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12/03
8 October 2003
FINAL ASSESSMENT REPORT
PROPOSAL P273
INTENSE SWEETENERS IN JELLY
FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ)
FSANZ’s role is to protect the health and safety of people in Australia and New Zealand through the
maintenance of a safe food supply. FSANZ is a partnership between ten Governments: the
Commonwealth; Australian States and Territories; and New Zealand. It is a statutory authority under
Commonwealth law and is an independent, expert body.
FSANZ is responsible for developing, varying and reviewing standards and for developing codes of
conduct with industry for food available in Australia and New Zealand covering labelling,
composition and contaminants. In Australia, FSANZ also develops food standards for food safety,
maximum residue limits, primary production and processing and a range of other functions including
the coordination of national food surveillance and recall systems, conducting research and assessing
policies about imported food.
The FSANZ Board approves new standards or variations to food standards in accordance with policy
guidelines set by the Australia and New Zealand Food Regulation Ministerial Council (Ministerial
Council) made up of Commonwealth, State and Territory and New Zealand Health Ministers as lead
Ministers, with representation from other portfolios. Approved standards are then notified to the
Ministerial Council. The Ministerial Council may then request that FSANZ review a proposed or
existing standard. If the Ministerial Council does not request that FSANZ review the draft standard,
or amends a draft standard, the standard is adopted by reference under the food laws of the
Commonwealth, States, Territories and New Zealand. The Ministerial Council can, independently of
a notification from FSANZ, request that FSANZ review a standard.
The process for amending the Australia New Zealand Food Standards Code is prescribed in the Food
Standards Australia New Zealand Act 1991 (FSANZ Act). The diagram below represents the
different stages in the process including when periods of public consultation occur. This process
varies for matters that are urgent or minor in significance or complexity.
 Comment on scope, possible
options and direction of
regulatory framework
 Provide information and
answer questions raised in
Initial Assessment report
 Identify other groups or
individuals who might be
affected and how – whether
financially or in some other way
INITIAL
ASSESSMENT
Public
Consultation
DRAFT
ASSESSMENT
 Comment on scientific risk
assessment; proposed
regulatory decision and
justification and wording of
draft standard
 Comment on costs and
benefits and assessment of
regulatory impacts
Public
Consultation
FINAL
ASSESSMENT
 Those who have provided
submissions are notified of the
Board’s decision
Public
Information
MINISTERIAL
COUNCIL
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 An IA report is prepared with an outline of issues and
possible options; affected parties are identified and
questions for stakeholders are included
 Applications accepted by FSANZ Board
 IA Report released for public comment
 Public submissions collated and analysed
 A Draft Assessment (DA) report is prepared using
information provided by the applicant, stakeholders and
other sources
 A scientific risk assessment is prepared as well as other
scientific studies completed using the best scientific
evidence available
 Risk analysis is completed and a risk management plan is
developed together with a communication plan
 Impact analysis is used to identify costs and benefits to all
affected groups
 An appropriate regulatory response is identified and if
necessary a draft food standard is prepared
 A WTO notification is prepared if necessary
 DA Report considered by FSANZ Board
 DA Report released for public comment
 Comments received on DA report are analysed and
amendments made to the report and the draft regulations
as required
 The FSANZ Board approves or rejects the Final
Assessment report
 The Ministerial Council is notified within 14 days of the
decision
 If the Ministerial Council does not ask FSANZ to review a
draft standard, it is gazetted and automatically becomes
law in Australia and New Zealand
 The Ministerial Council can ask FSANZ to review the draft
standard up to two times
 After a second review, the Ministerial Council can revoke
the draft standard. If it amends or decides not to amend the
draft standard, gazettal of the standard proceeds
Final Assessment Stage (s.36)
FSANZ has now completed the assessment of the Proposal and held a single round of public
consultation under section 36 of the FSANZ Act. This Final Assessment Report and its
recommendations have been approved by the FSANZ Board and notified to the Ministerial
Council.
If the Ministerial Council does not request FSANZ to review the draft amendments to the Code,
an amendment to the Code is published in the Commonwealth Gazette and the New Zealand
Gazette and adopted by reference and without amendment under Australian State and Territory
food law.
In New Zealand, the New Zealand Minister of Health gazettes the food standard under the New
Zealand Food Act. Following gazettal, the standard takes effect 28 days later.
Further Information
Further information on this Proposal and the assessment process should be addressed to the
FSANZ Standards Liaison Officer at one of the following addresses:
Food Standards Australia New Zealand
PO Box 7186
Canberra BC ACT 2610
AUSTRALIA
Tel (02) 6271 2222
www.foodstandards.gov.au
Food Standards Australia New Zealand
PO Box 10559
The Terrace WELLINGTON 6036
NEW ZEALAND
Tel (04) 473 9942
www.foodstandards.govt.nz
Assessment reports are available for viewing and downloading from the FSANZ website
www.foodstandards.gov.au or alternatively paper copies of reports can be requested from
FSANZ’s Information Officer at [email protected] including other general
enquiries and requests for information.
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CONTENTS
EXECUTIVE SUMMARY AND STATEMENT OF REASONS ....................................... 5
1.
INTRODUCTION ...................................................................................................... 8
2.
REGULATORY PROBLEM .................................................................................... 8
3.
OBJECTIVE ............................................................................................................... 8
4.
BACKGROUND ......................................................................................................... 9
4.1
5.
HISTORICAL BACKGROUND ........................................................................................... 9
RELEVANT ISSUES ............................................................................................... 10
5.1
5.2
5.3
5.4
5.5
5.6
PUBLIC HEALTH AND SAFETY....................................................................................... 10
TECHNOLOGICAL JUSTIFICATION FOR USE OF CYCLAMATES AND SACCHARIN ............. 12
FAIR TRADING ............................................................................................................. 13
LEVEL OF SACCHARIN .................................................................................................. 14
OTHER APPLICATIONS TO EXTEND USE OF CYCLAMATES AND SACCHARIN................... 15
FSANZ INTENSE SWEETENER SURVEY ....................................................................... 15
6.
REGULATORY OPTIONS .................................................................................... 15
7.
IMPACT ANALYSIS ............................................................................................... 16
7.1
8.
GROUPS AFFECTED BY THE PROPOSAL ......................................................................... 16
CONSULTATION .................................................................................................... 17
8.1
WORLD TRADE ORGANIZATION (WTO) ...................................................................... 18
9.
CONCLUSION AND RECOMMENDATION ...................................................... 19
10.
IMPLEMENTATION AND REVIEW................................................................... 20
ATTACHMENT 1 - DRAFT VARIATIONS TO THE AUSTRALIA NEW ZEALAND
FOOD STANDARDS CODE.................................................................................................. 21
ATTACHMENT 2 - DIETARY ASSESSMENT REPORT............................................... 22
ATTACHMENT 3 - SUMMARY OF SUBMISSIONS RECEIVED IN RESPONSE TO
THE DRAFT ASSESSMENT REPORT ............................................................................. 24
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Executive Summary and Statement of Reasons
Issues
The New Zealand Food Regulations, 1984 (the NZFR) permitted the use of cyclamates and
saccharin in low joule jelly. In the former Australian Food Standards Code, there was an
express prohibition on the use of saccharin and cyclamates in pre-prepared low joule jellies,
but manufacturers produced jelly crystals with these sweeteners, making use of the generic
provision for addition of them to other low joule foods. In the review, concern about
excessive intakes of these sweeteners led to the removal of these general permissions. At the
time, no significant concerns were raised from jelly manufacturers or others about these
changes. At the end of the transition period (December 2002), old permissions were formally
repealed, making such products illegal to manufacture, though the stock-in-trade provisions
would permit some older product to remain on the market until sold.
Shortly before the repeal of the NZFR, New Zealand jelly manufacturers raised the lack of
permission for these intense sweeteners as a problem. After consultation with New Zealand
food industry representatives; Australian Food and Grocery Council; and members of
FSANZ’s Office of Legal Counsel, and Monitoring and Evaluation Program; FSANZ agreed
to raise a proposal to reinstate permission to use cyclamates and saccharin in low joule jelly.
Without permission in the Australia New Zealand Food Standards Code (the Code) for the
continued use of cyclamates and saccharin in jelly, consumers of these specialty products will
be disadvantaged. Consumers of these products include people with type 1 or type 2
diabetes, obesity, hypertension, or other conditions calling for weight loss and/or dietary
sugar restriction.
Consultation
Under section 36 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) the
Authority decided to omit one round of public consultation as it was satisfied that the
Proposal raised issues of minor significance and complexity only, and that omitting to invite
public consultation at the Initial Assessment stage would not have a significant adverse
impact on the interests of concerned parties.
The FSANZ Board agreed to the Initial/Draft Assessment at its meeting of 5 March 2003 and
public notice inviting submissions was given on 19 March 2003. The consultation period
ended on 16 April 2003. A summary of submissions is at Attachment 3.
FSANZ received eleven submissions in response to the Initial/Draft Assessment Report.
Most submissions fully supported the proposed amendments, which would permit the use of
cyclamates and saccharin in low joule jelly. Two submissions suggested that issues relating
to consumption of low joule jelly by ‘at-risk’ populations groups such as children, Aboriginal
and Torres Strait Islanders, and high consumers of cyclamates and saccharin required further
investigation and/or consideration. One submission, from a major jelly manufacturer
strongly opposed reinstating the permissions, claiming it will be commercially disadvantaged
because it has incurred considerable costs reformulating and repackaging its diet jelly
products to conform to current permissions in the Code.
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In an effort to resolve the unexpected conflict between industry members, FSANZ undertook
further consultation (via teleconference), targeting industry representatives in Australia and
New Zealand. This consultation confirmed the continuing opposition of one manufacturer
and the support of all the other manufacturers for the reinstatement of the permissions for the
use of cyclamate and saccharin in jelly.
Conclusion and Statement of Reasons
In making its recommendation on this matter FSANZ has considered:




the issues raised in submissions received in response to the Draft Assessment report;
issues raised in further consultation with Australia and New Zealand industry
representatives to resolve unexpected conflict;
issues associated with technological justification for the use cyclamates and saccharin
in low joule jelly; and
public health and safety issues associated with the dietary modelling that assessed the
likely exposure to cyclamates and saccharin from low joule jelly.
FSANZ recommends that Item 20.2 Mixed Foods, sub-item jelly in Schedule 1 of Standard
1.3.1 – Food Additives be amended to include permissions for the use of cyclamates and
saccharin in jelly at the maximum permitted levels of 1600 mg/kg and 160 mg/kg
respectively in the final food.
The proposed level for cyclamate (1600 mg/kg) is more than ten times lower then the generic
permission in the old Code for non-specified low joule foods, which was 20,000 mg/kg. The
proposed level for saccharin (160 mg/kg) is nearly ten times lower than the generic
permission in the old Code for non-specified low joule foods, which was 1500 mg/kg.
Reasons for these recommendations are that the proposed amendment:

presents no significant increase in risk to public health and safety because, dietary
surveys and dietary modelling show that even for high consumers of these sweeteners,
the contribution of low joule jelly to the overall intake of cyclamates and saccharin is
likely to be insignificant;

is technologically justified because manufacturers will be permitted to use low cost and
highly stable intense sweeteners with favourable taste profiles in low joule jellies;

will provide jelly manufacturers with a broader range of intense sweeteners than is
currently permitted in the Code;

is unlikely to have a significant effect on international trade because the proposed
amendment broadens intense sweetener permissions rather than restricts them, which
would have the effect of a slight increase in international trade in jelly, although the
volume and value the of international trade in low joule jelly is low;

would facilitate the continued importation of jelly containing these artificial
sweeteners; and
6

will result in significant benefits to consumers (including people with type 1 and type 2
diabetes, obesity, hypertension, or other conditions calling for weight loss and/or
dietary sugar restriction) and manufacturers, which will outweigh the significant costs
associated with the unavailability of locally made low joule jelly.
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1.
Introduction
The New Zealand Food Regulations, 1984 (the NZFR) permitted the use of cyclamates and
saccharin in low joule jelly. In the former Australian Food Standards Code, (former Volume
1) there was an express prohibition on the use of saccharin and cyclamates in pre-prepared
low joule jellies, but manufacturers produced jelly crystals with these sweeteners, making use
of the generic provision for addition of them to other low joule foods. In the review, concern
about excessive intakes of these sweeteners led to the removal of these general permissions.
At the time, no significant concerns were raised from jelly manufacturers or others about
these changes. At the end of the transition period (December 2002), old permissions were
formally repealed, making such products illegal to manufacture, though the stock-in-trade
provisions would see some older product remain on the market until sold.
Shortly before the repeal of the NZFR, New Zealand jelly manufacturers raised the lack of
permission for these intense sweeteners as a problem. After consultation with New Zealand
food industry representatives; Australian Food and Grocery Council; and members of
FSANZ’s Office of Legal Counsel, and Monitoring and Evaluation Program; FSANZ agreed
to raise a proposal (Proposal P273) to reinstate permission to use cyclamates and saccharin in
low joule jelly. The matter was considered to be straightforward and non-contentious, and so
was progressed with a single consultation strategy.
Late in 2002, shortly before the repeal of the NZFR and former Volume 1, industry
representatives contacted FSANZ requesting that the permissions be continued in the former
Volume 2 of the joint Australia New Zealand Food Standards Code (now the Australia New
Zealand Food Standards Code (the Code)).
Without permission in the Code for the use of cyclamates and saccharin in jelly, these
products would no longer be compliant, and consumers of these specialty products would be
disadvantaged. Consumers of these products include people with type 1 or type 2 diabetes,
obesity, hypertension, or other conditions calling for weight loss or dietary sugar restriction.
2.
Regulatory problem
The regulatory problem is that the food industry in both Australia and New Zealand has an
established history of the use of cyclamates and saccharin in low joule jellies. During the
recent review of food standards, neither industry or government submissions from New
Zealand or Australia commented on the omission from the Code of the permissions for the
use of cyclamate and saccharin in low joule jelly. Only late in the transition period, shortly
before repeal of Volume 1 of the former Code and the NZFR, was the issue raised as a
problem for the manufacturers of these products.
3.
Objective
In developing or varying a food standard, FSANZ is required by its legislation to meet three
primary objectives which are set out in section 10 of the Food Standards Australia New
Zealand Act 1991. These are:

the protection of public health and safety;
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
the provision of adequate information relating to food to enable consumers to make
informed choices; and

the prevention of misleading or deceptive conduct.
In developing and varying standards, FSANZ must also have regard to:

the need for standards to be based on risk analysis using the best available scientific
evidence;

the promotion of consistency between domestic and international food standards;

the desirability of an efficient and internationally competitive food industry;

the promotion of fair trading in food; and

any written policy guidelines formulated by the Ministerial Council.
The main objective of this Proposal is to determine if it is appropriate to permit the use of
saccharin and cyclamates in jelly and to evaluate any impacts on public health and safety
from such permission.
4.
Background
4.1
Historical Background
The review for the development of the joint food additives standard (P150) proposed that
permissions for cyclamates and saccharin be reduced and/or deleted for many foods. This
decision was based on the outcome of dietary modelling that showed a high intake of
cyclamates and saccharin in some consumers, where intake levels were approaching or
exceeding the Acceptable Daily Intakes (ADIs) for these intense sweeteners as determined by
the Joint WHO/FAO Expert Committee on Food Additives (JECFA).
The former National Food Authority (NFA) conducted two dietary surveys (one in 1994 and
one in 1995), which were used during the review of food additives permissions. The dietary
modelling for the 1994 survey, which focussed on ‘high consumers’ of intense sweetened
foods (identified in a preliminary study) found that cordial was the major dietary exposure
source for cyclamate (86%) and cordials and table top sweeteners the main sources for
saccharin. The same study found that jelly contributed only 4% to the mean cyclamate
exposure and 1% to the mean saccharin exposure in these high consumers. The dietary
modelling conducted for the 1995 survey found dietary exposure to cyclamates and saccharin
to be at similar levels to those found in the 1994 survey.
In summary, the dietary modelling found that although the intake of cyclamates and saccharin
was high in some consumers, therefore warranting restriction of these sweeteners in many
foods, it also found that the contribution of low joule jelly to the intake of cyclamates and
saccharin was not significant, even in high consumers of these intense sweeteners.
9
The Proposal P150 review was finalised in June 1999 and at no time before its finalisation
did industry or government submissions, from either Australia or New Zealand, request that
permission for cyclamates and saccharin use in jelly be considered for inclusion in the new
Code. The joint Australia New Zealand standard regulating food additives was gazetted in
June 2000 and again, with amendments, in December 2000, along with the rest of the Code.
5.
Relevant issues
5.1
Public health and safety
FSANZ and its predecessors have conducted two major dietary exposure assessments for
saccharin and cyclamates over the last 10 years. The first of these was a detailed, brand-level
study in 1994 of the consumption of intense sweetened foods by Australians aged 12-39
years. The second was an estimate of exposure prepared using food consumption data
derived from the 1995 Australian National Nutrition Surveys (NNS), prepared as part of the
review of food additives during the development of the joint food standard on food additives
(P150 – Review of food additives).
The dietary assessment report (Attachment 2) is based on these surveys. The 1994 study
found that intense sweetened jelly was not a major contributor to dietary exposure for either
saccharin or cyclamate. Jelly contributed only 4% to the mean cyclamate exposure and 1% to
the mean saccharin exposure. Only 1% of the total survey population (not only those
identified as high consumers) ate intense sweetened jelly during the survey period, with
females and those on weight control or low sugar diets or with a medical condition requiring
restricted sugar intake being more likely to consume it.
The dietary modelling conducted for the development of the joint food additives standard
found dietary exposure to cyclamates and saccharin to be at similar levels to those found in
the 1994 survey.
5.1.1
Issues raised in submissions
The submission from Queensland Health’s Environmental Health Unit (Qld Health)
suggested that the following matters required further investigation and/or consideration:



the estimated dietary exposure to saccharin and cyclamate for population sub-groups
that are mostly likely to consume jelly, particularly children;
further dietary modelling to consider consumption of all sources of artificial sweeteners
rather than just jelly when estimating dietary exposure; and
further investigation into the ‘small but significant proportion of the population at risk
of exceeding the Acceptable Daily Intake for cyclamate’.
The New Zealand Food Safety Authority (NZFSA) submission:


noted that there has been no dietary modelling in children and that UK Food Safety
Authority has issued warnings about children not consuming too much cordial with
cyclamates as the ADI may be exceeded; and
suggested that FSANZ consider the potential consumption of low joule jellies by
children and if necessary conduct dietary modelling on children before approval is
given to use these sweeteners in low joule jellies.
10
The submissions from Bronson and Jacobs Pty Ltd (New Zealand Division) (B&J)and from
Hansells (NZ) Pty Ltd (Hansells) observed that initially there was some concern over the
daily intakes of such sweeteners by children but pointed out that these low joule jellies are
not something that children would normally consume.
The Australian Food and Grocery Council (AFGC) submission considered that in view of the
satisfactory safety assessment outlined in the Draft Assessment report, Proposal P273 should
be approved.
5.1.2
Evaluation
Most of the matters raised by Qld Health for further investigation and/or consideration were
in fact considered in the Draft Assessment report, although only the conclusions of the
dietary modelling were included in the main section of the report. The following provides
more detail from the dietary modelling report included at Attachment 2.
The dietary modelling for this Proposal was based on two dietary surveys conducted by the
NFA, one in 1994 and one in 1995, which were used during the review of food additives
permissions. The dietary modelling for the 1994 survey, which focussed on ‘high
consumers’ of intense sweetened foods (identified in a preliminary study) found that cordial
was the major dietary exposure source for cyclamate (86%) and cordials and table top
sweeteners the main sources for saccharin. The same study found that jelly contributed only
4% to the mean cyclamate exposure and 1% to the mean saccharin exposure in these high
consumers. The dietary modelling conducted for the 1995 survey found dietary exposure to
cyclamates and saccharin to be at similar levels to those found in the 1994 survey. That is,
jelly was not identified as being a significant source of exposure to either saccharin or
cyclamates.
In summary, the 1994 and 1995 surveys focussed on high consumers of intense sweeteners
who were identified in a preliminary study. The dietary modelling on both surveys found
that, even in these high consumers, the contribution of low joule jelly to the intake of
cyclamates and saccharin was not significant.
FSANZ has commissioned a survey of the use of intense sweetened products by Australians
and New Zealanders aged 12 years and over as part of its ongoing programme to monitor the
levels and use of some food additives. This survey is expected to provide refined estimates
of exposure to cyclamates, saccharin and other permitted intense sweeteners. Results of this
latest survey may have some bearing on cyclamates and saccharin permissions in the Code.
That is, the results may lead to a re-examination of Code permissions for cyclamates and
saccharin, including those for jelly.
Children below the age of 12 years will not be included in this survey due to the difficulties
associated with getting reliable records of dietary intake in young children. This means that
FSANZ will have no better estimate of the intake of intense sweetened jelly in young
children than it now does. However there is no reason to suppose that children would eat any
more intense sweetened jelly than would adults and indications from all existing surveys is
that consumption of intense sweetened jelly is not high in any group. Therefore, even in
those children who are high consumers of intense sweeteners, the contribution of jelly to their
overall intake is likely to be insignificant.
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The proposed level for cyclamate (1600 mg/kg) is more than ten times lower then the generic
permission in the old Code, which was 20,000 mg/kg. The proposed level for saccharin (160
mg/kg) is nearly ten times lower than the generic permission in the old Code, which was
1500 mg/kg.
After considering all the available data, FSANZ concludes that there is unlikely to be any
adverse effect to public health and safety if the proposed amendment to the Code were to be
approved.
5.2
Technological justification for use of cyclamates and saccharin
Cyclamates are one of the most economical non-caloric sweeteners. Saccharin also is low in
cost compared with other intense sweeteners. The two sweeteners when combined have a
synergistic effect – that is the sweetness of the combination is greater than the sum of the
individual parts. Cyclamates have a more favourable taste profile than saccharin in most
food applications and do not leave an unpleasant aftertaste at normal use concentrations.
The primary advantage of the sweetener blend is that saccharin (300 times sweeter than
sucrose) boosts the sweetening power of cyclamates (30 times sweeter than sucrose), whereas
cyclamates mask the aftertaste that some people associate with saccharin. Both saccharin and
cyclamates are also more stable than most other intense sweeteners. In dry form both are
stable for several years. They also are highly soluble and remain stable over a wide pH range
and temperature range.1
Alitame and acesulphame potassium are currently permitted in the Code for use in jelly.
Aspartame and sucralose are also permitted in a wide range of foods, including jelly.
5.2.1
Issues raised in submissions
The submissions from AFGC, B&J, Cadbury Schweppes Asia Pacific, the Calorie Control
Council, and Hansells all indicated the advantages of using cyclamates and saccharin blends
in jelly:




the use of a saccharin and cyclamate results in products with an excellent taste profile;
the synergistic properties and stability of the cyclamate/saccharin combination are well
documented;
the use of the blend lowers the concentration of each of the component sweeteners,
thereby reducing any off-taste that might occur from the use of higher concentrations of
the individual sweeteners; and
their use will allow low cost manufacture and thus help keep retails costs down.
The submissions also pointed out that while reformulation with other permitted sweeteners
was possible their use was associated with significant disadvantages such as:


alitame and acesulphame potassium were unacceptable in terms of bitter taste;
aspartame degradation with hot water make up;
Alternative Sweeteners (3rd Edition, Revised and Expanded) Nabors L O’B (ed) Marcel Dekker Inc 2001 New
York, Basel.
1
12




use of aspartame triggers mandatory labelling requirements to advise people with
phenylketonuria;
sucralose is extremely cost prohibitive and there are difficulties associated with its
handling because powdered Sucralose is only available as a micronised powder;
shorter shelf life; and
although there is little scientific data to support the brain tumour/aspartame link many
consumers are nevertheless turned off this sweetener due to this publicity.
The submissions further stated that low joule jellies made with cyclamate and saccharin have
long been available in Australia and New Zealand with a high degree of consumer
acceptability and they provide a low cost dessert option for people with diabetes and those on
sugar restricted or calorie control diets.
5.2.2
Evaluation
Use of the blend of cyclamates and saccharin is technologically justified on the basis of the
low cost, extreme stability and favourable taste profile of the two sweeteners used in
combination.
5.3
Fair trading
5.3.1
Issues raised in submissions
McCormick Foods Australia Pty Ltd strongly opposed the proposed permission for the use of
cyclamates and saccharin in jelly on fair-trading grounds because it has incurred considerable
costs reformulating its diet jelly products to conform to current permissions in the Code.
The company provided commercial-in-confidence information , describing the size of the
Australian jelly market, the diet jelly segment and McCormick’s’ share of that market.
McCormick’s also provided commercial-in-confidence information on the costs the company
incurred in reformulating diet jelly products without cyclamates and saccharin in order to
comply with the current Code. These costs included: artwork redesign, packaging write off,
raw material write off, additional ongoing raw material costs, product development including
sensory evaluation, and factory trialling.
In an effort to resolve the unexpected conflicting views between industry members, FSANZ
undertook further consultation (via teleconference), targeting industry representatives in
Australia and New Zealand. The teleconference included:





the product development manager, marketing director and managing director, Hansells
(NZ) Pty Ltd;
the technical director and a food technologist, Cadbury Schweppes Asia Pacific;
the technical director, McCormick Foods Australia Pty Ltd;
the assistant technical director of the Australian Food and Grocery Council; and
the project manager for Proposal P273, a senior legal advisor, the principal food
technologist, and the General Manager the New Zealand office, Food Standards
Australia New Zealand.
The background for the Proposal, including past and present regulations, was presented by
FSANZ then industry representatives stated their positions with respect to the Proposal.
13
McCormick’s acknowledged that there were benefits and advantages associated with the use
of cyclamates and saccharin as compared to other intense sweeteners, and agreed that there
were no pubic health or safety concerns associated with their use in jelly. However, the
company remained opposed to the reinstatement of the permission because it had
reformulated and repackaged its products to comply with the current Code. This targeted
consultation confirmed McCormick’s continued opposition to reinstating the cyclamates and
saccharin permissions in jelly and the support of the other manufacturers for the
reinstatement of such permissions.
5.3.2
Evaluation
Notwithstanding the significant commercial outlay by McCormick’s to reformulate and
repackage its intense sweetened jelly products in order to comply with the new Code, all jelly
manufacturers are subject to the same commercial burdens in order to continue
manufacturing products that comply with the current Code. On balance, McCormick’s is in
the same position as other intense sweetened jelly manufacturers who have reformulated and
repackaged their products in order to comply with the Code.
Other than McCormick’s, those manufacturers who have reformulated and repackaged their
products expressed strong support for returning to a formulation using cyclamates and
saccharin notwithstanding the significant costs associated with repackaging the product
again.
There are a number of benefits for manufacturers and consumers associated with reinstating
the permissions for use of cyclamates and saccharin in jelly and there would be no significant
increase in risk to public health and safety associated with doing so (see Sections 5.1 and
5.2).
FSANZ concludes that the benefits of reinstating the permission for cyclamates and saccharin
outweigh the costs of any commercial disadvantage to manufacturers. The recommendation
to reinstate the permissions, although opposed by one manufacturer, is supported by those
manufacturers who have reformulated and repackaged their products and who therefore have
faced financial burdens comparable with the manufacturer opposing the recommendation.
5.4
Level of saccharin
5.4.1
Issues raised in submissions
Hansells supported the level proposed for cyclamates in the Draft Assessment report.
However the submission requested that the level for saccharin proposed in the Draft
Assessment report be raised from 150 mg/kg to 160 mg/kg. The rationale for this was that
saccharin and cyclamate always work best when used in combination at approximately 1:10
ratio respectively. Since the proposed level for cyclamates in the Draft Assessment report
was 1600 mg/kg then a more appropriate level for saccharin would be 160 mg/kg, which
provide more scope for slight changes to the sweetness profile of jelly products.
14
5.4.2
Evaluation
Raising the proposed level of saccharin to 160 mg/kg will provide manufacturers with more
flexibility in tailoring the formulation of their product than would the level of 150 mg/kg
proposed at Draft Assessment. The proposed level for saccharin (160 mg/kg) is nearly ten
times lower than the generic permission in the old Code for non-specified low joule foods,
which was 1500 mg/kg. The proposed level for cyclamate (1600 mg/kg) is more than ten
times lower then the generic permission in the old Code for non-specified low joule foods,
which was 20,000 mg/kg.
There are no public health and safety issues associated with a saccharin level of 160 mg/kg in
jelly. Therefore FSANZ proposes that the level for saccharin be 160 mg/kg in the final food.
5.5
Other applications to extend use of cyclamates and saccharin
FSANZ is currently preparing an Initial Assessment report for Application A469 – Artificial
sweetener levels in flavoured drinks. The outcome of the assessment of this application may
significantly affect the intake of cyclamates and saccharin. Dietary modelling has not yet
been done for Application A469. However, whatever the outcome of Application A469, the
additional contribution for low joule jelly to the overall intake of these intense sweeteners is
likely to be negligible (see dietary assessment report at Attachment 2).
5.6
FSANZ Intense Sweetener Survey
Following the development of the Code, FSANZ put in place a programme to monitor the
levels and use of some food additives, including both cyclamates and saccharin. As part of
this programme, FSANZ has commissioned a survey of the use of intense sweetened products
by Australians and New Zealanders aged 12 years and above.
This survey is expected to provide refined estimates of exposure to cyclamates, saccharin and
other permitted intense sweeteners. Results of the survey may have some bearing on
cyclamates and saccharin permissions in the Code.
6.
Regulatory Options
Possible options are:
1.
include permission for the use of cyclamates and saccharin in jelly in Schedule 1 of
Standard 1.3.1 – Food Additives; or
2.
do not include permission for the use of cyclamates and saccharin in jelly in Schedule 1
of Standard 1.3.1 – Food Additives.
15
7.
Impact Analysis
7.1
Groups affected by the proposal
7.1.1
Option 1 – If the proposed permission is approved:
7.1.1.1 Food industry


Jelly manufacturers will have permission in the Code to use low cost, stable and
reliable intense sweeteners that have had a long history of safe use in Australia and
New Zealand.
Jelly manufacturers who have reformulated and repackaged their intense sweetened
jelly products at significant cost in order to comply with the new Code would face
significant repackaging costs if/when they revert to a formulation using cyclamates and
saccharin. However they can choose to continue to formulate their products using the
other intense sweeteners permitted in the Code.
7.1.1.2 Consumers




Low joule jelly products will continue to be available to consumers who need to reduce
caloric intake for weight loss purposes, including people with type 1 or type 2 diabetes,
obesity, hypertension, or other conditions calling for weight loss and/or dietary sugar
restriction.
The low cost of cyclamates and saccharin compared with other intense sweeteners will
help keep the retail cost of these products down.
Longer shelf life of products formulated with cyclamates and saccharin would make it
easier for consumers to obtain and store product for consumption before its ‘bestbefore’ date.
Food additive labelling requirements in the Code will inform consumers of the presence
of these intense sweeteners.
7.1.1.3 Government and enforcement agencies

The regulatory framework would be the same as that under the old Code and NZFR.
Option 2 –If the proposed permission is not approved:
7.1.1.4 Food industry


Jelly manufacturers would have a restricted choice of intense sweeteners with which to
formulate their products. Those available would be less suitable than cyclamate and
saccharin blends, being more expensive, less stable and having an inferior flavour
profile.
The shorter shelf life of other intense sweeteners would require increased surveillance
for best-before dates.
16
7.1.1.5 Consumers


Once product packaged on or before 20 December 2002 runs out, there will be no
locally made low joule jelly products available until reformulation and repackaging
processes have been undertaken and completed satisfactorily.
Jelly that has been reformulated using intense sweeteners other than cyclamates and
saccharin would be more expensive (due to raw material costs and shorter shelf life)
and less palatable than those made with cyclamates and saccharin.
7.1.1.6 Government and enforcement agencies

Import and domestic production of jelly containing cyclamates and saccharin would be
prohibited, requiring increased surveillance to ensure Code compliance.
Based on the issues listed here and considered in detail in Section 5, the preferred option is
Option 1. That is, to amend the Code to include permission for cyclamates and saccharin in
low joule jelly. The proposal is technologically justified and dietary modelling indicates that
there will be no significant increase in risk to public health and safety if the amendment were
to be approved.
8.
Consultation
FSANZ decided, pursuant to section 36 of the FSANZ Act, to omit to invite public
submissions in relation to the Proposal prior to making a Draft Assessment. FSANZ made its
decision under section 36 because it was satisfied that omitting to invite public submissions
prior to making a Draft Assessment would not have an adverse effect on anyone’s interests.
Section 63 of the Act provides that, subject to the Administrative Appeals Tribunal Act 1975,
an application for a review of FSANZ’s decision may be made to the Administrative Appeals
Tribunal by a person whose interests are significantly affected by the decision to omit to
invite public submissions in relation to the Proposal.
Eleven submissions were received in response to the Initial/Draft Assessment Report:








one from a manufacturer of low joule jelly in New Zealand (Hansells (NZ) Ltd));
two from manufacturers of low joule jelly in Australia (McCormick Foods Australia
Pty Ltd and Cadbury Schweppes Asia Pacific);
one from the New Zealand division of a company that provides ingredients to the food
industry (Bronson and Jacobs Pty Ltd);
one from the peak industry body representing Australian packaged food, drink and
grocery products industry, including jelly manufacturers (Australian Food and Grocery
Council);
one from a US-based international association of companies who make and use lowcalorie sweeteners (Calorie Control Council);
one from a professional association (Dietitians Association of Australia);
one from a state based food technology association (Food Technology Association of
Victoria Inc.);
one from an Australian State Government Department (Queensland Health
(Environmental Health Unit));
17


one from a New Zealand Government Authority (New Zealand Food Safety Authority);
and
one from a Commonwealth government agency (Australian Quarantine and Inspection
Service).
Eight submissions fully supported the proposed amendments to the Code, which would
permit the use of cyclamates and saccharin in low joule jelly. One of these, from a jelly
manufacturer, requested that the level of saccharin proposed in the Draft Assessment report
be raised from 150 mg/kg to 160 mg/kg in the final food.
Two submissions (Queensland Health (Environmental Health Unit) and New Zealand Food
Safety Authority) suggested that there were a number of matters needing further investigation
and/or consideration. These were issues relating to consumption of low joule jelly by ‘atrisk’ populations groups such as children, Aboriginal and Torres Strait Islanders, and high
consumers of cyclamates and saccharin.
One submission, from a jelly manufacturer (McCormick Foods Australia) strongly opposed
the proposal on fair trading grounds because it had incurred considerable costs reformulating
and repackaging its diet jelly products to conform to current permissions in the Code. The
company believes that it will be commercially disadvantaged if the Code is changed in
accordance with Proposal P273. Should this change be implemented, there would also be a
significant cost associated with another potential change in product formulations.
In an effort to resolve the unexpected conflict between industry members, FSANZ undertook
further consultation (via teleconference), targeting industry representatives in Australia and
New Zealand. This targeted consultation confirmed the continuing opposition of one
manufacturer and the support of all the other manufacturers for the reinstatement of the
permissions for the use of cyclamate and saccharin in jelly.
The issues raised in submissions and during the further targeted industry consultation are
considered in Section 5, above.
A summary of submissions received in response to the Draft Assessment Report is at
Attachment 3.
8.1
World Trade Organization (WTO)
As members of the World Trade Organization (WTO), Australia and New Zealand are
obligated to notify WTO member nations where proposed mandatory regulatory measures are
inconsistent with any existing or imminent international standards and the proposed measure
may have a significant effect on trade.
Amending the Code to allow cyclamates and saccharin in low joule jelly is unlikely to have a
significant effect on international trade because:


low joule jellies are low value products that are not traded in large volumes; and
broadening these food additive permissions is likely to slightly increase rather than
restrict trade in low joule jelly products.
WTO notification therefore is considered unnecessary.
18
9.
Conclusion and Recommendation
In making its recommendation on this matter FSANZ has considered:




the issues raised in submissions received in response to the Initial/Draft Assessment
Report;
issues raised in further consultation with Australia and New Zealand industry
representatives to resolve unexpected conflict;
issues associated with technological justification for the use cyclamates and saccharin
in low joule jelly; and
public health and safety issues associated with the dietary modelling that assessed the
likely exposure to cyclamates and saccharin from low joule jelly.
FSANZ recommends that Item 20.2 Mixed Foods, sub-item ‘jelly’ in Schedule 1 of Standard
1.3.1 – Food Additives be amended to include permissions for the use of cyclamates and
saccharin in jelly at the maximum permitted levels of 1600 mg/kg and 160 mg/kg
respectively in the final food.
The proposed level for cyclamate (1600 mg/kg) is more than ten times lower then the generic
permission in the old Code for non-specified low joule foods, which was 20,000 mg/kg. The
proposed level for saccharin (160 mg/kg) is nearly ten times lower than the generic
permission in the old Code for non-specified low joule foods, which was 1500 mg/kg.
Reasons for these recommendations are that the proposed amendment:

presents no significant increase in risk to public health and safety because, dietary
surveys and dietary modelling show that even for high consumers of these sweeteners,
the contribution of low joule jelly to the overall intake of cyclamates and saccharin is
likely to be insignificant;

is technologically justified because manufacturers will be permitted to use low cost and
highly stable intense sweeteners with favourable taste profiles in low joule jellies;

will provide jelly manufacturers with a broader range of intense sweeteners than is
currently permitted in the Code;

is unlikely to have a significant effect on international trade because the proposed
amendment broadens intense sweetener permissions rather than restricts them, which
would have the effect of a slight increase in international trade in jelly, although the
volume and value the of international trade in low joule jelly is low;

would facilitate the continued importation of jelly containing these artificial
sweeteners; and

will result in significant benefits to consumers (including people with type 1 and type 2
diabetes, obesity, hypertension, or other conditions calling for weight loss and/or
dietary sugar restriction) and manufacturers, which will outweigh the significant costs
associated with the unavailability of locally made low joule jelly.
19
10.
Implementation and review
FSANZ recommends that the effective date for the proposed amendments be from the date of
gazettal.
Following the development of the Code, FSANZ put in place a programme to monitor the
levels and use of some food additives, including both cyclamates and saccharin. FSANZ has
commissioned a survey of the use of intense sweetened products by Australians and New
Zealanders aged 12 years and above. This survey is expected to provide refined estimates of
exposure to cyclamates, saccharin and other permitted intense sweeteners. Results from this
latest survey may have a bearing on permissions for the use of intense sweeteners. That is,
the results may lead to a re-examination of Code permissions for cyclamates and saccharin,
including those for jelly.
ATTACHMENTS
1.
Draft variations to the Australia New Zealand Food Standards Code.
2.
Dietary Assessment report: Estimated dietary exposure to saccharin and cyclamates
through consumption of intense-sweetened jelly in Australia and New Zealand.
3.
Summary of submissions received in response to the Initial/Draft Assessment Report.
20
Attachment 1
DRAFT VARIATIONS TO THE AUSTRALIA NEW ZEALAND FOOD
STANDARDS CODE
To commence: On gazettal
[1]
Standard 1.3.1 of the Australia New Zealand Food Standards Code is varied by
inserting in Schedule 1, under item 20.2, sub-item jelly –
952
954
1600
160
Cyclamates
Saccharin
21
mg/kg
mg/kg
Attachment 2
Dietary Assessment Report
Estimated dietary exposure to saccharin and cyclamate through consumption of
intense-sweetened jelly in Australia and New Zealand
FSANZ has conducted two major dietary exposure assessments for saccharin and cyclamate
over the last 10 years. The first of these was a detailed, brand-level study in 1994 of the
consumption of intense sweetened foods by Australians aged 12-39 years. The second was
an estimate of exposure prepared using food consumption data derived from the 1995
Australian National Nutrition Surveys (NNS), prepared as part of the review of food additives
during the development of the joint food standard on food additives (Proposal P150 – Review
of food additives).
In both these assessments, the Acceptable Daily Intakes (ADIs) used were 11 mg/kg bw for
cyclamate and 5 mg/kg bw for saccharin.
1994 study
This study focussed on those people identified in a preliminary study as being ‘high
consumers’ of intense sweetened foods. Among those in this group who consumed foods
containing either cyclamate or saccharin, mean exposure to cyclamate and saccharin
represented 23% and 9% respectively of the relevant ADI. At the 90th percentile of exposure,
cyclamate exposure marginally exceeded the ADI (107%), with saccharin exposure at 56% of
the ADI. While the sample size in this study was too small to allow a precise estimate of
exposure at the 90th percentile, the study findings suggest there may be a small but significant
proportion of the population at risk of exceeding the ADI for cyclamate. For example
Aboriginal and Torres Strait Islander consumers reported mean daily consumption of cordial
of 1275 mL/day, resulting in the ADI for cyclamate being exceeded from this product alone.
The 1994 study found that intense sweetened jelly was not a major contributor to dietary
exposure to either saccharin or cyclamate. Jelly contributed only 4% to the mean cyclamate
exposure and 1% to the mean saccharin exposure. Cordial was the major dietary exposure
source for cyclamate (86%) and cordials and tabletop sweeteners the main sources for
saccharin.
Only 1% of the total survey population (not only those identified as high consumers) ate
intense sweetened jelly during the survey period, with females and those on weight control or
low sugar diets or with a medical condition requiring restricted sugar intake being more likely
to consume it. Among those who consumed intense sweetened jelly, mean daily
consumption was 7414 g. 90th percentile consumption of intense sweetened jelly was 229 g
per day.
22
Review of food additives (P150)
The dietary modelling conducted for the development of the joint food additives standard
found dietary exposure to cyclamates and saccharin to be at similar levels to those found in
the 1994 survey. For cyclamates, there was found to be potential for a high consumer of soft
drinks containing cyclamates to exceed the ADI. For saccharin, it was found that some
individual consumers of saccharin based tabletop sweeteners may exceed the ADI.
Jelly was not identified as being a significant source of exposure to either saccharin or
cyclamate.
Current activity
Following the development of the Australia New Zealand Food Standards Code, FSANZ put
in place a program to monitor the levels and use of some food additives, including both
cyclamate and saccharin. As part of this program, FSANZ has commissioned a survey of the
use of intense sweetened products by Australians and New Zealanders aged 12 years and
above. This survey is expected to provide refined estimates of exposure to cyclamate,
saccharin and other permitted intense sweeteners.
23
Attachment 3
Summary of submissions received in response to the Draft Assessment
Report
List of submitters:
1
2
3
4
5
6
7
8
9
10
11
Australian Food and Grocery Council
Australian Quarantine and Inspection Service
Bronson and Jacobs Pty Ltd (New Zealand Division)
Cadbury Schweppes Asia Pacific
Calorie Control Council
Dietitians Association of Australia
Food Technology Association of Victoria Inc.
Hansells (NZ) Ltd
McCormick Foods Australia Pty Ltd
New Zealand Food Safety Authority
Queensland Health (Environmental Health Unit)
Australian Food and Grocery Council
The AFGC supports FSANZ Proposal P273 to permit the addition of cyclamates and
saccharin to jelly.
Cyclamates and saccharin have been used in low joule jelly for many years and the AFGC
has found reference to permission for their use in these products in the publication by the
Commonwealth Department of Health National Health and Medical Research Council –
Model Food Legislation – dated 1986. It is known, however, that permission for use of
cyclamates and saccharin in low joule jellies existed well before that time.
For some reason, when Standard 1.3.1 – Food Additives was developed and gazetted, the
industry did not notice that these permissions had not been carried over into it, although
permission for the use of acesulphame potassium, alitame and sucralose were included.
As stated in the FSANZ Proposal, almost all low joule jellies produced in Australia and New
Zealand use only cyclamates and saccharin. It is therefore essential that the previous
provision for their use be reinstated in the Australia New Zealand Food Standards Code.
There is clear technological justification for their use, which FSANZ has detailed in Section
5.1 of the Initial/Draft Assessment Report. The AFGC supports this justification but will not
repeat it here, as that would be superfluous.
In assessing this Proposal against the objectives of food standards contained in Section 10 of
the FSANZ Act, FSANZ has carried out dietary modelling that demonstrates there is
‘unlikely to be any adverse effect to public health and safety if the proposed amendment to
the Code were to be approved’. The AFGC considers that in view of this satisfactory safety
assessment, Proposal P273 should be approved.
24
The second objective is ‘the provision of adequate information relating to food to enable to
consumers to make informed choices’. Low joule jellies containing cyclamates and saccharin
would be required to be labelled with a list of ingredients (as they are now) under Standard
1.2.4 – Labelling of Ingredients. This would disclose the presence of cyclamate and
saccharin, thus providing the information required to make informed choice. The AFGC
considers no additional labelling requirements are necessary.
The third objective is ‘the prevention of misleading or deceptive conduct’. Products
containing cyclamate and saccharin will be sold as ‘low joule’, thus alerting consumers to the
fact that they are different from the conventional ‘jelly mix’. This will avoid any suggestion
of misleading or deceptive conduct. The AFGC considers no additional labelling
requirements are necessary.
The AFGC does not possess information relating to the difficulty of reformulation of low
joule jelly products if cyclamates and saccharin are not permitted in the code. AFGC
considered it unlikely that manufacturers would have this information readily to hand. To
obtain this information it would be necessary to develop new formulations using various
combinations of these sweeteners, carry out organoleptic testing to determine acceptability to
consumers and undertake storage tests to ensure appropriate stability. To do this would take
considerable time (in excess of a year in the case of storage tests). Thus, it would be unlikely
that this information could be provided in a timely manner, even if undertaken.
The AFGC is aware, as FSANZ would be, that aspartame tends to break down when
subjected to heat, particularly in acid conditions. These conditions are likely to exist when
jelly mix is prepared and when ready prepared jellies are stored. It is considered that
aspartame would be the least likely of these sweeteners to be able to be used as an alternative
to cyclamate and saccharin.
Australian Quarantine and Inspection Service
AQIS does not anticipate any major operational issues arising from the proposed amendment
to the Code as outlined in Proposal P273. AQIS commented that the proposed amendment
would facilitate the continued importation of jelly containing these artificial sweeteners.
Bronson and Jacobs Pty Ltd (New Zealand Division)
Bronson and Jacobs Pty Ltd expressed full support for Proposal P273. The submission cited
that lower cost and longer shelf life associated with the use of cyclamates and saccharin in
jellies, together with a safe history of use, are sound reasons for the re reinstatement of
permissions in the Code for their use in low joule jelly.
The submission states that initially there was some concern over the daily intakes of such
sweeteners by children but that these low joule jellies are not something that children would
normally consume.
25
Calorie Control Council
The Council is a US-based international association of companies who make and use lowcalorie sweeteners, including companies that make and use cyclamate and saccharin in their
products. The Council fully supports FSANZ’s proposal to permit the use of cyclamates and
saccharin for use in low joule jelly because:






both saccharin and cyclamate have a long history of safe use;
animal and epidemiological studies strongly support their safety;
the use of a saccharin and cyclamate results in products with an excellent taste profile;
the synergistic properties and stability of the cyclamate/saccharin combination are well
documented;
the use of the blend lowers the concentration of each of the component sweeteners,
thereby reducing any off-taste that might occur from the use of higher concentrations of
the individual sweeteners; and
low calorie jellies made with cyclamate and saccharin have long been available in
Australia and New Zealand with a high degree of consumer acceptability.
Cadbury Schweppes Asia Pacific
Submission supports the proposal to allow re-use of saccharin and cyclamate in diet jellies
because:






their use will allow low cost manufacture and thus help keep retails costs down;
other permitted sweeteners typically need to be use in conjunction with other
sweeteners for sensory optimisation and suffer technical disadvantages such as:
aspartame degradation with hot water make up, and
advisory statements for aspartame – phenylketonurics;
sucralose is extremely cost prohibitive; and
if there is little risk from dietary exposure then these sweeteners should be permitted.
Dietitians’ Association of Australia
Submission stated support for the proposal to reintroduce permission for the use of
cyclamates and saccharin in low joule jelly.
Food Technology Association of Victoria Inc
The Technical Sub Committee of FTA Victoria agreed with Option 1 – to include permission
for the use of cyclamates and saccharin in Jelly in Schedule 1 of Standard 1.3.1 – Food
Additives.
Hansells (NZ) Ltd
Hansells (NZ) Ltd strongly supports the proposal to allow the reinstatement saccharin and
cyclamate to jellies.
26
During the review of Food Additive permissions (Proposal P150) saccharin and cyclamate
were identified as having the potential to exceed the ADI for children and adults and food
manufacturers were encouraged to use alternative sweeteners. However P273 has identified
that the intake of saccharin and cyclamate via low joule jellies accounts for an insignificant
contribution to the overall intake, so the justification for excluding these sweeteners from low
joule jellies was questionable.
Saccharin and cyclamate have been used in low joule/diet jellies in New Zealand for at least
25 years.
From a manufacturer’s point of view: 



Hansells are manufacturers of low joule/diet jellies. In reformulating our diet jellies
with the permitted sweeteners (Alitame, Acesulphame K, Sucralose, Aspartame) the
following difficulties were noted: Alitame &/or Acesulphame K were simply unacceptable in terms of taste (bitterness).
Any combination that included Sucralose - too expensive, some handling difficulties of
powdered Sucralose, which is still available only as a micronised powder.
Aspartame and Acesulphame K – this was the most suitable combination but not cost
effective compared with saccharin and cyclamate combination. Issues with stability of
aspartame at high temperatures (jelly requires addition of boiling water). Shorter shelf
life.
From a consumer’s point of view: 



Current diet jellies using saccharin and cyclamate are a low cost dessert option for
diabetics and those on weight control diets. These groups are often at the lower end of
the socio-economic scale.
[provided commercial-in-confidence information about the higher cost of reformulated
low joule jellies that do not contain cyclamates and saccharin.]
Diet jellies sweetened with saccharin and cyclamate have a preferred flavour profile
compared to other options (results of in house sensory testing).
Although little scientific data to support the brain tumour/aspartame link many
consumers are nevertheless turned off this sweetener due to this publicity.
Requested that proposed level of saccharin be raised from 150 mg/kg to 160 mg/kg on the
basis that saccharin and cyclamate always work best when used in combination (usually at
approx 1:10 ratio respectively).
McCormick Foods Australia Pty Ltd
McCormick Foods Australia strongly opposes the proposed permission for the use of
cyclamates and saccharin in jelly on fair-trading grounds because it has incurred considerable
costs reformulating its Aeroplane brand diet jelly products to conform to current permissions
in the Code.
McCormick Foods Australia believe that they will be commercially disadvantaged if the
Code is changed in accordance with Proposal P273. Should this change be implemented,
there would also be a significant cost associated with another potential change in product
formulations, if indeed, that decision was taken.
27
The company provided commercial-in-confidence information, which describes the size of
the Australian jelly market, the diet jelly segment and the Aeroplane brand’s share of that
market [Source: Nielssen and Aztec Grocery Market Scan data (2003)]. Also provided were
commercial-in-confidence information on the costs the company incurred in reformulating
diet jelly products without cyclamates and saccharin to comply with the current Code
permissions. These costs included: artwork redesign, packaging write off, raw material write
off, additional ongoing raw material costs, product development including sensory
evaluation, and factory trialling.
New Zealand Food Safety Authority
Submission acknowledged the regulatory problem and that there is a need to amend the Code
to permit use of cyclamate and saccharin in low joule jellies.
Submission comments that children are traditional consumers of jellies rather than adults and
that children are likely to eat low joule jellies as well, especially overweight children, who
might be given them as healthier alternatives by their caregivers.
Notes that there has been no dietary modelling in children and that UK Food Safety Authority
has issued warnings about children not consuming too much cordial with cyclamates as the
ADI may be exceeded.
Suggests that FSANZ consider the potential consumption of low joule jellies by children and
if necessary conduct dietary modelling on children before approval is given to use these
sweeteners in low joule jellies.
Queensland Health (Environmental Health Unit)
Following across government consultation, the Queensland Health submission stated that
while Proposal P273 appeared satisfactory, the following matters required further
investigation and/or consideration:



the estimated dietary exposure to saccharin and cyclamate for population sub-groups
that are mostly likely to consume jelly, particularly children;
further dietary modelling to consider consumption of all sources of artificial sweeteners
rather than just jelly when estimating dietary exposure. This is highlighted by the
excess consumption of cordial by the Aboriginal and Torres Strait Islander population
as noted in the FSANZ Dietary Assessment report; and
further investigation into the ‘small but significant proportion of the population at risk
of exceeding the Acceptable Daily Intake for cyclamate’.
28