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Australia and New Zealand Amend Food Standards Code, Involving Infant Formula, Processing Aids and GM Food

FSANZ Amends the Code, reflecting the New Zealand Government’s decision to opt out of the revised Standard 2.9.1 on infant formula products. Other amendments include the two nutritive substances, two processing aids and one GM food.

On July 22, 2025, Food Standards Australia New Zealand (FSANZ) issued Amendment No. 240 to amend to the Food Standards Code. The amendments include two nutritive substances, two processing aids, one GM food and Australian only Infant Formula Product Standard, which commence on the date of gazettal.

Major Amendments

Infant Formula

1. FSANZ permits the use of bovine milk fat globule membrane-enriched whey protein concentrate as a nutritive substance in infant formula products. Key amendments are shown in the tables below.

  • Optional nutritive substances in infant formula and special medical purpose product for infants

Substance

Minimum Maximum amount per amount 100 kJ per 100 kJ

MRL (mg/kg)

Milk fat globule membraneenriched whey protein

concentrate

0.14 g

0.28 g

  • Infant formula products—conditions on use of permitted nutritive substances

Substance

Permitted Form

Conditions of use

Milk fat globule membraneenriched whey protein concentrate

Bovine milk fat globule membrane-enriched whey protein concentrate

1.During the exclusive use period, may only be sold under the brand Lacprodan® MFGM-10 for use as a nutritive substance in an infant formula product.

2.For the purposes of condition 1 above, exclusive use period means the period commencing on the date of gazettal of the Food Standards (Application A1307 – Milk fat globule membrane as a nutritive substance in infant formula products) Variation and ending 15 months after that date.

2. FSANZ permits a new genetically modified source organism Escherichia coli W for the production of 2′-Fucosyllactose (2′-FL) in infant formula products. 

Substance

Source

Conditions of use

2′-Fucosyllactose

(f) Escherichia coli W

containing the gene for

alpha-1,2-

fucosyltransferase

from Helicobacter mustelae

1. May only be added to infant formula products.

2. During the exclusive use period, may only be sold under the brand 2′-FL Kyowa.

3. For the purposes of condition 2 above, exclusive use period means the period commencing on the date of gazettal of the Food Standards (Application A1308 - 2′-FL from GM Escherichia coli W in infant formula products) Variation and ending 15 months after that date.

3. The New Zealand Government opted out of the amended infant formula products standard. As s a result, Standard 2.9.1 of the Food Standards Code does not apply in New Zealand. FSANZ inserts annotations to the Food Standards Code, which reflect the New Zealand Government's decision.

Processing Aids

1. FSANZ permits a fermented preparation of Lentinula edodes mycelia as a processing aid.

Definition

Usage scope

Usage Condition

Specification

A fermented preparation means a fermented preparation of Lentinula edodes (shiitake mushroom) mycelia

Used as a processing aid for fermentation of:
• Pea protein
• Rice protein
• Pea and rice protein

GMP

The fermented preparation must be produced from a glycerol stock of Lentinula edodes (shiitake mushroom) mycelia that complies with each of the following specifications:

(a) species—Lentinula edodes;

(b) arsenic—not more than 10 µg/kg;

(c) cadmium—not more than 5 µg/kg

(d) lead—not more than 5 µg/kg;

(e) mercury—not more than 5 µg/kg;

(f) aerobic plate count—not more than 10 cfu/g

2. FSANZ permits prolyl oligopeptidase (EC 3.4.21.26) from genetically modified Trichoderma reesei to be used as a processing aid in the production of brewed beverages.

Substance

Technological purpose and food

Maximum permitted level (mg/kg)

Prolyl oligopeptidase (EC 3.4.21.26)

sourced from Trichoderma reesei

containing the prolyl oligopeptidase

gene from Aspergillus niger

For use in brewing

GMP

lxbg_2025_09_10_0560ad9698194cefa2ad456c805b5e1c.jpgFood Produced Using Gene Technology

FSANZ permits the sale and use of food derived from a new food produced using gene technology: soybean line MON94637. This soybean line has been genetically modified for protection against insect pests.

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