Australia and New Zealand approve allulose as a novel Food

i
19 August 2024
301-24
Approval report – Application A1247
D-allulose as a novel food
Food Standards Australia New Zealand (FSANZ) has assessed an application made by
Samyang Corporation to amend the Australia New Zealand Food Standards Code to permit
the sale of D-allulose produced from the enzymatic conversion of fructose by D-psicose 3-
epimerase (EC 5.1.3.30) contained in Microbacterium foliorum.
On 8 November 2023, FSANZ sought submissions on a draft variation and published an
associated report. FSANZ received 16 submissions.
FSANZ approved the draft variation on 7 August 2024. The Food Ministers’ Meeting1 was
notified of FSANZ’s decision on 19 August 2024.
This Report is provided pursuant to paragraph 33(1)(b) of the Food Standards Australia New
Zealand Act 1991 (the FSANZ Act).
1 Formerly referred to as the Australia and New Zealand Ministerial Forum on Food Regulation
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Table of contents
EXECUTIVE SUMMARY ……………………………………………………………………………………………………………………. 2
1 INTRODUCTION ……………………………………………………………………………………………………………………… 4
1.1 THE APPLICANT ………………………………………………………………………………………………………………………… 4
1.2 THE APPLICATION ……………………………………………………………………………………………………………………… 4
1.2.1 D-allulose and associated enzyme used in its production ……………………………………………………….. 4
1.2.2 Metabolizable energy………………………………………………………………………………………………………… 5
1.2.3 Labelling requirements………………………………………………………………………………………………………. 5
1.3 THE CURRENT CODE REQUIREMENTS ……………………………………………………………………………………………….. 5
1.3.1 Novel foods………………………………………………………………………………………………………………………. 5
1.3.2 Processing aids…………………………………………………………………………………………………………………. 6
1.3.3 Contaminant and natural toxicant requirements…………………………………………………………………… 6
1.3.4 Identity and purity requirements…………………………………………………………………………………………. 7
1.3.5 Labelling ………………………………………………………………………………………………………………………….. 7
1.4 INTERNATIONAL STANDARDS …………………………………………………………………………………………………………. 8
1.4.1 USA…………………………………………………………………………………………………………………………………. 8
1.4.2 South Korea……………………………………………………………………………………………………………………… 9
1.4.3 Japan ………………………………………………………………………………………………………………………………. 9
1.5 REASONS FOR ACCEPTING APPLICATION…………………………………………………………………………………………….. 9
1.6 PROCEDURE FOR ASSESSMENT……………………………………………………………………………………………………….. 9
1.7 DECISION……………………………………………………………………………………………………………………………….. 9
2 SUMMARY OF THE FINDINGS………………………………………………………………………………………………….. 10
2.1 SUMMARY OF ISSUES RAISED IN SUBMISSIONS …………………………………………………………………………………… 10
2.2 RISK ASSESSMENT ……………………………………………………………………………………………………………………. 10
2.2.1 D-allulose……………………………………………………………………………………………………………………….. 10
2.2.2 D-psicose 3-epimerase …………………………………………………………………………………………………….. 11
2.3 RISK MANAGEMENT …………………………………………………………………………………………………………………. 12
2.3.1 Risk management options………………………………………………………………………………………………… 12
2.3.2 Permission for D-allulose as a novel food and MPLs…………………………………………………………….. 12
2.3.3 Food classes……………………………………………………………………………………………………………………. 13
2.3.4 Specification …………………………………………………………………………………………………………………… 15
2.3.5 Exclusivity ………………………………………………………………………………………………………………………. 16
2.3.6 Energy factor for D-allulose………………………………………………………………………………………………. 16
2.3.7 Labelling of foods containing D-allulose …………………………………………………………………………….. 17
2.3.8 D-psicose 3-epimerase …………………………………………………………………………………………………….. 20
2.3.9 Risk management conclusion……………………………………………………………………………………………. 21
2.3.10 Consultation …………………………………………………………………………………………………………………… 21
2.3.11 World Trade Organization (WTO) ……………………………………………………………………………………… 22
2.4 FSANZ ACT ASSESSMENT REQUIREMENTS……………………………………………………………………………………….. 22
2.4.1 Section 29………………………………………………………………………………………………………………………. 22
2.4.2 Subsection 18(1)……………………………………………………………………………………………………………… 24
2.4.3 Subsection 18(2) considerations………………………………………………………………………………………… 25
3 REFERENCES…………………………………………………………………………………………………………………………. 27
APPENDIX 1 – SUMMARY OF SUBMITTER COMMENTS AND FSANZ RESPONSES …………………………………….. 29
ATTACHMENT A – DRAFT VARIATION TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE …………………………………. 52
ATTACHMENT B – EXPLANATORY STATEMENT………………………………………………………………………………………………. 56
ATTACHMENT C – DRAFT VARIATION TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE (CALL FOR SUBMISSIONS)…… 63
Supporting document
The following document, which informed the assessment of this application, is available on
the FSANZ website:
SD1 Technical and risk assessment
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Executive summary
Samyang Corporation (Samyang) submitted an application to amend the Australia New
Zealand Food Standards Code (the Code) to permit the sale of D-allulose as a novel food. Dallulose would be added to specified foods as a lower-energy substitute for sugar
ingredients. Samyang’s D-allulose is produced from enzymatic epimerisation of fructose by
D-psicose 3-epimerase, contained in Microbacterium foliorum. Samyang has requested
permission in the Code for D-psicose 3-epimerase as it is not currently permitted for use as a
processing aid.
Approach at Call for Submissions
D-allulose
FSANZ considered D-allulose a novel food, being used as a replacement for regular sugar in
foods, providing similar functionality when used as an ingredient. Samyang’s D-allulose
conformed with specifications for D-allulose established in the United States Pharmacopeial
Convention and the Merck Index and would be incorporated by reference in the Code.
The microbiological safety assessment concluded there are no public health or safety
concerns in healthy adults. It was noted that uropathogenic bacteria such as Klebsiella
species could use D-allulose as a food source if present in urine. While this could lead to the
proliferation of such species, there are no reports that either establish or specifically
investigate if this occurs or would lead to adverse health effects, especially in sensitive
subpopulations, such as diabetics. Noting the history of safe use of D-allulose internationally,
the weight-of-evidence suggests adverse microbiological effects are unlikely.
No toxicological concerns were identified in studies in laboratory animals or clinical studies in
humans. The critical health endpoint identified in the human health risk assessment was the
potential for D-allulose to cause a laxative effect due to the osmotic effect of D-allulose that is
not absorbed from the gastrointestinal tract. To manage the risk of a laxative effect, FSANZ
recommended that consumption of D-allulose should not exceed 0.4 g/kg body weight (bw)
in a single serving, or 0.9 g/kg bw on a daily basis.
Estimated mean and high chronic dietary intakes of added D-allulose ranged between 160
and 730 mg/kg bw/day based on proposed MPLs noted in the application. In the short-term
dietary intake assessment, there was the potential for a laxative effect to occur based on
normal consumption patterns of some foods. As such, further assessments were undertaken
to determine what use levels mitigate a laxative effect. This resulted in lower concentration
levels compared to those requested in the application for some foods. Samyang agreed that,
for these foods, the proposed MPLs could be reduced from those originally requested. The
draft variation at the call for submissions therefore contained reduced MPLs for these
particular foods.
D-allulose would be added to specified foods as a lower-energy substitute for sugar. FSANZ
determined that the metabolisable energy for D-allulose is 1.88 kJ/g and the approved
variation contains a (rounded) energy factor of 2 kJ/g. The energy factor of 2 kJ/g will be
used for including the energy contribution from D-allulose in the declaration of average
energy content in the nutrition information panel (NIP).
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D-psicose 3-epimerase
The use of D-psicose 3-epimerase for the production of D-allulose is justified at a level
consistent with Good Manufacturing Practice (GMP). D-psicose 3-epimerase has a history of
safe use, with no significant homology found with any known toxins or allergens. On the
basis of the available data the likelihood of consumer exposure to the production organism,
the enzyme, or residues from the immobilized cell system in the final D-allulose food
ingredient is negligible. As such, FSANZ concluded that there were no safety concerns
associated with the use of D-psicose 3-epimerase in the production of D-allulose.
Submissions on the draft variation
Following assessment and the preparation of the draft variation, FSANZ called for
submissions regarding the draft variation. FSANZ received 16 submissions.
Approach at Approval
D-allulose
On consideration of the submissions received, FSANZ amended the approved variation to
revert to the D-allulose MPLs originally requested and to add a new clause to requiring the
labelling of a food containing D-allulose to display an advisory statement to manage the risk
of a laxative effect from high intakes of some foods.
FSANZ also revised the food classes to more closely align with the foods requested in the
application, allowing innovation and regulatory harmonisation whilst providing certainty for
compliance and enforcement purposes.
FSANZ confirmed the energy factor of 2 kJ/g for D-allulose, which is included in the
approved draft variation for the purposes of calculating the energy content of food containing
D-allulose.
In the approved draft variation, D-allulose is excluded from the average quantity of sugars
declared in the NIP and FSANZ confirmed the approach at CFS to permit foods containing
D-allulose to make nutrition content claims about sugars including no added sugar(s),
provided existing claim conditions are met.
For reasons set out in this report, FSANZ has approved a draft variation to the Code. In
summary, the approved draft variation will provide an exclusive permission for the use of
Samyang’s Nexweet brand of D-allulose as a novel food for a period of 15 months,
commencing on the date of gazettal.
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1 Introduction
1.1 The applicant
The applicant is Samyang Corporation (Samyang), a food ingredient manufacturer based in
South Korea.
1.2 The application
1.2.1 D-allulose and associated enzyme used in its production
Samyang submitted an application to amend the Australia New Zealand Food Standards
Code (the Code) to permit the sale of D-allulose as a novel food in Australia and New
Zealand. D-allulose would be added to foods as a low-energy substitute for conventional
sugar ingredients, particularly sugar. The requested levels and the food classes in the
application are set out in Table 1, in below.
Table 1 Food classes and levels requested the in the application
Food classes requested in application
MPLs (% w/w)
requested in
application
Beverages (water based, non-alcoholic); low- and reduced energy, low- and
reduced sugar (including sweetened teas, instant coffees but not including
cereal/nut/legume-based milk analogues)
3.5
Gelatins, pudding and fillings; low- and reduced energy, low- and reduced
sugar
10
Breakfast cereals and cereal based bars; regular
Breakfast cereals and cereal bars; reduced energy; reduced sugar 5
Frozen dairy desserts (ice cream, soft serve, sorbet); low- and reducedenergy and low- and reduced sugar 5
Yogurt and frozen yogurt; low- and reduced energy; low- and reduced sugar 5
Bakery products (bread rolls, cakes, cake-type rolls, pastries, doughnuts,
biscuits (including cookies, shortbread, butter milk and whole wheat biscuits,
crackers)); reduced energy
10
Fat-based cream (used in modified fat/energy cookies, cakes, pastries, and
pie) 5
Icings and frostings 5
Jams and jellies 10
Dressings for salads 5
Sweet sauces and syrups; low- and reduced- energy, low- and reduced sugar 10
Hard candies/confectionery; low- and reduced energy 50
Soft candies/confectionery; low- and reduced energy (not including chocolate) 25
Chewing gum 50
Sugar substitutes 100
5
Samyang’s D-allulose is manufactured by enzymatic epimerisation of fructose, utilising a Dpsicose 3-epimerase contained in M. foliorum. There is no permission in the Code for a Dpsicose 3-epimerase enzyme, therefore the application also requested permission for the
use of this enzyme as a processing aid.
1.2.2 Metabolizable energy
D-allulose does not contribute significant metabolizable energy after consumption when
compared to sugar. In order to include the energy contribution from D-allulose in the
declaration of average energy content in the nutrition information panel (NIP), Samyang
requested the establishment of a new energy factor of 1.0 kilojoule per gram (kJ/g) for Dallulose in subsection S11—2(3) of the Code.
1.2.3 Labelling requirements
Samyang requested that D-allulose not be included in the declaration of ‘sugars’ in the NIP
given it would not be included in the declaration of ‘carbohydrate’ content under Code
provisions when the ‘available carbohydrate by difference’ calculation is used.
Additionally, Samyang sought amendment of the Code’s requirements for nutrition content
claims about sugar(s) for foods containing added D-allulose. According to Samyang, foods
containing added D-allulose as a sugar replacer or substitute will contain less conventional
sugars – such as sucrose and metabolizable energy – than traditionally sweetened
counterparts.
Samyang considered that foods containing added D-allulose should be permitted to carry
nutrition content claims about sugar(s) listed in the table to section S4—3 (except for
unsweetened claims), when the content of conventional sugars complies with the conditions
listed in column 3 of the table in that section. Recognising there are multiple sections in the
Code that relate to the definition of sugar(s) and the conditions for making nutrition content
claims about sugar(s), Samyang requested FSANZ investigate the most appropriate
amendment to the Code, rather than specifying which section(s) of the Code should be
amended.
Samyang requested an exclusive use permission for D-allulose as a novel food for a period
of 15 months from gazettal. The brand names for the three Samyang D-allulose products are
Nexweet Crystalline Allulose, Nexweet Allulose 95L and Nexweet Allulose 10L.
1.3 The current Code requirements
Australia and New Zealand food laws require that food for sale must comply with the Code
requirements listed below.Novel foods
Section 1.1.2—8 describes which foods are novel foods for the purposes of the Code. It
defines a ‘novel food’ as a ‘non-traditional food’ that requires an assessment of public health
and safety considerations having regard to:
(a) the potential for adverse effects in humans; or
(b) the composition or structure of the food; or
(c) the process by which the food has been prepared; or
(d) the source from which it is derived; or
(e) patterns and levels of consumption of the food; or
(f) any other relevant matters.
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A ‘non-traditional’ food is defined in the Code as, among other things, a food that does not
have a history of human consumption in Australia or New Zealand.
Paragraphs 1.1.1—10(5)(b) and 1.1.1—10(6)(f) of the Code provide that, unless expressly
permitted by the Code, a food offered for retail sale must not be a novel food or have a novel
food as an ingredient.
Section 1.5.1—3 provides that a novel food is permitted by the Code if the novel food is listed
in the table to section S25—2 and any conditions of use specified in that table are complied
with.
The table to section S25—2 (sale of novel foods) lists permitted novel foods together with
their conditions for use including use levels, restrictions on use and labelling requirements.
Novel foods must undergo pre-market assessment and approval by FSANZ before they can
be listed in the table to section S25—2.
D-allulose is not currently listed in the above table as a permitted novel food.
1.3.2 Processing aids
Paragraph 1.1.1—10(6)(c) of the Code provides that food for sale cannot contain, as an
ingredient or component, a substance ‘used as a processing aid’ unless that substance’s use
as a processing aid is expressly permitted by the Code.
Section 1.1.2—13 provides that a substance ‘used as a processing aid’ in relation to a food is
a substance used during the course of processing that meets all of the following conditions:
• it is used to perform a technological purpose during the course of processing
• it does not perform a technological purpose in the food for sale, and
• it is a substance listed in Schedule 18 or identified in section S16—2 as an additive
permitted at Good Manufacturing Practice (GMP).
Standard 1.3.3 and Schedule 18 of the Code list the permitted processing aids.
Enzymes of microbial origin permitted to be used as processing aids are listed in the table to
subsection S18—4(5) or in the table to subsection S18—9(3) of Schedule 18, depending on
whether a technological purpose has been specified. Enzymes of microbial origin listed in the
table to subsection S18—4(5) are permitted for use as a processing aid to perform any
technological purpose if the enzyme is derived from the corresponding source specified in
the table. The table to subsection S18—9(3) lists those substances, including enzymes
derived from particular sources, that are permitted to be used as processing aids for specific
technological purposes in relation to:
• if a food is specified—that food; or
• if no food is specified—any food.
Additionally, paragraph 1.3.3—11(c) specifies that the substance may only be used as a
processing aid if it is not present in the food at greater than the MPL for that substance
indicated in the table to section S18—9.
Samyang’s D-allulose production utilises several substances as processing aids. With one
exception, all are currently permitted under the above provisions for use as processing aids.
The exception is the enzyme used to produce D-allulose, D-psicose 3-epimerase.
1.3.3 Contaminant and natural toxicant requirements
Subsection 1.1.1—10(3) of the Code requires food for sale to comply with all relevant
composition requirements in the Code for that food. This includes requirements imposed by
Standard 1.4.1 and Schedule 19 of the Code in relation to the maximum levels of
contaminants and natural toxicants that may be present in food.
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1.3.4 Identity and purity requirements
Section 1.1.1—15 of the Code requires that, when added to food in accordance with this
Code, or sold for use in food, a substance that is a novel food or a processing aid must
comply with any relevant identity and purity specifications set out in Schedule 3 of the Code.
D-allulose
Subsection S3—2(1) incorporates by reference the United States Pharmacopeial Convention
(2022) Food chemicals codex (13th edition), which establishes specifications for ‘Allulose’. It
also incorporates by reference The Merck Index, 15th Edition, being a secondary source
within S3—3, which establishes a specification for D-psicose (O’Neil et al 2013).
In addition, section S3—4 requires that if there is no relevant specification under section
S3—2 or S3—3, or if the monographs referred to in those sections do not contain a
specification for identity and purity of a substance relating to arsenic or heavy metals, the
specification is that the substance must not contain on a dry weight basis more than:
(a) 2 mg/kg of lead; or
(b) 1 mg/kg of arsenic; or
(c) 1 mg/kg of cadmium; or
(d) 1 mg/kg of mercury.
D-psicose 3-epimerase
Of relevance to D-psicose 3-epimerase, subsection S3—2(1) of Schedule 3 incorporates by
reference the specifications listed in the Joint FAO/WHO Expert Committee on Food
Additives (JECFA) Combined Compendium of Food Additive Specifications (FAO JECFA
Monographs 26 (2021)), and the United States Pharmacopeial Convention (2022) Food
chemicals codex (13th edition). These include general specifications for enzyme preparations
used in food processing for identity and purity parameters.
1.3.5 Labelling
Subsection 1.1.1—10(8) provides that food for sale must comply with all relevant labelling
requirements imposed by the Code for that food.
Standard 1.2.4 requires packaged food products to be labelled with a statement of
ingredients unless exempt. Ingredients must be included in the statement of ingredients
using either a name by which the ingredient is commonly known, a name that describes the
true nature of the ingredient, or a generic name if one is specified in Schedule 10.
Paragraphs 1.2.4—3(2)(d) and (e) exempt processing aids from the requirement to be
declared in the statement of ingredients, unless other requirements apply.
Subsection 1.2.3—2 sets out requirements for an advisory statement to the effect that
excess consumption may have a laxative effect for foods containing specified substances
above certain concentrations.
Subsection 1.2.3—4(3) requires certain foods and substances (e.g. allergens) to be declared
when present as ingredients in a food for sale.
Standard 1.2.7 sets out the requirements and conditions for voluntary nutrition, health and
related claims made about food. Section S4—3 lists the conditions for making nutrition
content claims about sugars including low, reduced or light/lite, and no added sugar(s).
Changes to conditions for no added sugar(s) claims were gazetted in December 2023 from
Proposal P1062 – Defining added sugars for claims.
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Standard 1.2.8 requires most packaged food products to be labelled with a NIP. Subsection
S11—2(3) prescribes energy factors for specific food components, including low energy
sweeteners, to be used when calculating the amount of energy to declare in a NIP.
Subsection 1.2.8—6(9) requires that if one or more components (other than organic acids)
listed in subsection S11—2(3) is present in the food, singly or in combination, in an amount
of no less than 5 g/100 g; and if either the available carbohydrate by difference method is
used (and any of those components have been subtracted in the calculation); or the available
carbohydrate method is used (and any of those substances have been quantified or added to
the food), then the NIP must include individual declarations of those substances.
Section 1.1.2—2 provides that, when used in Standard 1.2.7, Standard 1.2.8 and Schedule
4, the term ‘sugars’ means monosaccharides and disaccharides and, when used elsewhere
in the Code, means any of the following products derived from any source:
(i) hexose monosaccharides and disaccharides, including dextrose, fructose,
sucrose and lactose;
(ii) starch hydrolysate;
(iii) glucose syrups, maltodextrin and similar products;
(iv) products derived at a sugar refinery, including brown sugar and molasses;
(v) icing sugar;
(vi) invert sugar;
(vii) fruit sugar syrup;
but does not include:
(i) malt or malt extracts; or
(ii) sorbitol, mannitol, glycerol, xylitol, polydextrose, isomalt, maltitol, maltitol syrup,
erythritol or lactitol.
1.4 International standards
In developing food regulatory measures, FSANZ must have regard to the promotion of
consistency between domestic and international food standards. In terms of food safety, the
relevant international standard setting body is the Codex Alimentarius Commission (Codex).
There are no international standards for novel foods or for the use of D-allulose as a food
and food ingredient. However, D-allulose is used in a number of regions, including the United
States of America (USA), Japan and Korea. The requirements of each are outlined below.
Similarly, there are no international standards for the calculation of energy factors for food
components such as D-allulose, which is not metabolised like other simple carbohydrates.
The Codex Alimentarius Guidelines on Nutrition Labelling (CAC/GL 2-1985) includes
guidance on calculation of energy for carbohydrates (17 kJ/g), protein (17 kJ/g), fat (37 kJ/g)
and alcohol (29 kJ/g), and organic acid (13 kJ/g).
1.4.1 USA
Several sources of D-allulose have a Generally Recognised as Safe (GRAS) status. The
United States Food and Drug Administration (FDA) has issued ‘no questions’ letters for
seven GRAS notifications related to food uses of D-allulose (GRN 400; GRN 498; GRN 693;
GRN 828; GRN 1024; GRN 1029; GRN 1057). Samyang’s D-allulose from M. foliorum was
the subject of GRN 828. The energy value to be used for labelling of foods containing Dallulose in the USA is 1.7 kJ/g.
9
1.4.2 South Korea
D-allulose is permitted in South Korea. M. foliorum with D-allulose-3-epimerase activity has
been approved in South Korea to produce D-allulose. D-allulose is considered to be a zeroenergy carbohydrate in South Korea, that is, the energy value to be used for labelling of
foods containing D-allulose is zero (0) kcal/g as set out in the Ministry of Food And Drug
Safety’s ‘Foods Labelling Standards’ (MFDS 2016 – p157).
1.4.3 Japan
D-allulose has been marketed in Japan without the need for regulatory approval. D-allulose’s
energy factor for food labelling purposes in Japan is also 0 kcal/g.
1.5 Reasons for accepting application
The application was accepted for assessment because:
• it complied with the procedural requirements under subsection 22(2) of the Food
Standards Australia New Zealand Act 1991 (FSANZ Act)
• it related to a matter that warranted the variation of a food regulatory measure.
1.6 Procedure for assessment
The application was assessed under the General Procedure in the FSANZ Act.
1.7 Decision
The draft variation as proposed following assessment was approved with amendments, as
explained below in sections 2.3.2.3 and 2.3.3.2. The approved draft variation as amended
after consideration of submissions is at Attachment A. The approved draft variation takes
effect on the date of gazettal.
The related explanatory statement is at Attachment B. An explanatory statement is required
to accompany an instrument if it is lodged on the Federal Register of Legislation.
The draft variation on which submissions were sought is at Attachment C.
10
2 Summary of the findings
2.1 Summary of issues raised in submissions
FSANZ called for submissions on the draft variation to the Code from 8 November to 20
December 2023. Sixteen submissions were received – four from government, ten from
industry and two from individual submitters. FSANZ’s responses to issues raised in
submissions are provided in Appendix 1.
The majority of submitters provided support for permitting the voluntary addition of D-allulose
as a novel food, some of those subject to it being widened to additional food categories.
Several issues were raised, including the proposed MPLs, the range of foods which may
contain D-allulose, the exclusive use permission and the dietary intake assessment
conclusions.
Labelling matters such as excluding D-allulose from sugars in the NIP, permitting foods
containing D-allulose to make no added sugar(s) claims, aligning requirements for D-allulose
with those for D-tagatose and an advisory statement about a laxative effect were also raised.
Four submitters expressed support for using D-psicose 3-epimerase in the production of Dallulose. No submitter raised concerns about the use of D-psicose 3-epimerase.
2.2 Risk assessment
FSANZ has undertaken a food technology and risk assessment of both the D-allulose and
the D-psicose 3-epimerase contained in the organism M. foliorum, which is used to
manufacture Samyang’s D-allulose. A summary of these assessments is provided below.
2.2.1 D-allulose
2.2.1.1 Food technology assessment
Samyang has demonstrated an ability to produce D-allulose through numerous batch
records, which conform with specifications set out in Food Chemicals Codex (FCC 2020) and
the Merck Index, 15th Edition, (O’Neil et al 2013) which have specifications for Allulose and
D-psicose, respectively. Therefore, no specification will be inserted into the Code, rather the
above specifications will be referenced by S3—2 and S3—3 of the Code.
Samyang’s manufacturing plant operates in accordance with Good Manufacturing Practice
(GMP), under International Standards Organisation (ISO) 9001:2000 and Hazard Analysis
and Critical Control Point (HACCP) certification.
Stability studies provide assurance that the D-allulose crystalline powder (Nexweet
Crystalline Allulose) and syrups,(Nexweet Allulose 95L and Nexweet Allulose 10L) are stable
under typical storage conditions and when contained in a food matrix typical of the proposed
end use.
2.2.1.2 Toxicological assessment
Most (80%) of an oral dose of D-allulose is rapidly absorbed from the small intestine, but
rapidly excreted in the urine. There is some metabolism of D-allulose by microbiota in the
large intestine, but it appears that most D-allulose that reaches the large intestine is excreted
unchanged in the faeces.
11
D-allulose was of very low acute toxicity in laboratory animals. Results of genotoxicity assays
were negative, and D-allulose was not associated with carcinogenicity or with adverse
reproductive or developmental effects in rats. Laxative effects, attributed to the osmotic effect
of D-allulose that is not absorbed from the gastrointestinal tract, have been observed in
laboratory animals and in humans. To avoid a laxative effect, consumption of D-allulose
should not exceed 0.4 g/kg body weight (bw) at one time, or 0.9 g/kg bw/day.
2.2.1.3 Dietary intake assessment
Estimated mean and high chronic dietary intakes of added D-allulose ranged between 160
and 730 mg/kg bw/day based on proposed MPLs noted in the application. In the short-term
dietary intake assessment, there was the potential for a laxative effect to occur based on
normal consumption patterns of some foods. An assessment was then undertaken to
determine what use levels would result in intakes not exceeding the level that causes a
laxative effect based on normal food consumption patterns when consumed as one food
class or combination of similar food classes containing D-allulose per eating occasion. This
resulted in lower levels compared to the proposed MPLs in the application for some foods.
The assessments included the intake from brewed soft drinks that was included at approval
following a request made during the public consultation at call for submissions (CFS).
2.2.1.4 Microbiological assessment
No public health or safety concerns were identified in the microbiological safety assessment
of D-allulose and healthy adults. D-allulose intakes for chronic human feeding trials (≥8
weeks duration) were similar to the estimated dietary intakes for single day of consumption.
Exclusion criteria for the human feeding studies did not include sub-populations such as
diabetics, which may be a potentially sensitive sub-population.
The microbiological safety assessment concluded there are no public health or safety
concerns in healthy adults. It was noted that uropathogenic bacteria such as Klebsiella
species could use D-allulose as a food source if present in urine. While this could lead to the
proliferation of such species, there are no reports that either establish or specifically
investigate if this occurs or would lead to adverse health effects, especially in sensitive
subpopulations, such as diabetics. Noting the history of safe use of D-allulose internationally,
the weight-of-evidence suggests adverse microbiological effects are unlikely.
2.2.1.5 Nutrition assessment
No evidence was identified to indicate that D-allulose consumption would affect the
absorption of other nutrients. Details regarding the calculation of an energy factor for Dallulose are covered below in section 2.3.6.
2.2.2 D-psicose 3-epimerase
No public health or safety concerns were identified in relation to the use of M. foliorum in the
production of D-psicose-3-epimerase. It is neither pathogenic nor toxigenic. D-psicose 3-
epimerase has a history of safe use for the production of D-allulose, and the applicant has
provided analytical evidence that there is negligible likelihood of consumer exposure to the
production organism, the intact enzyme, or residues from the immobilized cell system. No
significant homology was found with any known toxins or allergens.
The proposed use of D-psicose 3-epimerase exclusively for the production of D-allulose is
justified. The evidence presented to support the proposed use provides adequate assurance
that the use of the enzyme, in the form and requested amount (i.e. at a level consistent with
GMP) is technologically justified and has been demonstrated to be effective in achieving its
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stated purpose.
D-psicose 3-epimerase performs its technological purpose during the production of Dallulose. The enzyme functions as a processing aid for the purposes of the Code and does
not perform a technological purpose in the food for sale. There are relevant identity and
purity specifications for the enzyme in the Code.
2.3 Risk management
2.3.1 Risk management options
Following assessment, FSANZ prepared a draft variation and called for submissions on that
draft variation for a period of six weeks.
The risk management options available to FSANZ following the CFS are to either:
• approve the draft variation proposed following assessment, or
• approve that draft variation subject to such amendments as FSANZ considers
necessary, or
• reject that draft variation.
FSANZ had regard to the requirements of the FSANZ Act (see section 2.5 below) in
developing the proposed regulatory measure. For the reasons set out in this report, and after
consideration of submissions, FSANZ considers it appropriate to approve an amended
version of the draft variation proposed following assessment. The reasons for amending the
draft variation proposed in the CFS are outlined in Section 2.3.2.3 below.
The approved draft variation will permit:
• the use of D-allulose as a novel food
• D-psicose 3-epimerase to be used as a processing aid in the production of D-allulose.
Further details on the permissions and associated conditions are provided below.
2.3.2 Permission for D-allulose as a novel food and MPLs
2.3.2.1 Approach in the CFS
In the CFS, the draft variation contained a permission for D-allulose as a novel food in certain
food classes, subject to MPLs for each food class. The proposed draft variation included
lower MPLs of D-allulose than those requested in the application, for the following reasons.
The dietary intake assessment using the MPLs requested in the application identified a risk
of a laxative effect for some food classes. As outlined in Section 2.2.1.2 above and SD1, this
would have occurred where the intake of D-allulose was above the threshold of 0.4 g/kg/bw
(28 g for a 70 kg adult) or 0.9 g/kg bw/day, based on normal food consumption patterns.
The risk of a laxative effect arising from consumption of D-allulose in excess of the threshold
was discussed with the applicant, whereupon they agreed that, for these food classes, the
MPLs be reduced to mitigate this risk. The applicant also provided examples of products
being marketed where actual usage levels align with the lower proposed levels of addition.
2.3.2.2 Decision and rationale
Having had regard to the submissions received and for the reasons stated in this report,
FSANZ has decided to amend the Code to permit D-allulose as a novel food when offered for
retail sale as a tabletop sweetener or used as an ingredient in manufactured foods. The
permission for use of D-allulose as an ingredient is limited to certain food classes and is
subject to MPLs.
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FSANZ considers that regulation of D-allulose as a novel food, rather than a food additive, is
appropriate. Although D-allulose adds sweetness, this is not its sole function, as would be
the case with a food additive (intense sweetener). It is used as a replacement for sugar in
foods, providing similar functionality when used as an ingredient, including as a bulking
agent, providing mouthfeel, browning capability, and depression of freeze point. It would
typically be added as an ingredient in amounts considerably higher than most food additives,
in particular in comparison to intense sweeteners. Approval as a novel food provides
consistency with the regulatory approach for other sugar replacements such as D-tagatose
and trehalose, both being novel foods.
After having regard to the submissions, FSANZ amended the draft variation to increase the
MPLs for D-allulose in the permitted foods to the levels requested in the application (see
Table 2). In particular, FSANZ notes comments from submitters that the higher MPLs are
more aligned with the use of D-allulose as a sugar replacer, offering advantages in terms of
sensory and flavour profiles and provide greater international harmonisation.
In the dietary intake assessment, FSANZ identified the risk of a laxative effect associated
with consuming foods containing D-allulose in some food classes based on the MPLs
requested by the applicant. Those MPLs, when specified in the Code will limit this risk,
including for both a single eating occasion and repeated intake across a day.
The MPLs have also been used as the basis for further risk management decisions to be
made in response to the identified risks. Discussion on the labelling requirements for foods
containing D-allulose can be found in section 2.3.7.
2.3.3 Food classes
2.3.3.1 Approach in the CFS
At the CFS, the draft variation permitted the addition of D-allulose to food classes based on
food classes in Schedule 15 – Substances that may be used as food additives. The specific
food class names referred to in the application were not used in the draft variation but the
foods were broadly captured to provide certainty for compliance and enforcement purposes.
The proposed revised food class names and MPLs up to which D-allulose could be added,
were shown in Table 1 of the CFS.
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A number of submitters requested the permitted food classes be expanded to include
additional foods, citing the benefit to industry and potential positive impact addition of Dallulose to foods, could have on obesity. One government submitter considered that if Dallulose is regulated as a novel food, the drafting should align with the permissions for other
novel foods which refer to names in relevant Chapter 2 standards.
2.3.3.2 Decision and rationale
Following the CFS and having had regard to submitter comments, FSANZ has decided to
amend the draft variation to revise the food classes permitted to have added D-allulose
(Table 2) to more closely align with the foods requested in the application (Table 1). There
are no requirements however, relating to levels of sugar or energy content, or associated
claims/representations, as referred to by the applicant. This is because such an approach
may result in a very narrow range of foods (for example, food meeting conditions for low
energy only) or require the making of a claim or particular representation in order to be
enforceable (for example a ‘reduced sugar’ claim). It is considered that using D-allulose as a
sugar replacer does not necessarily mean a food will meet the conditions for low or reduced
energy/sugar claims. The food classes are appropriate without additional criteria for sugar
and/or energy content.
Where applicable, the food classes align with those in Schedule 15 and/or with foods defined
in the Code and which are subject to specific Chapter 2 standards, for example, ice cream. It
was not always possible to align the requested foods with defined foods in the Code, as the
food class requested by the applicant was broader than the defined food. For example, the
term ‘bakery products’ rather than bread (a defined food) is used.
It is also noted that the food for sale must comply with any other compositional and labelling
requirements in the Code. For example, ‘fruit spreads’ rather than jam is used in the
approved draft variation, noting that a fruit spread made with D-allulose as a replacement for
sugar may not meet the compositional requirements for a food sold as jam.
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Table 2 Food classes and MPLs for D-allulose at approval
Food class names in the approved draft variation Approved MPLs (%w/w)
Non-alcoholic water based flavoured drinks1 3.5
Desserts (with or without gelatine) 10
Breakfast cereals 5
Cereal bars 5
Ice cream 5
Edible ices (including sorbet) 5
Yoghurt 5
Bakery products 10
Imitation cream 5
Icing 5
Frostings 5
Fruit spreads (but not chutney) 10
Salad dressings 5
Sweet sauces 10
Syrups 10
Confectionery (but not chocolate) 50
Chewing gum
50
Bubble gum
Tabletop sweeteners No limit
1 (a) includes: brewed soft drinks; non-brewed soft drinks; cola type drinks; formulated
caffeinated beverages; fruit drinks; tea beverages; coffee beverages; powdered drink
concentrates; and liquid drink concentrates; and
(b) does not include: milk analogues; fruit juices; vegetable juices; formulated beverages;
electrolyte drinks; and electrolyte drink bases.
2.3.4 Specification
There are relevant identity and purity specifications in primary and secondary sources of
specifications listed in Schedule 3 of the Code for ‘Allulose’ and ‘D-psicose respectively (refer
to section 2.2.1.1 above). D-allulose would need to meet the relevant specification when
added to food as an ingredient or sold as a tabletop sweetener. Section S3—4 contains
additional MPLs for arsenic and heavy metals for any substance, including D-allulose:
• 2 mg/kg of lead; or
• 1 mg/kg of arsenic; or
• 1 mg/kg of cadmium; or
• 1 mg/kg of mercury.
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2.3.5 Exclusivity
An applicant may request an exclusive use permission to use and sell a novel food for up to
15 months. Further information is available on the FSANZ website2
.
The applicant requested an exclusive use permission for their brand of D-allulose for a period
of 15 months on the basis that they have invested significantly in the technology
development, safety studies and the preparation of the application.
FSANZ determined that this request was justified and decided to provide the applicant with a
15 month exclusive use period for the use of D-allulose as a novel food. The approved draft
variation includes a condition that, for a limited period of 15 months from gazettal of the draft
variation, only D-allulose under Samyang’s brand name ‘Nexweet’ may be added to food in
accordance with the specified conditions. Once this period ends, this exclusive use
permission will revert to a general permission, meaning that the D-allulose novel food
permission will apply to and permit any and all brands of D-allulose that comply with the
Code.
An exclusive use permission does not, and cannot, prevent approval of second or
subsequent applications under the Code, either within the exclusive use period or during the
progression of an application, for the use of the same food or ingredient by other food
companies, providing the application process is undertaken.
If other brands of D-allulose are produced using an enzyme that is not permitted under the
Code, approval is required for that enzyme, via the FSANZ application process.
2.3.6 Energy factor for D-allulose
The *average energy content of food is calculated according to factors, expressed as kJ/g,
for general and specific energy yielding components as listed in Schedule 11. Energy factors
are used in the calculation of a food’s energy content, and components that are recognised
as contributing significantly to the energy content of a food (e.g. macronutrients) are
assigned values for this purpose. Other food components can contribute to energy intake in a
more moderate way and may be assigned an energy factor where there is sufficient
supporting evidence.
The applicant submitted data that enabled derivation and listing of an estimated energy
factor. Section 3.2.5.B.2 of the FSANZ Application Handbook sets out the equation that must
be used in establishing or varying the energy factor for a food ingredient. This equation (set
out below) has been used as the basis for FSANZ’s calculation of the energy factor of Dallulose.
ME = GE – FE – UE – GaE – SE where:
ME means metabolisable energy
GE means gross energy (as measured by bomb calorimetry)
FE means energy lost in faeces
UE means energy lost in urine
GaE means energy lost in gases produced by fermentation in the large intestine
SE means energy content of waste products lost from surface areas.
2 Exclusivity of use for novel foods and nutritive substances | Food Standards Australia New Zealand
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Evidence for the inputs to the equation is set out in the Nutrition Assessment in section 3.6 of
SD1, and the calculation for the energy factor is provided below.
The gross energy (GE) for D-allulose, based on bomb calorimetry of fructose, is 15.7 kJ/g.
The faecal energy (FE) for ingested D-allulose is 0.47 kJ/g.
The urinary energy (UE) for ingested D-allulose is 12.56 kJ/g.
The gaseous energy (GaE) for ingested D-allulose is 0.79 kJ/g.
The surface area energy (SE) for ingested D-allulose is 0 kJ/g.
Based on the equation, the metabolisable energy (ME) for ingested D-allulose is 1.88 kJ/g.
FSANZ therefore proposed that an energy factor of 2 kJ/g for D-allulose (rounded to a whole
number) is included in the table to subsection S11—2(3). Rounding the energy factor to a
whole number is consistent with the other energy factors in the Code.
Some submitters noted their support of the proposed energy factor whereas others
suggested a lower level in order to align more closely with international markets.
FSANZ has decided to retain the energy factor of 2 kJ/g for D-allulose in the approved draft
variation, for the purposes of calculating the energy content of food containing D-allulose.
This is based on the assessment outlined above and noting that there is no consistency in
energy factors used in other countries.
2.3.7 Labelling of foods containing D-allulose
Foods containing D-allulose are subject to existing generic labelling requirements in the
Code which provide information to enable consumers to make informed choices (see section
1.3.5). As the approved draft variation includes an energy factor of 2 kJ/g for D-allulose in
subsection S11—2(3), this energy factor will need to be applied in the calculation of the
average energy content of a food containing D-allulose for the NIP (section S11—2).
2.3.7.1 Declaration of sugars and carbohydrate in the NIP
2.3.7.1.1 Approach at CFS
At the CFS, FSANZ proposed D-allulose be excluded from the average quantity of sugars
declared in the NIP. Most D-allulose is absorbed intact from the small intestine and not
metabolised (section 2.2.1.1 in this report and section 3.2 in SD1). This is different to
conventional monosaccharides and disaccharides which affect blood glucose and insulin
levels.
FSANZ stated in the CFS that under existing provisions in the Code (section S11—3),
D-allulose would not be included in carbohydrate declarations in the NIP. The amounts of
carbohydrate and sugars in the NIP would therefore both exclude D-allulose.
2.3.7.1.2 Decision and rationale
FSANZ’s decision is to maintain the approach at CFS. In the approved draft variation,
D–allulose is excluded from the average quantity of sugars declared in the NIP.
Industry submitters who commented on this matter supported the approach.
Government submitters suggested labelling requirements for low energy sugars should be
consistent to avoid confusion for consumers. While excluding D-allulose from sugars in the
NIP differs to requirements in the Code for D-tagatose, the only other permitted low energy
sugar, FSANZ considers labelling requirements are best considered on a case-by-case basis
taking into account all relevant information. As noted above, excluding D-allulose from
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sugars in the NIP is also aligned with existing requirements for carbohydrate declarations in
the NIP.
In response to a government submitter request for clarification on requirements for
carbohydrate declarations in the NIP, FSANZ notes section S11—3 sets out two methods for
determining the amount of carbohydrate: calculation of available carbohydrate and the
calculation of available carbohydrate by difference. Either method excludes D-allulose as the
calculation of available carbohydrate by difference specifically excludes those substances
listed in subsection S11—2(3) and the calculation of available carbohydrate only includes
available sugars. D-allulose is not considered an ‘available’ sugar compared with traditional
sugars as it is largely excreted unchanged.
2.3.7.2 Nutrition content claims
2.3.7.2.1 Approach at CFS
At the CFS, FSANZ proposed foods containing D-allulose would be permitted to make
nutrition content claims about sugars (% free, low sugar(s), reduced/lite, no added sugar(s)
but not unsweetened) provided other claim conditions for sugars are met. FSANZ considered
such permissions were appropriate given most D-allulose is not metabolised in the human
body and has a low energy factor of 2 kJ/g.
2.3.7.2.2 Decision and rationale
FSANZ’s decision is to maintain the approach at CFS to permit foods containing D-allulose to
make nutrition content claims about sugars, including no added sugar(s), provided existing
claim conditions are met. Since the CFS was publicly released, FSANZ has gazetted
changes to the conditions for no added sugar(s) claims in section S4—3 arising from
Proposal P1062 -Defining added sugars for claims. The draft variation at CFS relating to the
permission for foods containing D-allulose to display no added sugar(s) claims has therefore
been amended at approval (see item 8 at Attachment 1) to maintain the approach.
Under Proposal P1062, conditions for unsweetened claims were amended to not permit such
claims on foods containing low energy sugars, as ingredients, listed in subsection S11—2(3).
Therefore foods containing D-allulose will not be permitted to display unsweetened claims.
While industry submitters who commented on this matter supported permitting claims about
sugars, government submitters did not support the permission for foods containing D-allulose
to make no added sugar(s) claims. Government submitters considered consumers could be
misled from such claims and that D-allulose and D-tagatose should be treated similarly with
respect to claims as a different approach could be confusing for consumers. In addition,
government submitters stated a different approach for D-allulose and D-tagatose could
create an unfair competitive advantage when similar products have different requirements
and may be considered inconsistent with fair trading legislation.
FSANZ maintains that as most D-allulose is not metabolised and has a very low energy
factor, it is appropriate to regulate D-allulose differently to traditional sugars and permit no
added sugar(s) claims. The applicant who sought permission to use D-tagatose (Application
A472 – D-tagatose as a novel food) did not request permission to make nutrition content
claims about sugars and therefore FSANZ did not specifically consider the matter at that
time. The recently completed Proposal P1062 maintained the existing approach in the Code
to not permit foods containing D-tagatose to make no added sugar(s) claims because of the
energy factor of 11 kJ/g which is 65% of the energy content of traditional monosaccharides
and disaccharides (17 kJ/g in the Code). It appears there has been minimal use of
D-tagatose in foods for sale in Australia and New Zealand since it was approved in 2004.
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FSANZ considers claim permissions for foods containing low energy sugars are best
considered on a case-by-case basis at the time applications for permission to add are
assessed. This will ensure all relevant information is considered, noting that energy factors
and metabolic impacts may vary. FSANZ can prepare information for consumers to explain
labelling requirements for low energy sugars.
2.3.7.3 Risk of a laxative effect from excess consumption of foods containing added
D-allulose
2.3.7.3.1 Approach at CFS
As discussed in section 2.3.2, the draft variation at the CFS stage prescribed lower MPLs for
D-allulose in certain food classes than the applicant originally requested, in order to mitigate
the risk of a laxative effect from some food classes. Consequently, FSANZ did not need to
consider whether an advisory statement about the risk of a laxative effect should be required.
2.3.7.3.2 Decision and rationale
Based on the outcomes from the risk assessment about a potential laxative effect from Dallulose at a dosage exceeding 0.4 g/kg bw and the dietary intake assessment based on the
applicant’s original MPLs for D-allulose in certain food classes, FSANZ’s decision is to
amend the draft variation to require an advisory statement about the risk of a laxative effect
for some food classes (see Table 3). Consistent with the advisory statement required for
foods with polyols and other substances listed in section 1.2.3—2, a statement to the effect
that excess consumption may have a laxative effect, is required for certain food classes as
discussed below. This statement will alert consumers to a possible laxative effect at high
intakes of the foods, thereby providing information for informed choice.
Table 3 Food classes required and not required to have an advisory statement about a
laxative effect
Food classes for which an advisory
statement1 IS required
Food classes for which an advisory
statement1 is NOT required
Bakery products Cereal bars
Bubble gum Icings
Breakfast cereals Frostings
Chewing gum Fruit spreads
Confectionery (excluding chocolate) Imitation cream
Desserts (with or without gelatine) Salad dressings
Edible ices (including sorbet) Sweet sauces
Ice cream Syrups
Non-alcoholic water based flavoured drinks Tabletop sweeteners
Yoghurt
1 statement to the effect that excess consumption may have a laxative effect.
Dietary intakes of D-allulose in at least one of the three population groups were estimated to
be over 0.4 g/kg bw for the following food classes (Table 7 in SD1): bakery products, bubble
gum and chewing gum, breakfast cereals, desserts (with or without gelatine), ice cream and
edible ices, non-alcoholic water based flavoured drinks and yoghurt, including frozen
yoghurt. Foods containing D-allulose in these classes are therefore required to display an
advisory statement about a laxative effect. Where there was at least one dietary intake
estimate of D-allulose over 0.4 g/kg bw for individual food classifications (e.g. fancy breads
and cakes within the ‘bakery products’ class), FSANZ decided to take a conservative
approach and require the advisory statement on all foods in the class e.g. bakery products.
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For breakfast cereals, a similar approach was taken given the dietary estimate of D-allulose
for porridge was determined to be over 0.4 g/kg bw. Additionally, FSANZ considers that even
though the dietary estimate for ready-to-eat breakfast cereals for New Zealand children aged
5-14 years was 0.39 g/kg bw, requiring the statement for these cereals is justified given the
estimate is very close to the 0.4 g/kg bw threshold and children are a vulnerable population.
Dietary intakes of D-allulose were estimated to be 0.4 g/kg bw or below for the following food
classes (Table 7 in SD1): cereal bars, fruit spreads, icings and frostings, salad dressings and
tabletop sweeteners. Foods containing D-allulose in these classes are therefore not required
to display an advisory statement about a laxative effect.
Food classes that required a specific assessment based on the data available for them for
the dietary intake were confectionery (excluding chocolate), imitation cream and sweet
sauces & syrups. Additional analysis was undertaken to determine the maximum amount of
D-allulose that could be added before causing a laxative effect (see section 3.5.2.6 in SD1).
For confectionery, it was determined that a D-allulose concentration of 10% could cause a
laxative effect. Given the MPL of D-allulose in confectionery (excluding chocolate) is 50%,
FSANZ has decided an advisory statement about a possible laxative effect is required. For
sweet sauces & syrups, it was determined that a D-allulose concentration of 15% could
cause a laxative effect. Given the MPL of D-allulose in this food class is 10%, FSANZ has
decided an advisory statement about a possible laxative effect is not required. For imitation
cream, it was determined that an excessive amount would need to be consumed before
exceeding a D-allulose intake of 0.4 g/kg bw (see section 3.5.2.6 in SD1). Consequently,
FSANZ has decided an advisory statement about a possible laxative effect is not required for
imitation cream.
In response to the CFS, government submitters suggested the existing approach for
requiring advisory statements for food containing maltitol and other polyols could be applied
to foods containing D-allulose. Current provisions require an advisory statement for foods
containing specified polyols, either alone or in combination, at a concentration of 10% or
more (subsection 1.2.3—2(2)). FSANZ decided not to apply an approach for the advisory
statement similar to that for maltitol, because the dietary intake assessment indicated there
was no consistent concentration across all food classes that posed a risk of a laxative effect
(see Table 8 in SD1).
In summary, FSANZ decided to amend the draft variation to require an advisory statement
for food classes shown to pose a risk of a laxative effect at high intakes.
2.3.8 D-psicose 3-epimerase
2.3.8.1 Approach at CFS
The conclusions from the risk and technical assessment were that the proposed use of Dpsicose 3-epimerase contained in M. foliorum is technologically justified and there were no
safety concerns associated with its proposed use.
In the CFS, the draft variation contained a permission for the use of D-psicose 3-epimerase
M. foliorum as a processing aid, with no concerns from submitters raised on that approach.
2.3.8.2 Decision and rationale
As stated above, FSANZ has approved a draft variation to the Code to permit the D-psicose
3-epimerase enzyme contained in M. foliorum to be used as a processing aid to manufacture
D-allulose. The permission is subject to the condition that the MPL or amount of the enzyme
that may be present in D-allulose must be an amount consistent with GMP.
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However, the draft variation has been amended to remove the statement that the enzyme
within M. foliorum is ‘immobilised’. FSANZ decided, after further consideration, that there was
no reason to limit the permission for the use of D-psicose 3-epimerase enzyme contained in
M. foliorum to immobilised forms only. This is in line with previously assessed enzymes
which have been immobilised prior to use.
Other risk management considerations for this aspect of the application are related to the
enzyme and source microorganism nomenclature, specifications and labelling, as follows.
The International Union of Biochemistry and Molecular Biology (IUBMB) uses the accepted
name ‘D-psicose 3-epimerase’ and this is the name used in the approved draft variation.
Nomenclature for the organism M. foliorum is in accordance with accepted international
norms.
There are relevant identity and purity specifications in primary sources of specifications listed
in Schedule 3 for enzyme preparations used in food processing (refer to section 1.3.4
above).
The generic exemption in the Code from listing processing aids in the statement of
ingredients applies to food containing D-allulose which have been produced using D-psicose
3-epimerase as no allergens have been identified.
2.3.9 Risk management conclusion
Having considered all aspects of the assessment against the statutory requirements,
including having regard to submitter comments and relevant Ministerial Policy Guidelines,
FSANZ has approved a variation to the Code to permit D-allulose as a novel food for retail
sale as a tabletop sweetener; or as an ingredient in certain manufactured foods. The
permission for use of D-allulose as an ingredient is limited to certain food classes and is
subject to MPLs and relevant requirements and conditions. The approved amended draft
variation includes provisions as follows:
• a novel food permission and conditions of use for D-allulose listed in Schedule 25
• a permission in Schedule 18 for the use of the D-psicose 3-epimerase as a processing
aid in the production of D-allulose
• an energy factor of 2 kJ/g for D-allulose included in the table to subsection S11—2(3)
• an exclusive use period of 15 months for Samyang’s Nexweet brand of D-allulose,
commencing on the date of gazettal
• a requirement for an advisory statement about the risk of a laxative effect for some food
classes in Standard 1.2.3.
• excluding D-allulose from the definition of sugars for the purposes of nutrition labelling
and certain claims about sugars
• permitting food containing D-allulose to make nutrition content claims about no added
sugar(s) provided other conditions are met.
2.3.10 Consultation
Consultation is a key part of FSANZ’s standards development process. FSANZ developed
and applied a standard communication strategy to this application. All calls for submissions
are notified via the Food Standards Notification Circular, media release, FSANZ’s social
media channels and Food Standards News.
The process by which FSANZ considers standards development matters is open,
accountable, consultative and transparent. Public submissions were called to assist
consideration of the draft variation to the Code. FSANZ acknowledges the time taken by
individuals and organisations to make submissions on this application.
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The draft variation was considered for approval by the FSANZ Board having regard to all
submissions made during the CFS period.
2.3.11 World Trade Organization (WTO)
As members of the World Trade Organization (WTO), Australia and New Zealand are obliged
to notify WTO members where proposed mandatory regulatory measures are not
substantially the same as existing international standards and the proposed measure may
have a significant effect on trade.
To date, there are few relevant overseas standards on the use of D-allulose in foods and no
international standard. However, there may be differences in permitted food classes, levels
at which D-allulose is permitted to be added, the energy factor used for labelling and labelling
about a laxative effect amongst the USA, South Korea, Japan and Australia and New
Zealand. These differences may require overseas manufacturers to vary product composition
and labelling specifically for the Australian and New Zealand markets as would be needed for
other markets given the lack of consistency across countries.
A notification to the WTO under Australia’s and New Zealand’s obligations as a part of the
WTO Technical Barriers to Trade agreement has been made to enable WTO members to
comment on the amendments to the Code.
2.4 FSANZ Act assessment requirements
2.4.1 Section 29
2.4.1.1 Consideration of costs and benefits
The Office of Best Practice Regulation (OBPR), now called the Office of Impact Analysis
(OIA), exempted FSANZ from the need to undertake a formal Regulation Impact Statement
(RIS) in relation to the regulatory change proposed in response to this application (OBPR
correspondence dated 6 May 2022, OBPR Reference: OBPR22-02203). That is because the
OBPR considered the application is unlikely to have a more than minor regulatory impact.
In relation to the assessment of processing aids, the OIA have previously advised FSANZ
that a RIS is not required for applications relating to these substances. This is because
applications relating to permitting the use of processing aids, such as D-psicose 3-
epimerase, that have been determined to be safe are considered to be minor and
deregulatory in nature, as their use will be voluntary if the draft variation concerned is
approved.
FSANZ, however, gave consideration to the potential costs and benefits that may arise from
the proposed measure for the purposes of meeting FSANZ Act considerations. The FSANZ
Act requires FSANZ to have regard to whether costs that would arise from the proposed
measure outweigh the direct and indirect benefits to the community, government or industry
that would arise from the proposed measure (paragraph 29(2)(a)).
The purpose of this consideration was to determine if the community, government and
industry as a whole is likely to benefit, on balance, from a move from the status quo. This
analysis considered permitting the sale of D-allulose as a novel food, and permitting the use
of D-psicose 3-epimerase to be used as a processing aid to manufacture D-allulose. FSANZ
is of the view that no other realistic food regulatory measures exist.
23
The consideration of the costs and benefits in this section is not intended to be an
exhaustive, quantitative economic analysis of the proposed measures. In fact, most of the
effects that were considered cannot easily be assigned a dollar value. Rather, the
assessment seeks to highlight the likely positives and negatives of moving away from the
status quo by permitting food offered for retail sale to be, or have as an ingredient, D-allulose
as a novel food, and permitting D-psicose 3-epimerase to be used as a processing aid.
2.4.1.1.1 Costs and benefits to:
Industry
Approving the draft variation would give industry an extra option for a low-energy substitute
for sugar as an ingredient in the foods that D-allulose would be permitted. Industry may also
benefit from the permission for D-psicose 3-epimerase to be used as a processing aid to
manufacture D-allulose. Different businesses may take-up this option if a net benefit existed
for them. Given the range of low-energy substitutes for sugars as food ingredients already in
the market, permitting this voluntary use of D-allulose is not expected to significantly impact
market dynamics.
D-allulose products are already permitted for sale in the USA, Japan and South Korea. The
European Union is also considering whether to permit use of D-allulose products. Hence,
permitting use of D-allulose in Australia and New Zealand may facilitate international trade.
That is particularly the case given FSANZ would permit MPLs that are consistent with levels
permitted in other jurisdictions. That may benefit exports containing D-allulose and also lead
to greater competition from imported products containing D-allulose.
Granting an exclusive use permission will prevent D-allulose from other businesses (i.e. that
are not Nexweet brand) from being added to food in the short-term. However, granting of the
exclusive use permission does not preclude any other business from applying to amend the
Code to permit the use of their own brand of D-allulose. Therefore, the market for supplying
D-allulose could be opened during the 15 month exclusive use period for any other business
willing to make an application. At the end of the exclusive use period all businesses will
experience the same benefits in offering D-allulose for retail sale or using brands other than
‘Nexweet’ as an ingredient in accordance with the specified conditions that D-allulose may be
added to food.
Consumers
Permitting D-allulose may increase the choice and numbers of products available to
consumers, particularly to consumers who seek lower energy alternatives.
The requirement of an advisory statement about the risk of a laxative effect for some food
classes will alert consumers to a possible laxative effect at high intakes of the foods, thereby
providing information for informed choice.
A large range of low-energy alternatives to sugar are already on the market and would
compete with D-allulose. Therefore, granting the exclusive use permission to the applicant
(where only D-allulose under the brand name ‘Nexweet’ may be added to food in accordance
with the specified conditions) is not expected to result in notably higher food prices for
consumers during the period than if exclusive use was not granted.
24
Government
Approving this draft variation may result in a small cost to government in terms of an addition
to the current range of ingredients and enzymes that are monitored for compliance. If the use
of D-allulose increases the choice and numbers of lower-energy products, that may
eventually lead to small, unquantified benefits to public health such as a reduction in obesity
rates.
Conclusions from cost benefit considerations
FSANZ’s assessment is that the direct and indirect benefits that would arise from approving
the draft variation most likely outweigh the associated costs. No further information was
provided during the consultation process that changed that assessment.
2.4.1.2 Other measures
There are no other measures (whether available to FSANZ or not) that would be more
cost-effective than a food regulatory measure developed or varied as a result of the
application.
2.4.1.3 Any relevant New Zealand standards
The proposed regulatory measures apply in both Australia and New Zealand. There are no
other relevant New Zealand Standards.
2.4.1.4 Any other relevant matters
Other relevant matters are considered below.
2.4.2 Subsection 18(1)
FSANZ has also considered the three objectives in subsection 18(1) of the FSANZ Act
during the assessment.
2.4.2.1 Protection of public health and safety
FSANZ has completed food technology, nutrition, microbiological, toxicology and dietary
exposure assessments, summarised in sections 2.2.1 to 2.2.3 above. FSANZ’s conclusion,
based on the best scientific evidence, was that use of D-allulose as a novel food in the
manner proposed would pose no public health and safety concerns.
FSANZ did not identify any public health and safety concerns in relation to the use of the Dpsicose 3-epimerase enzyme as a processing aid to manufacture D-allulose.
2.4.2.2 The provision of adequate information relating to food to enable consumers to
make informed choices
The labelling requirements relevant to this application are discussed above in section 2.3.7 of
this report.
2.4.2.3 The prevention of misleading or deceptive conduct
There were no issues identified with this application relevant to this objective.
25
2.4.3 Subsection 18(2) considerations
FSANZ has also had regard to:
• the need for standards to be based on risk analysis using the best available
scientific evidence
FSANZ has used the best available scientific evidence to conduct the risk analysis. The
applicant submitted a dossier of scientific studies as part of the application. FSANZ had
regard to this dossier, together with other technical information including scientific literature,
in assessing the application.
• the promotion of consistency between domestic and international food standards
There are relevant international specifications for D-allulose and enzyme preparations as
referred to in section 1.3.4 of this report, with which D-allulose and D-psicose 3-epimerase
would have to comply. In addition, there is a Codex guideline – Guidelines on Substances
used as Processing Aids (CAC/GL 75-2010) – which sets out general principles for the safe
use of substances used as processing aids, including that substances used as processing
aids shall be used under conditions of GMP.
• the desirability of an efficient and internationally competitive food industry
Australia and New Zealand will remain competitive with other international markets, where
approval for D-allulose is already in place or occurs in the future. This will also help foster
continued innovation and improvements in food manufacturing techniques and processes.
The conclusion of the risk assessment is that there are no public health and safety concerns
associated with the proposed use of D-allulose. It is therefore appropriate that Australian and
New Zealand food industries are given the opportunity to benefit from the use of D-allulose
for the applications proposed by the applicant.
• the promotion of fair trading in food
No issues were identified for this application relevant to this objective.
• any written policy guidelines formulated by the Food Ministers’ Meeting
FSANZ must have regard to any written policy guidelines formulated by the Food Ministers’
Meeting. There are two policies relevant to this application:
• Policy Guidelines on Novel Foods
• Policy Guideline on the Addition to Food of Substances other than Vitamins and
Minerals.
FSANZ has had regard to these two policy guidelines as detailed in the following sections. In
addition, the high order principles in both guidelines reflect FSANZ’s statutory objectives in
subsections 18(1) and 18(2) in the FSANZ Act. FSANZ’s assessment in relation to these
objectives is described in sections 2.5.2 and 2.5.3 above.
26
D-allulose
Policy Guideline on Novel Foods
The ‘Ministerial Council Policy Guidelines on Novel Foods’ also includes the high order
principle ‘be consistent with and complement Australian and New Zealand national policies
and legislation including those relating to nutrition and health promotion’. With respect to that
principle, FSANZ considers the addition of D-allulose to the food classes as approved, is
consistent with national nutrition policies in Australia and New Zealand that recommend
limiting added sugars intake (NHMRC, 2013; MoH 2020).
The Specific Principles in this guideline are:
• To ensure that public and industry confidence in the food system is maintained.
• To provide an assessment process that aims to protect commercially sensitive
information and recognise industry’s intellectual property to the maximum extent
possible.
• To ensure consumers are not misled by novel foods or food ingredients, which appear
similar to existing foods but may differ in terms of nutrition or function.
Following assessment as outlined in this report and SD1, FSANZ has determined that
permitting the addition of D-allulose to the food classes as approved is consistent with the
above Specific Principles.
Policy Guideline on the Addition to Food of Substances other than Vitamins and
Minerals.
The ‘Policy Guideline Addition to Food of Substances other than Vitamins and Minerals’
includes Specific Order Policy Principles for substances added for a technological function as
well as for any other purpose. This application falls under ‘any other purpose’ and therefore
regard has been given to these policy principles in the assessment of this application. These
principles state that the addition of substances other than vitamins and minerals to food
should be permitted where:
a) the purpose for adding the substance can be articulated clearly by the manufacturer (i.e.
the ‘stated purpose’)
b) the addition of the substance to food is safe for human consumption
c) the substance is added in a quantity and a form which is consistent with delivering the
stated purpose
d) the addition of the substance is not likely to create a significant negative public health
impact to the general population or sub population
e) the presence of the substance does not mislead the consumer as to the nutritional quality
of the food.
Following assessment as outlined in this report and SD1, FSANZ has determined that
permitting the addition of D-allulose to certain foods as approved is consistent with the above
principles.
This policy guideline also includes a section on implementation. The points under that
section are covered as outlined above in sections 2.3.2 and 2.3.3.
27
D-psicose 3-epimerase
The ‘Ministerial Policy Guideline Addition to Food of Substances other than Vitamins and
Minerals’
3 includes specific order policy principles for substances added to achieve a solely
technological function, such as processing aids. These specific order policy principles state
that permission should be granted where:
• the purpose for adding the substance can be articulated clearly by the manufacturer as
achieving a solely technological function (i.e., the ‘stated purpose’)
• the addition of the substance to food is safe for human consumption
• the amounts added are consistent with achieving the technological function
• the substance is added in a quantity and a form which is consistent with delivering the
stated purpose
• no nutrition, health or related claims are to be made regarding the substance.
FSANZ determined that permitting the proposed use of D-psicose 3-epimerase is consistent
with these specific order policy principles for ‘Technological Function’. All other relevant
requirements of the policy guideline are similarly met.
3 References
FAO/WHO (2020). Chapter 6: Dietary exposure assessment of chemicals in food. Second Edition
2020. In Environmental Health Criteria 240. Principles and Methods for the Risk Assessment of
Chemicals in Food.
https://www.who.int/docs/default-source/food-safety/publications/chapter6-dietary-exposure.pdf
FCC (2020). Allulose. In: Food Chemicals Codex, Twelfth Edition. Rockville (MD): United States
Pharmacopeial Convention, pp. 1773 (accessed 7 December 2022)
FDA United States Food and Drug Administration: (2020) The Declaration of Allulose and Calories
from Allulose on Nutrition and Supplement Facts Labels: Guidance for Industry.
FSANZ (2009), Principles and Practices of Dietary Exposure Assessment for Food Regulatory
Purposes.
https://www.foodstandards.gov.au/sites/default/files/publications/Documents/Principlespractices%20ex
posure%20assessment%202009.pdf
MOH (2020) Eating and Activity Guidelines for New Zealand Adults: Updated 2020. Wellington:
Ministry of Health.
NHMRC (2013) Australian Dietary Guidelines. Canberra: National Health and Medical Research
Council. Canberra, Australia
O’Neil et.al. (2013).The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 15th
Edition, Royal Society of Chemistry, Great Britain.
Appendix
Summary of submitter comments and FSANZ response
3 https://foodregulation.gov.au/internet/fr/publishing.nsf/Content/publication-Policy-Guideline-on-the-Addition-ofSubstances-other-than-Vitamins-and-Minerals
28
Attachments
A. Approved draft variation to the Australia New Zealand Food Standards Code
B. Explanatory Statement
C. Draft variation to the Australia New Zealand Food Standards Code (call for
submissions)
29
Appendix 1 – Summary of submitter comments and FSANZ responses
Submitters to the A1247 call for submission are listed below, with a summary of issues raised by submitters and FSANZ responses listed in
Table 1.
List of submitters
• Ai Group
• Australian Beverages Council (ABC)
• Australian Food & Grocery Council (AFGC)
• Australian Institute of Food Science and Technology (AIFST)
• Buderim Foods
• Calorie Control Council
• New Zealand Beverage Council (NZBC)
• New Zealand Food and Grocery Council (NZFGC)
• Nutrishus Brands
• Queensland Health
• New South Wales Food Authority (NSWFA)
• New Zealand Food Safety (NZFS)
• Victorian Departments of Health and Energy, Environment and Climate Action (Vic DoH and DEECA)
• Senchai
• Two individual submitters
30
Table 1 Summary of submissions and FSANZ response
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Food classes
Requested expanding the food categories to include all
beverage types as classified under the Code to benefit
innovation and consumer options and align with the Food
Regulation System priorities 2017-2022. Expanding the
food categories would provide clarity for enforcement and
reduce the burden on industry to make further applications
to amend the Code. Some submitters stated that a limited
number of categories would negate benefit to industry.
Recommended aligning categories with S15 and listing
the category number to reduce ambiguity and confusion.
Noted that the applicant’s scope was based on the US
food class names and recommended FSANZ extend
these to other food class names: broader range of
confectionery, liquid milk products and flavoured liquid
milk, brewed soft drinks, carbonated, mineralised and
soda waters, fruit and vegetable juices, fruit and vegetable
juice products, other foods including snack and nutrition
bars.
D-allulose should be broadly permitted in the food supply
(no exclusivity) as it has the potential to reduce obesity if
used instead of sugar.
NZBC, ABCL,
Buderim,
AFGC, AIFST
FSANZ has decided to widen the food classes permitted in the draft variation to
maintain consistency with foods requested by the applicant to enable
innovation, regulatory harmonisation and provide clarity for compliance and
enforcement purposes. Brewed soft drinks are also included as a non-alcoholic
water based beverage.
FSANZ has only assessed the addition of D-allulose to the foods requested by
the applicant. Therefore, the permission must be limited to those foods.
31
Topic of submission Raised by FSANZ response (including any amendments to drafting)
MPLs
Higher levels should be permitted, based on the selflimiting nature of D-allulose (flavour profile) and its
similarity to fructose and polyols. Recommended either no
MPL set or revert to the levels requested in the
application, or levels overseas for reasons of
technological function, harmonisation and to provide trade
benefits.
ABCL, AIFST,
AFGC,
Buderim,
Individual, Ai
Group, NZBC
For the reason stated in this report, FSANZ has decided to amend the draft
variation to
• increase the MPLs to those originally requested by the applicant
• require an advisory statement for certain foods where a risk of a
laxative effect is present (summarised in Table 8, SD1).
Preferred unit of measurement
Recommended units of milligrams per kilogram (mg/kg)
for measurement in line with established treatment of
other MPLs in the Code.
ABCL FSANZ considers a percentage (% w/w) to be the most appropriate
measurement since the amounts of D-allulose used in production are generally
larger than other substances to which MPLs apply.
Drafting – novel food vs food additive
Agreed with classification of D-allulose as a novel food
Notes D-allulose is captured by the definition of sugars* in
the Code as a hexose monosaccharide and performs
technological purposes such as intense sweetener and/or
bulking agent.
D-tagatose
Noted D-tagatose is only listed as a novel food in the
Code, however, the FSANZ Nutrition Panel Calculator
(NPC) lists it as a food additive. Suggests FSANZ resolve
this misalignment so that users of the Code are in no
doubt as to the identity of certain substances.
Questioned the rationale not to list D-allulose (and Dtagatose) as a food additives under Standard 1.3.1. The
purpose of adding D-allulose meets the definition of ‘used
NSWFA FSANZ considers the novel food standard to be the most appropriate for the
regulation of D-allulose. The food classes to which D-allulose may be added,
as listed in the approved amended draft variation, now align more closely with
the approach used for the regulation of similar foods rather than for food
additives.
D-tagatose
FSANZ acknowledges NSWFA for pointing out that D-tagatose is described as
a food additive in the NPC. This will be corrected when the NPC is next
updated.
FSANZ does not agree. See section 2.3.2.2 of this report
32
Topic of submission Raised by FSANZ response (including any amendments to drafting)
as a food additive’ in the Code. The Code lists all other
permitted sugar substitutes such as polyols and intense
sweeteners as food additives.
Queried if section 1.3.1—5 applies to D-allulose. As this
provision only refers to MPLs of intense sweeteners
determined in Schedule 15, clarification is required how
this provision may apply.
Section 1.3.1—5
The application of section 1.3.1—5 of the Code is a matter for the jurisdictions
whose legislation give effect to the Code. FSANZ notes that section 1.3.1—5
applies to a substance used as a food additive to perform the technological
purpose of an intense sweetener. As explained in section 2.3.2.3 of this report,
FSANZ’s assessment is that D-allulose is not being used in this case as a food
additive. Nor is it an intense sweetener (as it is only 70% as sweet as sugar).
Laxative effect
Foods with D-allulose could be labelled with information
about the risk of a laxative effect if there was a broad
permission.
Supported FSANZ’s decision to lower the maximum
percentage limit of D-allulose to mitigate laxative effect.
FSANZ’s assessment identified a laxative effect of Dallulose, with the lowest dosage associated with
gastrointestinal symptoms of 0.4 g/kg bw as a single dose.
Noted the threshold value was based on a review of
human tolerance studies on mainly healthy young adults
and no studies on children were reviewed.
NSWFA also noted that FSANZ extrapolated the threshold
value to children in the dietary intake assessment of Dallulose based on consumption data for NZ children (5-14
years). Although estimated intakes of added D-allulose
tended to be higher for children due to their lower body
weight in comparison to adults, it is unknown if the use of
the same threshold value is appropriate for children.
NZFS noted there is limited human research to inform the
levels at which a laxative effect occurs. The tolerance
NSWFA,
NZFS Please see above comments for FSANZ’s rationale for the change back to the
originally requested MPLs. FSANZ considers the required labelling measures
(section 2.3.7 above) sufficiently manage the risk of a laxative effect.
As part of the hazard assessment of D-allulose, FSANZ conducted a literature
review to identify any studies, case reports or reviews not included in the
application. Several studies of the effects of D-allulose in patients with either
Type 1 or Type 2 diabetes, or in rodent models of diabetes, were found. No
information in the peer-reviewed scientific literature concerning the risk of a
laxative effect in the other subpopulations was found. In the studies on patients
with diabetes, no adverse clinical effects of the consumption of D-allulose were
identified in any of those studies. Beneficial effects on blood glucose and on
insulin tolerance were reported.
Since the risk assessment was first released for submissions, one study of
tolerance of D-allulose in children has been published. This study has been
reviewed and added to the SD1. No gastrointestinal effects were observed in
children, and there is no evidence that children are more sensitive to D-allulose
than adults.
FSANZ is therefore not aware of scientific evidence establishing a greater risk
to people with irritable bowel syndrome, diabetes or other chronic diseases.
However FSANZ has amended the draft variation to require an advisory
statement to the effect that excess consumption may have a laxative effect for
certain food classes and considers this is sufficient to minimise the risk of a
33
Topic of submission Raised by FSANZ response (including any amendments to drafting)
studies involved healthy participants consuming D-allulose
with no other food, or with a meal not described beyond
macronutrient composition. There is no laxative effect
hazard assessment specific to children, or to people with
irritable bowel syndrome, diabetes or other chronic
diseases. Additionally, D-allulose and fructose compete
for transport across the small intestine, so simultaneous
consumption reduces absorption of D-allulose, and this
may increase the risk of laxative effects due to a higher
proportion of D-allulose reaching the large bowel. Due to
the limited data, NZFS suggested additional risk
management via a mandatory advisory statement.
NZFS also noted the dietary intake assessment did not
consider the scenario of D-allulose being consumed
alongside other sugar substitutes including sugar
alcohols, which may add to the laxative effects of
consuming D-allulose.
The threshold value is based on a study on healthy young
adults. This evidence doesn’t consider limits for children
or people who are not ‘healthy’ (e.g., people with diabetes
or with gastrointestinal conditions). Also noted adverse
effects were sometimes described as ‘severe’ in the
threshold studies.
laxative effect including when being consumed alongside other sugar
substitutes. See labelling section in this table for more details.
FSANZ also notes that for those consumers wanting to avoid low energy
sugars, D-allulose will be listed in the statement of ingredients.
It would be very difficult to undertake a dietary intake assessment on products
containing D-allulose consumed alongside foods that also have the potential to
cause a laxative effect. FSANZ is confident that an advisory statement on such
products will provide consumers with a choice as to whether they consume
these foods together. Any such ingredient will also be listed in the ingredient
list on foods.
Dietary intake assessment
Recommend further interrogation and explanation of the
dietary modelling to justify any discrepancy with
international permitted levels.
Noted that the United States Food and Drug
Administration (FDA) considers D-allulose intake of less
than 0.5-0.6 g/kg bw/day as safe, which closely aligns with
FSANZ’s assessment of 0.4 g/kg bw/day. However, as
AIFST understands, this difference in the maximum levels
may be attributed to the dietary intake assessment
methodology and notes the food consumption data used
AFGC,
Buderim
Foods, AIFST
The short-term dietary intake of added D-allulose was estimated following
international best practice (FAO/WHO, 2020) and is appropriate to assess the
risk of a laxative effect for high consumers (P97.5) for this assessment. This
assessment resulted in proposing lower MPLs for some food classes than the
those originally requested by the Applicant at Call For Submissions.
Any discrepancies from differences to international intake assessments and
associated permitted levels might be attributed to the country/region based
consumption data and body weight data used, concentrations used and/or the
methodology followed. For instance, when determining the maximum use
concentration to not exceed the level that can cause a laxative effect, New
Zealand children aged 5-14 years represented the worst-case scenario
34
Topic of submission Raised by FSANZ response (including any amendments to drafting)
is up to 20 years old. because of the lower body weights for that age group in comparison to the
other two population groups assessed, which tend to result in higher estimates
of intake per kilogram of body weight. Another factor is the typically higher food
consumption per kilogram of body weight for children due to their growth and
development.
Furthermore there were some uncertainties in the data and information used
for this assessment. Hence FSANZ used conservative assumptions (as
described in the A1247 SD1, section 3.5.2.5) to ensure that the estimated
dietary intake was not an underestimation and was therefore representative of
the worst case scenario. This is a general practice as outlined in FSANZ’s
Principles and Practices of Dietary Exposure Assessment for Food Regulatory
Purposes (FSANZ, 2009).
A detailed description of the dietary intake assessment is provided in section
3.5 of the SD.
The consumption data used for the dietary intake assessment may not reflect
changes in the consumption of some food categories assessed (e.g., foods
containing low- and reduced-energy/sugar) since it was collected. This will be
reflected in future national nutrition surveys. FSANZ used consumption data
available from the latest Nutrition surveys in Australia and New Zealand for this
assessment. FSANZ has previously evaluated differences in consumption
amounts between national nutrition surveys. It was found that for the majority
of food groups, consumption amounts do not differ greatly, however there may
be some variation in consumption of more specific or niche types of foods. The
consumption amounts derived for food classes from national nutrition survey
data available for use in this assessment will be representative of typical
consumption amounts of current consumers. There will always be some
variation in consumption amounts within a population.
Supported FSANZ’s intention to reduce the MPLs of Dallulose from the amount originally requested by the
applicant to mitigate the risk of a laxative effect. However,
requested information to understand how the proposed
levels were determined.
The results of FSANZ’s dietary intake assessment (in
NSWFA FSANZ initially conducted a short-term assessment (assessment of potential
laxative effects) based on the MPLs originally proposed by the applicant (Table
5, SD1). The results provided in Table 7, SD1, indicated that consumption of
some food categories may exceed the threshold limit for a laxative effect (0.4
g/kg bw). As a result an additional analysis was undertaken to determine the
maximum amount of D-allulose (%w/w) that could be added to each food
category before causing a laxative effect as explained in the section ‘Maximum
35
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Table 7 of SD (page 36)) suggested high consumption of
some food categories may still exceed the daily intake
limit of D-allulose (0.4 g/kg bw) at the proposed MPLs.
use concentration to not exceed the level that can cause laxative effects’ in
SD1. For this estimation where possible, similar food categories were
combined to derive a high (P97.5) consumption value in order to determine a
single maximum possible concentration. This was undertaken for the entire
category such as ‘biscuits, cakes and pastries’ and ‘water based flavoured
drinks’ etc as indicated in Table A2.1. in SD1. The modelling was used to
determine the highest use level that would result in the laxative effect level not
being exceeded.
The exposure estimates provided in this submission are based on the
consumption amounts estimated for each sub food category that were
considered under combined/major categories by FSANZ for this estimation
(Table A2.1., SD1).
For the food category ‘coffee based beverages’ that included ‘coffee beverage,
decaffeinated, instant powder/granules’, the added D-allulose to cause a
laxative effect was estimated to be 0.7 %(w/w) and it was rounded to 1 % (w/w)
according to FSANZ’s standard rounding procedure and presented in Table 8,
SD1.
Please also note the comments above for details on the amendments made to
the MPLs for D-allulose in the draft variation.
36
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Noted the limitation of FSANZ’s dietary intake assessment
that it ‘does not include the possibility of two or more
foods being eaten in the same eating occasion or meal
(SD page 40)’.
NSWFA considered setting (reduced) MPLs of D-allulose
for each food category to be important but not sufficient to
minimise the risk of a laxative effect and suggested
additional measures to ensure consumers are aware of
the risks incurred if consuming more than the ADI of Dallulose, i.e., mandatory advisory statement of a laxative
effect, monitoring of low sugar product consumption
patterns in subpopulations such as diabetics and those
with hereditary fructose intolerance (HFI).
NZFS noted there may be some sub-groups, such as
people with type 2 diabetes, who could be more likely to
replace numerous food items with low-sugar or lowenergy alternatives, and therefore may consume multiple
foods containing D-allulose at one time.
NSWFA,
NZFS
FSANZ conducted chronic and short-term dietary intake assessments for
added D-allulose. The chronic dietary intake assessment included intake from
all the proposed food categories containing added-D-allulose, and does take
into account where consumers ate more than one food containing added Dallulose in a day. The short-term dietary intake estimates were used to
represent the high food consumer (P97.5) and a high intake, from a single food
or food category, from one meal or over one day. These are the standard
methods and internationally accepted best practices.
Although it is standard practice, consideration of only one food category/food is
a limitation of the short term assessment as noted in section 3.5.2.2 in the
SD1. However, where possible, similar food categories were combined
together or a higher level/ major food category was used to derive a high
consumption value in order to determine a single maximum possible
concentration for the entire/ combined category as explained in the section
‘Maximum use concentration to not exceed the level that can cause laxative
effects’ in the SD1 to address this limitation to a certain extent and minimise
any potential risk ’. The application of advisory labelling about possible laxative
effects will enable consumers to make informed choices about whether to
consume more than one food that could cause a laxative effect in one meal or
over one day. See section 2.3.7.3 of this report for further discussion on the
requirements for an advisory statement.
For the short-term assessment, FSANZ is currently not aware of any potential
adverse effects with subpopulations from the intake from other sugar
substitutes.
FSANZ risk assessment – vulnerable
subpopulation
Considered consumers with diabetes are more likely to
consume products containing low energy sugar
substitutes including D-allulose, however, FSANZ’s
assessment did not particularly investigate this population
group. Given the significance of diabetes prevalence,
encourage FSANZ to monitor consumption patterns of low
energy sugar substitutes and potential adverse effects in
NSWFA As part of the hazard assessment of D-allulose, FSANZ conducted a literature
review to identify any studies, case reports or reviews not included in the
Application. Several studies of the effects of D-allulose in patients with either
Type 1 or Type 2 diabetes, or in rodent models of diabetes, were found. No
adverse clinical effects of the consumption of D-allulose were identified in any
of those studies at the doses employed. Beneficial effects on blood glucose
and on insulin tolerance were reported (see SD1). FSANZ is currently not
aware of any potential adverse effects of low energy sugar substitutes on this
37
Topic of submission Raised by FSANZ response (including any amendments to drafting)
this population group. subpopulation.
Supported FSANZ’s proposal to monitor potential health
impacts with either Klebsiella pneumoniae or incidences
of urinary tract infections (UTIs) relating to consumption of
D-allulose.
Some submitters noted people living with diabetes may be
more at risk, given UTIs are common in this population
group due to a number of factors such as nephropathy,
high glucose in the urine and/or changes in the immune
system and noting that this subpopulation may be more
likely to seek out low energy and low sugar foods.
Considered that the maximum levels of use for each food
category may help to mitigate the possible microbiological
risk of high consumption.
NSWFA,
NZFS, NZFGC
As part of the hazard assessment of D-allulose, FSANZ conducted a literature
review to identify any studies, case reports or reviews not included in the
application. Several studies of the effects of D-allulose in patients with either
Type 1 or Type 2 diabetes, or in rodent models of diabetes, were found. In the
studies on patients with diabetes, no adverse clinical effects of the
consumption of D-allulose were identified in any of those studies.
Requested commentary from FSANZ about the risk of
consumption of D-allulose by population with hereditary
fructose intolerance (HFI).
FSANZ’s assessment identified that D-allulose is mainly
absorbed from the small intestine by the same
transporters as fructose (SD report page 13). Encouraged
FSANZ to investigate a risk of consumption of D-allulose
by the subpopulation with HFI.
Currently isomaltulose, tagatose, and sorbitol are
mentioned in the FSANZ website that should be avoided
by people with disorders in fructose metabolism.
Suggested updating this advice by reviewing other
permitted sugar substitutes and D-allulose.
NSWFA There is no information in the peer-reviewed scientific literature concerning
consumption of D-allulose by people with HFI. FSANZ notes that the metabolic
defect in HFI is a deficiency of aldolase B, which is responsible for breaking
down fructose-1-phosphate to glyceraldehyde and dihydroxyacetone
phosphate. Since D-allulose does not undergo any significant metabolism, but
is excreted unchanged, a lack of aldolase B would not be expected to affect the
kinetics of D-allulose.
38
Topic of submission Raised by FSANZ response (including any amendments to drafting)
FSANZ risk assessment – risk to those with renal
conditions
FSANZ’s safety assessment only included studies of Dallulose consumption in healthy adults as a result of study
exclusion criteria which consistently removed participants
with diabetes, hepatic and renal function disorders, and
those that were pregnant or lactating. Submitters were
concerned about the lack of data to establish
microbiological safety in these subpopulations, particularly
in individuals with renal conditions given it has been
demonstrated that a high proportion of D-allulose is
passed through and excreted via the kidneys, and in
diabetic populations as they may be large consumers of
foods containing low energy sugar substitutes. The
departments also note that while several microorganisms
were identified as carrying D-allulose metabolism genes
(and therefore presenting potential risk for bacterial
urinary tract infection), the clinical studies included in the
safety assessment only considered K. pneumoniae.
The VicDoH and DEECA suggested further consideration
of microbiological risks and mitigation, including across
uro-pathogenic bacteria and in potentially vulnerable
consumer subpopulations, is required to establish safety.
NZFS suggested the risk could be monitored via FSANZ’s
routine horizon scanning programme.
Vic DoH and
DEECA, NZFS
FSANZ’s assessment was based on the best available scientific evidence as
required by the FSANZ Act.
FSANZ is not aware of any evidence of a microbiological risk. There is no
information in the peer-reviewed scientific literature concerning the
consumption of D-allulose in trial participants with diabetes, hepatic and renal
function disorders, during pregnancy or who were lactating. There is also no
information in the peer-reviewed scientific literature concerning excretion of Dallulose in patients with renal insufficiency. Nor, were relevant studies on any
other uro-pathogenic bacteria were identified.
39
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Energy factor for D-allulose
Considered that future evidence could strengthen the
accuracy of FSANZ’s calculation of metabolisable energy
from D-allulose. Noted only two studies (one published,
one unpublished) were used to estimate the proportion of
D-allulose excreted in urine, and that urinary excretion
varies according to the dose of D-allulose and appears to
vary between individuals (based on the large standard
deviations). However, despite limitations in the available
data to inform energy calculations, the energy contribution
of D-allulose is very low.
NZFS FSANZ’s assessment was based on the best available scientific evidence as
required by the FSANZ Act.
To align more closely with international markets (USA: Dallulose energy factor 1.672 kJ/g; Korea and Japan 0 kJ/g)
and to address potential disparities resulting from
rounding, recommend either the adoption of the
applicant’s suggested value of 1.0 kJ/g or the allowance of
rounding to one decimal place. It is important to align with
global practices to mitigate potential trade implications
and to facilitate greater export market access for
Australian products. Rounding energy factor to a whole
number can significantly impact outcomes, particularly
when dealing with initial values that are very small
compared to the majority of other energy factors.
ABCL, NZBC FSANZ has assessed the energy factor for D-allulose using the equation set
out in section 3.2.5.B.2 of the FSANZ Application Handbook and the scientific
evidence as described in section 3.6 of SD1. Using this equation, FSANZ
determined that the energy factor for D-allulose is 1.88 kJ/g, rounded to 2 kJ/g.
There is no consistency with the energy factor for D-allulose internationally and
so it is not possible to achieve global alignment. Rounding of energy factors for
determining the energy content for the NIP was established before the joint
Food Standards Code was developed and this practice has been consistently
applied to new factors. FSANZ’s decision is to maintain this approach.
Rounding to 1.9 kJ/g instead of 2 kJ/g would have a minimal effect on the
energy content listed in the NIP for foods with ingredients contributing fat,
carbohydrate and/or protein which have much higher energy factors than Dallulose. Likewise, rounding the energy factor to one decimal place would have
minimal impact on the energy value for foods with ingredients contributing little
or no additional energy such as a zero sugar beverage with D-allulose.
Supports the proposed energy factor of 2 kJ/g. The value
aligns closely with that prescribed in the USA of 0.4 kcal/g
(equivalent to 1.67 kJ/g).
AFGC, AIFST,
Buderim
Noted.
40
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Labelling – Sugar and carbohydrate declarations
in the NIP
Low energy sugars and polyols are not included in the
carbohydrate declaration in the NIP when determined
using the calculation of available carbohydrate by
difference set out in subsection S11—3(2). Seeks
clarification as to whether the low energy sugars and
polyols are included in carbohydrate declarations if using
the calculation of available carbohydrate method.
Industry has the ability to choose which method (available
carbohydrate by difference or available carbohydrate) to
use to calculate carbohydrate content for the NIP,
therefore introducing potential ambiguity in how NIP
values are calculated. This seems to present a risk of
inconsistency. For example, carbohydrate claim
conditions for making comparative claims (i.e. ‘reduced or
light/lite’ and ‘increased’) in Schedule 4 of the Code
involve comparison of carbohydrate content with a
reference food. Consumers will not know which method
was used to derive the claim.
D-allulose is a monosaccharide but is proposed to be
excluded from the listing of sugars in the NIP. Other
sugars* permitted as novel foods (i.e. D-tagatose
(monosaccharide), trehalose (disaccharide) and
isomaltulose (disaccharide)) would continue to be
captured as sugars in the NIP. It may be confusing to
impose different requirements for the NIP to different
substances with the same function as traditional sugar
substitutes. Suggests there is room for education to assist
consumer understanding of the NIP and relevant
requirements.
NSWFA D-allulose would not be included in the average amount of carbohydrate
declared in the NIP when either method for determining carbohydrate
concentration set out in section S11—3 is used. See section 2.3.7 for further
discussion.
Reviewing the methods for determining carbohydrate content of a food for the
NIP is out of scope for this application. When adding the calculation of
available carbohydrate method to the Code was considered in Proposal P247
(Definition of carbohydrate) in 2001, FSANZ noted there was on average,
about 1.4% difference between analysed carbohydrate and carbohydrate by
difference over a broad range of foods. Under fair trading laws information on
food labels including claims should not be misleading or deceptive.
FSANZ considers labelling requirements for low energy sugars are best
considered on a case-by-case basis taking into account all relevant
information. Trehalose, isomaltulose, low energy sugars and traditional sugars
all have different properties, noting trehalose and isomaltulose are not low
energy sugars.
41
Topic of submission Raised by FSANZ response (including any amendments to drafting)
It is important the requirements for calculation of sugars in
the NIP for D-allulose is consistent with other low energy
sugars such as D-tagatose. From nutritional perspective
health professionals are concerned that D-allulose will not
be included in the calculation of sugars in the NIP unless
there is 5 g/100g or more present in the food.
QLDH The provision in subsection 1.2.8—6(9) requires the amount of D-allulose to be
declared in the NIP if it is present in a food (with or without other substances
listed in subsection S11—2(3), except for organic acids) in an amount no less
than 5 g/100 g. This requirement is not about sugars declaration in the NIP.
FSANZ’s decision is to exclude D-allulose in the sugars declaration in the NIP,
as discussed in section 2.3.7.1 of the report. Labelling requirements for low
energy sugars are best considered on a case-by-case basis, noting due to
differing properties there may be reasons to vary labelling requirements.
Labelling – Nutrition content claims
Requests FSANZ revise the draft variation at approval
and confirm how D-allulose will be aligned in the new
definition of ‘sugars’, as per the recent gazettal of
proposal P1062 – Defining added sugars for claims. Given
specified nutrition content claims will be allowed, requests
D-allulose be excluded from the added sugars definition.
ABCL, NZBC,
NSWFA The draft variation has been amended in view of changes made to the no
added sugar(s) claim conditions from Proposal P1062. See section 2.3.7.
FSANZ proposes to permit all sugar claims by not
counting D-allulose as sugar for the purposes of the NIP
and claims, for the rationale that ‘D-allulose is virtually
unmetabolized in the human body and for the purposes of
nutrition labelling a low energy factor of 2 kJ/g is
proposed’ (CFS report page 16). However, other aspects
of D-allulose such as cariogenic potential were not
assessed. Recommends including an assessment on
other aspects of D-allulose as sugar (e.g. cariogenic
potential, glycemic index) in the approval report in the
discussion about sugar claim eligibility.
NSWFA FSANZ notes that as part of the FDA’s consideration of D-allulose for nutrition
and energy labelling purposes, a review of the scientific evidence related to the
cariogenic potential, metabolism, and caloric value of, and glycemic response
to, allulose was undertaken. The FDA concluded D-allulose does not promote
dental caries due to its low cariogenic potential. It was also concluded that
allulose produces only a negligible increase in glycemic and insulinemic
responses (FDA, 2020). While FSANZ did not assess cariogenic potential or
glycemic index for this application, permitting foods containing D-allulose to
make claims about sugars does not appear to be inconsistent with the low
cariogenic potential and minimal impact of D-allulose on glycemic response.
42
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Considers there is potential for consumers to be misled by
no added sugar claims or there to be confusion by a
health halo concept that may promote some items as a
healthier choice. This is inconsistent with a key priority of
the food regulation system (Priority 2) to support the
public health objectives to reduce chronic disease related
to overweight and obesity.
Suggest FSANZ consider the recent World Health
Organization guideline ‘Use of non-sugar sweeteners’
which suggests that non-sugar sweeteners should not be
used as a means of achieving weight control.
As a low-energy substitute for conventional sugar
ingredients, it appears it may be appropriate for nutrition
content claims for energy to be used in relation to Dallulose. However, with a proposed energy factor of 2 kJ/g
(200 kJ/100 g), it appears products containing D-allulose
may not qualify for the energy nutrition content claims
‘low’ (energy) and ‘diet’.
It is inappropriate for an ‘unsweetened’ nutrition content
claim to be used for D-allulose and is not supported
because it is misleading. D-allulose has approximately
70% of the sweetness of sucrose and therefore
significantly contributes to sweetness. Similar to Dtagatose, if D-allulose was included in the definition of
‘sugars*’ it would not be permitted to include a nutrition
content claim for unsweetened.
QLDH Permission for foods containing D-allulose to display nutrition content claims
such as no added sugar(s) is consistent with the Policy Guideline on Nutrition,
Health and Related Claims. FSANZ had regard to this guideline in the
development of claim permissions and conditions under Proposal P293 –
Nutrition, health and related claims. More recently FSANZ amended conditions
for no added sugar(s) claims to ensure they aligned with dietary guidelines in
Australia and New Zealand to better inform food choice (Proposal P1062 –
Defining added sugars for claims).
As low energy sugars such as D-allulose and D-tagatose are specifically
excluded from the WHO guideline on the use of non-sugar sweeteners, FSANZ
has not considered the guideline for this application.
Foods containing D-allulose would need to meet existing conditions in Section
S4—3 for low energy and diet claims. For example, a beverage containing Dallulose could display a low energy claim if the beverage has an average
energy content of no more than 80 kJ/100 mL. Given the approved draft
variation permits D-allulose to be added to water based flavoured drinks up to
a maximum of 3.5% w/w, such a product is likely to meet claim conditions
provided D-allulose plus any other ingredients do not contribute more than 80
kJ/100 mL. There are requirements in addition to the maximum energy content
for diet claims as set out in Section S4—3.
FSANZ agrees that foods containing low energy sugars such as D-allulose
(and D-tagatose) should not be permitted to display unsweetened claims,
however this was not explicit in the Code when submissions were called on the
draft variation. The amendments made to the unsweetened claim conditions
from Proposal P1062 prohibit foods containing low energy sugars, as
ingredients, listed in subsection S11—2(3) of Schedule 11 from making such
claims. See section 2.3.7.2 of this report for further discussion.
43
Topic of submission Raised by FSANZ response (including any amendments to drafting)
There is limited available evidence demonstrating that the
energy contribution from D-allulose varies according to the
amount consumed and likely according to whether it is
eaten concurrently with fructose.
Suggests further consideration is needed for an energy
cut-off at which a low-sugar sweetener can be considered
an added sugar.
NZFS While evidence suggests the energy contribution from D-allulose may vary
depending on whether D-allulose is consumed with or without fructose, it is
likely that in both situations the energy contribution will be small (see section
3.2.1.5 of SD1).
FSANZ considers claim permissions for foods containing low energy sugars
are best considered on a case by case basis at the time applications for
permission to add are assessed. This will ensure all relevant information is
considered, noting that energy factors and metabolic impacts may vary.
Requests that in the first Note in Section S4—2 (i.e. the
definition of sugars in Section 1.1.2—2), ‘hexose
monosaccharide (other than D-allulose)’ is in parts (a) and
(b)(i), not just in part (a).
ABCL Not supported. The application sought an amendment to the Code to permit
the nutrition content claims % free, low sugar(s), reduced/lite and no added
sugar(s) on foods that contain added D-allulose. For the reasons listed in the
CFS and this report, FSANZ’s assessment is to permit such claims provided
certain conditions are met. The amendment in question implements that
outcome. The latter does not require the change to the Code requested by the
submitter. Additionally the submitter’s suggested Code change is not required
to exclude D-allulose from sugars declarations in the NIP (see responses
above).
Suggests a typographical error in the drafting is corrected.
The second ‘sugars’ in the title of Item 7 [Section S4—3
(table item dealing with nutrition content claims in relation
to ‘sugars or sugars’) should be sugars*.
QLDH FSANZ agrees there is a typographical error in the title of Item 7 in the drafting
in the CFS but sugars* is not correct. It should read: ‘table item dealing with
nutrition content claims in relation to ‘sugar or sugars’. This amendment has
been made in the approved draft variation (see item 8 at Attachment A).
44
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Labelling – Declaration of D-allulose in the NIP
Seek clarification on whether the inclusion of D-allulose in
the NIP from requirements in subsection 1.2.8—6(9)
would impact carbohydrate/sugar values and
consequently influence nutrition content claims related to
sugar.
Suggests D-allulose be labelled in the NIP akin to sugar
alcohols, positioned under sodium at the bottom of the
NIP. This would minimise consumer confusion arising
from assumptions about its metabolic properties.
The current regulatory framework presents a dual
perspective: while there is no obligation to disclose Dallulose on the label, except through an inclusion in the
ingredient statement, a contradictory provision exists.
When D-allulose is utilised singly or in combination with
substances outlined in subsection S11—2(3) (excluding
organic acids) and the value surpasses 5g/100g, there is
a requirement for identification in the NIP. This duality
poses challenges and may contribute to consumer
confusion, undermining the objective of facilitating
informed choices. The ABCL contends that consumers
can make informed decisions based on the ingredient
statement, as per established requirements.
ABCL, NZBC FSANZ’s decision is to exclude D-allulose from the average quantity of sugars
declared in the NIP as most D-allulose is not metabolised (see section 2.2.5.2
in the CFS).
As discussed above, based on provisions in Section S11—3, D-allulose would
also not be included in carbohydrate declarations in the NIP. A declaration of
D-allulose in the NIP (in accordance with subsection 1.2.8—6(9)) would not
affect nutrition content claims about carbohydrate or sugar(s). If required from
subsection 1.2.8—6(9), D-allulose must be listed in the NIP in accordance with
provisions set out in Schedule 12 of the Code.
The requirement in subsection 1.2.8—6(9) to declare D-allulose when used
singly or in combination with other substances listed in subsection S11—2(3)
(except for organic acids) at a concentration over 5 g/100 g was intended to
provide information to consumers who may be sensitive to a laxative effect
from excess consumption of polyols, isomalt and/or polydextrose. The advisory
statement about a laxative effect is required when such substances are present
either alone or in combination at a concentration of 10g/100g or 25 g/100g
depending on the substance concerned. The degree of a laxative effect from
D-allulose will vary amongst individuals with some having a greater sensitivity
than others. FSANZ therefore considers it is appropriate to require the average
quantity of D-allulose to be declared in the NIP in accordance with existing
provisions in subsection 1.2.8—6(9) to support informed choice.
Despite the requirement in Section 1.2.8—6(9), the NIP
created using Nutrition Panel Calculator does not show
special listing of substances listed in subsection S11—
2(3). Requests FSANZ addresses this issue so that the
NIP created using the calculator will be compliant.
NSWFA When the Nutrition Panel Calculator was developed, it focussed exclusively on
the seven mandatory components in a NIP. Expansion to include additional
components as listed items in the NIP would be resource intensive and require
significant redevelopment of the current system.
45
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Agrees that if D-allulose and other substances listed in
subsection S11—2(3) are present in an amount of no less
than 5 g/100 g and if carbohydrate content is determined
using the available carbohydrate by difference calculation,
then D-allulose would require separate declaration in the
NIP. This provision ensures transparency with the amount
of each substance used in the food.
AFGC
NSWFA
FSANZ notes subsection 1.2.8—6(9) requires that if D-allulose (with or without
other substances listed in subsection S11—2(3), except for organic acids) is
present in a food in an amount no less than 5 g/100 g, then D-allulose would
need to be listed in the NIP if carbohydrate content is determined using the
calculation of available carbohydrate by difference or the calculation of
available carbohydrate as set out in Section S11—3.
Advisory statement about laxative effect
The advisory statement is particularly important as the risk
of the novel food would not be well known among
consumers, and other favourable aspects of D-allulose
resulting from its low energy factor are likely to be
conveyed on the package in the form of the NIP and
claims (e.g. sugar/energy claims). Consider balanced
information should be provided on the package to enable
consumers to make informed food choices.
NSWFA Following consideration of the outcomes of the dietary intake assessment on a
potential laxative effect from foods containing D-allulose at the applicant’s
proposed MPLs, FSANZ has decided to amend the draft variation to require an
advisory statement to the effect that excess consumption may have a laxative
effect for certain food classes, irrespective of the D-allulose concentration in
the food (see section 2.3.7.3 of the report).
46
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Suggest there should be consideration of the need for a
mandatory advisory statement under Section 1.2.3 – 2
related to the risk of a laxative effect because D-allulose is
only partially absorbed from the gastrointestinal tract, and
there is evidence that this creates an osmotic laxative
effect at moderate intake levels.
Maximum limits are determined on the assumption that
only one D-allulose containing food is consumed at one
time. Concerned that setting MPLs as proposed by
FSANZ may still result in intake of D-allulose above the
threshold level to cause a laxative effect in high
consumers e.g. by consuming dessert and a soft drink
both containing D-allulose in one occasion, or for anyone
who is replacing many foods with low-energy, low-sugar
alternatives. This is due to the lack of evidence to inform
the threshold for requiring the mandatory advisory
statement, so a mandatory advisory statement would be
the most conservative option.
While the proposed MPLs for D-allulose are below the
level that would require the mandatory labelling under
Section 1.2.3 – 2 for most foods, there are a small number
of categories that pose a risk for laxative effect due to
higher permitted levels (chewing gum, sugar substitutes).
VIC DoH and
DEECA
NZFS
QLDH
As noted above FSANZ has decided to amend the draft variation to require an
advisory statement for certain food classes irrespective of D-allulose
concentration (see section 2.3.7.3 of the report). The dietary intake
assessment undertaken to determine the risk of a laxative effect takes into
account not only the MPLs for the food class but also the amount of the food
typically consumed. Therefore, a food with a higher concentration of D-allulose
doesn’t necessarily pose a risk of a laxative effect if a small amount is
consumed.
47
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Suggests FSANZ considers requiring a maximum one-day
intake statement for tabletop sweeteners. This could
mitigate the risk of an individual consuming a quantity far
above what has been assessed in threshold studies. We
note the animal studies indicate that extremely high levels
of intake may cause gastrointestinal haemorrhaging, but
there is no information on unsafe levels of intake in
humans.
Many food categories will contain less than 5 g/100g of Dallulose (as per Section S25—2), and for these foods, the
D-allulose content will not be required in the NIP. For
individuals who are more sensitive to non-digestible
carbohydrates, one of two labelling options may assist in
providing clear information – either requiring the
mandatory advisory statement at any level of D-allulose or
requiring that the NIP includes D-allulose at
concentrations below 5 g/100g.
NZFS The evidence suggests that it is unlikely that an individual would consume
more than 28 g D-allulose (0.4 g/kg bw) from a tabletop sweetener during one
day. The dietary intake assessment indicated a very low intake of D-allulose
from such a product (see Table 7 in SD1).
As discussed above, FSANZ has decided to amend the draft variation to
require the advisory statement for certain food classes, irrespective of Dallulose concentration.
WTO Notification
Recommended FSANZ notify the WTO of this application
to ensure harmonisation with international markets and so
that member states have the opportunity to respond.
ABCL, AFGC,
NZBC
A notification to the WTO under Australia’s and New Zealand’s obligations as a
part of the WTO Technical Barriers to Trade agreement has been made to
enable WTO members to comment on the amendments to the Code.
Public health benefit of D-allulose
Outright support for D-allulose in Australia and New
Zealand due to taste and benefit to public health (diabetes
and metabolic (illnesses).
Individual FSANZ notes this comment.
48
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Concern that FSANZ has not acknowledged the
magnitude of the potential impact of allulose on reducing
obesity rates. FSANZ has a duty of care to consider these
more serious risks as part of the National Obesity Strategy
2022-2032.
Provided a number of papers relating to carbohydrate
reduction and obesity management (see submission) and
provided an alternative solution:
• Secure the latest enzyme that allows for
continuous allulose manufacture at a lower price
point.
• Require product manufacturers to adequately
label their product packaging with laxative
information.
• Work with the sugar cane industry to convert their
materials to allulose.
• Allow self-regulation as there is only so much
allulose that can be added for product
performance and taste before it becomes cost
prohibitive.
Set the FSANZ application fee to be a nominal amount in
recognition of the public health service that Samyang
Corporation has done for the broader benefits of health.
Individual FSANZ is supportive of reducing overweight and obesity-related illnesses in
populations, especially populations that are more at-risk of such illnesses and
effects.
FSANZ limited its assessment to the specific request from the application, in
accordance with the FSANZ Act, therefore can only assess:
• the specific enzyme used by Samyang to manufacture their D-allulose.
• Laxative effect with regards to labelling (see section 2.3.7.3 of the
report).
FSANZ will consider applications relating to the use of a different technology or
enzyme(s) for the manufacture of D-allulose or to permit its broader use in
food.
An applicant is able to make an unpaid application.
49
Topic of submission Raised by FSANZ response (including any amendments to drafting)
In the application, FSANZ has not established a
significant, fatal health risk that warrants the allulose
limits. There is no mention of even having considered
laxative product labelling as a cost effective alternative
risk management solution. Instead, the misguided dosage
regulation being suggested represents the worst case
scenario ’for 50 different products across 15 broad food
classifications’. This will significantly hinder allulose from
practically being enabled in product formulations, as a
sugar substitute.
By limiting the role that allulose can play in mitigating
obesity related fatalities, justified based on managing nonfatal risks and exceptional scenarios, FSANZ is failing in
their legal duty of care to protect the health of people in
ANZ.
Individual FSANZ has only assessed the addition of D-allulose to the foods requested by
the applicant. Therefore, the permission must be limited to those foods.
FSANZ notes also that it is required to assess this application to amend the
Code in accordance with the FSANZ Act.
Exclusivity
Supported the exclusivity period as it recognises the
investment made in developing the application, food
and/or ingredient thereby supporting innovation.
Some submitters however, had general concerns
regarding FSANZ’s approach towards exclusivity and
sought clarity regarding the application of exclusivity and
its implications on the food industry to ensure a level
playing field.
ABCL, NZBC,
AFGC Exclusive permissions for novel foods were introduced in 2007 under Proposal
P305 – Permission for Exclusivity of Use of Novel Foods. This followed
requests from the food regulation ministers for FSANZ to consider:
• the capacity for including a specific provision for exclusivity of use for
novel foods in Standard 1.5.1, and
• a limit on the period of exclusive permission as a novel food for a
particular brand of up to 15 months, after which any exclusive
permissions revert to a generic permission at the expiration of the
approved period of exclusivity.
The above is reflected in the current Food Regulation Policy guideline on novel
foods, which includes the following specific policy principle: To provide an
assessment process that aims to protect commercially sensitive information
and recognise industry’s intellectual property to the maximum extent possible.
50
Topic of submission Raised by FSANZ response (including any amendments to drafting)
Exclusivity is likely to result in barriers to trade for
products already on the market outside of Australia and
New Zealand. Companies who wish to take up the
opportunity to incorporate D-allulose in their existing or
new products will have only one supply option which will
potentially reduce the number of new products available if
companies are nervous about continuity of supply from a
single company.
AIFST See above response.
The length of the exclusivity period will create personal
and societal costs that are significant with major impacts
on society, the economy, natural resources and
ecosystems.
Is an anti-competitive move which prevents anyone else
selling existing products with a different brand of allulose.
This is a breach of Trans-Tasman anti-trust legislation and
counter to making healthier food choices more accessible
particularly to indigenous people. Stated the exclusivity
section in the CFS was ‘poorly worded and not clear
enough for sufficient consultation’.
Questioned the costs incurred to Samyang:
• Samyang have already had 9 years of selling
allulose
• multiple GRAS notes have already been approved
• no new technology has been developed
specifically for the FSANZ approval process
• test results in the application were not funded by
Samyang
• similar wording is used across the USA, FSANZ
and European applications.
Suggested:
• Set the FSANZ application fee to be a nominal
amount in recognition of the public health service
Individual Any applicant for a novel food can legally request an exclusive use period
available option. Whether or not FSANZ should accept an exclusive use period
or mandate a length of that period is out of scope for this application.
See the response above for further information about exclusivity.
This permission is deregulatory in nature, meaning that Food Ministers, when
approving a relevant regulatory measure proposed by FSANZ, are permitting
addition to food of a substance that was not previously permitted.
Application fees or charges are set or fixed by the FSANZ Act, not FSANZ.
FSANZ is required to comply with that Act in this regard. In this case, the Act
required the fees in question to be imposed and paid.
An exclusive use permission in the Code does not prevent approval of
subsequent applications either within the exclusive use period, or during the
progression of an application for the use of the same food or ingredient, by
other food companies. The period of exclusive permission as a novel food or
nutritive substance for a particular brand is limited at up to 15 months from the
time of gazettal, after which any exclusive permissions would revert to a
generic permission at the expiration of the approved period of exclusivity.
An exclusive use permission in the Code does not prevent approval of
subsequent applications either within the exclusive use period, or during the
progression of an application for the use of the same food or ingredient, by
other food companies.
51
Topic of submission Raised by FSANZ response (including any amendments to drafting)
that Samyang Corporation has done for the
broader benefits of health.
• 4 month exclusivity to only the ingredient supply
and not the products that it’s made in.
This Application sets a precedent which prevents product
innovation as the nature of the applicant’s business is
sweetener manufacturing, not product manufacturing.
FSANZ risks accepting actions under one piece of
legislation aimed to encourage innovation, with the effect
of being illegal under the Commerce Act 1986 (NZ) which
prohibits a contract/arrangement that has the purpose, or
of substantially lessening competition in the market.
Australia also has the Competition and Consumer Act
2010.
Noted a new innovation developed since the US GRAS
application and stated the applicant’s technology was
obsolete.
Industry will have to experience 15 months of inflated
allulose prices but benefit will be negated as the enzyme
production methods available now are more innovative
than the one requested by Samyang.
Individual FSANZ appreciates that there may be other methods for producing D-allulose,
but must assess the method requested by the applicant as required by the
FSANZ Act.
The granting of an exclusive use permission does not preclude anyone else
from applying to amend the Code in relation to the sale or production of Dallulose, including permission for the use of a different enzyme(s) for its
manufacture or an alternative specific method of production, within or following
the 15 month exclusive use period. See comments above.
Enforcement
Questioned how the exclusivity permission would be
enforced at the border since the source (supplier) of Dallulose in a product would not be obvious at the point of
entry.
AIFST Noted. This is a matter for the Department of Agriculture, Fisheries and
Forestry at the relevant border under the Imported Food Inspection Scheme
and Ministry for Primary Industries in New Zealand. FSANZ notes that no
regulator raised this as an issue.
Other
The submitter also raised several concerns regarding the
applicant’s commercial activities in the marketplace.
Individual These concerns are outside the scope of this application and FSANZ’s
assessment.
52
Attachment A – Draft variation to the Australia New Zealand Food
Standards Code
Food Standards (Application A1247 – D-allulose as a novel food) Variation
The Board of Food Standards Australia New Zealand gives notice of the making of this variation under
Section 92 of the Food Standards Australia New Zealand Act 1991. The variation commences on the
date specified in clause 3 of this variation.
Dated [To be completed by the Delegate]
[Insert Delegate’s name and position title]
Delegate of the Board of Food Standards Australia New Zealand
Note:
This variation will be published in the Commonwealth of Australia Gazette No. FSC XX on XX Month
20XX.
53
1 Name
This instrument is the Food Standards (Application A1247 – D-allulose as a novel food) Variation.
2 Variation to Standards in the Australia New Zealand Food Standards Code
The Schedule varies Standards in the Australia New Zealand Food Standards Code.
3 Commencement
The variation commences immediately after the commencement of the Food Standards (Proposal
P1063 – Code Revision (2024) – Added Sugar(s) Claims) Variation.
Schedule
Standard 1.1.2—Definitions used throughout the Code
[1] Subsection 1.1.2—2(3) (paragraph (a) of the definition of “sugars”)
Repeal the paragraph, substitute:
(a) in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means
monosaccharides (other than D-allulose) and disaccharides; and
Standard 1.2.3—Information requirements – warning statements, advisory statements and
declarations
[2] Paragraph 1.2.3—2(2)(c)
Repeal the paragraph, substitute:
(c) one or more of the substances listed in paragraph (a), in combination with
one or more of the substances listed in paragraph (b), at a level of or in
excess of 10 g/100 g; or
(d) added D-allulose as an ingredient and the food is one of the following:
(i) a bakery product;
(ii) bubble gum;
(iii) chewing gum;
(iv) breakfast cereal;
(v) confectionery (but not chocolate);
(vi) a dessert (with or without gelatine);
(vii) ice cream;
(viii) edible ice;
(ix) a non-alcoholic water based flavoured drink (as defined in the table to
section S25—2);
(x) yoghurt.
Standard 1.2.7—Nutrition, health and related claims
[3] Section 1.2.7—2 (Note 1, definition of “sugars”)
Repeal the definition, substitute:
sugars, in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means monosaccharides (other than
D-allulose) and disaccharides. (Elsewhere in the Code it has a different definition).
Standard 1.2.8—Nutrition information requirements
[4] Section 1.2.8—4 (Note 1, definition of “sugars”)
Repeal the definition, substitute:
sugars, in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means monosaccharides (other than
D-allulose) and disaccharides. (Elsewhere in the Code it has a different definition).
54
Standard 2.6.2—Non-alcoholic beverages and brewed soft drinks
[5] Section 2.6.2—2 (Note 1, paragraph (a) of the definition of “sugars”)
Repeal the paragraph, substitute:
(a) in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means monosaccharides (other than
D-allulose) and disaccharides; and
Schedule 2—Units of measurement
[6] Section S2—2 (table, after item dealing with ‘w/v’)
Insert:
w/w weight per weight
Schedule 4—Nutrition, health and related claims
[7] Section S4—2 (Note, paragraph (a) of the definition of “sugars”)
Repeal the paragraph, substitute:
(a) in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means monosaccharides (other than
D-allulose) and disaccharides; and
[8] Section S4—3 (table entry dealing with “Sugar or sugars”, descriptor of ‘No added’ in
column 3, subparagraph (f)(i) in column 4)
Omit “hexose monosaccharides and disaccharides”, substitute “hexose monosaccharides (other than
D-allulose) and disaccharides”
Schedule 11—Calculation of values for nutrition information panel
[9] Subsection S11—2(3) (table, above item dealing with ‘erythritol’)
Insert:
D-allulose 2
Schedule 18—Processing aids
[10] Subsection S18—9(3) (table)
Insert:
D-psicose 3-epimerase (EC
5.1.3.30) from Microbacterium
foliorum
For use in the manufacture of
D-allulose
GMP
55
Schedule 25— Permitted novel foods
[11] Section S25—2 (table)
Insert:
D-allulose 1. May only be a food for retail sale if that food is a tabletop sweetener.
2. May only be added to a food listed in condition 4.
3. A food listed in condition 4 must not contain added D-allulose in an amount or at a level greater than
the limit, if any, specified in that condition for that food.
4. The listed foods are:
(a) bakery products (limit: 10% w/w);
(b) bubble gum (limit: 50% w/w);
(c) breakfast cereals (limit: 5% w/w);
(d) cereal bars (limit: 5% w/w);
(e) chewing gum (limit: 50% w/w);
(f) confectionery (but not chocolate) (limit: 50% w/w);
(g) desserts (with or without gelatine) (limit: 10% w/w);
(h) edible ices (including sorbet) (limit: 5% w/w);
(i) frostings (limit: 5% (w/w));
(j) fruit spreads (but not chutney) (limit: 10% w/w);
(k) ice cream (limit: 5% w/w);
(l) icings (limit: 5% w/w);
(m) imitation cream (limit: 5% w/w);
(n) non-alcoholic water based flavoured drinks (limit: 3.5% w/w);
Note See the definition of ‘a non-alcoholic water based flavoured drink’ in condition 5 below.
(o) salad dressings (limit: 5% w/w);
(p) sweet sauces (limit: 10% w/w);
(q) syrups (limit: 10% w/w);
(r) tabletop sweeteners (limit: 100% w/w);
(s) yoghurt (limit: 5% w/w);
Note An advisory statement to the effect that excess consumption may have a laxative effect is required for
certain foods for sale containing D-allulose. See subsection 1.2.3—2(2)
5. For the purposes of this permission, a non-alcoholic water based flavoured drink:
(a) includes: a brewed soft drink; a non-brewed soft drink; a cola type drink; a formulated caffeinated
beverage; a fruit drink; a tea beverage; a coffee beverage; a powdered drink concentrate; and a
liquid drink concentrate; and
(b) does not include: a food standardised in Part 2.9 of the Code; a dairy analogue; a fruit juice; a
vegetable juice; a formulated beverage; an electrolyte drink; and an electrolyte drink base.
6. During the exclusive use period, only D-allulose sold under the brand Nexweet may be a food for retail
sale in accordance with condition 1 or added to food in accordance with conditions 2 to 5 above.
7. For the purposes of condition 6 above, exclusive use period means the period commencing on the
date of gazettal of the Food Standards (Application A1247 – D-allulose as a novel food) Variation and
ending 15 months after that date.
56
Attachment B – Explanatory Statement
EXPLANATORY STATEMENT
Food Standards Australia New Zealand Act 1991
Food Standards (Application A1247 – D allulose as a novel food) Variation
1. Authority
Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides
that the functions of Food Standards Australia New Zealand (the Authority) include the
development of standards and variations of standards for inclusion in the Australia New
Zealand Food Standards Code (the Code).
Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for
the development or variation of food regulatory measures, including standards. This Division
also stipulates the procedure for considering an application for the development or variation
of food regulatory measures.
The Authority accepted Application A1247 which sought to amend the Code to permit the
use of D-allulose as a novel food from enzymatic conversion of fructose by D-psicose 3-
epimerase contained in M. foliorum. The Authority considered the application in accordance
with Division 1 of Part 3 and has approved a draft variation – the Food Standards (Application
A1247– D-allulose as a novel food) Variation (the approved draft variation).
Following consideration by the Food Ministers’ Meeting (FMM), Section 92 of the FSANZ Act
stipulates that the Authority must publish a notice about the approved draft variation.
2. Variation is a legislative instrument
The approved draft variation is a legislative instrument for the purposes of the Legislation Act
2003 (see Section 94 of the FSANZ Act) and is publicly available on the Federal Register of
Legislation (www.legislation.gov.au).
This instrument is not subject to the disallowance or sunsetting provisions of the Legislation
Act 2003. Subsections 44(1) and 54(1) of that Act provide that a legislative instrument is not
disallowable or subject to sunsetting if the enabling legislation for the instrument (in this case,
the FSANZ Act): (a) facilitates the establishment or operation of an intergovernmental
scheme involving the Commonwealth and one or more States; and (b) authorises the
instrument to be made for the purposes of the scheme. Regulation 11 of the Legislation
(Exemptions and other Matters) Regulation 2015 also exempts from sunsetting legislative
instruments a primary purpose of which is to give effect to an international obligation of
Australia.
The FSANZ Act gives effect to an intergovernmental agreement (the Food Regulation
Agreement) and facilitates the establishment or operation of an intergovernmental scheme
(national uniform food regulation). That Act also gives effect to Australia’s obligations under
an international agreement between Australia and New Zealand. For these purposes, the Act
establishes the Authority to develop food standards for consideration and endorsement by
the FMM. The FMM is established under the Food Regulation Agreement and the
international agreement between Australia and New Zealand, and consists of New Zealand,
Commonwealth and State/Territory members. If endorsed by the FMM, the food standards
on gazettal and registration are incorporated into and become part of Commonwealth, State
57
and Territory and New Zealand food laws. These standards or instruments are then
administered, applied and enforced by these jurisdictions’ regulators as part of those food
laws.
3. Purpose
The Authority has approved a draft variation to amend Standards 1.1.2, 1.2.3, 1.2.7, 1.2.8,
2.6.2 and Schedules 2, 4, 11, 18 and 25 to permit, subject to certain specified conditions: the
sale and use of D-allulose as a novel food; and the use of a particular enzyme – the Dpsicose 3-epimerase from M. foliorum – as a processing aid in the production of D-allulose.
4. Documents incorporated by reference
The approved draft variation does not incorporate any documents by reference.
However, existing provisions of the Code incorporate documents by reference that will
prescribe identity and purity specifications for the D-allulose and D-psicose 3-epimerase to
be permitted by the approved draft variation. Section 1.1.1—15 of the Code requires
substances used as novel foods and processing aids to comply with any relevant identity and
purity specifications listed in Schedule 3 of the Code.
Subsection S3—2(1) incorporates by reference the United States Pharmacopeial Convention
(2022) Food chemicals codex (13th edition), which establishes specifications for ‘Allulose’.
Subsection S3—3(g) incorporates by reference The Merck Index, 15th Edition, being a
secondary source within S3—3, which establishes a specification for ‘D-psicose’ (O’Neil et al
2013).
Section S3—2 of Schedule 3 incorporates by reference the specifications listed in: the Joint
FAO/WHO Expert Committee on Food Additives (JECFA) Combined Compendium of Food
Additive Specifications (FAO JECFA Monographs 26 (2021)); and in the United States
Pharmacopeial Convention (2022) Food Chemicals Codex (13th edition). Both include
general specifications for the identity and purity of enzyme preparations used in food
processing. These will be relevant for D-psicose 3-epimerase.
5. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s
consideration of application A1247 included one round of public consultation following an
assessment and the preparation of a draft variation and associated report. Submissions were
called for on 8 November 2023 for a 6-week consultation period.
The Office of Best Practice Regulation (OBPR), now called the Office of Impact Analysis
(OIA), exempted FSANZ from the need to undertake a formal Regulation Impact Statement
(RIS) in relation to the regulatory change proposed in response to application A1247 (OBPR
correspondence dated 6 May 2022, OBPR Reference: OBPR22-02203). That is because the
OBPR considered the proposed change was unlikely to have a more than minor regulatory
impact.
6. Statement of compatibility with human rights
This instrument is exempt from the requirements for a statement of compatibility with human
rights as it is a non-disallowable instrument under Section 44 of the Legislation Act 2003.
58
7. Variation
Clause 1 provides that the name of the approved draft variation is the Food Standards
(Application A1247 – D-allulose as a novel food) Variation.
Clause 2 provides that the Code is amended by the Schedule to the variation.
Clause 3 provides that the approved draft variation will commence and take effect
immediately after the commencement of the Food Standards (Proposal P1063 – Code
Revision (2024) – Added Sugar(s) Claims) Variation (the P1063 variation). The P1063
variation amends many of the same provisions that the approved draft variation amends. The
P1063 variation removes a redundant term from those provisions. For that reason, clause 3
provides that the approved draft variation shall take effect immediately after the P1063
variation takes effect.
Items [1] to [11] of the Schedule of the approved draft variation amend the Code.
Item [1]
Item [1] amends paragraph (a) of the definition of “sugars” in subsection 1.1.2—2(3) of the
Code. It repeals the paragraph and substitutes it with the following new paragraph (a):
“(a) in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means monosaccharides (other
than D allulose) and disaccharides; and”
The effect of this amendment is to expressly exclude D-allulose from the definition of
“sugars” for the purposes of Standard 1.2.7, Standard 1.2.8 and Schedule 4.
The amendments made to the Code by Items [3] – [5], and [7] are as a consequence of this
amendment.
Item [2]
Item [2] amends Section 1.2.3—2 of the Code. It repeals paragraph 1.2.3—2(2)(c) and
substitutes it with the following new paragraphs:
(c) one or more of the substances listed in paragraph (a), in combination
with one or more of the substances listed in paragraph (b), at a level
of or in excess of 10 g/100 g; or
(d) added D-allulose as an ingredient and the food is one of the following:
(i) a bakery product;
(ii) bubble gum;
(iii) chewing gum;
(iv) breakfast cereal;
(v) confectionery (but not chocolate);
(vi) a dessert (with or without gelatine);
(vii) ice cream;
(viii) edible ice;
(ix) a non-alcoholic water based flavoured drink (as defined in the
table to section S25—2);
(x) yoghurt.
59
Section 1.2.3—2 of the Code provides that the labelling of certain foods must include certain
statements in accordance with Standard 1.2.1. Subsection 1.2.3—2(2) lists the foods that, in
accordance with Standard 1.2.1, must have an advisory statement to the effect that excess
consumption may have a laxative effect. The amendment made by Item [2] will in effect
require such an advisory statement to appear on or in the labelling of a food for sale in
accordance with Standard 1.2.1 if the food for sale: is a food listed in subparagraphs 1.2.3—
2(2)(d)(i) – (x); and contains added D-allulose as an ingredient.
Item [3]
Item [3] amends the definition of “sugars” in Note 1 of section 1.2.7—2 by repealing the
paragraph and substituting it with the following new paragraph:
“sugars, in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means monosaccharides (other
than D-allulose) and disaccharides. (Elsewhere in the Code it has a different definition).”
This amendment reflects the amendment in item [1] above.
Item [4]
Item [4] amends the definition of “sugars” in Note 1 of section 1.2.8—4 by repealing the
paragraph and substituting it with the following new paragraph:
“sugars, in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means monosaccharides (other
than D-allulose) and disaccharides. (Elsewhere in the Code it has a different definition).”
This amendment also reflects the amendment in item [1] above.
Item [5]
Item [5] amends paragraph (a) of the definition of “sugars” in Note 1 of section 2.6.2—2 by
repealing the paragraph and substituting it with the following new paragraph (a):
“(a) in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means monosaccharides (other
than D-allulose) and disaccharides; and”
This amendment mirrors the amendment in item [1] above.
Item [6]
Item [6] amends Schedule 2 of the Code. It inserts the following entry into the table to section
S2—2 after table item dealing with ‘w/v’ (weight per volume):
“w/w weight per weight”
Schedule 2 sets out the meanings of certain symbols used in the Code. This amendment is
needed as the amendment in item [11] below refers to “w/w”. Schedule 2 does not currently
contain a meaning for that symbol.
Weight per weight (w/w) is a reference to the weight of each component being used to
calculate levels of addition, irrespective of whether either is a solid or a liquid. In the case of
a liquid, the volume is ignored. Instead, the weight of that liquid is used in the calculation.
60
Item [7]
Item [7] amends Schedule 4 of the Code by repealing paragraph (a) of the definition of
“sugars” in the Note to section S4—2 and substituting it with the following new paragraph (a):
“(a) in Standard 1.2.7, Standard 1.2.8 and Schedule 4—means monosaccharides (other
than D-allulose) and disaccharides; and”
This amendment mirrors the amendment in item [1] above.
Item [8]
Item [8] amends Schedule 4 of the Code. It amends the conditions listed in column 4 of the
table to section S4—3 for making “no added sugars” nutrition content claims. The
amendment replaces the words (“hexose monosaccharides and disaccharides”) in condition
(f)(i) with “hexose monosaccharides (other than D-allulose) and disaccharides”.
The amendment’s effect is provides that conditions (a) and (b) listed in the table to section
S4—3 for making a “no added sugars” nutrition content claim do not apply to D-allulose,
which is a hexose monosaccharide.
Item [9]
Item [9] amends Schedule 11 of the Code by inserting the following new entry into the table
to subsection S11—2(3) (above the table item dealing with ‘erythritol’):
“D-allulose 2”
The effect of this amendment is to assign D-allulose an energy factor of 2 kJ/g to be used in
the calculation of “average energy content” for the purposes of Standard 1.2.8 and Schedule
11.
Item [10]
Item [10] amends the table to subsection S18—9(3) in Schedule 18 of the Code. The table
lists substances permitted by the Code to be used as a processing aid for a specific
technological purpose. The amendment inserts, in alphabetical order, a new entry into the
table.
The new entry lists in column 1 of the table the permission to use the following enzyme as a
processing aid: “D-psicose 3-epimerase (EC 5.1.3.30) contained in Microbacterium foliorum”.
The new entry lists in column 2 of the table the specific permitted technological purpose for
which this enzyme may be used as a processing aid: “For use in the manufacture of
D-allulose”.
The permission is subject to the condition, as prescribed in column 3 of the table, that the
maximum permitted level or amount of this enzyme that may be present in a final food must
be consistent with GMP or Good Manufacturing Practice (as defined in section 1.1.2—2 of
the Code).
The effect of the amendment is to permit the proposed use of the above-mentioned enzyme
as a processing aid in accordance with the Code.
61
Item [11]
Item [11] amends the table to section S25—2 of Schedule 25 of the Code
Paragraphs 1.1.1—10(5)(b) and 1.1.1—10(6)(f) of the Code provide that, unless expressly
permitted by the Code, a food offered for retail sale must not be a novel food or have a novel
food as an ingredient. Section 1.5.1—3 of the Code provides that the express permission
required by those paragraphs. The section provides that a food offered for retail sale may
consist of, or have as an ingredient, a novel food if:
(a) the novel food is listed in the table to section S25—2;
(b) any conditions of use specified in that table are complied with.
The table to section S25—2 of the Code lists permitted novel foods together with their
conditions for use.
Item [11] inserts a new entry into the table. The new entry:
• permits D-allulose as a novel food to be a food for retail sale or to be present as an
ingredient in a food for retail sale; and
• specifies seven conditions of use for D-allulose as a permitted novel food.
The conditions specified are as follows.
Condition 1 provides that D-allulose may only be a food for retail sale if that food is a tabletop
sweetener. That is, D-allulose itself may be sold at retail sale only as a tabletop sweetener.
Condition 2 provides that D-allulose may only be added to a food listed in condition 4. That
is, D-allulose must not be added to any food which is not listed in condition 4.
Condition 3 provides that food listed in condition 4 must not contain added D-allulose in an
amount or at a level greater than the limit, if any, specified in that condition for that food.
Condition 4 lists the foods to which D-allulose may be added and the maximum permitted
amount for D-allulose in each food. As explained above, condition 3 requires that the amount
of D-allulose present in the relevant food not exceed that specified limit.
A Note is provided following condition 4 which directs the reader to the advisory statement
required by subsection 1.2.3—2(2). The Note states that an advisory statement to the effect
that excess consumption may have a laxative effect is required for certain foods for sale
containing D-allulose.
Condition 5 clarifies, for the purposes of the permission to add D-allulose to non-alcoholic
water based flavoured drinks, as per the condition at 4(n), that the meaning of a
non-alcoholic water based flavoured drink:
(a) includes: a brewed soft drink; a non-brewed soft drink; a cola type drink; a formulated
caffeinated beverage; a fruit drink; a tea beverage; a coffee beverage; a powdered
drink concentrate; and a liquid drink concentrate; and
(b) does not include: a food standardised in Part 2.9 of the Code; a dairy analogue; a fruit
juice; a vegetable juice; a formulated beverage; an electrolyte drink; and an
electrolyte drink base.
Condition 6 provides that, during the exclusive use period as defined by condition 7, only
D-allulose sold under the brand Nexweet may be:
62
• a food for retail sale in accordance with condition 1 above; or
• added to food in accordance with conditions 2 to 5 above.
Condition 7 defines the term “exclusive use period” for the purposes of condition 6 as the
period commencing on the date of gazettal of the Food Standards (Application A1247 –
D-allulose as a novel food) Variation and ending 15 months after that date. On the expiry of
the exclusive use period, condition 6 will automatically cease to have effect. At that point, the
D-allulose novel food permission provided by the new entry will apply to – and permit – any
and all brands of D-allulose that comply with the Code.
63
Attachment C – Draft variation to the Australia New Zealand Food
Standards Code (call for submissions)
Food Standards (Application A1247 – D-allulose as a novel food) Variation
The Board of Food Standards Australia New Zealand gives notice of the making of this variation under
Section 92 of the Food Standards Australia New Zealand Act 1991. The variation commences on the
date specified in clause 3 of this variation.
Dated [To be completed by the Delegate]
[Insert Delegate’s name and position title]
Delegate of the Board of Food Standards Australia New Zealand
Note:
This variation will be published in the Commonwealth of Australia Gazette No. FSC XX on XX Month
20XX. This means that this date is the gazettal date for the purposes of clause 3 of the variation.
64
1 Name
This instrument is the Food Standards (Application A1247 – D-allulose as a novel food) Variation.
2 Variation to Standards in the Australia New Zealand Food Standards Code
The Schedule varies Standards in the Australia New Zealand Food Standards Code.
3 Commencement
The variation commences on the date of gazettal.
Schedule
Standard 1.1.2—Definitions used throughout the Code
[1] Subsection 1.1.2—2(3) (paragraph (a) of the definition of “sugars”)
Repeal the paragraph, substitute:
(a) in Standard 1.2.7, Standard 1.2.8 and Schedule 4 (except where it appears
with an asterisk as ‘sugars*’)—means monosaccharides (other than
D-allulose) and disaccharides; and
Standard 1.2.7—Nutrition, health and related claims
[2] Section 1.2.7—2 (Note 1, definition of “sugars”)
Repeal the definition, substitute:
sugars, in Standard 1.2.7, Standard 1.2.8 and Schedule 4 (except where it appears with an asterisk as
‘sugars*’)—means monosaccharides (other than D-allulose) and disaccharides. (Elsewhere in the Code
it has a different definition).
Standard 1.2.8—Nutrition information requirements
[3] Section 1.2.8—4 (Note 1, definition of “sugars”)
Repeal the definition, substitute:
sugars, in Standard 1.2.7, Standard 1.2.8 and Schedule 4 (except where it appears with an asterisk as
‘sugars*’)—means monosaccharides (other than D-allulose) and disaccharides. (Elsewhere in the Code
it has a different definition).
Standard 2.6.2—Non-alcoholic beverages and brewed soft drinks
[4] Section 2.6.2—2 (Note 1, paragraph (a) of the definition of “sugars”)
Repeal the paragraph, substitute:
(a) in Standard 1.2.7, Standard 1.2.8 and Schedule 4 (except where it appears with an asterisk as
‘sugars*’)—means monosaccharides (other than D-allulose) and disaccharides; and
Schedule 2—Units of measurement
[5] Section S2—2 (table, after item dealing with ‘w/v’)
Insert:
w/w weight per weight
Schedule 4—Nutrition, health and related claims
[6] Section S4—2 (Note, paragraph (a) of the definition of “sugars”)
Repeal the paragraph, substitute:
(a) in Standard 1.2.7, Standard 1.2.8 and Schedule 4 (except where it appears with an asterisk as
‘sugars*’)—means monosaccharides (other than D-allulose) and disaccharides; and
[7] Section S4—3 (table item dealing with nutrition content claims in relation to ‘sugars or
sugars’)
Omit “contains no added sugars*”, substitute “contains no added sugars* with the exception
of D-allulose which may be present, and no”.
Schedule 11—Calculation of values for nutrition information panel
65
[8] Subsection S11—2(3) (table, above item dealing with ‘erythritol’)
Insert:
D-allulose 2
Schedule 18—Processing aids
[9] Subsection S18—9(3) (table)
Insert:
D-psicose 3-epimerase (EC
5.1.3.30) from immobilised
Microbacterium foliorum
For use in the manufacture of
D-allulose
GMP
Schedule 25— Permitted novel foods
[10] Section S25—2 (table)
Insert:
D-allulose 4. May only be added to a food listed in condition 3.
5. Must not be present in a food listed in condition 3 in an amount or at a level greater than the limit
specified in condition 3 for that food.
3. The permitted foods are:
(a) water based flavoured drinks (limit: 1.5% (w/w));
(b) fruit filling for confectionery containing not less than 200g/kg of fruit (limit: 3% (w/w));
(c) processed cereal products (limit: 3.5% (w/w));
(d) processed meal products (limit: 3.5% (w/w));
(e) ice cream (limit: 4% (w/w));
(f) edible ices (limit: 4% (w/w));
(g) fermented milk products (limit: 4% (w/w));
(h) rennetted milk products (limit: 4% (w/w));
(i) bakery products (including bread) (limit: 5% (w/w));
(j) dairy based dessert products (limit: 5% (w/w));
(k) fat based dessert products (limit: 5% (w/w));
(l) dips (limit: 5% (w/w));
(m) snacks (limit: 5% (w/w));
(n) icings (limit: 5% (w/w));
(o) frostings (limit: 5% (w/w));
(p) fruit spreads (including related products such as fruit jams or chutneys) (limit: 10% (w/w));
(q) vegetable spreads (including related products such as vegetable jams or chutneys) (limit: 10%
(w/w));
(r) jelly products (limit: 10% (w/w));
(s) sauces and toppings (including mayonnaises and salad dressings) (limit: 10% (w/w));
(t) sugar confectionery (limit: 10% (w/w));
(u) bubble gum and chewing gum (limit: 30% (w/w));
(v) tabletop sweeteners (limit: 100% (w/w)).
4. During the exclusive use period, only D-allulose sold under the brand Nexweet may be added to food
in accordance with conditions 1, 2 and 3 above.
5. For the purposes of condition 4 above, exclusive use period means the period commencing on the
date of gazettal of the Food Standards (Application A1247 – D-allulose as a novel food) Variation and
ending 15 months after that date.