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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 SULFITES

    First draft prepared by 
    Dr Michael DiNovi
    Division of Product Manufacture and Use, Office of Premarket Approval
    (HFS-246), Center for Food Safety and Applied Nutrition United States
    Food and Drug Administration 
    Washington DC, United States


    1.  INTRODUCTION

         The Committee assessed the intake of sulfur dioxide and related
    compounds, including calcium, potassium, and sodium hydrogen sulfite,
    calcium, potassium, and sodium metabisulfite, calcium, potassium, and
    sodium sulfite, and sodium thiosulfate, which are related food
    additives used as preservatives. Maximum limits have been proposed for
    their use in a wide variety of solid foods and beverages in the draft
    General Standard for Food Additives (GSFA) being developed by the
    Codex Committee on Food Additives and Contaminants (CCFAC). These
    compounds were evaluated previously by the Committee at its sixth,
    eighth, ninth, seventeenth, twenty-seventh, and thirtieth meetings
    (Annex 1, references 6, 8, 11, 32, 41, 62, and 73). They were also
    evaluated at the present meeting (see monograph, p. 95). The Committee
    established a group ADI for sulfites of 0-0.7 mg/kg bw at its
    seventeenth meeting, which was retained at the thirtieth and the
    present meeting. 

         The sulfites are in some ways unique additives, in that the level
    of use typically does not reflect the level remaining in a food at the
    time of ingestion owing to losses during the processing and storage of
    treated foods. For example, dried vegetables, which may contain up to
    5000 ppm sulfites according to the GSFA, are usually rehydrated and
    cooked before ingestion, resulting in much lower concentrations of
    sulfite in the food at the time of consumption.

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

    2.  SCREENING OF SULFITES BY THE BUDGET METHOD

         The budget method was used to determine the maximum concentration
    of sulfite that would be safe for use in food at an ADI of 0-0.7 mg/kg
    bw. National submissions included information on whether sulfites were
    used in solid foods only, in beverages only, or in both. When they are
    used in both solid foods and beverages, the ADI is 'shared' in stated
    proportions. The GSFA proposes to permit sulfites in a wide range of
    solid foods and beverages. Table 2 summarizes the data for each

        Table 1. Summary of submissions on sulfites

                                                                                       

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

    Aus-NZ             x                                   x        x
    China              x                                   x        
    Finland                      x                                  
    France                                   x                      x
    India              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
    
    country, including the permitted patterns of use, the proportion of
    the solid food and beverage supply likely to be treated with sulfites,
    the maximum levels of use permitted nationally, and the theoretical
    maximum level calculated from the budget method for that country. 

         The five countries that submitted data reported that the
    theoretical maximum in solid foods was less than the GSFA maximum of
    5000 mg/kg. It was also less than the national maximum permitted level
    of use for three of the four countries that submitted data. The
    theoretical maximum level in beverages was less than the GSFA maximum
    of 2000 mg/kg and was also less than the national maximum permitted
    levels of use in the four countries that submitted data.

         Detailed assessments of the intake of sulfites when used in solid
    foods and beverages were therefore indicated.


    3.  ASSESSMENTS OF INTAKE OF SULFITES

    3.1  Assessments based on data on poundage (disappearance)

         Estimates based on poundage data of the amount of sulfite
    available  per capita are shown in Table 3 for four countries and
    compared with the ADI for sulfite. The estimated intakes are lower
    than the ADI in Finland, Spain and the United States and above the ADI
    in the United Kingdom.

         In the United States, the vast majority of sulfite (as SO2) is
    used in making high-fructose corn syrup, in which little residual
    sulfite remains (< 10 ppm) before formulation into food products. As
    significant quantities of sulfite are lost by evaporation during
    processing and storage of foods, estimates of  per capita intake
    based on disappearance may be overestimates. 

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

         A table of production and consumption levels of treated foods and
    a table combining information from food balance sheets with national
    maximum use levels were submitted by India. The data were used to
    derive an estimate of  per capita sulfite intake. Intake estimates
    based on household surveys and sales data were submitted by France and
    Spain, national maximum levels of use being assumed in each country.
    The data are summarized in Table 4. Although it is generally not
    possible to identify high consumers from household economic surveys or
    sales data, the submission from France included estimated potential
    high-consumer intakes at the 90th and 95th percentiles, based on data
    for households with high consumption.

         The household economic surveys and sales data indicate mean
    potential intakes at or above the ADI, ranging from a corrected figure
    of 0.7 mg/kg bw per day to an uncorrected figure of 1.0 mg/kg bw per
    day, both in France. The mean intake in Spain was estimated to be 0.88
    mg/kg bw per day. The intake in India was estimated to be 0.35 mg/kg
    bw per day. Because these data are not based on the residual levels of
    sulfite in the foods consumed, they are certainly overestimates of
    actual intake.

    3.3  Assessments based on model diets

         Six countries submitted estimates based on model diets. It is
    essential for the interpretation of such estimates that the
    assumptions made in constructing each model diet be stated. The
    results cannot be compared directly because different assumptions were
    made in each estimate. The model diets used in Aus-NZ and in the
    United Kingdom were constructed in order to to estimate the sulfite
    intakes of a high consumer, assuming national and GSFA maximum
    additive levels. The model diet used in the United States was
    constructed to predict the sulfite intakes of an average consumer by
    using food consumption data derived from food frequency data 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.
    National and GSFA maximum additive levels were assumed. These models
    do not take into account losses of sulfite before consumption. The
    Japanese model diet is different in that actual results of analyses of
    food additive concentrations were used with national food consumption
    data to derive an estimate of actual sulfite intake for the 'average'
    consumer. Only foods known to contain sulfite were analysed. These
    assumptions provide a more realistic estimate of actual sulfite intake
    in a population.


        Table 2. Estimates of theoretical maximum levels of sulfites by the budget method 

                                                                                                                   

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

    Australia-New Zealand  50% solid food              3000 solid food    5000 solid food    28 solid food
                           50% beverages               200 beverages      2000 beveragesb    7 beverages
    China                  20% solid food              1000 solid food    5000 solid food    70 solid food
                           50% beverages               1000 beverages     2000 beverages     7 beverages
    Indiac                 5% solid food               70 solid food      5000 solid food    280 solid food
                           29% beverages               70 beverages       2000 beverages     12 beverages
    Spain                  30% solid food              450 solid food     5000 solid food    47 solid food
                           30% beverages               200 beverages      2000 beverages     12 beverages
                                                                                                                   

    All include a 50:50 proportion of the ADI
    GSFA, General Standard for Food Additives
    a Maximum use levels proposed are: 5000 mg/kg for 4.1.2.2, 'dried fruit' and 2000 mg/kg for 14.1.2.3, 'concentrates 
      (liquid or solid) for fruit juice'.
    b The GSFA mqximum is for a beverage concentrate, which would be diluted before consumption.
    c The ratio of foods to beverages in the ADI was erroneously allocated as 5:29; the calculations reflect a 50:50 split 
      of the ADI allocation.

    Table 2. Estimates of theoretical maximum levels of sulfites by the budget method 

                                                                                                                   

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

    Australia-New Zealand  50% solid food              3000 solid food    5000 solid food    28 solid food
                           50% beverages               200 beverages      2000 beveragesb    7 beverages
    China                  20% solid food              1000 solid food    5000 solid food    70 solid food
                           50% beverages               1000 beverages     2000 beverages     7 beverages
    Indiac                 5% solid food               70 solid food      5000 solid food    280 solid food
                           29% beverages               70 beverages       2000 beverages     12 beverages
    Spain                  30% solid food              450 solid food     5000 solid food    47 solid food
                           30% beverages               200 beverages      2000 beverages     12 beverages
                                                                                                                   

    All include a 50:50 proportion of the ADI
    GSFA, General Standard for Food Additives
    a Maximum use levels proposed are: 5000 mg/kg for 4.1.2.2, 'dried fruit' and 2000 mg/kg for 14.1.2.3, 'concentrates 
      (liquid or solid) for fruit juice'.
    b The GSFA mqximum is for a beverage concentrate, which would be diluted before consumption.
    c The ratio of foods to beverages in the ADI was erroneously allocated as 5:29; the calculations reflect a 50:50 split 
      of the ADI allocation.
    

        Table 3. Estimates of intake estimate of sulfites based on poundage data

                                                                                                 

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

    Finland       1994        Population, 5.1 million    0.067b                           10

    Spain         ?           Not consumed by 15% of     0.48                             70
                              population < 3 years

    United        1984-86     Population, 56 million     1.6                              230
    Kingdom

    United        1987        Population, 244 million    Mean, 0.38                       50
    States                                               90th percentile, 0.77            110
                                                                                                 

    a JECFA ADI, 0-0.7 mg/kg bw
    b The report indicates that data on use in potatoes is missing; the effect of this exclusion 
      is unknown.
    

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

                                                                                                                                         

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

    France    1993-94   Sales data     Maximum European Union levels of use; means         0.70 (mean, corrected)                100
                                       corrected for foods that never contain sulfites in  1.0 (mean, uncorrected)               140
                                       France. Adjustment for catering outside the home    2.2 (90th percentile, uncorrected)b   310
                                                                                           3.2 (95th percentile, uncorrected) b  460

    India     1995-96   Food balance   All production consumed within India; national      0.35c                                 50
                        sheet          maximum levels

    Spain     1993      Household      All foods in permitted groups contain sulfites      0.88                                  130
                        survey         Consumption inside and outside home
                                       No distinction for subgroups or rural/urban groups
                                                                                                                                         

    a JECFA ADI, 0-0.7 mg/kg bw
    b Does not include wine intake
    c Corrected to account for a calculation error
    

         Table 5 summarizes the estimates of sulfite intake based on model
    diets. The ADI is exceeded in the estimates based on the high consumer
    models of Aus-NZ and the United Kingdom (United Kingdom, 2400% of the
    ADI; Aus-NZ, 1400% of the ADI) and those based on GSFA models (United
    Kingdom, 3100% of the ADI; Aus-NZ, 4700% of the ADI). The United
    Kingdom model for children indicates that the intakes of sulfite by
    young children (11 000 % of the ADI) is higher than that of adults
    because of higher ratios of food consumption to body weight. The
    estimates for China showed that the intake of high consumers would
    represent 460% of the ADI; however, this is likely to be an
    overestimate even for high consumers as the high consumption levels of
    seven food groups are summed to give a total intake.

         In general, the estimated intakes in Aus-NZ, China, and the
    United Kingdom are higher than those in the long-term consumer model
    of the United States, as would be expected from the assumptions made.
    In the latter model, the estimated sulfite intake of the mean consumer
    (national use levels) is lower than the ADI (40% of the ADI) but is
    equal to the ADI for 90th percentile consumers. If the GSFA sulfite
    levels are assumed, the intakes of both mean and high consumers exceed
    the ADI (640 and 960% of the ADI, respectively).

         The Japanese estimate for sulfite intake is much lower (5% of the
    ADI) than those based on other model diets because the sulfite levels
    used in the model are much lower than the maximum permitted levels.

    3.4  Assessments based on individual dietary records

         Estimates of sulfite intake based on individual dietary records
    were submitted by four countries. In each case, the mean and
    percentile intakes were derived from estimates of individual intake
    adjusted for individual body weight (except in the United Kingdom).
    The assumptions made and the intake estimates derived are summarized
    in Table 6.

         The estimates based on individual dietary records and national
    use levels indicate intakes lower than the ADI for mean consumers in
    France and the United Kingdom but above the ADI for mean consumers in
    Aus-NZ, for 90th and 95th percentile consumers in France, for 95th
    percentile consumers in Aus-NZ, and for 97.5th percentile consumers in
    the United Kingdom. The estimated intakes of sulfites based on GSFA
    levels 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 SULFITES

         Screening of sulfites by the budget method indicated that
    sulfites require further assessment for use as additives. Inclusion of
    national proportions of the food or beverage supply that may contain
    sulfites in the screening did not change this decision.


        Table 5. Estimates of intake of sulfites based on model diets
                                                                                                                                              

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

    Aus-NZ    1983     National, 24-h recall;   Two models: Aus-NZ /GSFA                   High consumerb
                       adults, 25-64 years;     -- maximum levels (Aus-NZ or GSFA)         Aus-NZ permissions     10               1400
                       sample, 6254             -- 95th percentile high consumption level  GSFA permissions       33               4700
                                                -- modified GSFA classification system 
                                                -- corrections for premixes/drink bases

    China     1992     National household       One model                                  Average consumer       0.63             90
                       survey, 24-h recall;     -- maximum GSFA levels                     High consumer          3.2              460
                       30 provinces; sample, 
                       91 818 

    Japan     1994     National nutrition       One model: Japan                           Average consumer       0.033            5
                       intake survey            -- Analysed food additive concentrations 
                                                   (zero values when not detected)

    United    1986-87  National; 7-day          Three models: UK adult/child, GSFA         High consumerb
    Kingdom            weighed record;          -- maximum additive levels (EU)            UK permissions/adult   17               2400
                       adults, 16-64 years      -- unit quantity diet (Codex model with    UK permissions/child   77               11 000
                                                   GSFA levels)                            GSFA permissions       22               3100
              1992     National; 7-day          -- 97.5th percentile high consumption 
                       weighed record;             level (UK adult/child models)
                       children, 1.5-4.5 years  -- GSFA classification system

    United    1982-88  14-day MRCA food         Two models/ US and GSFA                    Long-term consumer
    States             frequency data           -- maximum additive levels (US or GSFA)    US permissions/mean    0.30             40
                       (1982-87) combined with  -- 90th percentile high consumption        US permissions/90th    0.73             100
                       portion sizes from          level twice mean consumption            GSFA permissions/mean  4.5              640
                       USDA/NFCS (1987-88);     -- all respondents are consumers           GSFA permissions/90th  6.7              960
                       > 2 years                -- GSFA classification system (except 
                                                   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, 0-0.7 mg/kg bw
    b Assumed to consume one food with potentially highest sulfite 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 sulfite intake from each of the other major food groups at a mean 
      level for all respondents

    Table 6. Estimates of intake of butylated hydroxyanisole based on individual dietary records 

                                                                                                                                            

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

    Aus-NZ    1983      National survey;   -- maximum additive levels (Aus-NZ or GSFA)          Mean Aus-NZ              1.6         230
                        24-h recall;       -- modified GSFA classification system               Mean GSFA                6.0         860
                        adults, 25-64      -- maximum additive level within any one group
                        years;             -- corrections for premixes/drink bases              95th percentile Aus-NZ   4.3         610
                        sample, 6254       -- reports 95th percentile consumption               95th percentile GSFA     15          2100 
                                           -- intakes adjusted for individual body weight

    France    1993-94   5-75 years;        -- maximum additive levels (EU) but corrected        Mean                     0.59        80
                        sample, 1116          for foods that never contain sulfites in France   90th percentile          1.2         170
                                           -- adjusted for catering outside the home            95th percentile          1.6         230 
                                           -- intakes adjusted for individual body weight
                                           -- reports 90th, 95th percentile consumption
                                           -- reports by age group

    United    1995      National survey;   -- analysed residual levels (highest permissible     Mean                     0.35        50
    Kingdom             details missing       level if not available)                           97.5th percentile        1.0         140 
                                           -- reports 97.5th percentile
                                           -- only foods with sulfite permission considered
                                           -- individual body weights used
                                                                                                                                            

    Aus-NZ, Australia-New Zealand; GSFA, General Standard for Food Additives; EU, European Union
    a JECFA ADI, 0-0.7 mg/kg bw
    

         Estimates of sulfite intake were submitted by 10 countries.
    Estimates of  per capita intake based on poundage are generally lower
    than those based on actual consumption such as model diets and
    individual dietary records, because non-consumers of the additive are
    included in  per capita estimates, as is waste in the home. This was
    shown to be the case in all the data packages submitted, except that
    from the United Kingdom, where the  per capita estimate was above the
    ADI while dietary record analysis combined with actual measured
    residues of sulfite gave an estimate below the ADI. The difference is
    probably due to loss of sulfite in processing and storage, which would
    not be taken into account in disappearance poundages.

         Estimates of sulfite intake based on high-consumer model diets
    were submitted by Aus-NZ and the United Kingdom. Both estimates were
    much higher than those based on individual dietary records for
    reported high consumers (95th percentile, Aus-NZ; 97.5th percentile,
    United Kingdom). The inability of these models to consider the
    concentration of sulfite in foods as consumed results in extreme
    estimates of intake. For these two regions, the estimate based on
    individual dietary records was considered the most accurate. 

         The intake estimates based on individual records were higher for
    Aus-NZ than for France or the United Kingdom. In the calculations for
    Aus-NZ, several GSFA groups were combined and the maximum permission
    was assigned to the wider food group, resulting in overestimates of
    intake. The estimates for Aus-NZ were also based on 24-h recall data,
    which results in overestimates of long-term intake because of the
    inclusion of foods that are not eaten daily. For example, the reported
    intake from a one-day survey of a food that is typically eaten once a
    week would be seven times higher than the actual average daily intake.

         The mean intake estimates derived from the Chinese and United
    States model diets were lower than those from the Aus-NZ and United
    Kingdom models but were in the same range as those based on individual
    dietary records for France and the United Kingdom. The estimated mean
    intakes for Japan based on the model diet were lower than those for
    other countries because measured residue levels, rather than
    regulatory maximum levels, were used. Overall, the estimated national
    mean intakes of sulfites based on individual dietary records were
    lower than the ADI, with the exception of Aus-NZ. 

         Modelled dietary intakes of sulfites based on national food
    consumption patterns and GSFA maximum levels of use will always
    exceed, sometimes by a large margin, estimates based on national
    limits in those foods with regulated uses. This is because in many
    countries (if not most) the additive is allowed in far fewer foods
    under national standards than in the GSFA, and the use level often far
    exceeds the residual level in foods as consumed. The assumption that
    foods contain an additive at a GSFA limit based on the highest
    reported use in any country in the world when in fact they do not
    contain it results in gross misrepresentation of the actual
    consumption of the additive. For this reason, even the best models can

    be discounted if based on GSFA levels. Table 7 summarizes evaluations
    made assuming GSFA levels, but includes only models regarded as 'best'
    estimates.

        Table 7. Summary of estimates of intake of sulfites based on additive levels 
    permitted within the General Standard for Food Additives

                                                                                              

    Country   Model                                   Intake                     % ADIa
                                                                                              
                                                      mg/day     mg/kg bw 
                                                                 per day
                                                                                              
    Aus-NZ    Individual records, mean intake         360        6               860
              Individual records, 95th percentile     890        15              2100
              consumers
    China     Model diet, mean intake                 38         0.63            90
    United    Model diet, mean intake                 270        4.5             640
    States    Model diet, 90th percentile             400        6.6             940
              consumers
                                                                                              

    a JECFA ADI, 0-0.7 mg/kg bw
    
         The mean intakes of sulfites estimated from model diets in
    France, Japan, and the United States and the mean intakes estimated
    from individual dietary records in the United Kingdom suggest that the
    intake of sulfites worldwide is lower than the ADI. Use of measured
    levels of residual sulfites in foods as consumed, as was done in
    Japan, results in lower estimates than those presented by the other
    countries.


    5.  CONCLUSIONS AND RECOMMENDATIONS

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

         Evaluation of the proposed maximum limits for sulfites in the
    draft GSFA in conjunction with the data on food intake supplied by
    national governments leads to the conclusion that certain foods are
    major sources of overall sulfite intake. Ingestion of a 100-g portion
    of any food containing sulfite at a level above 400 mg/kg would result
    in an intake equal to the ADI. The consumption of solid foods such as
    dried fruits; frozen, dried, or canned vegetables; jams, jellies, and

    marmelades; fruit preparations; nut spreads (peanut butter);
    cocoa-based spreads; white and semi-white sugar; and composite foods
    and beverages such as fruit juices and wines, commonly leads to
    intakes above the ADI when the residual level of sulfites in the food
    approaches the maximum limit for these foods in the GSFA. 

         Some of the high maximum limits in the GSFA are the result of
    food groupings in which one type of food with a high level of use
    drives the use level of the overall group to an unlikely high level.
    For example, sucrose, which is included under white and semi-white
    sugar (category 11.1), requires a maximum limit of only 70 mg/kg, but
    the group maximum limit is taken from the maximum for molasses, of 500
    mg/kg. The group maximum for jams, jellies, and marmelades (category
    4.1.2.5) of 3000 mg/kg arises from a request for imitation fruit,
    while the remaining requested levels are at or below 500 mg/kg. The
    maximum limit for concentrates for fruit juice (category 14.1.2.3) of
    2000 mg/kg comes from a request for use in grape juice concentrate for
    wine-making, whereas all of the other requests for fruit juice
    concentrates for direct consumer use are at or below 350 mg/kg.
    Estimates of intake for this food group may not take into account
    either loss during processing or dilution before consumption of
    concentrates. The Codex Committee might consider separating the
    specific foods that require higher sulfite use levels in these
    categories in order to better differentiate specific products,
    resulting in lower maximum limits and consequently potentially lower
    estimated intake of sulfites.

         The maximum limit in the GSFA for fruit preparations, including
    pulp and fruit toppings (category 4.1.2.8), of 3000 mg/kg is the
    result of a request from only one country. Products of this type may
    not be produced with sulfites in other countries, nor may sulfites be
    needed. The Codex Committee might consider further examination of the
    need for sulfite use in this type of product in order to determine an
    appropriate level based on good manufacturing practice, if
    appropriate. The above recommendations are intended to aid the Codex
    Committee in the establishment of maximum limits in the GSFA, in order
    to limit the potential risk to high consumers of sulfite.

         Use in analyses of intake of measured levels of residual sulfite
    in foods as consumed, as was done in the Japanese and United States
    estimates, results in significantly lower estimates than those
    presented by the other countries, in which various maximum use levels
    were used. The estimates of mean intake of sulfites based on model
    diets in France, Japan, and the United States and national use levels
    and the mean intakes derived from analysis of individual dietary
    records in the United Kingdom suggest that the current mean intakes of
    sulfites worldwide are lower than the ADI established by the
    Committee. Although some models, notably those in which maximum use
    levels and the range of foods specified in the GSFA are used, showed
    that high consumers of sulfite may exceed the ADI, the data submitted
    were insufficient to estimate the number of such consumers or the
    magnitude or duration of intake of levels above the ADI.

    6.  BIBLIOGRAPHY

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

    Baines, J. Data sheets for Australia for TBHQ, BHA, BHT, sulfites, and
    benzoates. Personal communication. Australia-New Zealand Food
    Authority, Canberra, to J. Paakkanen, FAO, 5 January 1998.

    Chen Junshi. Food additive intake from China. Personal communication.
    Chinese Academy of Preventive Medicine, Beijing, to J. Paakkanen, FAO,
    16 March 1998.

    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).

    Codex Committee on Food Additives and Contaminants (1998)
    Consideration of the Codex General Standard for Food Additives:
    Proposed draft revised annex A at step 3. Request for comments and
    information. Rome, Food and Agriculture Organization of the United
    Nations (document CX/FAC 98/9).

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

    Fisher, C.E. Dietary exposure in the United Kingdom to the five
    additives referred to JECFA by CCFAC. Personal communication. Joint
    Food Safety and Standards Group, London, to J. Paakkanen, FAO, 29
    April 1998.

    India (1998) Intake estimate of sulfites in India. Submitted to FAO.

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    See Also:
       Toxicological Abbreviations
       SULFITES (JECFA Evaluation)