INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
SAFETY EVALUATION OF CERTAIN FOOD
ADDITIVES AND CONTAMINANTS
WHO FOOD ADDITIVES SERIES: 44
Prepared by the Fifty-third meeting of the Joint FAO/WHO
Expert Committee on Food Additives (JECFA)
World Health Organization, Geneva, 2000
IPCS - International Programme on Chemical Safety
EVALUATION OF NATIONAL ASSESSMENTS OF INTAKE OF ERYTHROSINE
First draft prepared by Janis Baines
Australia New Zealand Food Authority, Canberra, Australia
Introduction
Assessments of intake
Assessments based on data on poundage (disappearance)
Assessments based on model diets
Assessments based on individual dietary records
Evaluation of estimates of intake of erythrosine
National estimates
Estimates based on the draft General Standard for Food
Additives
Conclusion and recommendations
Bibliography
1. INTRODUCTION
Erythrosine, a food additive used to impart a red colour to food,
was last evaluated by the Committee at its thirty-seventh meeting
(Annex 1, reference 94), when it established an ADI of 0-0.1 mg/kg bw.
At its present meeting, the Committee assessed national intake
assessments for erythrosine. This compound is proposed for use in a
wide range of solid foods, in water-based flavoured non-alcoholic
drinks, and in spirits and liqueurs in the draft General Standard for
Food Additives (GSFA) being established by the Codex Committee on Food
Additives and Contaminants. Calculations by the budget method indicate
that the theoretical maximum level of use for erythrosine in solid
foods is less than the maximum level of 400 mg/kg proposed by the
draft GSFA and less than the maximum of 300 g/kg in beverages.
Detailed intake assessments for erythrosine are therefore required.
Information on erythrosine was received from seven member
countries: Australia, Brazil, Canada, Japan, New Zealand, the United
Kingdom, and the United States. A summary of the data submitted is
given in Table 1. No countries reported use of food balance sheets or
household economic surveys for assessing the intake of erythrosine.
Table 1. Summary of erythrosine submissions
Country Poundage FBS/HES/ Model diets Individual dietary
data sales data records
Australia-New Zealand ×
Brazil ×
Canada × ×
Japan ×
United Kingdom ×
United States × ×
FBS, Food balance sheet; HES, household economic survey
2. ASSESSMENTS OF INTAKE
2.1 Assessments based on data on poundage (disappearance)
Estimates of the amount of erythrosine available per capita on
the basis of poundage (disappearance) data are given in Table 2 for
three countries.
The estimated intake of erythrosine was less than the ADI in all
countries, although the estimates for Canada were 10 times higher than
those for Japan or the USA. In Japan, the intake of erythrosine per
capita was 0.21 mg/day in 1997 and 0.24 mg/day in 1996 (Ishimitsu et
al., 1997), corresponding to 3% and 4% of the ADI, assuming a mean
body weight of 60 kg. Similar estimates of the intake of erythrosine
available for use in the food supply were reported from the USA, with
a mean intake of 0.22 mg/person per day and a 'pseudo-90th percentile
intake' of 0.44 mg/person per day, representing 4% and 8% of the ADI,
respectively, assuming a 60-kg body weight. In the Canadian
submission, much higher intakes were reported, with a mean of 3.6
mg/person per day, representing 60% of the ADI, assuming a 60-kg body
weight.
Although the estimates of intake derived from poundage data tend
to be overestimates of the actual intakes of additives by the average
consumer, the estimates per capita may be underestimates of the
dietary intake of 'eaters only' of foods containing the additive.
2.2 Assessments based on model diets
Five countries submitted estimates of the intake of erythrosine
based on model diets, details of which are summarized in Table 3. In
order to interpret estimates based on model diets correctly, the
assumptions made in constructing each model diet must be known. In the
case of erythrosine, the estimates cannot be compared directly because
different assumptions were made and different databases used.
Table 2. Estimates of intake of erythrosine based on poundage data
Country Date Population Estimated % ADIa Comment
intake (mg/kg
bw per day)
Canada ? Not reported 0.06 60 No other details
submitted
Japan 1996 126 166 000 0.0039 4 Assumed 60-kg
1997 126 166 000 0.0035 3 body weight
United 1987 244 million
States mean per capita 0.004 4 Reported poundage
90th percentile 0.008 8 data adjusted for 60%
response rate to
survey. Pseudo-90th
percentile intake
calculated by
multiplying mean
intake by 2
a JECFA ADI, 0-0.1 mg/kg bw
Table 3. Estimates of intake of erythrosine based on model diets
Country Date Survey Model Erythrosine % ADIa Assumptions
intake
(mg/kg bw
per day)
Brazil 1986 Potential weekly Two-week food frequency 1986 survey reported
intake of artificial survey plus duplicate only two hard candy
food colours by diet survey products contained
3-14-year-old children Mean intake (eaters only) 0.01 10 additive out of 57 candy
Sample, 242 children High consumer intake 0.017 17 types; no other foods
contained additive;
assumed high consumer
intake × 2 mean intake
for eaters; high consumer
intake of 1986 adjusted
other foods recently
permitted to contain
erythrosine not included
in 1986 survey
(chewing-gum, breakfast
cereals, sausage)
Canada NR NR All persons, mean intake 0.095 95 Assumed actual use levels
not maximum use levels
(recent permission for
use in Filipino sausage
included)
Japan 1991-94 Total diet Average consumer Wide range of permissions,
survey/National 1983 adults 0.0004 0.4 except fresh food and
nutrition intake survey 1991 adults 0.0018 1.8 specified individual food
1994 adults 0.0002 0.2 items; analysed food
1994 aged 0.0005 0.5 additive concentrations
1992 children 0.0014 1.4 (0 for undetectable);
assumed 60-kg body weight
for adults and 30 kg
for children
Table 3. (cont'd)
Country Date Survey Model Erythrosine % ADIa Assumptions
intake
(mg/kg bw
per day)
United 1986-87 National survey: High consumer
Kingdom 7-day weighed EU permissions, 0.01 13 Restricted permission
record; adults adult for cocktail cherries
16-64 years with maximum additive
1992 National survey: EU permissions, 0.05 52 level (EU); 97.5th
7-day weighed record; child percentile high consumption
children 1.5-4.5 years level; adjusted for
individual body weight
United 1982-88 14-day menu from MRCA Long-term consumer Limited number of
States food frequency data Mean, all respondents 0.00013 0.1 permissions; maximum
(1982-87) plus portion Mean, eaters only 0.00037 0.4 additive levels; 90th
sizes from percentile high
Department of Agriculture consumption level (2 x
(1987-88) mean consumption for
MRCA survey sample, eaters; less than mean
25 726, > 2 years not reported because of
low numbers); corrections
for pre-mixes and drink
bases; assumed 60-kg
body weight
MRCA, Market Research Corporation of America; EU, European Union
a JECFA ADI, 0-0.1 mg/kg bw
The model diet used in the United Kingdom was constructed to
estimate the intake of erythrosine by a high consumer, assuming that
the additive was present at the maximum levels allowed in the Food
Additive Directive of the European Commission, with data on 97.5th
percentile food consumption from individual dietary records and
adjustment for individual body weight. The model diet used in the USA
was constructed to predict the intake of a long-term consumer. No
details were available of how the Canadian estimate of erythrosine
intake was derived.
The Japanese and Brazilian model diets differed from the others
in that the concentration of the additive derived analytically was
used. The Brazilian model diet was constructed by integrating
information from a two-week food frequency survey with analytical
results from a duplicate diet survey of over 200 children aged 3-14
years. The Japanese model diet integrated food additive levels with
national food consumption data from national nutritional surveillance
to obtain an estimate of the actual intake of erythrosine by the
'average' consumer. The national nutritional survey is undertaken in
the same year as each total diet survey. Erythrosine intake in Japan
was first reported from a total diet survey conducted in 1983 (Ito,
1988); data were also available for 1991 and 1994 for all adults, for
1992 for children, and for 1993 for the aged. The exact age ranges of
the last two population groups are not defined (Yada et al., 1995).
In the Brazilian submission (University of Campinas, 1999), the
intake of erythrosine was estimated from a survey conducted in 1986 of
242 children aged 3-14 years to be 0.01 mg/kg bw per day, representing
10% of the ADI. In this survey of 83 products of different brands and
57 types of confectionery, only two hard candies contained
erythrosine. More recent data indicate, however, that use of
erythrosine has increased, and a limited number of chewing-gums,
breakfast cereals, hard candies, and sausage products contain
erythrosine. Extrapolation of food consumption data integrated with
maximum use levels for these products indicates a maximum expected
intake of erythrosine of an additional 0.007 mg/kg bw per day or a
total of 0.017 mg/kg bw per day, representing 17% of the ADI.
The Canadian model diet (Health Canada, 1999) showed a mean
intake of erythrosine for the whole population of 3.9 mg/day or 0.065
mg/kg bw per day, representing 65% of the ADI, assuming 60-kg body
weight, and a maximum intake of 0.095 mg/kg bw per day or 95% of the
ADI, assuming the addition of erythrosine from Filipino sausage.
Actual levels of use were apparently used in the calculations, but
neither the foods in which erythrosine is allowed nor the use levels
were reported in the submission.
The Japanese total diet survey (Japanese Food Additives
Association, 1999) provided very low estimates of erythrosine intake.
The intake reported in the 1991 total diet survey of adults was 0.11
mg/day (approx. 2% of the ADI, assuming a 60-kg body weight); that in
the 1992 survey of children was 0.042 mg/day (1.4% of the ADI,
assuming a 30-kg body weight); that in the 1993 survey of the aged was
0.028 mg/day (approx. 0.5% of the ADI, assuming a 60-kg body weight);
and that in the 1994 survey of adults was 0.012 mg/day (approx. 0.2%
of the ADI). For all age groups except children, fish and meat foods
were the main sources of erythrosine (85-90%), with fruit, vegetables,
and seaweed contributing a further 1-10%. For children, the main
sources of intake were fruit, vegetables, and seaweed (65%), fish and
meat contributing 25% and sugar products and confectionery a further
10% to their total intake.
The 'high consumer' model used in the United Kingdom (Ministry of
Fisheries and Food, 1999) assumed that the maximum level in cocktail
and candied cherries was 200 mg/kg and that in Bigarreaux cherries was
150 mg/kg, These are the only permitted uses of erythrosine in the
European Union, but only cocktail and candied cherries, including
cherries used at 10% as an ingredient in cherry cakes, were reported
to be consumed in the United Kingdom national dietary surveys of
adults (Gregory et al., 1990) and young children (Gregory et al.,
1995). The estimated intake of high consumers of cherries (97.5th
percentile, consumers only) was 0.01 mg/kg bw per day for adults and
0.05 mg/kg bw per day for children aged 1.5-4 years, reported to
represent 13% and 52% of the ADI, respectively. No information was
available on other foods that contain a level permitted in the GSFA
but not a level permitted in the European Union.
The submission from the United Kingdom also noted that
erythrosine is widely used in pharmaceutical products in the European
Union. A report in 1998 (European Commission, 1998) indicated that
3639 products in Europe contained erythrosine. The maximum quantity of
erythrosine that can be ingested with a single capsule, sugar-coated
pill, or 1 mL of a liquid preparation has been estimated to be 0.013
mg/kg bw per day (assuming 70 kg body weight). The ADI would be
reached only by consuming five to seven pills or capsules or 5-7 mL of
a liquid preparation per day, which is considered unlikely on a
long-term basis.
The long-term consumer model of the USA (Food & Drug
Administration, 1999) was constructed by using data on food
consumption from food frequency surveys conducted in 1982-88 by the
Market Research Corporation of America and average portion sizes from
the a three-day national food consumption survey conducted in 1997-88
by the Department of Agriculture. Maximum additive levels were assumed
for two models, one based on national use levels and one based on GSFA
levels in the foods in which use of erthrosine is permitted. For most
food groups, the maximum permitted levels of erythrosine in the USA
were much lower than those of the GSFA, the concentrations in fruit
preserves, jams, fruit toppings, fruit fillings, frozen soups,
pourable salad dressings, and atole (cornmeal beverage) all being < 3
mg/kg; however, the maximum permitted in decorative glazing was 200
mg/kg.
The estimates for long-term consumers of erythrosine were also
low, with a mean for the whole population of 0.0013 mg/kg bw per day
and a mean for eaters only of 0.0037 mg/kg bw per day, representing
1.3% and 3.7% of the ADI, respectively. The intakes at the 90th
percentile were actually lower than the mean intakes for eaters only
since so few people reported eating foods in which erythrosine is
permitted. The intake estimates are comparable to those obtained from
US poundage data.
Estimates of the intake of erythrosine derived from US food
consumption data integrated with maximum GSFA levels and the range of
foods in which use is allowed are considerably higher than those based
on national levels of use and far exceed the ADI for both mean (1.1
mg/kg bw per day or 1100% of the ADI) and high consumers of the
additive (2.2 mg/kg bw or day or 2200% of the ADI). In this
calculation, the main contributions to the mean total intake of
erythrosine were water-based, flavoured drinks (62%), fruit juice
concentrates (9%), bread and rolls (9%), and flavoured milk (5%).
2.3 Assessments based on individual dietary records
The joint submission from Australia and New Zealand
(Australia-New Zealand Food Authority, 1999) provides estimates of the
intake of erythrosine based on individual dietary records. The
estimates of mean and 95th percentile intake were derived from
estimates for individuals adjusted for individual body weight (Table
4). The estimates of mean intake based on individual dietary records
and the levels of use permitted in Australia and New Zealand were 0.02
mg/kg bw per day for mean consumers (18.6% of the ADI) and 0.06 mg/kg
bw per day for high consumers (63% of the ADI). Erythrosine is
permitted for use only in maraschino cherries in Australia ad New
Zealand. As only a small number of people eat this product (0.3% of
the population), the estimate for 95th percentile consumers should be
discounted. In the reverse budget method, up to 26 g of cherries could
be consumed per day by males and 21 g/day by females before the ADI
was exceeded. The submission concluded that this level of consumption
is unlikely to be exceeded on a long-term basis. Nevertheless, since
only a small amount of cherries need be eaten before the ADI is
reached, the additive is restricted to use in maraschino cherries.
Integration of intake estimates for Australia and New Zealand
based on national food consumption data with maximum GSFA levels and
the range of foods in which use is allowed results in considerably
higher estimates than those based on national levels of use, which far
exceed the ADI for both mean (1.7 mg/kg bw per day or 1700% of the
ADI) and high consumers of the additive (5 mg/kg bw per day or 5000%
of the ADI). In this calculation, the major contributors to mean total
intake were bread and rolls (31%) and water-based, flavoured drinks
(26%), with smaller contributions from ice creams and edible ices
(7%), fruits and vegetables in sterile containers (8%, vegetables
included in the calculations), flavoured milk (6%), and sauces (5%).
3. EVALUATION OF ESTIMATES OF INTAKE OF ERYTHROSINE
3.1 National estimates
Estimates of the intale of erythrosine were submitted by seven
countries. Except in the approach based on poundage data, it was
assumed that the maximum permitted national levels represented the
levels at which the additive was present, except in Japan and Brazil,
where analytical data were used. Intake estimates based on maximum
permitted additive levels overestimate actual intake. Estimates of
intake per capita based on poundage 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 is the case;
however, for erythrosine, intake estimates derived from poundage data
in both Japan and the USA were similar to the estimates from the
Japanese total diet survey and the US national long-term consumer
model (< 5% of the ADI). The sources of erythrosine in Japan and the
USA differ significantly. Japan permits use of erythrosine in a wide
range of foods, with the exception of fresh food and other specific
food items, but the concentrations found in the analyses were very
low. In contrast, erythrosine is permitted in only a limited number of
foods in the USA but at higher levels than those reported in the
Japanese total diet survey. The maximum permitted levels of use in the
USA are lower than those permitted in the GSFA, except in decorative
glazes.
In models of the intake of high consumers, such as those
submitted by Brazil and the United Kingdom, the estimated intakes of
erythrosine are higher than those in Japan and the USA (10-20% of the
ADI), whereas that for Canada was much higher from both poundage data
(60% of the ADI) and for the mean total intake (95% of the ADI). The
estimates from the individual record model in Australia and New
Zealand indicate potentially higher intakes, ranging from 19 to 63% of
the ADI for mean and high consumers; however, since maraschino
cherries are eaten by < 1% population, the estimate for 95th
percentile consumer can be disregarded.
3.2 Estimates based on the draft General Standard for Food Additives
Intake estimates derived from the levels proposed in the draft
GSFA are gross overestimates of the actual intake in any country,
because the GSFA is generally compiled by adopting the highest level
of use for any one food category submitted by Member States. The range
of use specified in the draft GSFA is also much wider than in national
standards.
Intake estimates based on GSFA levels and ranges of foods were
submitted by Australia-New Zealand and the USA. The results were very
similar, with intakes well in excess of the ADI for both mean and high
consumers (Table 5).
4. CONCLUSIONS AND RECOMMENDATIONS
All of the national estimates of erythrosine intake were below
the ADI. In assessing the risk of exceeding the ADI, non-food sources
of erythrosine should also be considered, such as use in
pharmaceutical products, which may contribute significant amounts to
the total intake if consumed over a long period. The intake of
erythrosine could exceed the ADI if the maximum levels in the draft
General Standard for Food Additives are widely accepted at the
national level; however, models based on the maximum levels of use
proposed in the draft General Standard give overestimates of actual
intake, because erythrosine will be used in only a limited number of
red foods. Therefore, the Committee concluded that it is unlikely that
long-term intake of erythrosine will exceed the ADI.
Table 4. Estimated intake of erythrosine based on individual records
Country Date Survey Model Erythrosine % ADIa Assumptions
intake (mg/kg
bw per day)
Australia-New 1995 National nutrition Mean intake (all 0.0001 0.06 Maximum additive level
Zealand survey; 24-h recall; respondents) for maraschino cherries
sample, 13 858; Mean consumer intake 0.02 19 only; intake adjusted for
aged 2 to (eaters only) individual body weight
> 70 years 95th percentile consumer 0.06 63
a JECFA ADI, 0-0.1 mg/kg bw
Table 5. Summary of estimates of intake of erythrosine based on additive
levels permitted within the draft General Standard for Food
Additives
Country Model Intake % ADIa
(mg/kg bw
per day)
Australia-New Individual records, mean 1.72 1720
Zealand intake (all respondents)
Mean consumer intake 1.72 1730
(eaters only)
Individual records, 95th 5.01 5020
percentile consumer
United States Model diet, mean intake 1.1 1100
(all respondents are
consumers)
Model diet, 90th percentile 2.2 2200
consumers
a JECFA ADI, 0-0.1 mg/kg bw
5. BIBLIOGRAPHY
Australia-New Zealand Food Authority (1999) Submission to WHO.
European Commission (1998) Opinion on toxicological data on colouring
agents for medicinal products: Erythrosine. Adopted by the Scientific
Committee on Medicinal Products and Medical Devices, 21 October 1998.
Food & Drug Administration (1999) Submission to WHO.
Health Canada (1999) Submission to WHO.
Ishimitsu, S., et al. (1998) Production of food grade erythrosine in
Japan: Estimated production by the official inspection of coal tar
dyes (including dye aluminium lakes) in 1997. Bull. Natl Inst.
Health Sci., 116, 153-156 (in Japanese).
Ito, Y., ed. (1988) Daily Intakes of Food Additives in Japan:
Determination of Food Additive Residues in Food (1976-1985), Tokyo:
Ministry of Health and Welfare.
Japanese Food Additives Association (1999) Submission to WHO.
Ministry of Fisheries and Food (1999) Submission to WHO.
University of Campinas (1999) Submission to WHO.
Yada, T., et al. (1995) Intake level of erythrosine in Japan by market
basket method: A study of daily intake in Japan of Group A food
additives (additives that are not normally present as constituents in
foodstuffs) by age group, food group and area. Jpn. J. Food Chem.,
2, 54-63 (in Japanese).