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
Work is underway to amend policy guidance to ensure regulation of cell-based human milk products is consistent with ‘traditional’ infant formula products.
Completed work
This activity developed an issues paper which considers regulatory framework aspects of cell-based human milk.
