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On November 10, 2025, Food Standards Australia New Zealand (FSANZ) announced the approval of two variations to the Australia New Zealand Food Standards Code. These approvals permit the use of a new nutritive substance in infant formula and the sale of food derived from genetically modified purple tomatoes.
The decisions, addressing applications A1324 and A1333, were made by the FSANZ Board on October 29, 2025, and have been forwarded to the Food Ministers' Meeting for a 60-day review period. Both approvals followed comprehensive safety assessments and public consultation.
Application A1324: 3-Fucosyllactose in Infant Formula
FSANZ approved an application from Glycom A/S to permit the use of 3-fucosyllactose (3-FL) as a nutritive substance in infant formula products with the maximum usage level of 80 mg/100kJ. The approved substance is produced using a genetically modified (GM) strain of Escherichia coli K-12 containing the gene for alpha-1,3-fucosyl-transferase from Helicobacter pylor. The applicant, Glycom A/S, has a 15-month exclusive use permission for their product, marketed under the brand name 'GLYCARE®.
The approved variation to the Code will:
Amend Schedule 29 to permit 3-FL in infant formula products at a maximum level of 80 mg/100 kJ.
Amend Schedule 26 to list 3-FL as a permitted GM food for use in infant formula.
Insert a new specification for 3-FL into Schedule 3 to ensure identity and purity.
Application A1333: Food from Genetically Modified Purple Tomatoes
In a separate decision, FSANZ approved an application from Norfolk Healthy Produce Inc. to permit the sale and use of food derived from GM purple tomato lines containing event Del/Ros1-N. These tomatoes have been modified to produce high levels of natural blue pigments (anthocyanins) that give them a distinct deep purple skin and flesh.
Food derived from the purple tomato lines will be required to be labelled as 'genetically modified' regardless of whether it contains novel DNA or novel protein, because it has altered characteristics.
The approved variation to the Code will:
Add "tomato lines containing event Del/Ros1-N" to the list of permitted GM foods specified in Schedule 26.
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