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, which concluded that the safety of algal astaxanthin at the proposed use and dosage has not been established.
 
While disappointed by EFSA’s ruling, AstaReal AB, Gustavsberg, Sweden, noted that the opinion does not affect its ability to market dietary supplements, but rather only delays entry into new markets.
 
The EFSA report on AstaREAL was based on a recent scientific opinion by the panel on Additives and Products or Substances used in Animal Feed (FEEDAP) that evaluated the 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 was 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, noted AstaReal AB.
 
Furthermore, the panel concluded that algal astaxanthin poses no risk in regard to increased lung cancer in smokers. According to comments from AstaReal AB, 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.
 
AstaReal AB pointed to 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 subject was highlighted on March 7^th 2014, by an independent panel of experts brought together by the Natural Algae Astaxanthin Association (NAXA) at the Natural Products Expo West, Anaheim, CA.