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 BENZOATES
First draft prepared by B.J. Petersen
Novigen Sciences, Inc., Washington DC, United States
1. INTRODUCTION
The Committee assessed the intake of benzoates, a class of food
additives generally used as preservatives. Maximum limits for
benzoates have been proposed in a wide range of foods (solids and
liquids) in the draft General Standard for Food Additives (GSFA) being
developed by the Codex Committee on Food Additives and Contaminants
(CCFAC). A group ADI of 0-5 mg/kg bw, expressed as benzoic acid
equivalents, has been allocated to benzyl acetate, benzyl alcohol,
benzaldehyde, and benzoic acid, and its salts (Annex 1, reference
122).
Information was provided by nine countries (Australia, China,
Finland, France, Japan, New Zealand, Spain, United Kingdom, and the
United States). A combined assessment was provided by Australia and
New Zealand (Aus-NZ). Five types of assessment were submitted: budget
method, 'poundage', household economic surveys, model diets, and
intake assessments based on individual surveys. Most countries
provided assessments obtained by more than one method. Actual measured
concentrations of benzoates in foods were used in Japan; in the other
assessments, benzoate was assumed to be present at the maximum limit
in the GSFA, national limits, or regional limits. Table 1 summarizes
these submissions.
Table 1. Summary of submissions on benzoates
Country Budget Poundage FBS/HES/ Model Individual dietary
method data sales data diets records
Australia-New Zealand x x x
China x x x
Finland x
France x x
Japan x
Spain x x x
United Kingdom x x
United States x x
FBS, food balance sheet; HES, household economic survey; sales, retail stores
2. SCREENING OF BENZOATES BY THE BUDGET METHOD
In this method, countries report whether benzoates are used in
solid foods or beverages or both. The Codex GSFA proposes that
benzoates be permitted in a wide range of solid foods and beverages
(Codex Alimentarius Commission, 1997). Table 2 summarizes the data for
each country, including the patterns of permitted use, the proportion
of the solid food supply likely to contain benzoates, the maximum
levels of benzoate permitted, and a comparison of these levels with
the theoretical maximum level calculated from the budget method for
that country.
The theoretical maximum allowable level of use for benzoates in
solid foods ranged from 200 to 1000 mg/kg, depending on national
assumptions about the proportion of the food supply that would contain
benzoates. Except for solid food in China, the theoretical levels are
lower than the national maximum permitted level of use for the three
countries that submitted data and are also lower than the GSFA level
of 2000 mg/kg for a variety of solid foods, including ripened and
processed cheeses and vegetables in vinegar, oil, or brine, and the
level of 6000 mg/kg in cooked mollusk, crustaceans, and echinoderms.
The theoretical maximum allowable level of benzoates in beverages was
50 mg/kg, while the permitted levels are up to 2100 mg/kg. Detailed
intake assessments for the use of benzoates in foods are therefore
required.
3. ASSESSMENTS OF INTAKE OF BENZOATES
3.1 Assessments based on data on poundage (disappearance)
Estimates of the amounts of benzoates available per capita from
data on poundage are given in Table 3 for five countries and compared
with the ADI of 0-5 mg/kg bw for benzoates. The estimates for intake
of benzoates are all below the ADI; they range from 0.7 mg/kg bw per
day in Finland to 1.4 mg/kg bw per day in China. The estimates based
on poundage data are substantially lower than those based on the
results of food intake surveys.
3.2 Assessments based on data from household economic surveys
Two countries, France and Spain, submitted data based on
household surveys or sales data, assuming maximum levels of use in
each country. The data are summarized in Table 4. These estimates in
combination with national maximum limits indicate that potential
intake is lower than the ADI. The estimates for mean per capita
intake range from 0.4 mg/kg bw per day (9% of the ADI) in France
(based on European Union maximum limits) to 0.6 mg/kg bw per day (12%
of the ADI) in Spain. It should be noted that both the Spanish and the
European Union maximum limits are substantially lower than that of the
GSFA (Ishiwata et al., 1994; EU Directive, 1995; Aus-NZ National Food
Standards Code, 1997; Codex Alimentarius Commission, 1997; US Code
Federal Regulations, 1997).
Table 2. Estimation of theoretical maximum level for benzoates by the budget method
Country % food or beverage supply National maximum GSFA maximum Theoretical maximum
containing benzoates level (mg/kg) level (mg/kg) level (mg/kg)
Australia-New Zealand 50% solid food 2500 solid food 6000 for 2.1 'cooked crustaceae' 200 solid food
50% beverages 400 beverages 2100 for 14.1.2.1 'fruit and 50 beverages
vegetable juices'
China 10% solid food 800 solid food 1000 solid food
50% beverages 800 beverages 50 beverages
Spain 5% solid food 1000 solid food 400 solid food
15% beverages 200 beverages 50 beverages
GSFA, General Standard for Food Additives
Table 3. Estimates of intake of benzoates based on poundage data
Country Date Assumptions Estimated intake % ADIa
(mg/kg bw per day)
China ? Population, 1200 million 1.4 28
25 000 000 kg benzoates
Finland 1994 Population, 5.1 million 0.7 15
82 997 kg benzoates used
Four main uses: soft drinks,
juices, jams, juice drinks
39% used in soft drinks
Spain ? Average for population < 3 0.8 16
years (85% of population)
United Kingdom 1984-86 Population, 56 million 0.8 16
United States 1987 Population, 240 million 0.7 13
1995
Population, 260 million 0.9 18
a JECFA ADI, 0-5 mg/kg bw
Table 4. Estimates of intake of benzoates based on household economic surveys and sales data
Country Date Survey Assumptions Estimated intake % ADIa
(mg/kg bw per day)
France 1993 Sales data Maximum European Union levels of use Per capita mean, 0.4 9
Adjustment for catering outside the home Upper 90th percentile consumers, 0.8 17
Upper 95th percentile consumers, 1.1 22
Spain 1993 Household All foods in permitted groups contain benzoates 0.6 12
survey
a JECFA ADI, 0-5 mg/kg bw
High consumers generally cannot be identified from household
economic surveys or sales data. The submission from France included
estimates of high consumption of benzoate by household divided by the
number of members; this may result in an underestimate of high
exposure by individual consumers. The intake of French consumers in
the upper 90th percentile is 0.8 mg/kg bw per day (17% of the ADI),
and that of consumers in the upper 95th percentile is 1.1 mg/kg bw per
day (22% of the ADI).
3.3 Assessments based on model diets
Five countries submitted data based on model diets, details of
which are summarized in Table 5. The results from these models cannot
be compared directly because different assumptions about dietary
practices and levels of benzoates were applied in each country. In the
Japanese assessment, it was assumed that residues would be present at
the concentrations measured in a market-basket study (Ishiwata et al.,
1997). The average concentration of benzoates in non-alcoholic
beverages was 190 mg/kg, which is in contrast to the proposed GSFA
benzoate level in non-alcoholic beverages of 2000 mg/kg. In other
countries, intakes were calculated on the basis of national or GSFA
maximum limits. In each case, the intakes that were calculated on the
basis of the GSFA maximum limits were substantially higher than those
based on national limits. For example, a 'high consumer model' was
used in Aus-NZ to calculate that benzoate intake would be 11 mg/kg bw
per day (220% of the ADI) under national maximum limits and 44 mg/kg
bw per day (880% of the ADI) under the GSFA maximum limits. Intakes in
the United Kingdom were calculated from their 'high consumer model'
and the maximum limits of the European Union and the GSFA. The
resulting estimates were 43 mg/kg bw per day for adults with the GSFA
maximum limits and 32 mg/kg bw per day for adults and 93 mg/kg bw per
day for children with the European Union maximum limits. All three
estimates are substantially higher than the ADI of 0-5 mg/kg bw per
day.
The United States also submitted calculations based on both the
GSFA and national maximum limits in their long-term consumer model,
which includes food frequency estimates obtained for 14 days from a
panel of consumers combined with portion sizes from national food
consumption surveys. The results are presented in Table 5 for the
entire population and for selected age groups. The estimated mean
per capita consumption assuming GSFA maximum limits is 27 mg/kg bw
per day (550% of the ADI), and the upper 90th percentile consumption
is 35 mg/kg bw per day (690% of the ADI). When national limits were
used, only the intake of upper 90th percentile per capita and
'eaters only' exceeded the ADI.
Table 5. Estimates of intake of benzoates based on model diets
Country Date Survey Assumptions Type of model 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 44 880
25-64 years; -- 95th percentile high consumption GSFA permissions 11 220
sample size, 6254 level
-- modified GSFA classification system
-- corrections for premixes/drink bases
China 1992 National household One model Average and high
survey, 24-h -- maximum GSFA levels consumers
recall; Mean per capita 6 120
30 provinces; Maximum per capita 45 280
sample size, 91 818 Maximum per user 14 280
Japan 1994 National nutrition One model: Japan Average consumer
intake survey; -- Analysed food additive concentrations Mean per capita 0.18 30
body weight, 60 kg (zero values when not detected)
-- Mean benzoates in nonalcoholic
beverages, 0.19 g/kg
United 1986-87 National; 7-day Three models: UK adult/child, GSFA High consumerb
Kingdom weighed record; -- maximum additive levels (EU) Codex 43 860
adults,16-64 years -- unit quantity diet UK permissions/adult 32 640
-- 97.5th percentile high consumption UK permissions/child 93 1900
level (UK adult/child models)
-- GSFA classification system
Table 5. (continued)
Country Date Survey Assumptions Type of model Intake %ADIa
(mg/kg bw
per day)
United 1982-88 14-day menu Two models/US and GSFA Long-term consumer
States obtained from MRCA -- maximum additive levels (US or GSFA) GSFA permissions/mean 27 550
food frequency data -- 90th percentile high consumption level GSFA permissions/90th 35 690
(1982-87) combined -- GSFA classification system (except percentile
with portion sizes FSDU)
from USDA/NFCS -- corrections for premixes/drink bases
(1987-88); > 2 years
US permissions:
Entire population Per capita mean 2.3 46
Per capita 90th 6.4 130
Eaters only mean 2.8 56
Eaters only 90th 7.3 150
Age subgroups:
Children 3-11 years Per capita mean 3.4 68
Per capita 90th 8.5 170
Eaters only mean 3.9 78
Eaters only 90th 9.3 190
Females 12-19 years Per capita mean 2.4 48
Per capita 90th 6.7 130
Eaters only mean 3.0 60
Eaters only 90th 7.1 140
Males 12-19 years Per capita mean 3.1 62
Per capita 90th 8.0 160
Eaters only mean 3.6 72
Eaters only 90th 8.1 160
Table 5. (continued)
Country Date Survey Assumptions Type of model Intake %ADIa
(mg/kg bw
per day)
Females > 20 years Per capita mean 2.1 42
Per capita 90th 6.1 120
Eaters only mean 2.6 52
Eaters only 90th 6.8 140
Males > 20 years
Per capita mean 1.7 34
Per capita 90th 4.8 96
Eaters only mean 2.1 42
Eaters only 90th 5.6 110
Males > 20 years
Per capita mean 1.7 34
Per capita 90th 4.8 96
Eaters only mean 2.1 42
Eaters only 90th 5.6 110
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 Composition Survey; FSDU, foods for special dietary uses
a JECFA ADI, 0-5 mg/kg bw
b Assumed to consume one food with potentially highest benzoate intake from two major food groups at the 95th percentile (Aus-NZ) or
97.5th percentile (United Kingdom) and one food with potentially highest benzoate intake from each of the other maqjor food groups at a mean
level for all respondents
3.4 Assessments based on individual dietary records
Estimates of the intake of benzoates based on individual dietary
records were submitted by Aus-NZ, France, and the United Kingdom. In
each case, the estimates of mean and percentile intake were derived
from estimates of individual intakes adjusted for individual body
weight (except in the United Kingdom). The assumptions made and the
estimates are summarized in Table 6. Only in Aus-NZ was an evaluation
of intake conducted on the basis of the GSFA maximum limits; the
European Union maximum limits were used in France and the United
Kingdom.
Estimates of the intake of benzoates based on individual dietary
records and national maximum limits are lower than the ADI for both
mean and high (upper 95th and upper 97.5th percentile) consumers in
all three countries. The estimated intakes in Aus-NZ based on GSFA
maximum limits exceeded the ADI for both the mean (20 mg/kg bw per day
or 420% of the ADI) and the upper 95th percentile consumer (36 mg/kg
bw per day or 720% of the ADI).
4. EVALUATION OF ESTIMATES OF INTAKE OF BENZOATES
Screening of benzoates by the budget method at CCFAC indicated
that they require further assessment for use as additives. Inclusion
of national proportions of the food and beverage supply that may
contain benzoates resulted in the same conclusion.
Estimates of benzoate intake were submitted by eight countries.
Per capita intake estimates based on poundage data were all below
the ADI. Such estimates would be expected to be lower than those based
on household economic surveys, model diets, or individual dietary
records, which was the case for benzoates.
Estimates of benzoate 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 from the high-consumer models
were much higher than those based on individual dietary records for
reported high consumers (95th percentile in Aus-NZ; 97.5th percentile
in the United Kingdom). For these two countries, the intake estimates
based on individual dietary records were considered to be the most
accurate. The estimated intake based on individual records was higher
for Aus-NZ than the United Kingdom or France. In the calculations from
Aus-NZ, several GSFA groups were combined, and the maximum permitted
levels were assigned to the wider food group; this led to
overestimated intakes. Furthermore, the Aus-NZ estimates were based on
24-h recall, which also leads to overestimates because the range of
reported daily food consumption levels is wider.
The estimates of mean intake derived from the Chinese and United
States model diets were lower than those from the Aus-NZ and United
Kingdom model diets, but were in the same range as the mean intake
estimates based on individual dietary records for Australia and
slightly higher than the mean intakes based on individual dietary
records for France and the United Kingdom. It should be noted that in
all instances national maximum limits were used, and these are lower
than the GSFA maximum limits.
The estimates of mean intake in Japan, based on a model diet,
were lower than those for other countries. This reflects the use of
actual measured levels in foods as opposed to the GSFA or national
maximum limits.
5. CONCLUSIONS AND RECOMMENDATIONS
5.1 National estimates of intake of benzoates based on maximum
limits specified in the General Standard for Food Additives
The estimates of national mean and upper 95th percentile consumer
intake of benzoates based on individual dietary records were lower
than the ADI for all countries when national maximum limits were used
but were above the ADI when maximum limits in the GSFA and range of
use in foods were used. This reflects the fact that maximum limits in
the GSFA represent the highest maximum limit submitted by any member
country or international non-governmental organization.
The available data were insufficient to estimate the number of
people whose consumption may exceed the ADI or to determine the
duration of intake above the ADI.
Because diets differ among countries, the foods that contribute
most to benzoate intake would be expected to vary. The GSFA food
category that contributed most to benzoate intake was carbonated,
water-based, flavoured drinks (i.e. soft drinks; category 14.1.4.1)
for Aus-NZ, France, the United Kingdom, and the United States. In
Finland, 40% of the benzoates used in food is in soft drinks. Soya
sauce was the main source in China and the second most important
source in Japan.
Typically, estimates of individual dietary intake rely on
short-term (one- to seven-day surveys) of food consumption, which was
the case for benzoates. Generally, estimates of long-term consumption
of single foods are lower than when they are based on short-term
surveys. In the case of benzoates, however, soft drinks, which
contribute most to intake, are likely to be consumed regularly.
Because many consumers are likely to be loyal to a particular brand,
intake may reflect the levels of benzoates used in specific brands. A
person who consumes a single bottle (0.5 L) of soft drink per day
would ingest 8.3 mg/kg bw per day benzoate (170% of the ADI) if it
contains the maximum limit specified in the GSFA. Thus, the estimated
intake of benzoate is unlikely to be substantially lower if data on
longer-term intake are available. This conclusion is based on the
assumption that the levels remaining in foods at the time of
consumption are at the maximum limits. If the levels required to meet
technological needs were below the maximum limits in the GSFA, intake
would be correspondingly lower. The data submitted by Japan from an
actual market-basket survey suggest that this may be the case;
however, further data would be required to determine the levels that
are required to achieve the technological effect. In addition,
benzoates are not likely to be used in all foods for which their use
is authorized. Such information could be used to revise both the
intake assessment and the maximum limits specified in the GSFA.
The Committee concluded that, because of the potentially
significant intake of benzoates at the GSFA maximum limits, factors
that might contribute to exceedence of the ADI should be further
evaluated. Further information on levels of benzoates in foods 'as
consumed' is needed.
5.2 National estimates of intake of benzoates based on national or
European Union maximum limits
The best estimates of national mean intakes of consumers of
benzoates were below the ADI of 0-5 mg/kg bw, ranging from 0.18 mg/kg
bw per day in Japan to 2.3 mg/kg bw per day in the United States.
These estimates were based on analyses involving either model diets or
individual dietary records and maximum limits specified by national
governments or the European Union. The estimated intake by high
consumers of benzoates, based on food additive levels in national
standards, exceed the ADI in some cases (7.3 mg/kg bw per day or 150%
of the ADI in the United States and 14 mg/kg bw per day or 280% of
the ADI in China).
5.3 Recommendations to the Codex Committee on Food Additives and
Contaminants
The proposed draft GSFA lists several uses of benzoates proposed
by a single country at substantially higher levels than those in the
same or similar foods in other countries. These include ripened cheese
(category 1.6.2), processed cheese (category 1.6.4), cheese analogues
(category 1.6.5), vegetables in vinegar, oil, or brine (category
4.2.2.3), Crangon crangon and Crangon vulgaris (category 9.2.4.2),
semipreserved fish products (category 9.3), and liquid eggs (category
10.2.1). The Codex Committee may wish to review the appropriate levels
for these foods.
Levels of 350-1000 mg/kg benzoates were proposed by several
countries and by one non-governmental organization for use in
carbonated, water-based, flavoured drinks (i.e. soft drinks; category
14.1.4.1). Since soft drinks make an important contribution to the
estimated intakes in all countries that submitted data for this
assessment, with the exception of China, the Codex Committee may wish
to further consider an appropriate level for this category. Likewise,
a range of maximum limits was proposed for fruit juice (400-2100
mg/kg), which the Codex Committee may wish to reconsider.
Table 6. Estimates of intake of benzoates based on dietary data
Country Date Survey Model Intake %ADIa
(mg/kg bw
per day)
Aus-NZ 1983 National survey; Mean intake of consumers: Aus-NZ maximum limits 1.0 20
24-h recall; Mean intake of consumers: GSFA maximum limits 20 420
adults, 25-64 years; 95th percentile consumers: Aus-NZ maximum limits 3.8 80
sample, 6254 95th percentile consumers: GSFA maximum limits 36 720
France 1993-94 National survey of Maximum additive levels (European Union)
adults; 7-day Intakes adjusted for individual body weight
(corrected) weighed record; Mean 0.4 9
adults, 16-64 years; 90th percentile 0.9 17
sample, 3000 95th percentile 1.1 22
5-75 years; By age group (years) 5-9 0.89 18
sample, 1116 10-17 0.5 10
18-24 0.35 7
25-34 0.32 6
35-44 0.35 7
45-54 0.44 9
55-64 0.46 9
> 65 0.46 9
United 1986-87 National survey of Mean levels measured in foods or maximum limits Mean per capita, adults 0.6 12
Kingdom adults (values not given) Mean/consumer, adults 0.6 12
Upper 97.5th percentile 1.8 36
consumer, adults
Mean per capita, children 1.4 28
Mean/consumer, children 1.4 28
Upper 97.5th percentile 3.5 70
consumer, children
Aus-NZ, Australia-New Zealand; GSFA, General Standard for Food Additives; EU, European Union
a JECFA ADI, 0-5 mg/kg bw
The Committee noted that estimates of intake based on national
maximum limits are below the ADI, whereas estimates based on maximum
limits and the range of uses in foods specified in the GSFA exceed the
ADI. The differences arise because the range of foods specified in the
GSFA is wider and the proposed levels of use in specific food
categories generally higher than in national standards.
6. BIBLIOGRAPHY
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See Also:
Toxicological Abbreviations
BENZOATES (JECFA Evaluation)