Safety of algal meal from Haematococcus pluvialis containing astaxanthin as a novel food pursuant to Regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of the Novel Food (NF) 'algal meal from Haematococcus (H.) pluvialis containing astaxanthin (ATX)' pursuant to Regulation (EU) 2015/2283. The NF is produced by homogenising, crushing and spray-drying of the biomass of cultivated H. pluvialis and contains approximately 5% w/w ATX. It has been marketed in food supplements (FS) since the 90s. With the present dossier, the applicant seeks authorisation as a NF for its use in dairy analogues, including beverage whiteners and fruit juices as defined by Directive 2001/112/EC. The NF has been already assessed by the Panel in 2014. The applicant performed an intake assessment for ATX, which covered combined exposure from the background diet with the consumption of fish and crustacea plus intakes of the NF from the intended new uses. In such a scenario, the exposure for all population groups is below or at the acceptable daily intake (ADI) of 0.2 mg/kg bw per day. When adding also potential intake of ATX from FS, for children of 3 years of age and older and adolescents, the combined exposure from all three sources exceeds the ADI. For adults, the combined estimated intake is at the level of the ADI. The Panel concludes that the NF is safe at the intended new uses (dairy analogues, including beverage whiteners and fruit juices), provided that FS containing ATX are not consumed on the same day by children and adolescents.