The EU Commission (EC) has modified regulation for labelling and usage of astaxanthin-rich oleoresin from Haematococcus pluvialis algae, in response to a dossier submitted on behalf of The Natural Algae Astaxanthin Association (NAXA) in December 15, 2022.
Previous labelling requirements mandated a statement that food supplements containing the ingredient “should not be consumed by infants, children, and adolescents younger than 14 years.”
The new regulation (2023/1581 of 1 August 2023) extends use of the novel food, used for its anti-oxidant properties, in supplements intended for children aged 3-9 at levels of 23 mg/day of oleoresin (2,3 mg/day of astaxanthin), and to food supplements for adolescents aged 10-13 containing 57 mg/day oleoresin (5,6 mg/day of astaxanthin).
Tomás Arenas, VP Global Marketing at Atacama Bio Natural Products, in Chile, says the inclusion of children and teenagers in the European regulation for Astaxanthin consumption "marks a pivotal moment for our industry".
"This collective success, orchestrated by NAXA and bolstered by the diligent efforts of Atacama Bio's technical team, showcases the unity and drive of company-based organizations toward broader health benefits. We are deeply proud to be a part of this industry milestone, reflecting our shared vision of harnessing nature's potency for the well-being of all ages.
“We believe that the revision reflects more correctly the EFSA opinion on algae-based Astaxanthin and has confirmed safety at the indicated dosages for each age group of the population”, said Allen Levine, NAXA's president. “We are happy to have supported this
initiative for the benefit of all our members. We are pleased with this positive outcome”.
The EC's previous restrictive regulation stemmed from an interpretation of an EFSA Opinion issued in 2019 which concluded on the safety of the levels up to 8 mg of astaxanthin only for the population above 14 years of age.
In the new regulation, the EC states: "...the requested change in the conditions of use of astaxanthin-rich oleoresin from Haematococcus pluvialis algae is not liable to have an effect on human health and that a safety evaluation by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary.
"Taking into account the Acceptable Daily Intake (‘ADI’) of astaxanthin of 0,2 mg/kg body weight per day and the intakes of astaxanthin from the background diet as set out in the opinion of the authority published in 2020, the intake of astaxanthin from food supplements as proposed by the applicant would result in overall intakes of astaxanthin that do not exceed the ADI."
The dossier put to the EC was created by French consulting firm Orchidali on behalf of NAXA, an association made up of manufacturers, growers and marketers of natural algae astaxanthin, derived from Haematococcus pluviali.
Commenting on the news, Shaheen Majeed, CEO of Algae Health Science, a division of BGG focusing on production and distribution of Astaxanthin, said: "I am pleased that the stance we suggested has led to the decision to revise the existing regulation. The revised regulation now allows our customers to also offer Astaxanthin to consumers including children 3 to less than 10 years of age and adolescents 10 to less than 14 years of age. But more importantly it removed a mandatory and restrictive disclaimer from their labels.”
He added: “The previous EFSA opinions had established the safety of Astaxanthin for all consumers (except infants, for whom supplements are not authorised) within the acceptable daily intake (ADI). The removal of this restrictive disclaimer erases doubts that might have arisen among consumers regarding the safety of Astaxanthin-rich oleoresin derived from Haematococcus pluvialis algae for children, and adolescents under the age of 14.”
Matt Custer, CEO of Cyanotech Corporation, the largest producer of astaxanthin in the US and a founding member of NAXA, said: “We applaud Europe's decision recognizing astaxanthin for younger groups. This progressive move allows more people to benefit from Astaxanthin as a powerful natural antioxidant for health. The robust demand we experience from Europe for our premium Hawaiian astaxanthin underscores its value and reinforces our unwavering commitment to promote better health for all people across all continents.”