Scientific Opinion on the tolerable upper intake level for supplemental docosahexaenoic acid

Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the safe level of intake for supplemental docosahexaenoic acid (DHA). Systematic reviews of the literature were conducted to identify human intervention studies administering supplemental DHA alone from a source with an eicosapentaenoic acid (EPA)/DHA ratio < 0.3 for at least 8 weeks, without restrictions on population or outcome. Hazard identification focused on bleeding complications (including bleeding time, platelet function and blood clotting parameters), glucose homeostasis, blood lipid profile, markers of lipid peroxidation, immune function, pregnancy endpoints and safety, tolerability and adverse events. The risk of spontaneous bleeding was selected as the critical effect on which to base the UL/safe level of intake for supplemental DHA alone. In the absence of adequate data to characterise a dose-response relationship and identify a reference point, no UL for supplemental DHA alone can be established for any population group. Therefore, the Panel derived a safe level of intake, which differs from a UL in that it is based on intakes up to which no adverse effects have been observed. Based on the available evidence, the Panel retains the safe level of intake of 1 g/day for supplemental DHA alone established in 2012 for all population groups (i.e. infants, children, adolescents and adults, including pregnant and lactating women). This safe level of intake applies to DHA added to foods or consumed as food supplements in any chemical form (e.g. triacylglycerols, ethyl esters, phospholipids) from sources (e.g. fish oil concentrates, algal oils, krill oils) containing DHA alone or mostly DHA (i.e., EPA/DHA ratio < 0.3).