Abstract
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 an extension of use for the Novel Food (NF) 'oleoresin from Haematococcus (H.) pluvialis containing astaxanthin (ATX)' pursuant to Regulation (EU) 2015/2283. The NF is already authorised under Regulation (EU) 2015/2283 as an ingredient for use in food supplements (FS) as defined in Directive 2002/46/EC. The NF is produced by supercritical CO(2) extraction of the homogenised and dried biomass of cultivated H. pluvialis and contains approximately 10% w/w ATX With the present dossier, the applicant seeks authorisation for an extension of use of the NF for the use in dairy analogues, including beverage whiteners and fruit juices as defined by Directive 2001/112/EC. 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 the authorised use of the NF in 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.