EXPLANATORY STATEMENT
Food Standards Australia New Zealand Act 1991
Food Standards (Application A1334 – 2′-FL from GM Corynebacterium glutamicum (gene donor: Corynebacterium urealyticum) in infant formula products) 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 purpose of Application A1334 was to amend the Code to permit the use of 2′-fucosyllactose (2′-FL), a human-identical milk oligosaccharide (HiMO), produced using a new genetically modified (GM) source organism as a nutritive substance in infant formula products. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation - the Food Standards (Application A1334 – 2′-FL from GM Corynebacterium glutamicum (gene donor: Corynebacterium urealyticum) in infant formula products) 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 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.
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). 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 and Territory 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 the draft variation to:
- Amend Schedule 26 of the Code to permit 2′-FL produced from a new GM source, Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum, to be used as a GM food for the purposes of Standard 1.5.2 of the Code and, consequently, as a nutritive substance in infant formula products for the purposes of Standard 2.9.1 – these permissions will be subject to certain conditions, including an exclusive use permission for a period of 15 months linked to the applicant’s brand name ‘XINFU 2′-FL’.
- Amend the current specification in Schedule 3 of the Code for 2′-FL sourced from Corynebacterium glutamicum (section S3—51) to specify that this specification applies to 2′-FL sourced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from either Corynebacterium urealyticum (new permitted donor organism) or Pseudopedobacter saltans (existing permitted donor organism).
4. Documents incorporated by reference
The approved draft variation prepared by the Authority does not incorporate any documents by reference.
However, the approved draft variation will vary Schedule 3 of the Code which does incorporate documents by reference. Section 1.1.1—15 of Standard 1.1.1 requires certain substances (such as substances used as nutritive substances) to comply with any relevant identity and purity specifications listed in Schedule 3 of the Code when added to food in accordance with the Code or sold for use in food.
Schedule 3 incorporates documents by reference to set specifications for various substances in accordance with requirements specified in that Schedule. The documents incorporated include: the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Combined Compendium of Food Additive Specifications (FAO JECFA Monographs 26 (2021)); the United States Pharmacopeial Convention (2022) Food Chemicals Codex (13th edition); and the Commission Regulation (EU) No 231/2012.
5. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of application A1334 included one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 21 October 2025 for a 4-week consultation period. Further details of the consultation process, the issues raised during consultation and by whom, and the Authority’s response to these issues are available in an approval report published on the Authority’s website at www.foodstandards.gov.au.
A Standards Development Committee (SDC) was established with representatives from the industry sector, the relevant State and Territory government agencies and consumer organisations to provide ongoing advice to the Authority throughout the standard development process. The SDC contributed a broad spectrum of knowledge and expertise covering industry, government, research and consumers
A regulation impact statement (RIS) has not been prepared for this application. This is because applications relating to permitting the use of GM food and nutritive substances that have been determined to be safe are considered to be minor in impact and deregulatory in nature as their use will be voluntary. Therefore, FSANZ’s assessment is that a RIS is not required for this application
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.
7. Variation
A reference to ‘the variation’ in this section is a reference to the draft variation.
Clause 1 of the variation provides that the name of the variation is the Food Standards (Application A1334 – 2′-FL from GM Corynebacterium glutamicum (gene donor: Corynebacterium urealyticum) in infant formula products) Variation.
Clause 2 of the variation provides that the Code is amended by the Schedule to the variation.
Clause 3 of the variation provides that the variation will commence on the date of gazettal of the variation.
7.1 Items [1], [2] and [3]
Items [1], [2] and [3] of the Schedule to the variation amend Schedule 3 of the Code.
Schedule 3 contains specifications for the purposes of section 1.1.1—15 of the Code. Section 1.1.1—15 requires certain substances, e.g. substances used as nutritive substances, to comply with any relevant identity and purity specifications listed in Schedule 3 when added to food in accordance with the Code or sold for use in food. Specifications include those set out in provisions which are listed in the table to subsection S3—2(2) (see paragraph S3— 2(1)(a)).
Item [1] amends the table to subsection S3—2(2) by repealing the table item dealing with ‘2′-fucosyllactose sourced from Corynebacterium glutamicum’ and replacing the omitted table item with ‘2′-fucosyllactose sourced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from either Corynebacterium urealyticum or Pseudopedobacter saltans. This amendment is consequential to the amendment in item [3] below.
Item [2] amends the section heading of section S3—51 by repealing the section heading and substituting the repealed heading with: ‘S3—51 Specification for 2′-fucosyllactose sourced from Corynebacterium glutamicum’ to correct a typographical error in which ‘for’ had previously been left out of the heading. The inclusion of the word ‘for’ is consistent with other entries in Schedule 3.
Item [3] amends section S3—51, which sets out the specification for 2′-FL sourced from Corynebacterium glutamicum. The existing specification is relevant to the only 2′-FL sourced from Corynebacterium glutamicum listed in the table to subsection S26—3(7) prior to the variation coming into effect i.e., 2′-FL sourced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Pseudopedobacter saltans.
Item [3] amends that section by omitting ‘sourced from Corynebacterium glutamicum,’ in the specification, and substituting the omitted words with ‘sourced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from either Corynebacterium urealyticum or Pseudopedobacter saltans,’.
The effect of the amendments in items [1], [2] and [3] is that the amended specification applies to 2′-FL produced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum and to 2′-FL produced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Pseudopedobacter saltans. 2′-FL produced from either of those source organisms must comply with the amended specification set out in section S3—51 when added to infant formula products for use as a nutritive substance in accordance with the Code (or sold for such use).
7.2 Item [4]
Item [4] of the Schedule to the variation amends Schedule 26 of the Code.
Schedule 26 relates to GM food.
2′-FL sourced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum is a GM food (as defined in section 1.1.2—16 of the Code) because it is a food derived from an organism that has been genetically modified to contain novel DNA and does not fall within any of the exceptions listed in that section.
Paragraphs 1.1.1—10(5)(c) and (6)(g) of the Code prohibit food for sale from being, or having as an ingredient or a component, a GM food unless expressly permitted by this Code.
Section 1.5.2—3 permits a food for sale to contain, or consist of, a GM food if that GM food is listed in Schedule 26 and complies with any corresponding conditions listed in that Schedule.
The table to subsection S26—3(7) lists permitted GM food of microbial origin.
Item [4] amends item 1 of that table (2′-FL) by inserting a new paragraph (g) into the column headed ‘Source’. The new paragraph (g) refers to:
‘Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum’.
Associated conditions of use for 2′-FL from this new source are set out in column 3 of the table as follows:
- the substance may only be added to infant formula products;
- during the exclusive use period, the substance may only be sold under the brand XINFU 2′-FL; and;
- for the purposes of condition 2,’exclusive use period’ means the period commencing on the date of gazettal of the Food Standards (Application A1334 – 2′-FL from GM Corynebacterium glutamicum (gene donor: Corynebacterium urealyticum) in infant formula products) Variation and ending 15 months after that date.
Condition 2 means that 2′-FL sourced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum may only be sold under the brand XINFU 2′-FL during the exclusive use period. ‘Exclusive use period’ is defined in condition 3 as the period commencing on gazettal of the variation and ending 15 months after that date.
Once the exclusive use period ends, the exclusive use permission will revert to a general permission, meaning that 2′-FL sourced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum may be sold under any brand.
The effect of the amendment in item [4] is to permit the sale and use of the substance, 2′-FL from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum as a GM food, subject to the above conditions of use for the substance.
The amendment made by item [4] does make any substantive change to existing permissions and to other requirements in the Code relating to GM food.
Permission for the substance to be used as a nutritive substance in infant formula products
Standard 2.9.1 and Schedule 29 already permit ‘2′-fucosyllactose permitted for use by Standard 1.5.2’ to be used as a nutritive substance in infant formula products in accordance with the Code.
Consequently, the effect of the amendment in item [4] is to also permit 2′-FL from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum to be used as a nutritive substance in infant formula products in accordance with the Code.