Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of astaxanthin-rich ingredients AstaREAL A1010 and AstaREAL L10 as novel food ingredients in the context of Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States.
The novel food ingredients (NFIs) are produced from Haematococcus pluvialis, a microalga naturally rich in the carotenoid pigment astaxanthin. AstaREAL A1010 is a powder containing 5.0–5.6 % astaxanthin. AstaREAL L10 is available in the form of a red viscous oil, containing 10.0–12.0 % astaxanthin, or as a powder of modified starch encapsulating the red viscous oil, containing 2.5–2.7 % astaxanthin. The applicant provided sufficient information regarding the composition, specification, manufacture and stability of the NFIs.
The NFIs are intended to be used in fermented liquid dairy products, non-fermented liquid dairy products, fermented soya products and fruit drinks for healthy adults at a maximum incorporation level of 1.6 mg astaxanthin per 100 g or 100 mL. The applicant recommends a maximum consumption of astaxanthin from the NFIs of 4 mg/day. Based on data from the EFSA comprehensive European food consumption database, mean and high intakes of astaxanthin were estimated from the mean and 95th percentile consumption data of fermented liquid dairy products, non-fermented liquid dairy products and fruit drinks in European Union Member States. The highest daily intake estimates were of 0.106 mg/kg body weight (bw) for the mean consumption and 0.256 mg/kg bw astaxanthin for the high-level consumption. In the European diet, astaxanthin is primarily consumed through seafood, with wild and farmed salmonids as a major source. Considering the additional intake from salmon and trout consumption, total mean and high daily intakes of astaxanthin of 0.125 mg/kg bw and 0.286 mg/kg bw were calculated.
The Panel considers that the composition of the ingredients and results from available studies do not indicate that the consumption of the NFIs is nutritionally disadvantageous at the proposed daily intake.
Astaxanthin is absorbed in the human gastro-intestinal tract. Its bioavailability and distribution seem to depend on a variety of factors, including its form, its mode of consumption and the smoking habits of the consumer. Astaxanthin is also absorbed in rodents. The metabolic fate of astaxanthin involves the cleavage of the polyene chain at the C9, C9' positions and stepwise reduction in both rats and humans. On the basis of similarities in absorption and metabolic fate, the Panel considers that rats are an acceptable species for toxicity testing of astaxanthin.
Based on the results of in vitro and in vivo genotoxicity studies on the biomass of H. pluvialis andother astaxanthin products, the Panel concludes that it has no safety concerns regarding genotoxicity of the NFIs.
In the human studies provided, which addressed safety endpoints, no clinically relevant changes or adverse effects were observed after consumption of the NFIs or other astaxanthin-rich ingredients from H. pluvialis at doses ranging from 2 to 40 mg/day astaxanthin for 10 days to 3 months. However, as these studies were of only short duration, the Panel considers that no conclusion can be drawn as regards long-term effects.
Supplemental intakes of β-carotene have been shown to increase the risk of lung cancer in smokers, and concerns were expressed that the NFIs may induce similar effects. There are neither human nor animal studies that have investigated astaxanthin and smoking with regard to the risk of lung cancer. There are differences in structure, metabolism and function between astaxanthin and β-carotene. In contrast to β-carotene, astaxanthin is more polar, is not a precursor of vitamin A and is considered as an antioxidant with no indication of pro-oxidative properties. The Panel concludes that the available data do not indicate that the NFIs at the proposed level of use would increase the risk of lung cancer in smokers.
The Panel considers that the likelihood of adverse allergic reactions to the NFIs is low.
Biomass of H. pluvialis (algal meal containing 3 % astaxanthin) and astaxanthin-rich oil obtained by solvent extraction from H. pluvialis biomass (containing ca. 5 % astaxanthin) were tested for subchronic toxicity in rats. There is no indication from these studies that the NFIs would be more toxic than astaxanthin. Therefore, the Panel bases the evaluation of the NFIs on astaxanthin and considers the acceptable daily intake (ADI) of 0.034 mg/kg bw for astaxanthin derived by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP).
The Panel notes that the maximum intake of 4 mg astaxanthin per day (0.06 mg/kg bw per day for a 70 kg person) from the NFIs as proposed by the applicant and the estimated mean intake based on the use levels in the proposed food categories (0.106 mg/kg bw per day) exceed the ADI for astaxanthin of 0.034 mg/kg bw per day by approximately two- and three-fold, respectively. The Panel therefore concludes that the safety of the NFIs AstaREAL A1010 and AstaREAL L10 at the proposed use and use levels has not been established.