The company said it was “disappointed” by the “unexpected” opinion by the European Food Safety Authority (EFSA), covered here, that was a response to its EU novel foods application.
But it said the opinion that handed in an acceptable daily intake (ADI) of 0.034 mg/kg bw or equivalent to 2 mg/day exposure for a 60 kg human, was just a, “speed bump on the road for natural algal astaxanthin appearing in healthy functional food products.”
“This decision comes unexpectedly when there is a wealth of safety data and historical use of natural algal astaxanthin in Europe and rest of the world,” said Swedish-based AstaReal president Dr Arun Nair, noting the firm would provide EFSA with, “relevant additional data”.
“Sufficiently different”
Dr Nair added: “The safety concerns raised by the EFSA panel stems from a study where rats were exposed to over 200mg synthetic astaxanthin feed formulation/kg bw/day. No such observations were made in a similar mice and dog studies.
The NDA report also pointed out that the human studies provided had addressed safety endpoints that showed no adverse effects after consumption of algal astaxanthin at doses ranging from 2 to 40 mg/day for 10 days to 3 months. This is also backed by a large portfolio of sub-chronic, in-vitro and in-vivo safety data.
Furthermore, the panel concluded that algal astaxanthin poses no risk with regard to increased lung cancer in smokers. This is because algal astaxanthin is sufficiently different in structure, metabolism and function in contrast to beta-carotene so it does not behave similarly. The panel also raised no concerns for genotoxicity.
“There are obvious limitations in treating all astaxanthin as equal, as it has been established that synthetic astaxanthin has a completely different composition compared to algal astaxanthin.”
AstaReal sought to use its algae-sourced astaxanthin 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.
Research has linked astaxanthin with skin and eye health, immune function, healthy tendons, anti-aging, energy and heart benefits.