Issues Paper: Food Regulatory Framework Considerations for Cell-based Human Milk Products

The scope of this project was to explore and provide advice on regulatory framework considerations for cell-based human milk in the context of the food regulatory system.

Out of scope issues were:

• social and ethical issues
• change to novel food regulation
• broader definition changes such as ‘human tissue’ and ‘nutritive substance’.

The review of food regulatory frameworks found:

• cell-based human milk products are unlikely to replicate the composition and health benefits of human milk
• cell-based human milk products are comparable from a function and regulatory perspective to infant formula products
• existing food regulation frameworks are appropriate for cell-based human milk products
• these frameworks will require some specific provisions to address unique characteristics of cell-based human milk products
• the principles of the Policy Guideline on the Regulation of Infant Formula are relevant for cell-based human milk products. It is not clear whether cell-based human milk products would be captured in the scope
• there are outstanding matters that need further review to understand food regulatory gaps.

Note: Infant feeding guidelines in Australia and New Zealand recommend:

• exclusive breastfeeding for the first 6 months of life
• and then continued breastfeeding alongside the introducing solid foods (from around 6 months). 

Breastfeeding is the recommended way to feed infants. However, infants who are not breastfed need a safe and nutritious substitute. This activity explores cell-based human milk as a potential alternative breast-milk substitute to infant formula.