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.

6 July 2022

Christel Leemhuis

Delegate of the Board of Food Standards Australia New Zealand

1 Name

This instrument is the Food Standards (Application A1233 – 2’-FL from new GM source for infant formula) 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

[1] Schedule 3—Identity and Purity

[1.1] Subsection S3—2(2) (table item dealing with the substance 2′-fucosyllactose sourced from Escherichia coli K-12)

 Repeal the item, substitute:

[1.2] Section S3—40

 Repeal the section, substitute:

S3—40 Specification for 2′-fucosyllactose sourced from Escherichia coli K-12 containing the gene for alpha-1,2-fucosyltransferase from either Helicobacter pylori or Bacteroides vulgatus

 For 2′-fucosyllactose (2′-FL) sourced from Escherichia coli K-12 containing the gene for alpha-1,2-fucosyltransferase from either Helicobacter pylori or Bacteroides vulgatus, the specifications are the following:

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

 (b) chemical formula—C18H32O15;

 (c) molecular weight—488.44 g/mol;

 (d) CAS number—41263-94-9;

 (e) description— white to off-white powder

 (f) 2′-FL—not less than 83%;

 (g) D-lactose—not more than 10.0%;

 (h) L-fucose—not more than 2.0%;

 (i) difucosyl-D-lactose—not more than 5.0 %;

 (j) 2′-fucosyl-D-lactulose—not more than 1.5 %;

 (k) sum of saccharides (2′-FL, D-lactose, L-fucose, difucosyl-D-lactose, 2′-fucosyl-D-lactulose)—not less than 90%;

 (l) pH (20°C, 5% solution)—3.0-7.5;

 (m) water—not more than 9.0%;

 (n) ash, sulphated—not more than 2.0%;

 (o) acetic acid—not more than 1.0%;

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

 (q) microbiological:

(i)             aerobic mesophilic bacteria total count—not more than 3,000 cfu/g;

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

(iii)          moulds—not more than 100 cfu/g;

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

[2] Schedule 26—Food produced using gene technology

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

 Repeal the item, substitute: