,Following a request from the European Unionan Commission, the EFSA NDA Panel has delivered a scientific opinion on the revision of the safe level of intake for supplemental docosahexaenoic acid (DHA) when consumed alone or predominantly alone. After a comprehensive assessment of the available scientific evidence, EFSA has retained the previously established safe intake level of 1 g/day, originally set in 2012, for all population groups, including infants, children, adolescents, adults, pregnant women, and lactating women.
Scope and Methodology
EFSA conducted systematic literature reviews to identify relevant human intervention studies in which:
DHA was administered as a supplement alone, or from a source with an EPA/DHA ratio below 0.3
Supplementation lasted at least 8 weeks
No restrictions were applied with respect to population group or health outcomes
The evaluation focused exclusively on supplemental DHA, rather than DHA naturally present in foods.
Hazard Identification and Critical Effect
The Panel assessed a wide range of potential adverse effects, including:
Bleeding-related outcomes, such as bleeding time, platelet aggregation, and blood clotting parameters
Glucose homeostasis
Blood lipid profile
Markers of lipid peroxidation
Immune function
Pregnancy-related outcomes
General safety, tolerability, and reported adverse events
Among these, the risk of spontaneous bleeding was identified as the critical effect for risk characterization and for determining a tolerable intake threshold for DHA supplementation.
Derivation of a Safe Level of Intake
EFSA concluded that the available data were insufficient to establish a doseresponse relationship or to identify a reference point necessary to derive a Tolerable Upper Intake Level (UL) for supplemental DHA alone. As a result, no UL could be established for any population group.
Instead, the Panel derived a safe level of intake, defined as the highest intake at which no adverse effects have been observed in human studies. Based on the evidence reviewed, EFSA confirmed that:
A daily intake of up to 1 g of supplemental DHA alone is safe
This level is applicable to all age groups and physiological states, including pregnancy and lactation
Applicability and Sources
The confirmed safe intake level of 1 g/day applies to DHA:
Added to foods or consumed as food supplements
Present in any chemical form, including:
Triacylglycerols
Ethyl esters
Phospholipids
Derived from various sources, such as:
Fish oil concentrates
Algal oils
Krill oils
The assessment specifically covers DHA consumed alone or mostly alone, defined as products with an EPA/DHA ratio below 0.3.
Regulatory Significance
This opinion provides continued regulatory clarity for food business operators and supplement manufacturers formulating DHA-containing products in the EU. By reaffirming the 1 g/day safe intake level, EFSA supports ongoing use of DHA in foods and supplements while acknowledging the current limitations of the scientific evidence in setting a formal UL.