EFSA reaffirms natural astaxanthin safety for food supplements

04 Mar 2020 --- The European Food Safety Authority (EFSA) has reaffirmed its 2017 authorization of the use of astaxanthin-rich oleoresin from Haematococcus pluvialis microalgae in food supplements at levels of up to 8 mg per day. Amid rising consumer demand for natural ingredients and clean label products, the EFSA approved the microalgae-derived astaxanthin but not its synthetic and yeast-based counterparts due to lacking safety parameters and scarce established human clinical trials. The EFSA authorization can be understood as beneficial for natural astaxanthin-oriented companies, such as Algatech, as the natural versus synthetic debate continues.

“Astaxanthin from Haematococcus pluvialis origin has been used for human nutrition for many years and many clinical studies showing the product is safe and has many beneficial effects. Synthetic and yeast-origin astaxanthin are significantly different products on the molecular level. They are composed of different optical isomers of astaxanthin and have different biological effects,” Dr. Solli Brawer, Chief Science Officer at Algatech, tells NutritionInsight.

Algatech is involved in the research, cultivation and commercialization of microalgae.Touted for its natural antioxidant properties that support eye, cardiovascular and cognitive health, the majority of astaxanthin currently available in the market for human consumption is based on algae astaxanthin. 

According to Innova Market Insights data, there has been an average annual growth of 18 percent of product launches tracked with astaxanthin between 2014 and 2018. Among the top ten health claims in products with astaxanthin are eye, skin, bone and muscle health, the market researcher notes.

In terms of heeding caution of non-microalgae-derived astaxanthin, Brawer notes that there are currently no EFSA approvals for dietary supplements containing astaxanthin from non-microalgae origin. Synthetic and yeast-derived astaxanthin are approved for feed use – mainly as a color additive to salmon feed. Safety and bioavailability research is still warranted for such products to be approved for use in dietary supplements, Brawer explains. 

 In this space, NextFerm filed a patent for astaxanthin-producing yeast strains last January. Its commissioned study found high antioxidative capacity when compared to algae-derived astaxanthin.

“These findings support the benefits of a new and different natural source of astaxanthin, encouraging brands and consumers to embrace it and enjoy its huge advantages in terms of potency and flavor. Yeast-based astaxanthin is safe without any known health risks,” Elzaphan Hotam, Vice President Global Marketing and CEO of NextFerm USA, tells NutritionInsight. 

Microalgae production facility for AlgaEnergy, in Spain.Establishing the facts
The EFSA panel on Nutrition, Novel Foods and Food Allergens (NDA)’s safety review took the overall, cumulative intake of astaxanthin from all sources, including from its approved uses in food supplements and in other foods into account. The panel reviewed data collected from human, mechanistic, kinetic and toxicological studies. Besides compiling expert opinions, it also analyzed reviews on the regulatory status of astaxanthin and took new unpublished experimental in vitro data into account.

The local authorities of individual global regions determine recommended daily intake (RDI) of dietary supplements per the general diet habits of the citizens and other considerations. The RDI varies between 6 and 24 mg in different countries, Brawer further highlights. 

Moreover, there have been no records of significant adverse health consequences to consuming more than 8 mg per day. “Human studies have not identified any significant toxicity at high doses over any length of time for natural astaxanthin extracted from Haematoccocus pluvialis. This is established in at least 87 clinical trials involving more than 2,000 participants using short-term daily doses up to 100 mg and long-term daily doses averaging between 8 and 12 mg. No indicators of liver toxicity were reported in any clinical studies, but stool reddening is a minor adverse event occurring at high doses,” concludes Brawer. 

By Anni Schleicher