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 a request for the 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, taking into account the comments and objections of a scientific nature raised by Member States.
The NFI is already authorised for use in a range of foodstuffs at specified maximum levels of inclusion. The present application relates to the extension of the 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.
The NFI is an algal oil derived from Schizochytrium sp. with minimum contents of 22.5 % DHA and 10 % EPA. No changes are proposed to the specification, the source and the production process of the authorised ingredient.
In a previous opinion on the Tolerable Upper Intake Level (UL) of EPA, DHA and docosapentaenoic acid (DPA), the Panel concluded that available data were insufficient to establish a UL for n-3 long-chain polyunsaturated fatty acids (EFSA NDA Panel, 2012). The Panel considered that supplemental intake of EPA and DHA combined at doses up to 5 g/day, does not give rise to safety concerns for adults.
Anticipated intake of DHA and EPA from the NFI was estimated by combining intake of the NFI through enriched foods and food supplements. High intakes of 4.65 g/day (combination of enriched foods and food supplements), based on consumption data from the UK, and 5.37 g (combination of conventional foods, enriched foods and food supplements), based on consumption data from Germany, were estimated. These assessments are considered conservative in that they assume that all food items within a food category contain the NFI at the maximum authorised level of use and that an individual consumes all food categories enriched with the NFI together with food supplements. The Panel considers that the long-term level of no concern of 5 g/day for supplemental DHA and EPA will not be exceeded by the use of the NFI.
The conclusion that there are no safety concerns for the NFI is further supported by a 90-day study carried out with the NFI in rats, in which no adverse effect was observed with the highest dose tested of 5 %whichis equivalentto 3.149 and 3.343 g NFI/kg body weight per day for male and female rats, respectively.
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.