March 1, 2021
Human Nutrition

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

  • BASF’s prebiotic, PREBILAC®, the first 2’-Fucosyllactose (2’-FL) ingredient to receive Australia’s Therapeutic Goods Administration approval
  • Approval gives BASF the exclusivity to supply 2’-FL, a human milk oligosaccharide (HMO) for use in dietary supplements for two years in Australia
  • Scientifically backed health benefits of 2’-FL for immune and digestive health across all life stages can soon be commercially accessible to more consumers in Australia

Melbourne, Australia – March 1, 2021 – BASF today announced that PREBILAC, BASF’s brand of 2’-FL, has received approval from the Australia’s Therapeutic Goods Administration (TGA), making it the first and only 2’-FL ingredient to receive TGA approval as a prebiotic ingredient.

The TGA approval unlocks the long-awaited health opportunity to commercialize the prebiotic ingredient for applications in dietary supplements. BASF will have the rights to supply 2’-FL exclusively for two years in Australia for use in these specific applications:

a.  Up to 5 g of 2’-FL daily to individuals aged 18 years and older;

b.  Up to 2 g of 2’-FL daily to individuals aged between 4 to 17 years (inclusive); and

c.   Up to 1.2 g of 2’-FL daily to individuals aged between 1 to 3 years (inclusive).

Mother’s gift for health and nutrition

2’-FL is the most abundant 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 gold 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, commonly known as IBS. PREBILAC was launched globally in 2019 for digestive health in dietary supplements and functional nutrition.

“We’re delighted that PREBILAC breaks new ground for 2’-FL applications in Australia. The approval by the Australian authorities signals that the profound health benefits of 2’-FL in dietary supplements are recognized and will soon be available to more consumers in Australia,’’ said Tina Low, Vice President, Business Management, BASF Human Nutrition. “Our customers can be assured of a very high quality 2’-FL developed with the expert knowledge of pioneers in the field of HMO in conjunction with BASF’s manufacturing expertise, commitment to safety and reliability.”

“The news of PREBILAC receiving TGA approval in Australia is a milestone for BASF. The market potential is highly promising and our customers are eager to explore applications with our nature-designed HMO, bringing the benefits of gastrointestinal health  and more to consumers in Australia and beyond,” said Harry Haikalis, Business & Sales Manager, BASF Human Nutrition Australia.

In addition to the recent 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 United States, Mexico, Argentina, Brazil and Chile.

For further information on sales and marketing opportunities of PREBILAC 2’-FL in Australia, please contact Harry Haikalis at email: or telephone: +61 419 155 405.


About BASF’s Nutrition & Health division

BASF Nutrition & Health provides a comprehensive product and service range for human and animal nutrition, pharmaceutical, bioenergy and flavor & fragrance industries. With our science-driven portfolio, we address customers in globally growing markets to meet the demands of an expanding world population. Together with our customers, we play an active role in enhancing the nutrition, health and wellbeing of consumers all over the world. Our products fulfill the highest safety, regulatory and sustainability standards. BASF Nutrition & Health operates sites in Europe, North America, South America and in Asia-Pacific. For more information, go to

About BASF

At BASF, we create chemistry for a sustainable future. We combine economic success with environmental protection and social responsibility. More than 110,000 employees in the BASF Group contribute to the success of our customers in nearly all sectors and almost every country in the world. Our portfolio is organized into six segments: Chemicals, Materials, Industrial Solutions, Surface Technologies, Nutrition & Care and Agricultural Solutions. BASF generated sales of €59 billion in 2020. BASF shares are traded on the stock exchange in Frankfurt (BAS) and as American Depositary Receipts (BASFY) in the U.S. Further information at


Geraldine Lam
Geraldine Lam
Nutrition & Health Asia Pacific
BASF’s prebiotic, PREBILAC®, the first 2’-Fucosyllactose (2’-FL) ingredient to receive Australia’s Therapeutic Goods Administration approval
Last Update March 1, 2021