Ingredients

Omega-3 fatty acids (EPA and DHA)

Omega-3 supplements are food supplements, but EPA and DHA are outside the EU's positive lists of vitamins and minerals. EFSA has set no upper level; it says combined supplemental intakes up to 5 g a day raise no safety concern for adults.

At a glance

Legal route

"Other substances with a nutritional or physiological effect" under Directive 2002/46/EC, so not on the Annex I and II lists; national rules apply

Nutrient reference value

None in Regulation (EU) No 1169/2011, Annex XIII. EFSA notes that recommendations for European adults are between 250 and 500 mg/day

EFSA upper level

None set. EPA and DHA combined up to 5 g/day, and EPA alone up to 1.8 g/day, raise no safety concerns for adults (2012)

DHA alone

Safe level of 1 g/day of supplemental DHA for all population groups (retained in January 2026)

Legal status

Article 4(1) of Directive 2002/46/EC limits the positive lists to vitamins and minerals. EPA and DHA are instead covered by the definition of food supplements as sources of "other substances with a nutritional or physiological effect". The usual labelling rules for supplements still apply, and national rules govern the rest. Belgium, for example, requires prior notification of other substances. Fish oil must also meet the hygiene rules in Regulation (EC) No 853/2004, and some DHA sources are authorised novel foods.

What EFSA says about intake

In 2012 EFSA found the data insufficient to set a UL for long-chain omega-3 fatty acids, individually or combined, for any population group. It also concluded: "Supplemental intakes of EPA and DHA combined at doses up to 5 g/day, and supplemental intakes of EPA alone up to 1.8 g/day, do not raise safety concerns for adults."

In January 2026 EFSA retained a safe level of 1 g a day for supplemental DHA alone, for all population groups including infants, children and pregnant and lactating women. This applies to sources with DHA alone or mostly DHA (a ratio of EPA to DHA below 0.3). It does not apply to DHA from the background diet. National bodies do not all agree: the German BfR recommends no more than 1.5 g of DHA and EPA a day from all sources.

Authorised health claims

The last three claims also require information not to exceed a supplemental daily intake of 5 g of EPA and DHA combined, and may not be used for foods targeting children. Regulation (EU) No 440/2011 separately authorises DHA claims on infant visual development and on maternal intake. "Source of omega-3" and "high in omega-3" are nutrition claims with their own thresholds in the Annex to Regulation (EC) No 1924/2006.

Safety considerations

In September 2023 the European Medicines Agency's safety committee added atrial fibrillation as a common side effect of omega-3-acid ethyl ester medicines, used for raised triglycerides. The risk was dose-dependent and highest at 4 g a day, in patients with cardiovascular disease or risk factors. That finding concerned medicines, but the German BfR says the underlying studies involved both medicines and supplements, and that heart patients should take such supplements only after consulting a doctor.

On bleeding, EFSA's view, restated in 2026, is that combined intakes up to about 5 g a day for up to 2 years did not increase the risk of spontaneous bleeding, even in people taking antiplatelet or antithrombotic medicines. We found no official supplement-specific advice on anticoagulants, although patient leaflets for omega-3 medicines mention extra monitoring with warfarin. Anyone taking these medicines should ask a physician or pharmacist. This page does not give dosing advice.

Frequently asked questions

What is the EFSA upper limit for omega-3?

EFSA has not set a tolerable upper intake level. It concluded in 2012 that supplemental EPA and DHA combined up to 5 g per day, and EPA alone up to 1.8 g per day, do not raise safety concerns for adults. For supplemental DHA alone it retains a safe level of 1 g per day.

Is there a reference intake for omega-3 on EU labels?

No. EPA and DHA have no nutrient reference value in Annex XIII of Regulation (EU) No 1169/2011, so labels give the amount without a percentage.

Can omega-3 supplements cause atrial fibrillation?

The European Medicines Agency identified atrial fibrillation as a dose-dependent side effect of omega-3 medicines, mainly in people with cardiovascular disease or risk factors. The German BfR advises heart patients to take omega-3 supplements only after consulting a doctor.

Last reviewed: November 2026.