EFSA assesses safety of long-chain omega-3 fatty acids

Daily supplemental intakes of 5g of long-chain omega-3 fatty acids raise no safety concerns for adults, EFSA has concluded. The Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) delivered its scientific opinion after reviewing the data on the possible adverse health effects caused by excessive intake of these omega-3 fatty acids.

Omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) – such as eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA) – play an important role in the growth and development of the brain, the regulation of blood pressure, renal function, blood clotting, and inflammatory and immunological reactions. n-3 LCPUFA can be found in foods such as fish and fish oils, milk, and cultivated marine algae. They can also be added to food or consumed as food supplements.

EFSA has carried out a number of scientific assessments of health claims related to the benefits of n-3 LCPUFA intake. The NDA Panel has concluded that intakes of EPA and DHA of between 2g and 4g a day are needed to reach claimed effects such as the maintenance of blood pressure and triglyceride levels[1], and intakes of 250mg a day are sufficient for the maintenance of normal cardiac function. In addition, in its work on dietary reference values, the Panel has concluded that 250mg a day is an adequate intake for the maintenance of general cardiovascular health among healthy adults and children.

After concerns were raised by several Member States regarding possible adverse effects associated with excessive consumption of n-3 LCPUFA, the European Commission asked EFSA for scientific advice on safe intake levels and to investigate setting a tolerable upper intake level (UL)[2] for these substances.

The Panel concluded that the available data were not sufficient to establish a UL for n-3 LCPUFA – DHA, EPA, DPA, individually or combined – for any population group.

However, the Panel notes that at intake levels obtained from foods, n-3 LCPUFA has not been associated with adverse effects in healthy adults and children. It concludes that supplemental intakes of EPA and DHA combined at doses up to 5g a day do not raise safety concerns for adults.

Specifically, the experts say that supplemental intakes of EPA and DHA of up to 5g a day do not increase the risk of reported adverse effects such as bleeding episodes, impaired regulation of glucose levels or impaired immune function.

Observed intakes from food and food supplements in EU populations are generally significantly below 5g a day. Adults consume on average up to 400-500mg of n-3 LCPUFA a day from food; children consume up to about 320mg a day. Among consumers with the highest intakes of n-3 LCPUFA (from fatty fish and/or food supplements), levels can rise to 2,700mg a day for adults and 1,700mg a day for children.

[1] A triglyceride is a type of fat that is an important source of energy for the heart and other parts of the human body. High triglyceride levels are associated with adverse health effects.
[2] A tolerable upper intake level is the maximum level of total chronic daily intake of a nutrient (from all sources) judged to be unlikely to pose a risk of adverse health effects to humans.

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