Innovative infant nutrition: Kyowa Hakko’s 2’-FL HMO clears EU regulatory hurdles
08 Aug 2024 --- Kyowa Hakko Bio’s 2’-Fucosyllactose (2’-FL) human milk oligosaccharide (HMO) receives approval as a novel food ingredient by the EU’s European Commission (EC).
The Kirin Holdings Company subsidiary says the approval allows its 2’-FL HMO ingredient—its third EC-approved HMO—to be incorporated into several food categories, including infant formula, follow-on formula, foods for medical purposes and food supplements, across 27 EU member states.
HMOs are complex carbohydrates essential for the development of infants, which are only found in human breast milk. The company can begin including its 2’FL ingredient in formulations starting on 19 August of this year.
“To be approved by the European Commission, the novel food must undergo a safety assessment by the European Food Safety Authority (EFSA) as needed,” the company reveals. “Kyowa Hakko Bio received a positive opinion on the safety of its 2’-FL from EFSA in November 2023 and it has now been approved as a novel food.”
Latest HMO developments
Kyowa Hakko began commercial production of its HMO ingredients, which include 2’-FL, 3’-Sialyllactose sodium salt (3’-SL) and 6’- Sialyllactose sodium salt (6’-SL) in November 2022 at its newly constructed production facility in Thailand. The EC has already approved its 3’-SL and 6’-SL HMOs.
Additionally, the company partnered with the Singapore Ministry of Trade and Industry’s Agency for Science, Technology and Research to advance knowledge and understanding of HMOs’ health benefits and drive innovation in the space.
“As 3’-SL and 6’-SL had been previously approved, now we are ready to supply all three HMOs — 2’-FL, 3’-SL and 6’-SL — in the EU area,” the company underscores. “We will continue to expand the availability of HMOs in countries and regions where applications for new ingredients have been approved.”
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COMPANY DETAILS
Am Wehrhahn 50
Düsseldorf
40211
Germany
www.kyowa.eu
bio-chemicals@kyowa.de
Tel: +49 211 175 450HEALTH CATEGORIES
Kyowa Hakko is an international health ingredients manufacturer and world leader in the development, manufacturing, and marketing of pharmaceuticals, nutraceuticals, and food products. Drawing on its expertise in biotechnology and fermentation, Kyowa produces award-winning branded ingredients such as Cognizin® Citicoline, postbiotics IMMUSE® and EYEMUSE®, Setria® Glutathione and has a strong emphasis on research, science, and innovation.
Our ingredients bear the Kyowa Quality mark, which means that all products are manufactured to meet highest quality assurance standards, supplying quality and trusted materials for various industries such as pharmaceuticals, foods, and cosmetics.
Key branded ingredients include:
IMMUSE®Lactococcus lactis strain Plasma
IMMUSE® is the first lactic acid bacteria that has been clinically researched to directly activate pDCs, a rare subset of immune cells, to provide comprehensive innate and adaptive immune support. It is a well-studied ingredient supported by 30 published studies, 15 human trials and 13 clinical efficacy studies.
Cognizin® Citicoline
Cognizin® Citicoline is a proprietary brain-health nutrient that has been clinically shown to support mental energy, focus, attention and recall. Cognizin® is approved as Novel Food Ingredient in the European Union and can be added to food supplements and food for special medical purposes.
EYEMUSE®Lacticaseibacillus paracasei
EYEMUSE® is a heat-treated probiotic (postbiotic) ofLacticaseibacillus paracasei KW3110 that has shown to combat visual fatigue and promote optimal eye health.
Setria® Glutathione
Known as ‘The Master Antioxidant’, Setria® Glutathione is a tripeptide composed of L-Glutamic acid, L-Cysteine and Glycine. Setria® helps protect cells from the damaging effects of toxins and oxidative stress and plays a key role in supporting immune function.
Setria® Performance Blend
Setria® Performance Blend is a clinically researched blend of glutathione and made in the USA L-Citrulline that may support nitric oxide production. New research in resistance-trained males suggests that Setria® Performance Blend may help sustain NO levels which could lead to reduced fatigue and speed post-workout recovery.
VELOX™ Patented Performance Blend
VELOX™ Blend is a clinically studied blend of two made in the USA amino acids—L-Citrulline and L-Arginine— that has been shown to boost Nitric Oxide levels more rapidly than L-Arginine alone. Help your customers achieve their personal best with VELOX™ Patented Performance Blend .
