In fact, the company will enjoy a first-mover benefit by being the only firm that can supply 2’FL for use in supplements in Australia for two years.
The market exclusivity policy is a new framework introduced by TGA, where companies that invest in innovation and research will enjoy a two-year period of market exclusivity for newly approved ingredient.
For BASF, the 2’-FL ingredient trademarked PREBILAC is said to confer digestive and immune health benefits by promoting the growth of beneficial bacteria, inhibit pathogen adhesion, quenching inflammation, and normalising gut movement.
Being IP protected for use as prebiotic and as anti-inflammatory agent, it is already used as a prebiotic in supplements in several APAC markets, including Hong Kong, Singapore, Philippines, Vietnam, Malaysia, and New Zealand, the company told NutraIngredients-Asia.
Product examples include Holistica TigPro, a product marketed by Malaysia firm Eldon Healthcare.
The ingredient, produced by fermentation, is also used in supplements in Europe and the US – its largest market for the ingredient.
In some of the aforementioned markets, the company also supplies 2’-FL in infant formula.
In Australia, the ingredient is approved for use across different life stage, from toddlers the age of one to children, adults, and the seniors.
The permitted dosage, as approved by the TGA, is up to 1.2g of 2’FL daily for children between 1 and 3 years; up to 2g for those between 4 and 17 years; and up to 5g for adults aged 18 and above.
The company said the application to the TGA was in response to consumer demands for 2’-FL use in supplements.
At the same time, the company also believes that there are more opportunities to drive new uptake of 2’-FL in the supplements market, since 2’-FL is already becoming a common feature in infant formula.
“The approval by the Australian authorities signals that the profound health benefits of 2’-FL in dietary supplements are recognised and will soon by available to more consumers in Australia,” said Tina Low, vice president, Business Management at BASF Human Nutrition.
Formats wise, the company said the ingredient has been used in dietary supplements that come in the form of powder stick, liquid shot, and chewable tablets.
“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 and sales manager at BASF Human Nutrition Australia.
There are evidence showing that 2’-FL is beneficial for digestive health throughout different stages of life.
For instance, it could specifically promote the growth of the beneficial bifidobacterium and counteract gut microbiome dysbiosis.
On the other hand, 2'FL produces anti-pathogenic and anti-inflammatory activities by acting as a decoy receptor for pathogens, preventing pathogens from adhering to the host cells.
It can also improve the function of the enteric nervous system, such as helping to manage stress-induced gut dysmotility.