AstaREAL: Negative EFSA Astaxanthin Opinion Does Not Affect Our Ability to Market Dietary Supplements

29 Jul 2014 --- Last week, the EFSA panel on Dietetic Products, Nutrition and Allergies (NDA) published a scientific opinion on the proposed use of 4 mg algal astaxanthin in dairy products and fruit drinks. The panel concluded that the safety of algal astaxanthin at the proposed use and dosage has not been established. AstaReal note that “this opinion does not affect our ability to market dietary supplements, it only delays our entry into a new market area.”

“This decision comes unexpectedly when there is a wealth of safety data and historical use of natural algal astaxanthin in Europe and the rest of the world. The EFSA report on AstaREAL was based on a very recent scientific opinion by the panel on Additives and Products or Substances used in Animal Feed (FEEDAP) that evaluated safety and efficacy of synthetic astaxanthin formulation as feed additives for fish. An acceptable daily intake (ADI) of 0.034 mg/kg bw or equivalent to 2 mg/day exposure for a 60 kg human was proposed by EFSA. The ADI proposed by EFSA in 2007 based on earlier studies were much higher than the current proposed levels.”

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 in 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. This fact is well known and was highlighted on March 7th 2014, by an independent panel of experts brought together by the Natural Algae Astaxanthin Association (NAXA) at the Natural Products Expo West, Anaheim, USA. As market leaders and experts within the field of microalgae technology, we are committed to setting industry standards in terms of safety and quality of our natural astaxanthin products. We are fully confident in the safety of our natural astaxanthin products and will provide EFSA with the relevant additional data so that consumers will have the opportunity to benefit from natural algal astaxanthin as an NFI in the near future,” the AstaREAL statement concluded.