RISK
ASSESSMENT ON
ARTIFICIAL SWEETENERS
IN BEVERAGES
November 2003
Food and Environmental Hygiene Department
HKSAR
This is a publication of the Food and Public
Health Branch of the Food and Environmental
Hygiene Department of HKSAR Government. Under
no circumstances should the research data contained
herein be reproduced, reviewed, or abstracted
in part or in whole, or in conjunction with
other publications or research work unless a
written permission is obtained from the Department.
Acknowledgement is required if other parts of
this publication are used.
Correspondence:
Risk Assessment Section
Food and Environmental Hygiene Department
43/F, Queensway Government Offices,
66 Queensway, Hong Kong.
Email: enquiries@fehd.gov.hk
This
study estimated the exposures to artificial
sweeteners from beverages by secondary school
students in Hong Kong and assessed the effects
on their health. Five artificial sweeteners
including acesulfame potassium, aspartame,
cyclamic acid, saccharin and sucralose were
studied.
Artificial sweeteners are substances which
are substantially sweeter than the common
carbohydrate sweeteners such as sucrose. Their
sweetness potencies range from about 30 times
to several thousand times that of sucrose.
They provide little or no caloric value to
the normal diet and they do not affect insulin
or glucose levels. Hence, they may assist
in weight management and provide sweet-tasting
foods for people with diabetes.
The exposures to the studied artificial sweeteners
from beverages by secondary school students
in Hong Kong were estimated by using the local
consumption data and the concentrations of
artificial sweeteners in beverage samples
taken from the local market.
Results showed that the daily exposures to
the studied artificial sweeteners were all
within their respective Acceptable Daily Intakes
(ADIs) for both average and high consumers.
The exposures ranged from 0.8% of the ADI
for saccharin to 6.5% of the ADI for acesulfame
potassium for average consumers, and from
2.6% of the ADI for saccharin to 23.4% of
the ADI for acesulfame potassium for high
consumers.
Based on this finding, it could be concluded
that exposures to the artificial sweeteners
including acesulfame potassium, aspartame,
cyclamic acid, saccharin and sucralose from
beverages do not pose a health risk to secondary
school students in Hong Kong in both average
and high consumers.
Risk Assessment on
Artificial Sweeteners in Beverages
OBJECTIVE
The aims of this study are (i) to estimate the dietary
exposures to artificial sweeteners by the secondary
school students in Hong Kong and (ii) assess the
health effects of artificial sweeteners resulting
from these exposures.
2.
The use of artificial sweeteners in food industry
has been growing rapidly in recent years. Whereas
in the past they were chiefly used in diabetic products,
they have become more popular as alternative sweeteners
in many food products especially in soft drinks
and other beverages, as consumers aim to eat less
sugar. Thus, the Food and Environmental Hygiene
Department (FEHD) initiated this study to estimate
the dietary exposures to artificial sweeteners by
secondary school students in Hong Kong and assess
the health effects of artificial sweeteners to secondary
school students.
3.
Artificial sweeteners are generally considered as
those substances which on a weight basis are substantially
sweeter than the common carbohydrate sweeteners
such as sucrose. Their sweetness intensities range
from about 30 times to several thousand times that
of sucrose.1 Accordingly,
they can be used at much lower concentrations in
foods. 2
4.
Artificial sweeteners are also called non-nutritive
sweeteners as they contribute little or no caloric
value to the normal diet. For example, saccharin
has no caloric value while aspartame produces 4
kcal/g.13
5.
Artificial sweeteners have become more popular and
their use has been expanding for many years. They
are now common ingredients in a wide range of foods
and beverages including soft drinks, candies, chewing
gum, desserts like pudding, gelatin, and ice cream.
In addition, several artificial sweeteners are available
for use as table-top sweeteners, which consumers
add directly to coffee, tea, fruits, breakfast cereal,
etc. 4
6.
Artificial sweeteners can deliver an equivalent
sweetness value to sugar at a lower cost and can
offer consumers a way to enjoy the taste of sweetness
with little or no energy intake.5
Hence, they may assist in weight management. They
may also be used to provide sweet-tasting foods
and beverages for people who have to restrict carbohydrate
intake, such as people with diabetes as they do
not affect insulin or glucose levels.34
7.
As with all food additives, artificial sweeteners
have been assessed for their safety before they
are permitted for use in foods. The Joint Food and
Agriculture Organization/ World Health Organization
Expert Committee on Food Additives (JECFA) evaluated
the safety of artificial sweeteners based on toxicological
data obtained from animal and/or human studies.
An Acceptable Daily Intake (ADI) would be allocated
according to the safety evaluation.
8.
An ADI is the amount of a food additive, expressed
on a body weight basis that can be ingested daily
over a lifetime without appreciable health risk.6
Animal tests are normally used to determine the
maximum dietary level of an additive which demonstrates
no toxic effects, i.e. the ¡§no-observed-effect-level¡¨
or NOEL and the most sensitive animal species are
used. The NOEL is then used to determine the ADI
by applying a safety factor usually of 100.7
9.
Nowadays, a wide range of artificial sweeteners
is available for the food industry. Examples of
some popular artificial sweeteners include aspartame,
acesulfame potassium and saccharin. General information
on some artificial sweeteners is described in Annex
I.
10.
This study focused on the exposures to artificial
sweeteners from beverages as they are recognized
as the main dietary source of artificial sweeteners.
For the purpose of this study, beverages means any
pre-packed non-alcoholic ready-to-drink drinks which
include carbonated drinks, flavoured bottled water,
sports drinks, herbal drinks, dairy-based drinks,
soy-based drinks, juice drinks, tea and coffee.
11.
Secondary school students were chosen as the population
of this study because they are generally recognized
as the population group which is more likely to
have above average consumption of foods containing
artificial sweeteners, such as soft drinks, candies
and chewing gums.
12.
According to the Food Adulteration (Artificial Sweeteners)
Regulations of the laws in Hong Kong, six groups
of artificial sweeteners are permitted for use in
food in Hong Kong. They are (i) acesulfame potassium,
(ii) aspartame, (iii) cyclamic acid and its sodium
and calcium salts, (iv) saccharin and its sodium
and calcium salts, (v) sucralose and (vi) thaumatin.
13.
The term ¡§artificial sweeteners¡¨ employed in this
study includes both synthetic compounds and naturally
occurring sweetening agents. This is in line with
the existing legislation. As stipulated in the Regulations,
artificial sweetener means ¡§any chemical compound
which is sweet to the taste, but does not include
any sugars or other carbohydrates or polyhydric
alcohols¡¨.
14.
Among the six groups of artificial sweeteners listed
above, all except thaumatin were included in this
study. Thaumatin was not included in this study
because, according to the JECFA¡¦s evaluation8
, thaumatin is a protein that is readily digested
to food component. The dietary effect of thaumatin
is only to make an insignificant contribution to
the normal protein intake. JECFA allocated an ADI
of ¡§Not Specified¡¨ to thaumatin meaning that it
is of very low toxicity which, on the basis of the
available data, the total dietary intake of the
substance arising from its use at the levels necessary
to achieve the desired effect and from its acceptable
background in food does not represent a hazard to
health.
15.
The consumption patterns of beverages of secondary
school students were derived from the Food Consumption
Survey conducted on local secondary school students
in 2000 by FEHD. In the survey, a stratified three-stage
sampling plan was used, with a sampling frame of
472 secondary schools and more than 380,000 students,
covering almost all the local secondary schools.
A total of 967 students from 27 schools participated
in the survey yielding a response rate of 77% at
the school level and 96% at the student level. The
mean weight of the participated students was 52.0
kg. 9
16.
The Food Consumption Survey covered both ¡§diet¡¨
and ¡§non-diet¡¨ beverages. In this study, except
the two items which were known not to contain artificial
sweeteners, i.e. drinking water and (non-diet) soda
drinks, consumption data on all other beverages
covered in the Survey were included. Apart from
¡§diet soda drinks¡¨, the Food Consumption Survey
does not provide information on the proportion of
these beverages being sweetened by artificial sweeteners.
Thus, to err on the conservative side, all these
beverages were assumed to contain artificial sweeteners.
These beverages were categorized into three groups,
namely (i) carbonated drinks, (ii) flavoured bottled
water and (iii) other beverages included in this
study.
Sampling Plan
17.
A market survey was conducted in the major local
supermarkets to obtain a list of beverages containing
artificial sweeteners that are available for sale
in Hong Kong. In the market survey, all food items
meeting our definition of beverage as stated in
paragraph 10 were checked against the labels to
see whether they contain artificial sweeteners.
As a result, a total of 62 beverages were found
to contain artificial sweeteners and all were taken
for analyses.
18.
These samples were categorized into those three
groups according to the method of categorization
as listed in paragraph 16. Samples of tea, coffee,
soy-based drinks, juice drinks, dairy-based drinks,
sports drinks and herbal drinks were put together
under the group ¡§other beverages¡¨.
Laboratory Analysis
19.
Samples were then sent to the Food Research Laboratory
(FRL) of FEHD for analyses. The levels of studied
artificial sweeteners in each sample were analysed
quantitatively by High Performance Liquid Chromatography
(HPLC).
20.
The limit of quantification for this study was 4
mg/L for each studied artificial sweetener in the
samples. Artificial sweeteners are food additives
and are not expected to be present in food unless
they are added intentionally. The level necessary
to achieve the desired effect should be higher than
the limit of quantification (i.e. 4 mg/L). Therefore,
samples with levels below the limit of quantification
were assigned zero for enumeration purpose.
Dietary Exposures to Artificial Sweeteners from
Beverages
21.
By using the consumption data and the concentrations
of artificial sweeteners in the samples, exposures
to artificial sweeteners from beverages were estimated
according to the following formula. 10
22.
The exposure estimates were then compared with the
respective ADIs established by JECFA for these artificial
sweeteners (Table 1).
Table 1: Acceptable
Daily Intake (ADI) of the Artificial Sweeteners
Established by JECFA
23.
The average levels of consumption of beverages for
secondary school students for the three groups were
shown in Table 2.
Table 2: Average
Consumption of Beverages for Secondary School Students
who Consumed the Beverages
Concentration of
Artificial Sweeteners in Beverages
24.
A total of 62 beverage samples were analyzed. The
number of samples in each beverage group is given
in Table 3. All the 62 samples contained one or
more artificial sweeteners. The number of samples
containing the studied artificial sweeteners and
the minimum and maximum concentrations of the artificial
sweeteners among those samples containing the respective
artificial sweeteners are summarized in Tables 4
and 5 respectively. The mean concentrations of the
artificial sweeteners for each beverage group are
given in Table 6. Distributions of the level of
artificial sweeteners in the samples are provided
in Annex II.
Table 3: Number
of Samples Taken for Analysis
Table 4: Number
of Samples Containing the Studied Artificial Sweeteners
Table 5: Minimum
and Maximum Concentration of the Artificial Sweeteners
among those Samples Containing the Respective Artificial
Sweeteners
Table 6: Mean
Concentrations of Artificial Sweeteners in Beverages
Dietary Exposures
to Artificial Sweeteners from Beverages
Average Consumers
25.
By combining the consumption data listed in Table
2 and the mean concentrations of artificial sweeteners
in beverages listed in Table 6, the exposures to
the studied artificial sweeteners of an average
consumer were calculated and were then compared
with the respective ADIs. The results are shown
in Table 7.
Table 7: Dietary
Exposures to Artificial Sweeteners from Beverages
for an Average Consumer in Secondary School Students
High Consumers
26.
A further analysis was undertaken to estimate the
risk that high consumers might be exposed to. In
this study, the 95th percentile of the exposure
levels to artificial sweeteners was used to represent
the exposures for high consumers. The results are
shown in Table 8.
Table 8: Dietary
Exposure to Artificial Sweeteners from Beverages
for High Consumers in Secondary School Students
Dietary Exposures
to Artificial Sweeteners from Beverages
27.
For an average consumer in secondary school students,
daily exposures to the studied artificial sweeteners
from beverages were 0.98 mg/kg bw for acesulfame
potassium, 0.57 mg/kg bw for aspartame, 0.64 mg/kg
bw for cyclamic acid, 0.04 mg/kg bw for saccharin
and 0.22 mg/kg bw for sucralose. The percentages
of the respective ADIs contributed by these exposures
were 6.5% for acesulfame potassium, 1.4% for aspartame,
5.8% for cyclamic acid, 0.8% for saccharin and 1.5%
for sucralose. The exposures were well below the
respective ADIs established by JECFA for all five
artificial sweeteners.
28.
For high consumers, the daily exposures to the studied
artificial sweeteners were 3.51 mg/kg bw (23.4%
of ADI) for acesulfame potassium, 1.85 mg/kg bw
(4.6% of ADI) for aspartame, 1.82 mg/kg bw (16.5%
of ADI) for cyclamic acid, 0.13 mg/kg bw (2.6% of
ADI) for saccharin and 0.67 mg/kg bw (4.5% of ADI)
for sucralose. Exposures to the five artificial
sweeteners for high consumers were also below the
respective ADIs.
29.
Therefore, it could be concluded that exposures
to the studied artificial sweeteners, acesulfame
potassium, aspartame, cyclamic acid, saccharin and
sucralose, from beverages do not pose a risk to
secondary school student's health for both average
and high consumers.
Artificial Sweeteners Concentration in Beverages
30.
Beverages were chosen in the estimation of exposures
to artificial sweeteners in this study because they
have been recognized as the major source of artificial
sweeteners in the diet. 1617 Besides, some market
surveys also reported that the soft drink industry
has been identified as the biggest user of artificial
sweeteners worldwide. 18
31.
From the results, we found that, of the 62 beverage
samples, acesulfame potassium was found in 44 samples
(71%), aspartame was found in 37 (60%), sucralose
was found in 17 (27%) and saccharin were found in
8 samples (13%). Cyclamic acid was a less commonly
used artificial sweetener in beverages, which was
only found in 4 samples (6%).
32.
The results also showed that 43 out of 62 samples
(70%) contained more than one artificial sweetener.
Sweetener blends have become more popular in the
production of foods and beverages, making use of
the benefits of multiple sweeteners, as synergistic
taste enhancement and sweetness profile modifications
offer advantages over the use of single sweeteners.
19
33.
From a food safety point of view, this practice
allows sweeteners to be present at lower levels,
and thus, consumption of single sweetener can be
lowered.19
Exposures to Artificial Sweeteners from Sources
Other Than Beverages
34.
Although beverages are recognized as the major source
of artificial sweeteners in the diet, exposures
to artificial sweeteners may also result from other
dietary sources such as table-top sweeteners, candies
and chewing gums. A study conducted in Italy on
the exposures to four artificial sweeteners from
various sources including beverages, chewing gum,
candies, table-top sweeteners, jam and yoghurt in
teenagers showed that beverages were the main source
of both cyclamate (85%) and acesulfame potassium
(75%), but only represented 25% of aspartame intake
and 4% of saccharin intake.16
35.
We applied the Italian data to our study results
to have a crude estimation of the dietary exposures
to artificial sweeteners from dietary sources other
than beverages. Adding these estimates to our results,
the percentage ADI of exposures to the four artificial
sweeteners from beverages and other dietary sources
ranged from 6% for aspartame to 20% for saccharin
for average consumers, and ranged from 19% for both
aspartame and cyclamic acid to 65% for saccharin
for high consumers. The estimated exposures for
both average and high consumers were still below
the ADIs.
Limitation
36.
Food consumption data of beverages containing artificial
sweeteners used in this study were derived from
the Food Consumption Survey. However, only one item,
soda drinks (diet), was indicated to contain artificial
sweeteners in the Survey. Except drinking water
and ¡§ordinary¡¨ soda which do not contain artificial
sweeteners, it was assumed in the study that all
other beverages consumed by secondary school students
were sweetened by artificial sweeteners. This is
a conservative approach and would overestimate the
actual exposure to artificial sweeteners.
37.
Due to the lack of the consumption data of each
beverage containing artificial sweetener by each
person, exposures from beverages for those who exhibit
¡§brand loyalty¡¨ cannot be estimated.
38.
Only beverage was included in this study but exposure
to artificial sweeteners from other dietary sources
was possible. However, the estimated exposures from
beverages together with other dietary sources as
mentioned in paragraph 35 were still below the ADIs.
39.
The estimated exposures from beverages to the studied
artificial sweeteners for an average consumer in
secondary school students were 0.98 mg/kg bw for
acesulfame potassium, 0.57 mg/kg bw for aspartame,
0.64 mg/kg bw for cyclamic acid, 0.04 mg/kg bw for
saccharin and 0.22 mg/kg bw for sucralose. They
were all well within their respective ADIs established
by JECFA, ranging from 0.8% of the ADI for saccharin
to 6.5% of the ADI for acesulfame potassium.
40.
As for high consumers, the exposures to the studied
artificial sweeteners were also below the ADIs,
ranging from 2.6% of the ADI for saccharin to 23.4%
of the ADI for acesulfame potassium.
41.
It can be concluded that exposures to the five artificial
sweeteners, acesulfame potassium, aspartame, cyclamic
acid, saccharin and sucralose, from beverages do
not pose a risk to the health of secondary school
students for both average and high consumers.
42.
Some advices are given to the trade and the consumers
over the use of artificial sweeteners:
Advice to Trade
(a) Food manufacturers
should only use the permitted artificial sweeteners
stipulated in the Food Adulteration (Artificial
Sweeteners) Regulations (Cap. 132 Sub. Leg. U)
in accordance with Good Manufacturing Practices;
(b)
To reduce the amount of exposure to each sweetener by
consumers, using of more than one sweetener in a product
can be considered;
(c)
Artificial sweeteners should be properly labelled either
by their specific names or the category on the packages
according to the Food and Drugs (Composition and Labelling)
Regulations.
Advice to Consumers
(a) A balanced
diet is recommended to avoid excessive intake
of any artificial sweeteners from a small range
of food items;
(b)
Persons who have concerns and medical reasons about the
use of products containing artificial sweeteners should
seek advice from health professionals.
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Last
review date: 19-01-2005