Australia New Zealand Food Standards Code – Schedule 25 – Permitted novel foods

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00440 In force Legislative Instrument

Legislation content

Schedule 25 Permitted novel foods

Note 1 This instrument is a standard under the Food Standards Australia New Zealand Act 1991 (Cth). The standards together make up the Australia New Zealand Food Standards Code. See also section 1.1.1—3.

 Novel foods are regulated by paragraphs 1.1.1—10(5)(b) and (6)(f) and Standard 1.5.1. This Standard lists permitted novel foods, and specifies conditions for their use, for section 1.5.1—3.

Note 2 The provisions of the Code that apply in New Zealand are incorporated in, or adopted under, the Food Act 2014 (NZ). See also section 1.1.1—3.

S25—1 Name

  This Standard is Australia New Zealand Food Standards Code – Schedule 25 – Permitted novel foods.

 Note Commencement:This Standard commences on 1 March 2016, being the date specified as the commencement date in notices in the Gazette and the New Zealand Gazette under section 92 of the Food Standards Australia New Zealand Act 1991 (Cth). See also section 93 of that Act.

S25—2 Sale of novel foods

  For section 1.5.1—3, the permitted *novel foods and their conditions for use are:

Sale of novel foods

Permitted novel food

Conditions of use

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.

α-cyclodextrin

1. The name ‘alpha cyclodextrin’ or ‘α- cyclodextrin’ must be used when declaring the ingredient in the statement of ingredients.

γ-cyclodextrin

1. The name ‘gamma cyclodextrin’ or ‘γ- cyclodextrin’ must be used when declaring the ingredient in the statement of ingredients.

Diacylglycerol oil (DAG-Oil)

1. The name ‘Diacylglycerol oil’ must be used when declaring the ingredient in the statement of ingredients.

Dried marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)

1. May be added to infant formula products in accordance with Standard 2.9.1.

Oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695)

1. Only permitted for use in infant formula products in accordance with Standard 2.9.1

Oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)

1. May be added to infant formula products in accordance with Standard 2.9.1.

Oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA)

1. May be added to infant formula products in accordance with Standard 2.9.1.

Isomalto-oligosaccharide

 

  1.         Must not be added to:
  1.       food for infants; and
  2.       formulated supplementary food for young children.

Isomaltulose

 

*Phytosterols, phytostanols and their esters

1. The food must comply with requirements in Standard 1.2.1 insofar as they relate to section 1.2.3—2.

2. May only be added to edible oil spreads:

(a) according to Standard 2.4.2; and

(b) where the total *saturated and *trans fatty acids present in the food are no more than 28% of the total fatty acid content of the food; and

 

 

3. May only be added to breakfast cereals, not including breakfast cereal bars, if:

(a) the total fibre content of the breakfast cereal is no less than 3 g/50 g; and

(b) the breakfast cereal contains no more than 30 g/100 g of total sugars; and

(c) the *total plant sterol equivalents content is no less than 0.5 g per serving and no more than 2.2 g per serving.

4. Foods to which phytosterols, phytostanols or their esters have been added must not be used as ingredients in other foods.

5. May only be added to milk in accordance with Standard 2.5.1.

6. May only be added to yoghurt in accordance with Standard 2.5.3

  7. May only be added to a beverage derived from legumes, cereals, nuts, seeds, or a combination of those ingredients if, after that addition, each of the following compositional limits are met:

(a) the calcium content of the beverage is no less than 100 mg per 100 mL; and

(b) the beverage contains no more than 0.75 g saturated fatty acids per 100 mL; and

(c) the total plant sterol equivalents content of the beverage is no less than 0.8 g and no more than 2.2 g per 250 mL of the beverage.

8. During the exclusive use period, a beverage to which phytosterols, phytostanols and/or their esters have been added in accordance with condition 7 above may only be sold under the brand SANITARIUM HEALTH FOOD COMPANY.

9. For the purposes of condition 8 above, exclusive use period means the period commencing on the date of gazettal of the Food Standards (Addition of phytosterols, phytostanols or their esters as novel food to plant-based milk alternatives) Variation and ending 15 months after that date

 

Rapeseed protein isolate

 

1. Must be derived from rapeseed press cake retained after oil pressing from the seeds of one or more of:

(a)  Brassica napus;

(b)  Brassica rapa; or

(c)    Brassica juncea.

2. Must not be added to food for infants.

3. Must comply with the specifications for rapeseed protein isolate listed in section S3—39(A).

D-Tagatose

 

 

 

Tall oil phytosterol esters

1. Tall oil phytosterol esters must comply with the specification for tall oil phytosterol esters in Schedule 3.

2. The food must comply with the requirements in Standard 1.2.1 insofar as they relate to section 1.2.3—2.

3. The name ‘tall oil phytosterol esters’ or ‘plant sterol esters’ must be used.

4. May only be added to cheese and processed cheese, in accordance with Standard 2.5.4.

6. Foods to which tall oil phytosterol esters have been added must not be used as ingredients in other foods.

 

Trehalose

1. May be added to infant formula products only as a cryo-preservative for L(+) lactic acid producing microorganisms.


Application, saving and transitional provisions

The table below details information on application, saving or transitional provisions in instruments affecting this Standard.

 

Instrument items affected

A’ment No.

FRLI registration

Gazette

Instrument’s transitional provision

Description of transitional arrangement

Food Standards (Proposal P1028 – Infant Formula Products – Consequential Amendments) Variation

Items [24], [25], [26] and [27] of Schedule 2

231

F2024L01151

13 Sept 2024

FSC 171

13 Sept 2024 

Clause 4

 

Clause 4 establishes a transitional arrangement for variations to the Code made by Items [24], [25], [26] and [27] of Schedule 2 and by the Food Standards (Proposal P1028 – Infant Formula Products – Consequential Amendments) Variation.

 

The transition period is the period of time that commences on 13 September 2024 and ends on 13 September 2029.

 

Subclause 4(1) provides that section 1.1.1—9 of the Code does not apply to the variations.

 

Subclause 4(2) provides that during the transition period a food product may be sold if the product complies with one of the following:

 

(a) the Code as in force without the above variations;

(b) the Code as amended by the above variations.

 

Subclause 4(3) provides that a food product that was labelled before the end of the transition period may be sold after the transition period if the product complies with one of the following:

 

(a) the Code as in force without the above variations;

(b) the Code as amended by the above variations.
 

 

Amendment History

The Amendment History provides information about each amendment to the Schedule. The information includes commencement or cessation information for relevant amendments.

 

These amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. Amendments do not have a specific date for cessation unless indicated as such.

 

About this compilation

 

This is compilation No. 9 of Schedule 25 as in force on 29 October 2024 (up to Amendment No. 233). It includes any commenced amendment affecting the compilation to that date.

 

Prepared by Food Standards Australia New Zealand on 29 October 2024.

 

Uncommenced amendments or provisions ceasing to have effect

 

To assist stakeholders, the effect of any uncommenced amendments or provisions which will cease to have effect, may be reflected in the Schedule as shaded boxed text with the relevant commencement or cessation date. These amendments will be reflected in a compilation registered on the Federal Register of Legislation including or omitting those amendments and provided in the Amendment History once the date is passed.

 

 


The following abbreviations may be used in the table below:

 

ad = added or inserted am = amended

exp = expired or ceased to have effect rep = repealed

rs = repealed and substituted

 

Schedule 25 was published in the Food Standards Gazette No. FSC96 on 10 April 2015 as part of Amendment 154 (F2015L00440 –- 1 April 2015) and has since been amended as follows:

 

Section affected

A’ment No.

FRL registration

Gazette

Commencement

(Cessation)

How affected

Description of amendment

Note 1 to Std

168

F2017L00414

11 April 2017

FSC110

13 April 2017

13 April 2017

am

Cross-reference.

table to S25—2

170

F2017L00586

23 May 2017

FSC112

25 May 2017

25 May 2017

ad

Entry for oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695)

 

table to S25—2

170

F2017L00584

23 May 2017

FSC112

25 May 2017

25 May 2017

am

Entry for *Phytosterols, phytostanols and their esters.

table to S25—2

171

F2017L00915

11 July 2017

FSC113

13 July2017

13 July 2017

 

ad

Entry for isomalto-oligosaccharide.

table to S25—2

200

F2021L00684

2 June 2021

FSC141

3 June 2021

3 June 2021

am

Entry for *Phytosterols, phytostanols and their esters.

table to S25—2

139

F2021L00324

24 March 2021

FSC 139

26 March 2021

30 June 2021

ad

Entry for Rapeseed protein isolate

table to S25—2

215

F2023L00032

12 January 2023

FSC155

16 January 2023

16 January 2023

ad

Entry for *Phytosterols, phytostanols and their esters

table to S25—2

220

F2023L01004

11 July 2023

FSC160

19 July 2023

19 July 2023

rs

Entry for rapeseed protein isolate

table to S25—2

231

F2024L01151

13 Sept 2024

FSC171

13 Sept 2024

13 September 2024

rs

Repeal table entries for Dried marine micro-algae, Oil derived from marine micro-algae Schizochytrium sp., Oil derived from marine micro-algae and Oil derived from marine micro-algae and substitute.

table to S25—2

231

F2024L01151

13 Sept 2024

FSC171

13 Sept 2024

13 September 2024

rs

Repeal table item Isomalto-oligosaccharide and substitute.

table to S25—2

231

F2024L01151

13 Sept 2024

FSC171

13 Sept 2024

13 September 2024

rs

Repeal the condition entry for Rapeseed protein isolate and substitute.

table to S25—2

231

F2024L01151

13 Sept 2024

FSC171

13 Sept 2024

13 September 2024

rs

Repeal table item for Trehalose and substitute.

Table 2 S25—2

233

F2024L01377

28 October 2024

FSC173

29 October 2024

29 October 2024

ad

Insert D-allulose and associated Conditions of use into S25—2 table.

 

Overview

The Food Standards Australia New Zealand Act 1991 (Cth) introduced a framework for regulating food standards across Australia and New Zealand. This Act was designed to address the need for consistent and comprehensive regulation of food products to ensure public health and safety. Enacted by the Australian Parliament, the Act established Food Standards Australia New Zealand (FSANZ), a bi-national government agency responsible for developing and maintaining the Australia New Zealand Food Standards Code. The policy objective of the Act is to provide a unified approach to food regulation, ensuring that food standards are science-based and protect consumers while facilitating trade in food between Australia and New Zealand. The Act allows for the establishment of standards that cover various aspects of food, including the regulation of novel foods, which are foods or food ingredients that have not been traditionally consumed in significant amounts in Australia or New Zealand. This legislative instrument, a standard under the Act, lists permitted novel foods and specifies conditions for their use, ensuring that any novel food introduced into the market meets safety and quality standards. The standards are developed through a transparent process involving scientific assessment and public consultation, reflecting the commitment to evidence-based regulation and consumer protection.

Scope and Application

This legislative instrument pertains to the Australia New Zealand Food Standards Code and specifically to Schedule 25, which lists permitted novel foods and specifies the conditions for their use. This Code is applicable across Australia and New Zealand and is designed to regulate the sale and use of novel foods, ensuring that they meet specific safety and quality standards before being introduced to the market. The instrument applies to food manufacturers, importers, and retailers who intend to sell novel foods within these jurisdictions. The listed novel foods include various substances such as D-allulose, α-cyclodextrin, γ-cyclodextrin, diacylglycerol oil, marine micro-algae oil, isomalto-oligosaccharide, isomaltulose, phytosterols, phytostanols, their esters, rapeseed protein isolate, D-tagatose, tall oil phytosterol esters, and trehalose, each with specific conditions governing their use. For example, D-allulose can only be used in certain food products and must adhere to specified concentration limits, while phytosterols and phytostanols can only be added to edible oil spreads, breakfast cereals, and certain beverages under strict compositional limits. This legislative instrument also includes transitional provisions and amendments to adapt to changes in food technology and market practices, ensuring the Code remains relevant and effective. The instrument does not explicitly state any exclusions or exemptions but implies that any novel food not listed or not meeting the specified conditions would not be permitted for sale. The legislative instrument extends its application through subordinate instruments, which may further define the conditions and standards for specific novel foods or introduce new substances into the list.

Key Provisions

This legislative instrument, which is Schedule 25 of the Australia New Zealand Food Standards Code, outlines the permitted novel foods and their conditions for use under section 1.5.1—3 of the Food Standards Australia New Zealand Act 1991. This Standard commenced on 1 March 2016. The permitted novel foods and their conditions for use include D-allulose, which can be sold as a tabletop sweetener or added to specific foods with certain concentration limits. Other permitted novel foods include alpha-cyclodextrin, gamma-cyclodextrin, diacylglycerol oil, dried marine micro-algae rich in docosahexaenoic acid (DHA), oil derived from marine micro-algae rich in DHA, isomalto-oligosaccharide, isomaltulose, phytosterols, phytostanols and their esters, rapeseed protein isolate, D-tagatose, tall oil phytosterol esters, and trehalose. Each of these substances has specific conditions and restrictions on their use, such as concentration limits, permitted food categories, and compliance with other standards. The obligations imposed on parties by this Act include adhering to the specified conditions for the use of permitted novel foods. Manufacturers and retailers must ensure that novel foods are used in accordance with the conditions outlined in the Schedule. For instance, D-allulose can only be used as a tabletop sweetener or added to specific foods with specified concentration limits. Similarly, phytosterols, phytostanols, and their esters must be added to edible oil spreads, breakfast cereals, milk, yoghurt, and certain beverages, adhering to specific compositional limits and other conditions. Failure to comply with these conditions can result in non-compliance with food standards and potential legal consequences. There are no explicit criminal or civil offences outlined in the Schedule itself, but non-compliance with the conditions for using permitted novel foods can lead to various consequences under the broader Food Standards Australia New Zealand Act 1991. These consequences may include legal action by regulatory authorities, fines, and other penalties. Additionally, failure to comply with food standards can result in the seizure and destruction of non-compliant food products, as well as potential reputational damage for businesses. The maximum penalties for breaches of the Act are not detailed in the Schedule but are specified elsewhere in the Act and can include substantial fines and imprisonment for serious or repeated offences.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.