Safety of astaxanthin for its use as a novel food in food supplements

摘要

Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens ( ) was asked to deliver an opinion on the safety of astaxanthin when used as a novel food in food supplements at maximum levels of 8 mg/day, taking into account the overall cumulative intake of astaxanthin from all food sources. In 2014, the Panel assessed the safety of the novel astaxanthin‐rich ingredient derived from microalgae in the context of an application submitted under Regulation ( ) No 258/1997. In that opinion, the Panel considered that the acceptable daily intake ( ) for astaxanthin was 0.034 mg/kg body weight (bw) set by the Panel in 2014. In 2019, the Panel adopted an opinion which concerned the renewal of the authorisation of dimethyldisuccinate‐astaxanthin and a new use of the additive for crustaceans and other fish than salmonids. In that assessment, the Panel derived a new of 0.2 mg astaxanthin/kg bw which replaced the of 0.034 mg/kg bw established in 2014. By taking into account an updated exposure assessment for astaxanthin from the background diet (fish and crustaceans) in combination with 8 mg from food supplements, the Panel concludes that (i) such combined exposure to astaxanthin is safe for adults, (ii) 14 to ADI, and (iii) the is exceeded by 28% in children aged 10 to