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 19 March 2021

Glen Neal

General Manager, Risk Management and Intelligence

Delegate of the Board of Food Standards Australia New Zealand

1 Name

This instrument is the Food Standards (Application A1155 – 2′-FL and LNnT in infant formula and other 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

[1] Standard 2.9.1 is varied by

[1.1] omitting section 2.9.1—7, substituting

2.9.1—7 Restriction on addition to infant formula product of inulin-type fructans and galacto‑oligosaccharides

 (1) If an inulin-type fructan or a galacto-oligosaccharide is added to an infant formula product, the product must contain (taking into account both the naturally-occurring and added substances) no more than:

 (a) if only *inulin-type fructans are added—110 mg/100 kJ of inulin-type fructans; or

 (b) if only *galacto-oligosaccharides are added—290 mg/100 kJ of galacto-oligosaccharides; or

 (c) if both inulin-type fructans and galacto-oligosaccharides are added:

 (i) no more than 110 mg/100 kJ of inulin-type fructans; and

 (ii) no more than 290 mg/100 kJ of combined inulin-type fructans and galacto-oligosaccharides.

 (2) An infant formula product to which an inulin-type fructan or a galacto‑oligosaccharide is added must not contain any of the following added substances:

 (a) 2′-O-fucosyllactose; or

 (b) a combination of 2′-O-fucosyllactose and lacto-N-neotetraose.

[1.2] inserting after paragraph 2.9.1—24(1)(c)

 (ca) the words ‘human milk oligosaccharide’, ‘human milk identical oligosaccharide’ or any word or words having the same or similar effect; or

 (cb) the abbreviations ‘HMO’ or HiMO’ or any abbreviation having the same or similar effect; or

[2] Schedule 2 is varied by inserting in the table to section S2—2, in alphabetical order

[3] Schedule 3 is varied by

[3.1] inserting in the table to subsection S3—2(2) in alphabetical order

[3.2] inserting in the table to subsection S3—2(2) in alphabetical order

 [3.3] inserting after subsection S3—39

S3—40 Specification for 2′-O-fucosyllactose

  For 2′-O-fucosyllactose (2′-FL), 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) CAS number—41263-94-9;

 (d) description— white to off white powder or agglomerates;

 (e) assay (water free) for sum of 2′-FL, lactose, difucosyllactose and fucose—not less than 96.0%;

 (f) assay (water free) 2′-FL—–not less than 94.0%;

 (g) D-lactose—–not more than 3.0%

 (h) L-fucose—–not more than 1.0%

 (i) difucosyllactose—–not more than 1.0%

 (j) 2′-fucosyl-D-lactulose—–not more than 1.0%

 (k) pH (20°C, 5% solution)—–3.2 to 5.0

 (l) water—–not more than 5.0%

 (m) ash, sulphated—–not more than 1.5%

 (n) acetic acid (as free acid and/or sodium acetate)—–not more than 1.0%

 (o) residual proteins—–not more than 0.01%

 (p) lead—–not more than 0.1 mg/kg

 (q) microbiological:

 (i)  salmonella—–absent in 25 g

  (ii)  total plate count—–not more than 500 cfu/g

 (iii)  enterobacteriaceae—–absent in 10 g

 (iv)  cronobacter (Enterobacter) sakazakii—–absent in 10 g

 (v)  listeria monocytogenes—–absent in 25 g

 (vi)  bacillus cereus—–not more than 50 cfu/g

 (vii)  yeasts—–not more than 10 cfu/g

  (viii) moulds—–not more than 10 cfu/g

 (ix) residual endotoxins—–not more than 10 EU/mg

S3—41 Specification for lacto-N-neotetraose

  For lacto-N-neotetraose (LNnT), the specifications are the following:

 (a)  chemical name—–β-D-galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose

  (b)  chemical formula—–C26H45NO21

 (c)  CAS number—–13007-32-4

 (d) description—–white to off white powder or agglomerates

 (e)  assay (water free) for sum of LNnT, lactose, lacto-N-triose II, and para-lacto-N-hexaose—–not less than 95.0%

 (f) assay (water free) LNnT—–not less than 92.0%

 (g)  D-lactose—–not more than 3.0%

 (h) lacto-N-triose II—–not more than 3.0%

 (i) para-lacto-N-neohexaose—–not more than 3.0%

 (j) LNnT fructose isomer—–not more than 1.0%

 (k)  pH (20°C, 5% solution) —–4.0 to 7.0

 (l) water—–not more than 9.0%

 (m)  ash, sulphated—–not more than 1.5%

 (n) methanol—–not more than 100 mg/kg

 (o) residual proteins—–not more than 0.01%

 (p) lead—–not more than 0.1 mg/kg

 (q) microbiological:

 (i)  salmonella—–absent in 25 g

 (ii)  total plate count—–not more than 500 cfu/g

 (iii) enterobacteriaceae—–absent in 10 g

 (iv) cronobacter (Enterobacter) sakazakii—–absent in 10 g

 (v) listeria monocytogenes—–absent in 25 g

 (vi) bacillus cereus—–not more than 50 cfu/g

 (vii) yeasts—–not more than 10 cfu/g

 (viii) moulds—–not more than 10 cfu/g

 (ix) residual endotoxins—–not more than 10 EU/mg

[4] Schedule 26 is varied by

[4.1] omitting subsections S26—3(1), (2), (2A), and (3), substituting

 (1) The table to subsection (4) and the table to subsection (7) list permitted food produced using gene technology.

 (2) Items 1(g), 2(m), 7(e), (g) and (h), and 9(a) of the table to subsection (4) are subject to the condition that their labelling must comply with section 1.5.2—4.

 Note That section requires the statement ‘genetically modified’.

(2A)  Products containing beta-carotene from item 6(b) of the table to subsection (4) are subject to the condition that their labelling must comply with section 1.5.2—4.

 (3) Item 2(m) of the table to subsection (4) is also subject to the condition that, for the labelling provisions, unless the protein content has been removed as part of a refining process, the information relating to *foods produced using gene technology includes a statement to the effect that the high lysine corn line LY038 has been genetically modified to contain increased levels of lysine.

[4.2] omitting the words ‘gene technology’ from the heading to the table to subsection (4), substituting the words’ ‘gene technology of plant origin’.

[4.3] inserting after the table to subsection (4)

 (5) A food listed in the table to subsection (7) must comply with any corresponding conditions listed in that table.

 (6) A source listed in the table to subsection (7) may contain additional copies of genes from the same strain.

 (7) The table for this subsection is:

Food produced using gene technology of microbial origin

[5] Schedule 29 is varied by

[5.1] omitting section S29—5, substituting

S29—5 Infant formula products—substances permitted as nutritive substances

  For section 2.9.1—5, the table is set out below.

Infant formula products—substances permitted for use as nutritive substances