In Indonesia, the ingredient marketed as GLYCARE® 2FL 9000 can be used in flavoured liquid milk drinks for kids three years old and above, the company announced on June 2.
The approval comes after the strain Escherichia coli K-12 DH1 MDO used in the production of 2′-FL has received safety clearance from the Indonesia Biosafety Clearing House.
The strain expresses enzymes involved in 2′-FL biosynthesis, as such, it can be used to produce 2′-FL and secrete 2′-FL into the fermentation media.
The company said that the approval also showed that the ingredient did not show any potential to cause allergies, has been classified as a non-toxic substance and safe for consumption as a food ingredient.
“This safety clearance is a significant step forward in dsm-firmenich’s mission to improve access to HMOs worldwide, with ingredients from our GLYCARE® HMO portfolio now available for use in more than 165 countries,” said Elaine Tan, regulatory affairs manager for the Asia-Pacific team at dsm-firmenich.
India is one of the countries that has also approved dsm-firmenich’s HMO in recent months.
In April, the company announced that its GLYCARE 2FL has been approved as a functional ingredient for early life nutrition in India - also its first HMO approved in the country.
The approval allows GLYCARE 2FL to be used in nutritional products for infants up to six months old at a maximum level of 1.2g/L of reconstituted formula each day.
HMOs: For kids and adults
While HMOs is becoming a staple in infant formulas due to its abundance in human breast milk, companies are also exploring the use of HMOs in nutritional products designed for adults.
This is also the approach that dsm-firmenich is taking with the new approval.
The company believes that the approval could open doors for new product development that supports gut health in adults. Part of the reason is because HMOs can serve as natural prebiotics.
“Emerging evidence shows a myriad of health benefits provided by HMOs in early life nutrition, through childhood and beyond.
“The newly secured market access for GLYCARE® 2FL 9000 opens new opportunities for innovators in Indonesia to harness these benefits in nutritional solutions that support the gut health of children and adults," said Anita Wichmann, lead expert in regulatory affairs for Early Life Nutrition, Medical Nutrition and HMOs at dsm-firmenich.
In fact, the company has been building up its research on HMOs on not just infant health, but also on immunity, metabolism, ageing and mental health.
Among adults, decreased levels of Bifidobacteria have been linked to irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), obesity, and allergies, but HMOs have been shown to modulate the abundance of Bifidobacteria, said dsm-firmenich in a recent paper published this year.
Writing in Advances in Nutrition, it cited the findings of a double-blind, placebo-controlled study from Denmark, which showed that adults who took 2′-FL and LNnT at a daily dose of 20g or less had increased levels of Bifidobacterium.
Among older adults, there is also potential of using HMOs in addressing inflammaging, dysbiosis, and supporting healthy ageing.
Last year, the company also funded £50k (US$52k) to five research teams each to study the effects of HMOs and postbiotics together with or independently of probiotics within the Asian populations.
