01.16.24
Ingredient supplier dsm-firmenich received approval from Foods Standards Australia New Zealand (FSANZ) for four of its human milk oligosaccharide ingredients as nutritive substances in infant formula products.
The company applied for these approvals through daughter company Glycom A/S to FSANZ, and became the first HMO manufacturer applicant to receive approval for four HMOs in this region. This approval paves the way for early life nutrition solutions in Australia and New Zealand which are more closely matched to the function and composition of breastmilk, the company reports.
The four dsm-firmenich ingredienst approved were: GlyCare 2’-fucosyllactose/difucosyllactose (2’-FL/DFL); GlyCare lacto-N-tetraose (LNT); GlyCare 6’-sialyllactose (6’-SL) sodium salt; and GlyCare 3’-sialyllactose (3’-SL) sodium salt.
FSANZ concluded that there were “no public health and safety concerns associated with incorporating these HMOs as nutritive substances in infant formula products, either individually or in combination, at the specified levels.”
A 15-month exclusive use period was granted for all four GlyCare HMO products, commencing on the date in which the approvals take effect.
FSANZ’s assessment also evaluated potential health benefits of the HMOs for infants. It verified that there is well-founded evidence that HMOs elicit positive effects when added to infant formula, including the promotion of beneficial gut microbiota, anti-pathogenic effects, suppression of inflammation, and support of immune responses and anti-genic memory, according to dsm-firmenich.
“dsm-firmenich is passionately committed to delivering safe and innovative infant nutrition solutions, and this latest development is a significant stride towards achieving that goal,” said Christoph Röhrig, head of HMO regulatory at dsm-firmenich. “We were the first company to bring 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) HMOs to Australia and New Zealand. But the approval of these additional four ingredients opens up even more avenues for pioneering advancements in the realm of early life nutrition, ultimately extending the reach of our HMOs’ unique health benefits to more infants globally.”
“Australia and New Zealand are important markets as FSANZ opinions are highly valued by regulatory authorities in other countries, particularly in Asia-Pacific, and therefore support market access to these HMOs in other regions”, adds Maryse Darch, regulatory and scientific affairs manager at dsm-firmenich. “We have also received approval for the same six HMO products in other markets including the EU, US, Singapore and Thailand. These approvals unlock new commercialization opportunities in over 160 markets globally for infant formula products with HMO blends that include HMOs from all three structural classes found in breastmilk: fucosylated; neutral core; and sialylated.”
The company applied for these approvals through daughter company Glycom A/S to FSANZ, and became the first HMO manufacturer applicant to receive approval for four HMOs in this region. This approval paves the way for early life nutrition solutions in Australia and New Zealand which are more closely matched to the function and composition of breastmilk, the company reports.
The four dsm-firmenich ingredienst approved were: GlyCare 2’-fucosyllactose/difucosyllactose (2’-FL/DFL); GlyCare lacto-N-tetraose (LNT); GlyCare 6’-sialyllactose (6’-SL) sodium salt; and GlyCare 3’-sialyllactose (3’-SL) sodium salt.
FSANZ concluded that there were “no public health and safety concerns associated with incorporating these HMOs as nutritive substances in infant formula products, either individually or in combination, at the specified levels.”
A 15-month exclusive use period was granted for all four GlyCare HMO products, commencing on the date in which the approvals take effect.
FSANZ’s assessment also evaluated potential health benefits of the HMOs for infants. It verified that there is well-founded evidence that HMOs elicit positive effects when added to infant formula, including the promotion of beneficial gut microbiota, anti-pathogenic effects, suppression of inflammation, and support of immune responses and anti-genic memory, according to dsm-firmenich.
“dsm-firmenich is passionately committed to delivering safe and innovative infant nutrition solutions, and this latest development is a significant stride towards achieving that goal,” said Christoph Röhrig, head of HMO regulatory at dsm-firmenich. “We were the first company to bring 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) HMOs to Australia and New Zealand. But the approval of these additional four ingredients opens up even more avenues for pioneering advancements in the realm of early life nutrition, ultimately extending the reach of our HMOs’ unique health benefits to more infants globally.”
“Australia and New Zealand are important markets as FSANZ opinions are highly valued by regulatory authorities in other countries, particularly in Asia-Pacific, and therefore support market access to these HMOs in other regions”, adds Maryse Darch, regulatory and scientific affairs manager at dsm-firmenich. “We have also received approval for the same six HMO products in other markets including the EU, US, Singapore and Thailand. These approvals unlock new commercialization opportunities in over 160 markets globally for infant formula products with HMO blends that include HMOs from all three structural classes found in breastmilk: fucosylated; neutral core; and sialylated.”
