (JECFA Evaluation)