Safety and efficacy of a feed additive consisting of astaxanthin‐rich Phaffia rhodozyma for salmon and trout (Igene Biotechnology, Inc.)

Abstract

Following a request from the European Commission, the FEEDAP Panel was asked to deliver a scientific opinion on the safety and efficacy of astaxanthin (ATX)‐rich Phaffia rhodozyma. The additive, belonging to the category ‘sensory additives’ and the functional group ‘substances which, when fed to animals, add colours to food of animal origin’ is intended to be used in feed for salmon and trout from an age of six months onwards up to a maximum content of 100 mg ATX/kg complete feed. The product is produced by the telemorph of Phaffia rhodozyma, Xanthophyllomyces dendrorhous, and it is declared to contain 995 g dried inactivated biomass and 5 g ascorbic acid per kg additive. The main active principle of the additive is ATX; however, the FEEDAP Panel noted that some other carotenoids are also present in lower quantities. The minimum ATX concentration is specified to be 5,000 mg per kg additive. The yeast Xanthophyllomyces dendrorhous is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment; therefore, the use of the production strain in the production of the additive would not raise any safety concern for the target species, the consumers of products from animals fed the additive and the environment. In the absence of a tolerance study with the additive, the FEEDAP Panel cannot conclude on the safety for the target species. In the absence of residue and toxicity data of ATX, no final conclusions on the safety for the consumer can be drawn. The FEEDAP Panel concluded that the additive is irritant to skin and eyes, and a skin and respiratory sensitiser, although exposure by inhalation is likely low. The FEEDAP Panel considers that ATX from the biomass does not pose a significant additional risk to the environment compared with other natural sources of ATX. In absence of adequate evidence, no conclusion can be made on the efficacy of the additive.

Safety of a change in specifications of the novel food oleoresin from Haematococcus pluvialis containing astaxanthin pursuant to Regulation (EU) 2015/2283

“…The safety of ATX, both synthetic and of biological origin has been extensively assessed by EFSA (EFSA, 2004(EFSA, , 2006(EFSA, , 2007aEFSA FEEDAP Panel, 2010, 2014a,b, 2019, 2022.…”

“…In their assessment, which addresses also consumer safety, the FEEDAP Panel assessed several times the safety and efficacy of synthetic ATX and ATX produced by microorganism, as feed additive for fish such as salmon and trout (EFSA, 2004(EFSA, , 2006(EFSA, , 2007aEFSA FEEDAP Panel, 2010, 2014a,b, 2019, 2022.…”

Enhancing Carotenoids’ Efficacy by Using Chitosan-Based Delivery Systems

“…The red yeast Xanthophyllomyces dendrorhous can accumulate up to 5000 µg/g DW of astaxanthin [87]. Phaffia rhodozyma yeast is recognized by both the FDA and EFSA as a GRAS additive in feed as a source of astaxanthin [92]. Phaffia rhodozyma wild type can produce up to 200-400 µg/g DW of astaxanthin but engineered strains are being experimented with to achieve higher yields for industrial applications [83].…”

Omics driven onboarding of the carotenoid producing red yeastXanthophyllomyces dendrorhousCBS 6938

“…Xanthophyllomyces dendrorhous is a nonconventional yeast that has gained attention in the aquaculture (Kheirabadi et al 2022;Bjerkeng et al 2007;Bampidis et al 2022) and nutraceutical (Ambati et al 2014;Wang et al 2019;Gimeno-Pérez et al 2015;Fernández-Arrojo et al 2007) industries due to its natural ability to produce astaxanthin, a vibrant red pigment with potent antioxidant properties (Naguib 2000;Higuera-Ciapara et al 2006;Zhang et al 2020). It is currently the only Tremellomycete with biotechnology applications.…”