Scientific Opinion on the extension of use for DHA and EPA-rich algal oil from Schizochytrium sp. as a Novel Food ingredient

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 an extension of use for docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)-rich algal oil from Schizochytrium sp. as a novel food ingredient (NFI) in the context of Regulation (EC) No 258/97. The NFI is already authorised for use in a range of foodstuffs at specified maximum levels. The applicant requests an extension of use of the NFI in food supplements up to a maximum DHA and EPA content of 3 g per daily dose for the adult population, excluding pregnant and lactating women. In a previous opinion on the Tolerable Upper Intake Level of EPA, DHA and docosapentaenoic acid (DPA), the Panel concluded that supplemental intake of EPA and DHA combined at doses up to 5 g/day, does not give rise to safety concerns for adults. Based on estimations of high intake of DHA and EPA from the NFI which are considered to be conservative, the Panel considers that this level will not be exceeded by the use of the NFI. The conclusion that there are no safety concerns for the NFI is supported by a 90-day study in which no adverse effect was observed at the highest dose tested of 5 %, equivalent to 3.149 and 3.343 g NFI/kg body weight per day for male and female rats. Following a request from a Member State, the Panel reviewed the evidence for an association between DHA and/or EPA intake and risk of prostate cancer. The Panel considers that, on the basis of available data, there is no evidence for a role of EPA and/or DHA intake in the development of prostate cancer. The Panel concludes that the NFI is safe under the proposed extension of use. (C) European Food Safety Authority, 2014