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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

    EVALUATION OF NATIONAL ASSESSMENTS OF INTAKE OF BUTYLATED
    HYDROXYANISOLE (BHA)

    First draft prepared by 
    Janis Baines 
    Australia New Zealand Food Authority, Canberra, Australia


    1.  INTRODUCTION

         The Committee assessed the intake of butylated hydroxyanisole
    (BHA), for which maximum limits have been proposed in a wide range of
    solid foods and water-based, flavoured, non-alcoholic drinks in the
    draft General Standard for Food Additives (GSFA) being developed by
    the Codex Committee on Food Additives and Contaminants (CCFAC). An ADI
    of 0-0.5 mg/kg bw has been allocated to BHA (Annex 1, reference 83).

         BHA is a food additive generally used as an antioxidant in
    products containing fats or oils and can be use in conjunction with
    butylated hydroxytoluene,  tert-butylhydroquinone, and propyl
    gallate, for a synergistic combination of antioxidants.

         Information was provided by 10 countries: Australia, Brazil,
    China, Finland, France, Japan, New Zealand, Spain, the United Kingdom,
    and the United States. A combined assessment was provided by Australia
    and New Zealand (Aus-NZ). The assessments were based on data on
    poundage, household economic surveys or sales data, information from
    model diets, and/or individual dietary records. A summary of the data
    submitted is given in Table 1. 

        Table 1. Summary of submissions on butylated hydroxyanisole

                                                                                             

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

    Australia-New Zealand    X                                 X         X
    Brazil                   X                    X                      
    China                    X        X                        X         
    Finland                           X                                  
    France                                        X                      X
    Japan                                                      X         
    Spain                    X        X           X                      
    United Kingdom                    X                        X         X 
    United States                     X                        X 
                                                                                             

    FBS, food balance sheet; HES, household economic survey; sales, retail stores
    
    2.  SCREENING OF BUTYLATED HYDROXYANISOLE BY THE BUDGET METHOD

         The Codex GSFA proposes to permit use of BHA in a wide range of
    solid foods and in water-based, flavoured drinks. Table 2 summarizes
    the calculations made by the budget method in each country, including
    the permitted patterns of BHA use, the proportion of solid foods and
    beverages likely to contain BHA, the maximum levels of BHA permitted,
    and a comparison of those levels with the theoretical maximum level
    calculated by the budget method for that country. 

         The theoretical maximum level of use for BHA in solid foods was
    less than the national permitted maximum in the four countries that
    submitted data and was also less than the GSFA level of 1000 mg/kg.
    The submission from the United Kingdom noted that a previous
    assessment of intake of BHA by the budget method had indicated to
    CCFAC that detailed intake assessment was required. 

         Spain and United States were the only countries in which use of
    BHA was reported to be permitted in beverages. As for solid food, the
    theoretical maximum level calculated by the budget method was less
    than the Spanish or GSFA permitted level of use. The United States did
    not submit detailed budget calculations, but it is likely that, as in
    Spain, at least 15% of the United States population consumes beverages
    that contain BHA. The theoretical maximum concentration would
    therefore be 17 mg/kg, which is lower than the 90 mg/kg permitted in
    beverage mixes in the United States.

         Detailed intake assessments are required for use of BHA in solid
    foods and beverages.

    3.  ASSESSMENTS OF INTAKE OF BUTYLATED HYDROXYANISOLE

    3.1  Assessments based on data on poundage (disappearance)

         Estimates based on poundage data of the amount of BHA available
     per capita in five countries are shown in Table 3. The estimates are
    all below the ADI, with the exception of those for Spain, and vary
    widely, from 0.01 mg/kg bw per day (1% of the ADI) for China to 
    0.48 mg/kg bw per day (100% of the ADI) for Spain. The mean
     per capita intake of BHA appears to have declined from 0.03 to 0.01
    mg/kg bw per day (from 6 to 2% of the ADI) in Finland between 1980 and
    1995, but appears to have increased from 0.01 to 0.07 mg/kg bw per day
    (from 2 to 10% of the ADI) in the United States between 1987 and 1995.

         The estimated intake of 100% of the ADI in Spain is higher than
    in other countries, even for high consumers in the United States
    (0.14 mg/kg bw per day for those in the 90th percentile in 1995).
    These differences may be due to the reported use of BHA in both solid
    foods and beverages in Spain. Furthermore, the maximum permitted level
    in beverages (200 mg/kg) is higher than that in all other countries
    (90 mg/kg). It should be noted that the European Union does not permit
    use of BHA in beverages. The Spanish data may have been collated
    before the European Directive was agreed. 


        Table 2. Estimates of theoretical maximum level for butylated hydroxyanisole (BHA) by the budget method 

                                                                                                                  

    Country                  % food or beverage      National maximum    GSFA maximum       Theoretical maximum
                             supply containing BHA   level (mg/kg)       levela (mg/kg)     level (mg/kg)
                                                                                                                  

    Australia-New Zealand    50% solid food          200                 1000 solid food    40 
    Brazil                   25% solid food          200                 1000 solid food    80
    China                    20% solid food          200                 1000 solid food    100
    Spainb                   5% solid food           400 solid food      1000 solid food    200 solid food
                             15% beverages           200 beverages       90 beverages       17 beverages
                                                                                                                  

    GSFA, General Standard for Food Additives
    a  Maximum use levels proposed are: 1000 mg/kg for 9.2.1, 'frozen fish, fish fillet and fish products, including 
       molluscs, crustacea and echinoderms'; 
       90 mg/kg for 14.1.4.3 'concentrates (liquid or solid) for water-based flavoured drinks'.
    b  Assumes that 50% BHA is used in solid food, 50% in beverages; current European Union directives do not permit 
       use of BHA in beverages
    

    3.2  Assessments based on data from food balance sheets and household 
         economic surveys

         No countries reported use of data from food balance sheets to
    assess the intake of BHA. The submission of the United Kingdom notes
    that such data are expressed as raw commodities, and the percentages
    of the commodities that are processed and likely to contain the
    additive are not usually known.

         Four countries submitted data based on household surveys or sales
    data, in which maximum levels of use were assumed. The data are
    summarized in Table 4. Although high consumers generally cannot be
    identified from household economic surveys or sales data, the
    submission from France included estimates of the potential intake of
    consumers at the 90th and 95th percentiles on the basis of data for
    high consumer households.

         Estimates of the intake of BHA based on household economic
    surveys and sales data indicate that the potential intakes are all
    below the ADI, ranging from 0.02 mg/kg bw per day (3% of the ADI) in
    France to 0.25 mg/kg bw per day (50% of the ADI) in Spain. The higher
    estimate for Spain may reflect the use of BHA in both solid foods and
    beverages, whereas it is permitted for use only in solid foods in
    France and Brazil.

    3.3  Assessments based on model diets

         Six countries submitted data based on model diets, details of
    which are summarized in Table 5. It is essential for the
    interpretation of estimates made with a model diet that the
    assumptions made in constructing each model diet be stated. The
    results cannot be compared directly because different assumptions were
    made. The model diets used in Aus-NZ and the United Kingdom were
    constructed to estimate the intake of a high consumer, assuming
    maximum additive concentrations. The model diet used in the United
    States was constructed to predict intake by a long-term consumer by
    using data on food consumption derived from food frequency tables for
    1982-88 from the Market Research Corporation of America (MRCA) and
    average portion sizes from a three-day national food consumption
    survey conducted in 1987-88 by the US Department of Agriculture.
    Maximum additive concentrations were assumed. The Japanese model diet
    is different in that analytical values for food additive
    concentrations were used with data on national food consumption to
    derive an estimate of actual BHA intake for the average consumer.

         Table 5 summarizes the estimates based on model diets. The
    estimates based on the high-consumer models of Aus-NZ and the United
    Kingdom both exceed the ADI, with adult intakes of 2 mg/kg bw per day
    (400% of the ADI) in the United Kingdom, and 1.8 mg/kg bw per day
    (360% of the ADI) in Aus-NZ. The model used in the United Kingdom for
    children indicates that the intake of BHA by young children, 5.4 mg/kg
    bw per day (1000% of the ADI), tends to be higher than the intake of
    adults because of higher ratios of food consumption to body weight. A

    similar estimate, 4.8 mg/kg bw per day (950% of the ADI), was
    submitted by China for high consumers; however, this is an
    overestimate of intake even for a high consumer, as high levels of
    consumption of five food groups are summed to give a total BHA intake.

         In general, the estimates of intake in Aus-NZ, China, and the
    United Kingdom are higher than those from the long-term consumer model
    in the United States, as might be expected from the assumptions made.
    In the United States model, the estimated intakes are 0.38 mg/kg bw
    per day (76% of the ADI) for a mean consumer and 0.76 mg/kg bw per day
    (150% of the ADI) for a 90th percentile consumer. If GSFA levels of
    BHA are assumed, both the mean and high-consumer intakes of BHA exceed
    the ADI.

         The Japanese estimate for BHA intake from their total diet survey
    was much lower (0.003 mg/kg bw per day or 1% of the ADI) than the
    results from other model diets, because the concentrations of BHA were
    those actually measured -- for example, 0 for frozen fish, fats, and
    oils, 12 mg/kg for dried fish, 1 mg/kg for salted fish -- which were
    much lower than the maximum GSFA permitted levels of 200 mg/kg for
    frozen, dried, or salted fish, fats, and oils. In the absence of
    information on national levels of permitted use, BHA intake in Japan
    was estimated by assuming maximum GSFA levels and the reported
    Japanese food consumption data (the model assumed 200 mg/kg for all
    surveyed foods except 750 mg/kg in chewing gum). The revised estimate
    of intake for Japan was 0.11 mg/day (20% of the ADI). 

         One useful aspect of the Aus-NZ and United Kingdom high-consumer
    models is that individual foods or food groups for which high
    consumption is likely to exceed the ADI can be identified. In the
    Aus-NZ model, assuming national additive use levels, high consumers of
    edible fat and fat emulsions may have BHA intakes that exceed the ADI
    (260% of the ADI). High consumers of dried mashed potato may have BHA
    intakes at the ADI (100%). In the United Kingdom model, high consumers
    of soup, processed vegetables, and comminuted meats may exceed the ADI
    (150, 140, and 130% of the ADI, respectively); however, this model
    diet assumed that the maximum concentration in fine bakery wares was
    200 mg/kg, a level that actually applies to fine bakery ware mixes.
    Fine bakery wares would not be identified if the correct level of 25
    mg/kg were used. If the proposed GSFA levels of BHA are substituted
    for national use levels in the models for the range of foods in which
    use is allowed, an additional list of foods is identified for which
    high consumption may result in BHA intakes that exceed the ADI. In the
    Aus-NZ model, such additional foods include cocoa and chocolate
    products, processed comminuted meat, fresh fish, and products
    including frozen fish, supplementary foods for dietary uses, and
    soups. Information on additional foods in which the concentration of
    BHA is at the GSFA level but not that of the European Union was not
    available for the United Kingdom model.


        Table 3. Estimates of intake of butylated hydroxyanisole (BHA) based on poundage data

                                                                                                                                           

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

    China            ?         Population, 1200 million     0.005                               1        Used only in solid foods
                               70% consumes BHA

    Finland          1980      Population, 4.9 million      0.03                                6        Used in 75% margarines, 25% oil
                     1994      Population, 5.1 million      0.01                                2        dressings only

    Spain            ?         Not consumed by 15% of       0.48                                100      Used in solid foods and beverages
                               population < 3 years

    United Kingdom   1984-86   Population, 56 million       0.007                               1        Used in limited number of solids
                                                                                                         foods only

    United States    1987      Population, 240 million      Mean, 0.01                          2        Used in solid foods and beverage
                                                            90th percentile consumers, 0.02     5        mixes
                     1995      Population, 260 million      Mean, 0.07                          10
                                                            90th percentile consumers, 0.14     30
                               100% consumes BHA
                               Intake for 90th percentile 
                               consumers is twice the mean
                                                                                                                                           

    a JECFA ADI, 0-0.5 mg/kg bw

    Table 4. Estimates of intake of butylated hydroxyanisole (BHA) based on household economic surveys and sales data

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

    Brazil   1992-96   AC Nielsan      Maximum national use levels for all foods, except chewing gumb    0.08                  20
                       Brazil;         Maximum national use levels, including chewing gum at             0.13                  20
                       sales data      GSFA level
                                       Population, 160 million

             1984-94   Datamark;       Maximum national use levels for all foods, except chewing gumb    0.09                  20
                       mainly from     Maximum national use levels, including chewing gum at             0.14                  30
                       manufacturers   GSFA level

    France   ?         Sales data      Maximum European Union levels of use; mean corrected for          0.02 (corrected)      3
                                       foods that never contain BHA in France (fats/oils)                0.08 (uncorrected)    20
                                       Adjustment for catering outside the home:
                                       90th percentile consumers                                         0.16 (uncorrected)    30
                                       95th percentile consumers                                         0.2 (uncorrected)     40

    Spain    1993      Household       All foods in permitted groups contain BHA                         0.25                  50
                       survey          Consumption inside and outside home
                                       No distinction for subgroups or rural/urban groups
                                                                                                                                       

    a JECFA ADI, 0-0.5 mg/kg bw
    b Assumed maximal level in final coconut and chewing gum products even though the use level in coconut is based on 60% fat content 
      and that in chewing gum is based on 20% gum content, resulting in overestimates of BHA intake

    Table 5. Estimates of intake of butylated hydroxyanisole (BHA) based on model diets       

                                                                                                                                               

    Country   Date     Survey                         Assumptions                                 Type of model             BHA intake   %ADIa
                                                                                                                            (mg/kg bw 
                                                                                                                            per day)
                                                                                                                                               

    Aus-NZ    1983     National, 24-h                 Two models: Aus-NZ /GSFA                    High consumerb
                       recall; adults,                -- maximum levels (Aus-NZ or GSFA)          Aus-NZ permissions        1.78         360
                       25-64 years;                   -- 95th percentile high consumption level   GSFA permissions          6.77         1400
                       sample, 6254;                  -- modified GSFA classification system 
                       body weight, 71 kg             -- corrections for premixes/drink bases

    China     1992     National household survey,     One model                                   Average consumer          0.69         140
                       24-h recall; 30 provinces;     -- maximum GSFA levels                      High consumer             4.77         950
                       sample, 91 818; 
                       body weight, 60 kg

    Japan     1994     Total diet/national            One model: Japan                            Average consumer levels   0.003        1
                       nutrition intake survey;       -- Analysed food additive concentrations    GSFA permissions          0.11         20
                       body weight, 60 kg                (zero values when not detected)          (selected foods only) 

    United    1986-87  National; 7-day weighed        Three models: UK adult/child, GSFA          High consumerb
    Kingdom            record; adults, 16-64 years;   -- maximum additive levels (EU)             UK permissions/adult      2.02         400
                       body weight, 60 kg             -- unit quantity diet (Codex model with     UK permissions/child      5.38         1100
              1992     National; 7-day  weighed          GSFA levels)                             Unit quantity diet/       5.83         1200 
                       record; children, 1.5-4.5      -- 97.5th percentile high consumption       GSFA permissions
                       years; body weight, 14.5 kg       level (UK adult/child models)
                                                      -- GSFA classification system

    United    1982-88  14-day menu obtained           Two models/ US and GSFA                     Long-term consumer
    States             from MRCA food                 -- maximum additive levels (US or GSFA)     US permissions/means      0.38         80
                       frequency data (1982-87)       -- 90th percentile high consumption level   US permissions/90th       0.76         150
                       combined with portion             twice mean consumption                   GSFA permissions/mean     0.94         190
                       sizes from USDA/NFCS           -- all respondents are consumers            GSFA permissions/90th     1.88         380 
                       (1987-88); > 2 years;          -- GSFA classification system (except 
                       body weight, 60 kg                FSDU)
                                                      -- corrections for premixes/drink bases
                                                                                                                                               

    Table 5 (continued)

    Aus-NZ, Australia-New Zealand; GSFA, General Standard for Food Additives; EU, European Union; MRCA, Market Research Corporation of America;
    USDA/NFCS, US Department of Agriculture/National Food Consumption Survey; FSDU, foods for special dietary uses
    a JECFA ADI, 0-0.5 mg/kg bw
    b Assumed to consume one food with potentially highest BHA intake from two major food groups at the 97.5th percentile (United Kingdom) or 
      95th percentile (Aus-NZ) and from one food with potentially highest BHA intake from each of the other major food groups at a mean level 
      for all respondents
    

    3.4  Assessments based on individual dietary records

         Estimates of the intake of BHA based on individual dietary
    records were submitted by three countries. Aus-NZ and France derived
    the mean and percentile intakes from individual estimates adjusted for
    individual body weight, while the United Kingdom did not. The
    assumptions made in deriving these estimates and the estimated intakes
    of BHA are summarized in Table 6.

         The estimates of mean intake of BHA based on individual dietary
    records and national use levels range from 0.03 to 0.39 mg/kg bw per
    day and are lower than the ADI for mean consumers in all countries and
    for high consumers in France and the United Kingdom. The lower
    reported intake in France (0.03 mg/kg bw per day) may be due to the
    exclusion of category 2 (edible fats and oils) in the estimates. There
    may be cause for concern for high consumers in Aus-NZ where the BHA
    intake is 0.91 mg/kg bw per day (130% of the ADI). Estimates of the
    intake of BHA based on GSFA levels and the range of foods in which use
    is allowed in Aus-NZ are higher than those based on national levels of
    use and exceed the ADI for both mean and high consumers.


    4.  EVALUATION OF ESTIMATES OF INTAKE OF BUTYLATED HYDROXYANISOLE

         In screening additives by the budget method, CCFAC identified BHA
    as an additive requiring detailed assessment. Inclusion of national
    proportions of food or beverages that may contain BHA in the budget
    method of screening did not alter this decision.

         Estimates of the intake of BHA were submitted by 10 countries.
    All of the approaches except that based on poundage were based on the
    assumption that the maximum permitted national levels represented
    actual additive levels, except in Japan where analytical data were
    used. Estimates based on maximum permitted additive levels result in
    overestimated actual intakes of additives. 

         Estimates of  per capita BHA intake based on poundage, household
    surveys, or sales data would be expected to predict lower intakes than
    those based on actual consumption, such as model diets and individual
    dietary records. In general, this was shown to be the case. Spain was
    the only country to submit intake estimates based on both poundage and
    household or sales data, the former being twice as high (100% of the
    ADI) as that based on sales data (50% of the ADI). The differences may
    be due to the fact that loss of additives in exported foods, non-food
    uses, and wastage are not taken into account in the poundage approach.

         Estimates of BHA intake based on high-consumer model diets and
    individual dietary records were submitted by Aus-NZ and the United
    Kingdom. In both cases, the estimates were two to three times higher
    than those based on individual dietary records of high consumers (95th
    percentile in Aus-NZ, 97.5th percentile in the United Kingdom). For
    these two submissions, the estimate based on individual dietary
    records was considered to be the most accurate. 


        Table 6. Estimates of intake of butylated hydroxyanisole (BHA) based on individual records 

                                                                                                                                           

    Country   Date     Survey                 Assumptions                                      Type of model        BHA intake     %ADIa
                                                                                                                    (mg/kg bw
                                                                                                                    per day)
                                                                                                                                           

    Aus-NZ    1983     National survey;       -- maximum additive levels (Aus-NZ or GSFA)      Mean Aus-NZ          0.39           80
                       24-h recall;           -- modified GSFA classification system           Mean GSFA            0.91           180
                       adults, 25-64 years;   -- maximum additive level within any one group
                       sample, 6254           -- corrections for premixes/drink bases          95th Aus-NZ          1.3            260
                                              -- reports 95th percentile consumption           95th GSFA            2.51           500  
                                              -- intakes adjusted for individual body weight  
                                              -- all respondents are consumers


    France    1993-94  5-75 years;            -- maximum additive levels (EU) but corrected    Mean EU              0.07           14
                       sample, 1116              for foods that never contain BHA in France    Corrected mean EU    0.03           6
                                                 (fats/oils)                                   90th EU              0.14           30
                                              -- adjusted for catering outside the home        85th EU              0.16           30
                                              -- intakes adjusted for individual body weight
                                              -- reports 90th, 95th percentile consumption
                                              -- reports by age group  

    United    1986-87  National survey;       -- maximum additive levels (EU)                  Mean EU              0.19           40
    Kingdom            7-day weighed          -- reports 97.5th percentile                     97.5th EU            0.45           90 
                       record; adults,        -- GSFA classification system
                       16-64 years;           -- assumes average body weight of 60 kg  

                                                                                                                                           

    Aus-NZ, Australia-New Zealand; GSFA, General Standard for Food Additives; EU, European Union
    a JECFA ADI, 0-0.5 mg/kg bw
    

         The estimates based on individual records in Aus-NZ were higher
    than those for the United Kingdom, and both were higher than the
    estimates for France. In the Aus-NZ calculations, several GSFA food
    categories were combined, and the maximum permitted level was assigned
    to the wider food group. This tends to overestimate intake. The Aus-NZ
    estimates were also based on 24-h recall data, which is likely to lead
    to overestimated intakes in comparison with the seven-day record
    method used in the United Kingdom, because the range of reported daily
    food consumption levels tends to be wider. Some important differences
    in food consumption were seen, however, with much higher oil and fat
    consumption reported in Aus-NZ (mean, 130 g/day; 95th percentile, 450
    g/day) than in the United Kingdom (mean, 23 g/day; 97.5th percentile,
    58 g/day). These differences may be due to use of different
    assumptions about the BHA concentration in various classes of oils and
    fats: the Aus-NZ model included all fats and oils (all GSFA category 2
    foods), consumed both as fats and oils and as ingredients in mixed
    foods. The United Kingdom model may have assumed that BHA was used in
    a more specific group of fats and oils, for example fat emulsions
    only.

         The estimates of mean national intake from the Chinese and United
    States model diets were in the same range as those based on individual
    dietary records in Aus-NZ and the United Kingdom. The estimated mean
    intakes for Japan, based on a model diet, and for France, based on
    individual records, were lower than those for other countries. All of
    the estimates for national mean intake of BHA, whether based on model
    diets or on individual dietary records, were lower than the ADI. 

         The estimated intakes from individual records in Aus-NZ and from
    model diets in the United States indicate that high consumers of the
    whole diet might exceed the ADI. In addition, high consumers of
    individual foods may exceed the ADI, assuming maximum permitted
    additive levels in individual countries. 

         Estimates derived by using GSFA additive levels grossly
    overestimate the actual intakes in any one country, because the GSFA
    is generally compiled by adopting the highest level of use of any one
    food category submitted to the CCFAC. The range of use specified in
    the GSFA is also much wider than in national standards. The best
    estimates from countries that submitted calculations based on GSFA
    levels in the range of foods in which it is allowed and model diets or
    individual records are summarized in Table 7. The mean BHA intakes in
    Aus-NZ (0.91 mg/kg bw per day) and the United States (0.94 mg/kg bw
    per day) are similar. The estimate for 95th percentile consumers in
    Aus-NZ is approximately three times higher than the mean intake in
    Aus-NZ and higher than the United States 90th percentile intake
    derived by multiplying the United States mean intake by two. These
    relationships between mean and 90th and 95th percentile intakes are
    generally recognized (UNEP/FAO/WHO, 1987).

    Table 7. Summary of estimates of intake of butylated hydroxyanisole (BHA) 
    based on additive levels permitted within the General Standard for Food 
    Additives

                                                                            

    Country   Model                                  Intake of BHA   % ADIa                                                                    
                                                     (mg/kg bw 
                                                     per day) 
                                                                            

    Aus-NZ    Individual records, mean BHA intake    0.91            180
              (all respondents are consumers)
              Individual records, 95th percentile
              BHA consumers                          2.51            500

    United    Model diet, mean BHA intake            0.94            190
    States    (all respondents are consumers)
              Model diet, 90th percentile BHA 
              consumers                              1.88            380
                                                                            

    a JECFA ADI, 0-0.5 mg/kg bw


         Estimates of intake based on GSFA maximum levels and the range of
    foods in which use of BHA is allowed indicate that the mean and the
    high consumer of BHA in Aus-NZ and the United States could exceed the
    ADI.


    5.  CONCLUSIONS AND RECOMMENDATIONS

    5.1  National estimates of intake of butylated hydroxyanisole based on 
         maximum limits specified in the General Standard for Food
         Additives

         Estimates of national mean intake based on maximum limits and the
    range of foods specified in the GSFA were available from two countries
    only; the mean intake estimates exceeded the ADI in these countries:
    180% of the ADI for Aus-NZ and 190% of the ADI for the United States.

    5.2  National estimates of intake of butylated hydroxyanisole based 
         on national or European Union maximum limits

         All of the estimates of national mean intake by consumers of BHA
    were lower than the ADI of 0-0.5 mg/kg bw: 1% of the ADI for Japan to
    80% of the ADI for Aus-NZ and the United States. These estimates were
    based either on model diets or on individual dietary records submitted
    by six countries, Aus-NZ, China, France, Japan, the United Kingdom,
    and the United States. Estimates of the intake of high consumers of
    BHA, based on food additive levels in national standards, exceed the
    ADI in some cases (30% of the ADI for France, 260% of the ADI for

    Aus-NZ); however, the available data were insufficient to estimate the
    number of high consumers or the magnitude or duration of intake at
    levels above the ADI over a lifetime.

         All of the estimates, with the exception of that from Japan, are
    based on the assumption that BHA is the only antioxidant in foods in
    which its use is permitted and that all such foods contain the
    additive at maximum permitted levels, thus tending to overestimate
    actual intake. Actual intakes of BHA depend on the relative
    proportions of BHA, butylated hydroxytoluene,
     tert-butylhydroquinone, and other antioxidants used in foods, the
    actual levels of use according to good manufacturing practice, and the
    the proportion of foods in any one category that contain the additive.

    5.3  Recommendations to the Codex Committee on Food Additives and 
         Contaminants

         The Committee identified foods and food groups that could
    potentially contribute to a high intake of BHA. The Codex Committee
    may wish to review the appropriate levels of BHA in the GSFA for
    category 2, 'edible fats and oils'; category 4.2.2.2, 'dried
    vegetables'; category 4.1.3, 'cocoa products'; category 8.3.1,
    'processed comminuted meat'; category 9.2.1, 'frozen fish, fillets and
    products; category 12.5.1, 'ready to eat soup and broths'; and
    category 13.6, 'food supplements'. 

         The Committee noted that intake estimates based on national
    maximum use levels of BHA were below the ADI, but those based on the
    maximum limits and range of foods specified in the GSFA exceeded it.
    The differences arise because the range of foods specified in the GSFA
    is wider and the proposed levels of use in specific food categories
    are generally higher than in national standards.


    6.  BIBLIOGRAPHY

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    See Also:
       Toxicological Abbreviations
       Butylated hydroxyanisole (BHA) (WHO Food Additives Series 15)
       Butylated hydroxyanisole (BHA) (WHO Food Additives Series 18)
       Butylated Hydroxyanisole (BHA) (IARC Summary & Evaluation, Volume 40, 1986)