12.13.23
The European Commission has approved of dsm-firmenich’s 3-fucosyllactose (3-FL) ingredient, which is a human milk oligosaccharide (HMO) for sue as a novel ingredient in the European Union.
According to the company, this breakthrough represents a major step toward market access to a wider range of HMO products for use in early life nutrition, conventional food, and dietary supplements.
This achievement follows a recent publication of a positive scientific opinion from the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods, and Food Allergens, which validated 3-FL produced by a strain of Escherichia coli K-12 DH1 as a novel food.
GlyCare, the branded 3-FL ingredient marketed by dsm-firmenich, is authorized for infant formula, follow-on formula, conventional foods, food for special medical purposes, and food supplements. Compared to other 3-FL ingredients, GlyCare is approved for use at high levels of 1.75 g/L in infant and follow-on formulas, compared to typical concentrations ranging from 0.85 to 1.20 g/L.
This distinction between different approved use levels in these food categories will remain during a five-year exclusive approval period granted to dsm-firmenich for its 3-FL ingredient, after which the higher concentrations will be approved for all sources of 3-FL.
The authorization for a higher use level was made possible due to a review the company conducted on the mean concentration of HMOs in global pooled human milk, which included updated summary statistics for 3-FL.
“As a company devoted to creating healthier product choices, we’re excited to be at the forefront of advancements in early life nutrition with our science-backed 3-FL ingredient,” said Christoph Röhrig, head of the global HMO regulatory affairs team at dsm-firmenich. “3-FL is one of the most abundant fucosylated HMOs in human milk, and scientific studies have demonstrated its promising potential to support immunity, gut health and potentially cognitive development.”
“The recent regulatory approval of 3-FL as a novel food in the EU means the ingredient joins our existing authorized portfolio of six HMOs in the region, including 2’-fucosyllactose (2'-FL), lacto-N-neotetraose (LNnT), difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-sialyllactose (3’-SL) sodium salt and 6’-sialyllactose (6’-SL) sodium salt,” said Marta Miks, senior regulatory and scientific affairs manager at dsm-firmenich.
“3-FL stands out among other fucosylated HMOs as a distinctive component found in all maternal milks worldwide, because unlike most HMOs, 3-FL levels exhibit a gradual increase throughout the course of lactation. Addition of 3-FL may not only bring formula products closer to that of human breast milk, but also creates an opportunity for tailored innovation in age-appropriate solutions for early life nutrition. This is especially exciting, as emerging evidence indicates that HMOs may support the gut microbiota and immunity across the lifespan,” Miks continued.
“As an end-to-end partner and the global leader in HMO regulatory approvals, we’re immensely proud to be leading the way in HMO innovation and look forward to supporting more customers in the EU with HMO customized solutions and expert services.”
According to the company, this breakthrough represents a major step toward market access to a wider range of HMO products for use in early life nutrition, conventional food, and dietary supplements.
This achievement follows a recent publication of a positive scientific opinion from the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods, and Food Allergens, which validated 3-FL produced by a strain of Escherichia coli K-12 DH1 as a novel food.
GlyCare, the branded 3-FL ingredient marketed by dsm-firmenich, is authorized for infant formula, follow-on formula, conventional foods, food for special medical purposes, and food supplements. Compared to other 3-FL ingredients, GlyCare is approved for use at high levels of 1.75 g/L in infant and follow-on formulas, compared to typical concentrations ranging from 0.85 to 1.20 g/L.
This distinction between different approved use levels in these food categories will remain during a five-year exclusive approval period granted to dsm-firmenich for its 3-FL ingredient, after which the higher concentrations will be approved for all sources of 3-FL.
The authorization for a higher use level was made possible due to a review the company conducted on the mean concentration of HMOs in global pooled human milk, which included updated summary statistics for 3-FL.
“As a company devoted to creating healthier product choices, we’re excited to be at the forefront of advancements in early life nutrition with our science-backed 3-FL ingredient,” said Christoph Röhrig, head of the global HMO regulatory affairs team at dsm-firmenich. “3-FL is one of the most abundant fucosylated HMOs in human milk, and scientific studies have demonstrated its promising potential to support immunity, gut health and potentially cognitive development.”
“The recent regulatory approval of 3-FL as a novel food in the EU means the ingredient joins our existing authorized portfolio of six HMOs in the region, including 2’-fucosyllactose (2'-FL), lacto-N-neotetraose (LNnT), difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-sialyllactose (3’-SL) sodium salt and 6’-sialyllactose (6’-SL) sodium salt,” said Marta Miks, senior regulatory and scientific affairs manager at dsm-firmenich.
“3-FL stands out among other fucosylated HMOs as a distinctive component found in all maternal milks worldwide, because unlike most HMOs, 3-FL levels exhibit a gradual increase throughout the course of lactation. Addition of 3-FL may not only bring formula products closer to that of human breast milk, but also creates an opportunity for tailored innovation in age-appropriate solutions for early life nutrition. This is especially exciting, as emerging evidence indicates that HMOs may support the gut microbiota and immunity across the lifespan,” Miks continued.
“As an end-to-end partner and the global leader in HMO regulatory approvals, we’re immensely proud to be leading the way in HMO innovation and look forward to supporting more customers in the EU with HMO customized solutions and expert services.”
