The scientific regulatory agency conducted a systematic review of the available literature and concluded that the safe level is 1 gram per day – a ‘conservative approach’, according to Jerome Le Bloch, head of scientific affairs at FoodChain ID.
The decision means that the safe level remains unchanged since EFSA’s last scientific opinion, which was published in 2012. This time around, EFSA was also due to determine a Tolerable Upper Intake Level (UL) – the maximum total daily amount of a nutrient unlikely to cause adverse health effects. However, as in 2012, the UL could not be established.
“Setting up a UL requires the identification of a clear reference point, typically based on a well-characterized adverse effect and a robust dose-response relationship,” Le Bloch told NutraIngredients.
In this case, EFSA identified spontaneous bleeding as the most critical potential adverse effect associated with high DHA intake. However, the available data were insufficient to establish a reliable dose-response relationship for DHA alone.
“Given these uncertainties, EFSA adopted a conservative and protective approach, defining a safe level of intake at which no adverse effects have been observed,” he explained. “Importantly, this does not imply that intakes above 1 g/day are unsafe, but rather that the current evidence base does not allow EFSA to scientifically justify a higher intake level as a formal UL.”
Does DHA increase the risk of spontaneous bleeding?
DHA is an omega-3 fatty acid that is commonly found in omega-3 supplements alongside eicosapentaenoic acid (EPA). EPA and DHA are the most active, longer-chain forms and have been linked to a reduction in the risk of heart disease.
However, there is potential concern around increased bleeding risk when DHA is taken at high doses for a prolonged period. This is due to the fatty acid’s antiplatelet effects, which can reduce blood clotting, according to Le Bloch.
“There is a plausible mechanism by which DHA could influence haemostasis,” he said. “Studies on omega-3 fatty acids, including DHA, suggest effects on platelet aggregation and bleeding time. Proposed mechanisms include the incorporation of DHA into platelet membranes, leading to increased membrane fluidity; competition with arachidonic acid in the synthesis of platelet-active eicosanoids such as thromboxane; and potential modulation of nitric oxide pathways.”
However, EFSA also acknowledges that direct clinical evidence linking DHA intake to spontaneous bleeding events is limited, particularly for DHA alone at higher doses.
For example, a 2024 meta-analysis published in the Journal of the American Heart Association found that omega-3 PUFAs were not associated with increased bleeding risk. In fact, most reported side effects from supplementation were minor, such as gastrointestinal discomfort or headaches.
However, this evidence, alongside other published studies, was found to be insufficient to confidently exclude such effects at high intakes. This is due to the lack of well-designed, long-term DHA-only trials assessing this endpoint.
DHA intake has also been reported to impact glucose regulation and immune function, but the regulatory body found that supplemental DHA alone at doses up to 3 g/day showed no significant adverse effects on either of these health parameters.
How will EFSA’s scientific opinion impact omega-3 brands?
At this stage, the regulatory risk for products exceeding 1 g/day of DHA is context-dependent and varies across jurisdictions and ingredient sources, Le Bloch said.
“At EU level, there is currently no harmonized maximum level for DHA in food supplements under general food law,” he said. “As a result, risk management decisions largely sit at Member State level, and national rules differ. For example, Denmark has established a maximum level of 1,500 mg/day for DHA, while Spain applies a combined limit of 3 g/day for EPA and DHA. Several other Member States have not set explicit maximum levels. These national limits mainly concern DHA derived from fish oil.”
This means that while fish oil-derived DHA products which exceed 1g per day are not automatically non-compliant at EU level, they may face increased scrutiny depending on national rules.
When it comes to omega-3 products derived from other sources, such as microalgae, the regulatory landscape is slightly more complicated. Since microalgae are regulated as novel foods, maximum daily intakes are specified in individual novel food authorizations. Microalgae-derived DHA products which exceed the authorized intake levels therefore constitute a compliance risk.
“Importantly, EFSA’s recent opinion does not establish a legal threshold above which risk is proven, nor does it introduce a binding maximum level,” Le Bloch said. “The 1 g/day value is a safe level, not a Tolerable Upper Intake Level. However, in practice, this value is likely to become a key reference point for regulators, particularly when assessing the safety of new DHA sources.”
The safe level applies to all population groups, including infants, children, adolescents, and adults (including pregnant and lactating women).
