Food Standards (Application A1307 – Milk fat globule membrane as a nutritive substance 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 A1307 – Milk fat globule membrane as a nutritive substance 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)

Insert:

Bovine milk fat globule membrane-enriched whey protein concentrate

section S3—53

[2] After section S3—52

Insert:

S3—53 Specification for bovine milk fat globule membrane-enriched whey protein concentrate

(1) In this section, bovine milk fat globule membrane-enriched whey protein concentrate is a preparation of cow’s milk consisting of lipids and proteins.

(2) For bovine milk fat globule membrane-enriched whey protein concentrate, the specifications are the following:

(a) description—off white powder;

(b) total protein—not less than 69.0% and not more than 76.0%;

(d) fat—not less than 16.0% and not more than 22.0%;

(e) phospholipids—not less than 6.0% and not more than 10.0%;

(f) sphingomyelin—not less than 1.3% and not more than 2.3%;

(g) ash—not more than 3.0%;

(h) moisture—not more than 5.0%;

(i) arsenic—not more than 0.2 mg/kg;

(j) cadmium—not more than 0.1 mg/kg;

(k) lead—not more than 0.05 mg/kg;

(l) mercury—not more than 0.02 mg/kg;

(m) microbial limits:

(i) total plate count (30°C)—not more than 10000 cfu/g;

(ii) total plate count (55°C)—not more than 1000 cfu/g;

(iii) Bacillus cereus—not more than 50 cfu/g;

(iv) Sulphite-reducing Clostridia—not more than 10 cfu/g;

(v) Enterobacteriaceae—not more than 10 cfu/g;

(vi) Coagulase-positive staphylococci—absent in 1 g;

(vii) Yeast and moulds—not more than 10 cfu/g.

Schedule 29—Special purpose foods

[3] Section S29—7 (table)

Insert:

Milk fat globule membrane-enriched whey protein concentrate

0.14 g

0.28 g

[4] Section S29—8 (table)

Insert:

Milk fat globule membrane-enriched whey protein concentrate

0.14 g

0.28 g

[5] Section S29—9 (table)

Insert:

Milk fat globule membrane-enriched whey protein concentrate

Bovine milk fat globule membrane-enriched whey protein concentrate

[6] Section S29—9A (table)

Insert:

Milk fat globule membrane-enriched whey protein concentrate	Bovine milk fat globule membrane-enriched whey protein concentrate	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. 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.