According to the Taiwan Food and Drug Administration, 2’-FL can be used in infant formula, growing-up formula, and food or milk formula for kids below seven years old.
The permitted amount for use is 1.2gram/1litre, said the regulator who also specified standards for manufacturing 2’-FL.
Earlier in March, Australia also permitted the use of 2’-FL as a prebiotic in dietary supplements.
The ingredient is already widely used in infant formula products by major infant formula brands such as Nestle and Danone.
It is also used in supplements, with H&H launching a 2’-FL powder supplement for kids one year and above last month.
H&H said it expected a rapid growth in the HMOs subcategory in the next five to 10 years, while BASF, which is an ingredient supplier of 2’-FL, said it would be the “key new ingredient” in driving the development of new digestive health products.
“The digestive health segment in the global dietary supplement market continues to register positive growth momentum and we expect that consumer demand will continue to increase.
“As such, 2’-FL – a human designed prebiotic that can support digestive health, is expected to be a key new ingredient that will drive this growth traction. APAC is the second biggest region in the digestive health market and supplement manufacturers are expected to innovate in this health space to continue to meet the evolving needs of consumers in APAC,” Lay Kwan Goh, head of global marketing at BASF Human Nutrition said in response to NutraIngredients-Asia’s queries.
Current scientific evidence
Based on existing scientific evidence, 2’-FL is able to support the growth and colonisation of bifidobacterial, inhibit pathogen invasion, and aid digestion.
“Studies in healthy, term infants that were formula-fed with a formula supplemented with HMOs had a gut microbiota that more closely resembled that of breastfed infants, with a higher relative abundance of Bifidobacterium spp,” Dr Jonathan Lane, senior manager, Global Research, H&H Group told us, citing findings from Steenhout et al and Berger et al.
He added that HMOs could prevent the establishment of viral and bacterial pathogens in the gut by strengthening the gut barrier function. This is because HMOs have anti-adhesive properties and could modulate immune response.
He cited studies by Puccio et al and Vandenplas Y et al which showed that healthy full-term infants who were given formula supplemented with HMO had fewer parent-reported incidence of bronchitis, lower respiratory tract infections and fever-related medication use.
As for safety, an open food challenge of 64 children with cow’s milk protein allergy showed that 2’-FL met the clinical hypoallergenicity criteria and could be recommended for the management of cow’s milk protein allergy in infants and young children.
“2’-FL also has a softening effect on stools during early infancy when the GI tract is undergoing growth and maturation,” said Dr Lane.