Already approved in Japan and Korea, the compound extracted from sugar beet molasses and with homocysteine lowering properties, is now Generally Regarded As Safe in the US.
"The unique properties of betaine have stimulated clinical research around the world," said Dr Stuart Craig, scientific and regulatory affairs manager at Danisco.
Betaine, also known as trimethylglycine (TMG), has been growing in popularity following published research that shows the ingredient could reduce elevated levels of serum homocysteine and so play a role in reducing the risk of heart disease.
It has been suggested that a deficiency in methyl donors, including betaine, can lead to incomplete DNA methylation with subsequent genetic instability, aging and cancer, said Danisco.
Betaine, 20 years in development, protects against dehydration and other types of stress, and may even improve athletic performance, the company added.
The ingredient is predominantly used in the US in heart-healthy supplements, often combined with B vitamins and folic acid. But the new GRAS status paves the way for further sales growth, allowing the product to be included in more food and beverage applications.
"It is also an excellent humectant in foods since it reduces water activity thereby extending shelf life, adds nutritional benefits and improves flavours," commented Ariella Gastel at Health and Nutrition, Danisco.