BASF’s 2’-Fucosyllactose receives Australia’s Therapeutic Goods Administration approval

Approval allows BASF to supply 2- Fucosyllactose (2’-FL), a human milk oligosaccharide (HMO) for use in dietary supplements for two years in Australia.


BASF has announced that PREBILAC, the company’s brand of 2’-Fucosyllactose (2’-FL), has received approval from the Australia’s Therapeutic Goods Administration (TGA). The approval unlocks the healthy opportunity to commercialise the prebiotic ingredient for applications in dietary supplements.

BASF will be able to supply 2’-FL for two years in Australia for use in the below specific applications:

  1. Up to 5g of 2’-FL daily to individuals aged 18 years and older;
  2. Up to 2g of 2’-FL daily to individuals aged between 4-17 years; and
  3. Up to 1.2g of 2’-FL daily to individuals aged between 1-3 years.

2’-FL is a form of human milk oligosaccharides (HMO), complex carbohydrates which are naturally found in human breast milk. HMO is one of the key differentiating factors between human and cow’s milk, and underscores why human milk is considered the standard for infant nutrition.

Emerging scientific evidence shows that 2’-FL supports the development and maintenance of a healthy gut microbiome and immune system beyond infant nutrition. The prebiotic functions of 2’-FL support human gastrointestinal health and acts as an anti-inflammatory agent for managing inflammatory disorders of the gut such as irritable bowel syndrome. PREBILAC was launched globally in 2019 for digestive health in dietary supplements and functional nutrition.

In addition to the approval in Australia, PREBILAC has been approved for use as an ingredient in dietary supplement and infant nutrition in 13 countries across Asia-Pacific, Russia, Europe, the US, Argentina, Brazil and Chile.