A decision on whether to allow Cargill's Regenasure vegetarian glucosamine hydrochloride (HCl) as a novel food ingredient has been delayed because of a lack of information on whether it would affect people with diabetes.
Cargill applied to the UK's Food Standards Agency (FSA) last August for permission to market Regenasure as an ingredient for beverage products aimed at the joint health market.
The FSA had previously ruled in 2004 that Cargill's glucosamine HCl, derived from A. niger, was substantially equivalent to the shellfish derived glucosamine, but now the firm is seeking novel food permission to use the ingredient in a range of products, mainly beverages and fermented milk-based products, at levels that would provide 750mg per daily serving.
In the firm's application, Cargill said that A. niger has a history of safe use generally in food production since the 1920s. The strain used to produce the Novel Ingredient (NI) has been used in the US and other countries for citric acid production since 1993. The company also said no glucosamine of any source is presently used in beverages marketed in Europe.
In the FSA's draft opinion, which is now up for consultation, experts from the Advisory Committee on Novel Foods and Processes (ACNFP) looked at the various strict requirements to grant Novel Ingredient (NI) permission.
The committee report took into account a series of human studies, including the effect of glucosamine on glucose metabolism and studies on high intake levels.
However, the committee found there have not been enough data to date to determine whether long-term glucosamine intake has a detrimental effect in people with severe diabetes.
The report also raised concern that the target population for products containing glucosamine would include middle-aged or elderly people, including a significant proportion of diabetics, or those whose condition has not been diagnosed.
While the committee was satisfied with the safety of the novel ingredient in other respects, the report added that: "The available information is insufficient to reach a firm conclusion regarding the possible effect of the novel ingredient on glucose metabolism, which would be of particular concern for diabetic individuals."
The ACNFP ruled that the application therefore requires additional assessment.
A Cargill spokesperson was not available for comment prior to publication.
Glucosamine is a building block of proteins called glycosaminoglycans, which are part of the structure of cartilage.
If Cargill gained the go-ahead for glucosamine HCI to be used in functional beverages it would open up a whole new area for the joint health market in Europe.
According to Mintel's Global New Products Database from a search in August last year, glucosamine is contained in almost half of all joint health supplements launched since 2000.