Assessment on Astaxanthin-rich Oleoresin From <i>Haematococcus pluvialis</i> Algae Used as a Novel Food (RP2213)

AstaReal AB (“the applicant”) submitted a novel food (NF) application for the modification in condition of use of the NF Astaxanthin (ATX)-rich oleoresin from Haematococcus pluvialis algae to each nation of Great Britain in April 2024. The NF is produced from Haematococcus pluvialis algae and then dried and extracted into an oil containing ATX. The NF was authorised in the EU (and GB) in 2006 following an opinion through the substantial equivalence process of Regulation (EC) 258/97 to Haematococcus pluvialis biomass containing astaxanthin, which has been marketed in the EU since 1995. The NF is currently authorised for use as food supplements in the general population excluding infants, toddlers, children, and adolescents younger than 14 years. This application seeks to modify the specification of the oleoresin NF for ATX monoesters, ATX diesters, the 9-cis ATX stereoisomer, and the minimum protein content. The current maximum authorised level of the novel food is 40–80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day, which will remain unchanged. In 2023, the European Food Safety Authority (EFSA) published a scientific opinion on the safety of the change to the conditions of use of the NF ingredient. The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have reviewed the information available, including the EFSA opinion, and confirmed that the NF is safe under the proposed change to the conditions of use. The anticipated intake levels and use in food supplements were not considered to be nutritionally disadvantageous. This safety assessment represents the opinion of the FSA and FSS.