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.
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See Also:
Toxicological Abbreviations
SULFITES (JECFA Evaluation)