Eicosapentaenoic acid and docosahxaenoic acid in food supplements
Report no: 2021:17
VKM cannot conclude on the safety of daily intake of 1100 mg DHA, 1550 mg EPA, or both 1550 mg EPA and 1100 mg DHA, for 3- to 18-year-olds.
Additionally, VKM cannot pinpoint the highest safe doses of DHA, EPA, or DHA and EPA combined.
About DHA and EPA
DHA and EPA are omega-3 polyunsaturated fatty acids (n-3 PUFAs). Dietary sources of n-3 PUFAs are fatty fish, human milk, and food supplements enriched with n-3 PUFAs. EPA and DHA are synthesised endogenously from α-linolenic acid in varying amounts in animal tissues.
The Norwegian Food Safety Authority (NFSA) requested VKM to assess daily intake of a food supplement containing 1100 mg DHA, 1550 mg EPA, or both 1550 mg EPA and 1100 mg DHA. The food supplement doses included in the request from NFSA are higher than the EPA and DHA levels produced endogenously, and higher than the intake from food.
No ADME data for children and adolescents were identified, and VKM can therefore not rule out that there are important differences with regard to ADME in adults, and children and adolescents. Therefore, data from studies on adults were only used as supporting information.
VKM considered that bleeding, glucose/insulin homeostasis, inflammation, lipid homeostasis, and liver effects were the most important outcomes addressed in the randomised controlled trials on children and adolescents. Note that VKM considered the data to be insufficient and that the certainty in the evidence ranged from moderate to very low.
VKM concludes that a health-based guidance value or a point of departure for DHA, EPA, or DHA and EPA combined for 3-18-year-olds cannot be established or identified, says Camilla Svendsen, scientific leader of the project group. Therefore, it is not possible to conclude on the safety of the suggested daily doses of DHA, EPA, or DHA and EPA combined for children and adolescents, or pinpoint the highest safe doses.
The risk assessment is part of VKM's new assignment on "other substances" from the Norwegian Food Safety Authority. A protocol for the risk assessment of these substances is published.