Food Standards (Application A1308 – 2′-FL from GM Escherichia coli W in infant formula products) Variation

The Board of Food Standards Australia New Zealand gives notice of the making of this variation under section 92 of the Food Standards Australia New Zealand Act 1991. The variation commences on the date specified in clause 3 of this variation.

Dated 10 July 2025

Christel Leemhuis, General Manager, Public Health

Delegate of the Board of Food Standards Australia New Zealand

Note:

This variation will be published in the Commonwealth of Australia Gazette No. FSC 180 on 22 July 2025. This means that this date is the gazettal date for the purposes of clause 3 of the variation.

1 Name

This instrument is the Food Standards (Application A1308 – 2′-FL from GM Escherichia coli W in infant formula products) Variation.

2 Variation to Standards in the Australia New Zealand Food Standards Code

The Schedule varies Standards in the Australia New Zealand Food Standards Code.

3 Commencement

The variation commences on the date of gazettal.

Schedule

Schedule 3—Identity and purity

[1] Subsection S3—2(2) (table, after the table item dealing with 2′-fucosyllactose and difucosyllactose sourced from Escherichia coli K-12)

Insert:

2′-fucosyllactose sourced from Escherichia coli W

section S3—54

[2] After section S3—53

Insert:

S3—54 Specification for 2′-fucosyllactose sourced from Escherichia coli W

For 2′-fucosyllactose (2′-FL) sourced from Escherichia coli W containing the gene for alpha-1,2-fucosyltransferase from Helicobacter mustelae, the specifications are the following:

(a) chemical name—α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose;

(b)        chemical formula—C18H32O15;

(d)        CAS number—41263-94-9;

(e)        description—white to off-white powder;

(f)         2′-FL—not less than 82% (water free);

(g)        D-lactose—not more than 5.0% (water free);

(h)        L-fucose—not more than 1.0% (water free);

(i) fucosylgalactose—not more than 3.0% (water free);

(j) difucosyllactose (difucosyl-d-lactose)—not more than 3.0% (water free);

(k)        glucose and galactose—not more than 1.0% (water free);

(l)         water—not more than 9.0%;

(m)      ash, sulphated—not more than 0.5%;

(n)        residual proteins—not more than 0.01%;

(o)        lead—not more than 0.1 mg/kg;

(p)        arsenic—not more than 0.1 mg/kg;

(q)        cadmium—not more than 0.1 mg/kg;

(r)         mercury—not more than 0.1 mg/kg;

(s)        microbiological:

(i) aerobic mesophilic bacteria total count—not more than 1,000 cfu/g;

(ii) yeasts and moulds—not more than 100 cfu/g;

(iii)       Enterobacteriaceae—absent in 10 g;

(iv) residual endotoxins—not more than 10 EU/g.

Schedule 26—Food produced using gene technology

[3] Subsection S26—3(7) (table, table item 1)

Insert:

(f) Escherichia coli W containing the gene for alpha-1,2-fucosyltransferase from Helicobacter mustelae

May only be added to infant formula products.
During the exclusive use period, may only be sold under the brand 2′-FL Kyowa.
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.