🇺🇸 FDA
GRAS · DSHEA dietary supplement · ω-3 qualified health claims under the omega-3 framework (CHD risk reduction · 2003Q-0401; blood pressure · 2014Q-0337) when EPA+DHA dose meets the food-labelling threshold
Also known as: Microalgal DHA · Vegan DHA · Schizochytrium DHA · Crypthecodinium DHA
250 mg combined EPA + DHA daily meets the EFSA cardiovascular threshold; 200-300 mg DHA daily for cognitive and visual maintenance per EFSA. Arterburn 2007 PMID 17713804 Lipids 28-day randomized, placebo-controlled, parallel-group bioavailability study (n = 12 per group · four groups including algal-oil capsules and a DHA-fortified food) demonstrated algal-oil DHA bioequivalence at 200 / 600 / 1,000 mg doses with linear, dose-dependent plasma phospholipid DHA response
Excellent safety profile; no heavy-metal contamination concerns (microalgal cultivation is closed-system); confirm allergen disclosure for individuals with specific algal sensitivities; check for added vitamin E if antioxidant adequacy is monitored separately
GRAS · DSHEA dietary supplement · ω-3 qualified health claims under the omega-3 framework (CHD risk reduction · 2003Q-0401; blood pressure · 2014Q-0337) when EPA+DHA dose meets the food-labelling threshold
Authorized claims Reg 432/2012 (cardiovascular, brain, vision) when EPA+DHA / DHA per-serving threshold reached
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V alegação funcional verbatim: "Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos." (≥ 1.500 mg EPA+DHA/dia)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
Reg 432/2012
EPA and DHA contribute to the normal function of the heart.
Conditions: Reg 1924/2006 art 10(2): claim may be used only for food which provides a daily intake of at least 250 mg of EPA and DHA, and the consumer must be informed that the beneficial effect is obtained with a daily intake of 250 mg of EPA and DHA
Authorized 2012
Reg 432/2012
DHA contributes to the maintenance of normal brain function.
Conditions: Reg 1924/2006 art 10(2): claim may be used only for food which contains at least 40 mg of DHA per 100 g and per 100 kcal; consumer informed that the beneficial effect is obtained with a daily intake of 250 mg of DHA
Authorized 2012
Reg 432/2012
DHA contributes to the maintenance of normal vision.
Conditions: Reg 1924/2006 art 10(2): claim may be used only for food which contains at least 40 mg of DHA per 100 g and per 100 kcal; consumer informed that the beneficial effect is obtained with a daily intake of 250 mg of DHA
Authorized 2012
IN 28/2018 Anexo V alegação funcional
Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.
Conditions: IN 28/2018 Anexo V: alegação restrita a suplementos que forneçam ao menos 1.500 mg de EPA + DHA por dia
Authorized 2018
Health goals: heart health cognitive support eye protection reproductive health
Lifestyles: plant based pregnancy senior 60 plus
Full dossier: /ingredients/algal-oil/
Machine-readable JSON: /api/nc/algal-oil.json