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: | 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 |
Food 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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