AstaReal has announced its successful Canadian Product License approval for astaxanthin of up to 12mg per day. The company received its notification from Health Canada approving the use of AstaReal natural astaxanthin as a “source of antioxidants” and to “help improve muscle endurance”.
The company had previously been disappointed by a ruling from the EFSA panel on Dietetic Products, Nutrition and Allergies (NDA), which 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 had not been established.
The EFSA decision was, saud AstaReal, unexpected as the company says there is a wealth of safety data and historical use of natural algal astaxanthin in Europe and 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.
