The application sought to use the algae-sourced carotenoid in various forms in, fermented liquid dairy products, non-fermented liquid dairy products, fermented soya products and fruit drinks for healthy adults.
It proposed a level of 1.6 mg astaxanthin per 100 g or 100 mL of food or drink.
In the European Union the market is challenged due to the lack of novel foods approval and rejected health claims from the European Food Safety Authority (EFSA).
Research has linked astaxanthin with skin and eye health, immune function, healthy tendons, anti-aging, energy and heart benefits.
When looking at the current set of data for various forms of AstaReal’s algae-sourced carotenoid, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) found issues at the 4 mg level (0.06 mg per kilogram of body weight).
The NDA found there were no toxicity issues with the nutrients in the proposed oil and powder forms. “The consumption of the NFIs [novel food ingredients] is not considered to be nutritionally disadvantageous.”
But based on an already established average daily intake (ADI) of 0.034 mg/kg bw it said the daily level of 4 mg (0.06 mg/kg bw), “exceed the ADI by approximately two- and three-fold, respectively.”
This was based on use levels in the proposed food categories (0.106 mg/kg bw per day).
“The Panel therefore concludes that the safety of the NFIs AstaREAL A1010 and AstaREAL L10 at the proposed use and use levels has not been established.”
“In the European diet, astaxanthin is primarily consumed through seafood, with wild and farmed salmonids as a major source,” the NDA noted.
“Considering the additional intake from salmon and trout consumption, total mean and high daily intakes of astaxanthin of 0.125 mg/kg bw and 0.286 mg/kg bw were calculated.”
Bioavailability was affected by, “its form, its mode of consumption and the smoking habits of the consumer.”
AstaReal said it was preparing a reaction to the opinion.