EXPLANATORY STATEMENT
Food Standards Australia New Zealand Act 1991
Food Standards (Application A1324 – 3-fucosyllactose as a nutritive substance 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 Authority accepted Application A1324 which seeks to amend the Code to permit the use of 3-fucosyllactose (3-FL), a human-identical milk oligosaccharide (HiMO) produced using a genetically modified (GM) source organism, Escherichia coli K-12 to be used as a nutritive substance in infant formula products. The application also sought a 15-month exclusive use permission in relation to that substance. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation - the Food Standards (Application A1324 – 3-fucosyllactose as a nutritive substance 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. 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 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 the draft variation to the Code to:
- Amend Schedule 29 of the Code to permit the use of 3-FL as a nutritive substance in infant formula products at a maximum level of 80 mg/100 kJ
- Amend Schedule 26 of the Code to permit 3-FL produced from Escherichia coli K-12 containing the gene for alpha-1,3-fucosyltransferase from Helicobacter pylori, to be added to infant formula products subject to certain conditions, including an exclusive use period of 15 months linked to the applicant’s brand name ‘GLYCARE®’.
- Insert a new specification for this 3-FL into Schedule 3, with which this 3-FL will have to comply when used as a nutritive substance in infant formula products in accordance with the Code (or sold for such use).
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 varies Schedule 3 of the Code which does incorporate documents by reference. Section 1.1.1—15 of the Code 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 A1324 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 11 June 2025 for a 6-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 regulation impact statement (RIS) has not been prepared for this application. This is because applications relating to permitting the use of 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 if the draft variation concerned is approved. 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 approved draft variation.
Clause 1 of the variation provides that the name of the variation is the Food Standards (Application A1324 – 3-fucosyllactose as a nutritive substance 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 instrument.
Items [1] and [2]
Items [1] and [2] 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 subsection S3—2(2) by inserting, after the table item dealing with 2′-fucosyllactose and difucosyllactose sourced from Escherichia coli K-12, a new entry for ‘3-fucosyllactose sourced from Escherichia coli K-12 containing the gene for alpha-1,3-fucosyl-transferase from Helicobacter pylori’ and a corresponding reference to new section S3—56 (see item [2] below).
Item [2] inserts a new section S3—56 after section S3—55. The new section sets out the specifications relating specifically to ‘3-fucosyllactose sourced from Escherichia coli K-12 containing the gene for alpha-1,3-fucosyl-transferase from Helicobacter pylori’, the new substance sought to be permitted by the applicant.
Consequently, 3-FL sourced from Escherichia coli K-12 containing the gene for alpha-1,3-fucosyl-transferase from Helicobacter pylori must comply with these specifications when used in infant formula products as a nutritive substance in accordance with the Code (or sold for such use).
Item [3]
Item [3] of the Schedule to the variation amends Schedule 26 of the Code.
Schedule 26 relates to GM food. 3-FL sourced from Escherichia coli K-12 containing the gene for alpha-1,3-fucosyltransferase from Helicobacter pylori 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 contains 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 [3] amends that table by adding the following entry as new item 8 in that table:
- ‘3-fucosyllactose’ in column 1;
- ‘Escherichia coli K-12 containing the gene for alpha-1,3-fucosyltransferase from Helicobacter pylori’ in column 2; and
- associated conditions of use in column 3.
Associated conditions for the use of 3-FL from this source are 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 GLYCARE®; and
- for the purposes of condition 2, exclusive use period means the period commencing on the date of gazettal of the Food Standards (A1324 – 3-fucosyllactose as a nutritive substance in infant formula products) Variation and ending 15 months after that date.
Conditions 2 and 3 mean that 3-FL sourced from Escherichia coli K-12 containing the gene for alpha-1,3-fucosyltransferase from Helicobacter pylori may only be sold under the brand GLYCARE® during the exclusive use period. ‘Exclusive use period’ is defined in condition 3 as the period commencing on the gazettal date 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 3-FL sourced from Escherichia coli K-12 containing the gene for alpha-1,3-fucosyltransferase from Helicobacter pylori may be sold under any brand.
The effect of the amendment in item [3] is to permit the sale and use of the substance, 3-FL from Escherichia coli K-12 containing the gene for alpha 1,3-fucosyltransferase from Helicobacter pylori as a GM food in accordance with the Code, subject to the above conditions for use for the substance.
The amendment made by item [3] does not make any substantive change to existing permissions and to other requirements in the Code relating to GM food.
Items [4], [5] and [6]
Items [4], [5] and [6] of the Schedule to the variation amend Schedule 29 of the Code.
Item [4]
Subsection 2.9.1—9(1) and section 2.9.1—37 provide for the use of optional nutritive substances in infant formula and special medical purpose product for infants respectively. Those sections provide that a substance listed in Column 1 of the table to section S29—7 may be used as a nutritive substance in infant formula and special medical purpose product for infants, provided the amount of the substance in the product (including any naturally-occurring amount) is no less than any minimum amount specified in Column 2 of the table; and no more than any maximum amount specified in Column 3 of the table.
Item [4] amends the table to section S29—7 by inserting, after the table item dealing with 2′-fucosyllactose permitted for use by Standard 1.5.2, a new entry for 3-FL into the table as follows:
Column 1 – ‘3-fucosyllactose permitted for use by Standard 1.5.2’ as the substance;
Column 3 – ’80 mg’ as the maximum amount of the substance (per 100 kJ).
There is no entry to column 2 of the table to S29—7 as a minimum amount is not set for 3-fucosyllactose. This was not requested in the application and has not been determined by the Authority.
Item [5]
Subsection 2.9.1—9(2) provides for the use of optional nutritive substances in follow-on formula. This section provides that a substance listed in Column 1 of the table to section S29—8 may be used as a nutritive substance in follow-on formula, provided the amount of the substance in the product (including any naturally-occurring amount) is no less than any minimum amount specified in Column 2 of the table; and no more than any maximum amount specified in Column 3 of the table.
Item [5] amends the table to section S29—8 by inserting, after the table item dealing with 2′-fucosyllactose permitted for use by Standard 1.5.2, a new entry for 3-FL into the table as follows:
Column 1 – ‘3-fucosyllactose permitted for use by Standard 1.5.2’ as the substance;
Column 3 – ’80 mg’ as the maximum amount of the substance (per 100 kJ).
There is no entry to column 2 of the table to S29—8 as a minimum amount is not set for 3-fucosyllactose. This was not requested in the application and has not been determined by the Authority.
Item [6]
Section 2.9.1—10 requires that a substance used as a nutritive substance in infant formula or follow-on formula in accordance with section 2.9.1—9 (other than a vitamin, mineral or electrolyte) must be added in a permitted form listed in the table to section S29—9.
Section 2.9.1—38 requires that a substance used as a nutritive substance in a special medical purpose product for infants in accordance with section 2.9.1—37 (other than a vitamin, mineral or electrolyte) must be added in a permitted form listed in the table to section S29—9.
Item [6] amends the table to section S29—9 by inserting, after the table item dealing with 2′-fucosyllactose permitted for use by Standard 1.5.2, a new entry for 3-FL as follows:
Column 1 – ‘3-fucosyllactose permitted for use by Standard 1.5.2’ as the substance; and
Column 2 – ‘3-fucosyllactose’ as the permitted form of the substance.
The effect of the approved draft variation
The amendments set out in the variation have the effect of permitting 3-FL produced from Escherichia coli K-12 containing the gene for alpha-1,3-fucosyltransferase from Helicobacter pylori to be used as a nutritive substance in infant formula products in accordance with the Code (or sold for such use).