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Risk Assessment Studies
Report No. 15
Chemical Hazard Evaluation
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
Table of Contents:
Abstract
Objective
Introduction
Scope of Study
Methodology
Consumption Data
Sampling Plan
Laboratory Analysis
Dietary Exposures to Artificial Sweeteners from Beverages
Results
Beverage Consumption Data
Concentration of Artificial Sweeteners in Beverages
Dietary Exposures to Artificial Sweeteners from Beverages
Discussion
Conclusion and Recommendations
Advice to Trade
Advice to Consumers
References
Annex I: Summary Information on Artificial
Sweeteners
Annex II: Distributions of Artificial Sweeteners in Beverages
| Abstract
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.
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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.
INTRODUCTION
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.1 3
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.3
4
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.
SCOPE OF STUDY
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.
METHODOLOGY
Consumption Data
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
RESULTS
Beverage Consumption Data
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
DISCUSSION
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. 16
17 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.
CONCLUSION AND RECOMMENDATIONS
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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ANNEX I - Summary Information
on Artificial Sweeteners
ANNEX II - Distributions
of Artificial Sweeteners in Beverages
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