Algal DHA Oil | whatsinit

About

What it is and where it shows up.

Algal DHA oil is a triglyceride-rich oil derived from microalgae such as Schizochytrium sp., containing docosahexaenoic acid (DHA) as the primary fatty acid (typically 35–55% of total fatty acids). It is used as a nutritional ingredient to enrich foods and infant formulas with omega-3 DHA, supporting brain, nervous system, and visual development.

Safety summary

The regulatory and scientific consensus.

Algal DHA has a well-established safety profile with no significant adverse effects observed in multiple human and animal studies at typical supplemental intakes; EFSA concluded that supplemental DHA alone up to approximately 1 g/day does not raise safety concerns for the general adult population, and combined EPA+DHA up to 5 g/day is also considered safe. No tolerable upper intake level has been formally established by EFSA, reflecting the lack of evidence of harm at normal dietary levels. High-dose anticoagulant effects are a theoretical concern at very elevated intakes, and individuals on blood-thinning medication should consult a physician.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Authorised as a novel food ingredient under Regulation (EC) No 258/97 since 2003 for Schizochytrium sp. (ATCC 20888); extended uses authorised under Regulation (EU) 2015/2283. EFSA concluded use in food supplements up to 3 g DHA+EPA per daily dose is safe for adults (excluding pregnant and lactating women at that upper limit). Mandatory addition to infant and follow-on formula at 20–50 mg/100 kcal per Regulation (EU) 2016/127.source
Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom)	Approved	FSA and FSS confirmed that original UK/EFSA safety conclusions for Schizochytrium sp. oil rich in DHA and EPA remain accurate and reliable; approved as a novel food with conditions of use being updated to amend minimum DHA specification levels.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Permitted as an optional ingredient in infant formula and follow-on formula from Schizochytrium sp., Crypthecodinium cohnii, Mortierella alpina, and Ulkenia sp. at a maximum of 0.5% of total fatty acids as DHA, with ARA:DHA ratio of at least 1:1, per FSS (Foods for Infant Nutrition) Regulations, 2020.source
FDA (Food and Drug Administration) (United States)	Approved	Multiple GRAS notices accepted (GRN 137, 553, 677, 731, 732, 776, 844, 913, 1128) for algal oil derived from Schizochytrium sp. and related strains, for use in general food categories and infant formula. FDA raised no questions regarding the notifiers' GRAS conclusions.

Who should approach with care

Whose guidance would steer them away.

Pregnancy — EFSA's upper safe supplemental intake of 3 g/day (DHA+EPA) in food supplements explicitly excludes pregnant women pending further data; however, an additional 100–200 mg/day preformed DHA above the adult AI is recommended as adequate supply during pregnancy, so dose and source should be discussed with a healthcare provider.

Lactation — EFSA's 3 g/day supplement safety conclusion explicitly excludes lactating women; intake needs should be discussed with a healthcare provider to ensure both adequacy and safety.

Infants — While algal DHA is approved and even mandated in infant formula (20–50 mg/100 kcal per EU Regulation 2016/127 and FSSAI), the specific form and dose should match regulatory standards; unsupervised high-dose supplementation outside of formula use is not established for infants.

Heart Disease — At high supplemental doses, omega-3 fatty acids including DHA may have anticoagulant and blood pressure-lowering effects that could interact with antiplatelet or anticoagulant medications commonly used in cardiovascular disease management.

Research citations

The sources behind this verdict.

1FSSAI. Food Safety and Standards (Foods for Infant Nutrition) Regulations — Version II (04.01.2024), 2024. fssai.gov.in
2EFSA. Safety of oil from Schizochytrium sp. (strain ATCC 20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283, 2022. ncbi.nlm.nih.gov
3EFSA. Safety of oil from Schizochytrium limacinum (strain FCC-3204) for use in food supplements as a novel food pursuant to Regulation (EU) 2015/2283, 2021. ncbi.nlm.nih.gov
4FDA. GRAS Notice No. GRN 000844 — Algal Oil (55% DHA), Fermentalg, 2019. fda.gov
5FDA. GRAS Notice No. GRN 000731 — DHA Algal Oil (Schizochytrium sp.), Linyi Youkang Biology Co., Ltd., 2017. fda.gov
6EFSA. Extension of use for DHA and EPA-rich algal oil from Schizochytrium sp. as a novel food ingredient, 2014. efsa.europa.eu

Independently researched6 citations