Aim
To inform of potential food regulatory issues with the manufacture and creation of commercialising cell-based human milk that:
- may warrant Ministerial direction; or
- FSANZ standards development processes will not address.
The Food Regulation Standing Committee (FRSC) Cell-based Human Milk Working Group is considering these issues. The Department of Health Victoria is the lead for this activity.
The scope of the work consists of potential issues in the bi-national food regulation system. This includes:
- potential gaps or areas of uncertainty in the Australia New Zealand Food Standards Code
- interface with human tissue legislation
- interaction with import and export regulations.
Social and ethical issues are not in the scope of this project. Where the working group identifies such issues they will be provided to Food Ministers to refer the matter(s) to an appropriate body or committee.
Note: Infant feeding guidelines in Australia and New Zealand recommend:
- exclusive breastfeeding for the first 6 months of life
- and then continued breastfeeding alongside introducing solid foods (from around 6 months).
Breastfeeding is the recommended way to feed infants. However, a safe and nutritious substitute for breastmilk is needed for infants who are not breastfed. This activity explores cell-based human milk as a potential alternative breast-milk substitute to infant formula.
Authorisation
In November 2022, FRSC agreed to convene a new working group to investigate food safety issues related to cell-based human milk.
In May 2024 the Food Ministers’ Meeting agreed FRSC will progress work to amend policy guidance to ensure regulatory consistency between cell-based human milk and ‘traditional’ infant formula.
Status
In August 2025, FRSC agreed that the working group had achieved its objective and would be disbanded. Existing food regulation surveillance systems will monitor developments in cell-based human milk products going forward to identify any changes that require further regulatory consideration.
Completed work
Policy Guideline update
In November 2024, food ministers approved an updated policy guideline. The revised policy guideline expands the definition of ‘infant formula product’ to include cell-based human milk products.
Issues Paper
An issues paper was published in 2024 which analysed regulatory framework aspects of cell-based human milk. The issues paper recommended that the policy guideline on the regulation of infant formula products be updated to require cell-based human milk products to be regulated in a similar way to traditional information formula products.
