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FSANZ advice on imported human milk and human milk products

​(April 2020)

In late 2017, we were asked by the Department of Agriculture, Water and the Environment to consider the risks associated with the importation of human milk and human milk products into Australia. This advice has been provided to the Department of Agriculture, Water and the Environment who manage food safety risks at the border.

Read more about our imported food risk assessments.

What we looked at

We assessed 30 potential hazards in imported human milk and human milk products. When determining the level of risk, we assumed the most vulnerable category of infants (preterm infants in hospital neonatal intensive care units) would be receiving the products.

What are human milk products?

Human milk is expressed milk from lactating women that is fed to infants that are not the biological infant. Human milk products are derived from human milk that has been specially formulated to meet the specific nutritional needs of infants, such as fortifiers and formula.

The outcome of our assessments are outlined in the table below:

Imported food risk advice for human milk and human milk products table

Food Microorganism / analyte / contaminant Is it medium to high risk? Date of assessment
(latest update)
Human milk and human milk productsMicrobiological hazards ​October 2019 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​
Bacillus cereus (pdf 527kb)Yes
Coxiella burnetii (pdf 514kb)No
Cronobacter spp. (pdf 622kb)Yes
Cytomegalovirus (pdf 509kb)Yes
Extraintestinal pathogenic Escherichia coli (pdf 620kb)Yes
Group B Streptococcus (pdf 508kb)Yes
Hepatitis B virus (pdf 511kb)Yes
Hepatitis C virus (pdf 603kb)Yes
Herpes simplex virus (pdf 613kb)No
Human herpes viruses (other than herpes simplex virus & cytomegalovirus) (pdf 539kb)No
Human immunodeficiency virus (pdf 508kb)Yes
Human T-lymphotropic virus (pdf 605kb)Yes
Listeria monocytogenes (pdf 523kb)No

Live attenuated vaccines (pdf 625kb)

(measles virus, mumps virus, poliovirus, rotavirus, rubella virus, typhoid fever, varicella-zoster virus, yellow fever virus)

Yes for yellow fever virus vaccine.

No for the other live vaccines assessed

Mycobacterium tuberculosis (pdf 601kb)Yes
Prions (pdf 495kb)No
Rubella virus (pdf 600kb)No
Salmonella spp. (non-typhoidal) (pdf 615kb)Yes
Staphylococcus aureus (pdf 519kb)Yes
Toxoplasma gondii (pdf 612kb)No
Treponema pallidum (pdf 607kb)Yes

Viral haemorrhagic fevers (pdf 621kb)

(Ebola and dengue virus)

No
Zika virus (pdf 623kb)No
Chemical hazards ​ ​
Arsenic (pdf 494kb)No
Cadmium (pdf 395kb)No
Dioxins and dioxin-like polychlorinated biphenyls (pdf 400kb)No
Lead (pdf 397kb)No
Medicines or drugs of abuse (pdf 765kb)Yes for those categorised as contraindicated during breastfeed, e.g. classified as lactation risk category L5*
Mercury (pdf 508kb)No
Mycotoxins (pdf 511kb)No

* Hale TW (2019) Hale's medications & mothers' milk, 2019: A manual of lactational pharmacology, Eighteenth edition. Springer Publishing Company, New York, NY. Lactation risk categories for medicines range from compatible with breastfeeding (L1) to hazardous and contraindicated for breastfeeding mothers (L5).

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