The application for the extension of use comes after DSM Nutritional Products requested to raise the maximum level of use of its DHA and EPA rich algal oil to 3 grams per daily dose from the current maximum levels set in 2011 when the oil was approved as a novel food ingredient (NFI).
Writing in its scientific opinion, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA panel) noted that a previous opinion on the Tolerable Upper Intake Level of EPA, DHA and docosapentaenoic acid (DPA) concluded that supplemental intake of EPA and DHA combined at doses up to 5 grams per 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,” wrote the EFSA panel.
It added that the conclusion that there are ‘no safety concerns’ for the extention of use of the novel algal oil 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 grams of the DHA and EPA-rich algal oil per kg of body weight per day for male and female rats.
“The Panel concludes that the NFI is safe under the proposed extension of use," wrote the NDA Panel. "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 EFSA panel also noted that following a request from a Member State, it was asked to reviewed the evidence for an association between DHA and/or EPA intake and risk of prostate cancer, concluding 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."