FSANZ Approves 3-Fucosyllactose as a Nutritive Substance in Infant Formula

FSANZ has gazetted a variation to the Australia New Zealand Food Standards Code to permit the use of 3-fucosyllactose (3-FL) as a nutritive substance in infant formula products. The variation takes effect from the date of gazettal.

This amendment introduces new identity, purity, and compositional specifications for 3-FL, recognises it as a genetically modified food, and establishes its permitted use levels in special purpose foods.

Key Regulatory Changes
1. Identity and Purity Specifications (Schedule 3)

A new specification has been inserted for 3-fucosyllactose sourced from Escherichia coli K-12, genetically modified to contain the alpha-1,3-fucosyl-transferase gene from Helicobacter pylori.

Key parameters include:

Chemical name: ?-D-Galactopyranosyl-(1-4)-[?-L-fucopyranosyl-(1-3)]-D-glucose

Molecular formula: C??H??O??

Molecular weight: 488.44 g/mol

Purity:

1.? 90.0% 3-FL (water-free basis)

2.? 92.0% total saccharides

Impurity limits:

1.L-fucose ? 1.0%

2.D-lactose ? 5.0%

3.3-fucosyllactulose ? 1.5%

Microbiological criteria:

a)Total aerobic count ? 1,000 cfu/g

b)Enterobacteriaceae absent in 10 g

c)Yeasts and moulds ? 100 cfu/g

d)Residual endotoxins ? 10 EU/mg

2. Genetically Modified Food Listing (Schedule 26)

3-fucosyllactose produced using E. coli K-12 has been added to the list of approved genetically modified foods, subject to specific conditions:

Permitted use: Infant formula products only

Exclusive use condition:

During the 15-month exclusive use period following gazettal, the ingredient may only be sold under the brand name GLYCARE®

3. Special Purpose Foods – Maximum Use Levels (Schedule 29)

FSANZ has established maximum permitted levels for 3-fucosyllactose in infant formula and related special purpose foods:

Maximum level: 80 mg

Applicable across:

Section S29—7

Section S29—8

Section S29—9

These provisions align the regulatory treatment of 3-FL with existing human milk oligosaccharides already permitted under Standard 1.5.2.

Regulatory Significance

This approval expands the range of human milk oligosaccharides (HMOs) permitted in infant formula in Australia and New Zealand, supporting product innovation while maintaining strict compositional, microbiological, and safety controls. The decision also reinforces FSANZ’s framework for assessing GM-derived nutritive substances used in infant nutrition.