Fish Oil, Omega-3 & EPA

Fish oil reference formula with total omega-3 and EPA declared, shown at example amounts of 2,000 mg oil per serving, developed as an emulsified liquid or a softgel.

Fish Oil, Omega-3 & EPA is a reference formula for brands building a marine omega-3 product that declares the oil, the total omega-3 fatty acids and the EPA on the label. The example serving carries 2,000 mg of fish oil with 650 mg of total omega-3 fatty acids and 350 mg of EPA, and the example label also declares DHA. The brand sets the final amounts for its market.

The default example is a packet of emulsified liquid oil, with a two-softgel version built from the same oil for brands that prefer capsules. The development work centers on how the omega-3 amounts are declared, the oil grade, oxidation control and, for the liquid, the emulsion system and its preservation.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Fish Oil2000 mg (example amount)Refined marine fish oil as triglycerides, stabilized with mixed tocopherols; specification 2,000 mg oil per servingConcentrated fish oil at a smaller oil weight that keeps the same omega-3 content
Omega-3 Fatty Acids650 mg (example amount)Total omega-3 fatty acids contained in the fish oilA different concentration of the oil with the omega-3 weight declared per serving
EPA350 mg (example amount)Eicosapentaenoic acid contained in the fish oilAn oil with a higher EPA share, with the oil weight adjusted

The omega-3 and EPA rows are components of the declared fish oil, not additions to it. Total omega-3 fatty acids are 32.5% of the oil weight and EPA is 17.5% in this example, and the remaining omega-3 includes the DHA that the example label declares. The fatty acid weights are declared on one basis, triglyceride or free fatty acid, and the basis is written into the specification with the supplier.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around daily marine omega-3 intake and heart and circulatory nutrition. Fish oil is included as the single oil base so that the concentration, the declared fatty acids and the delivery system can be set around one ingredient.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Daily marine omega-3 intakeFish Oil, Omega-3 Fatty Acids, EPAIncluded as long-chain omega-3 fats from oily fish, in the form assessed by a Cochrane review of 86 trials of supplements, enriched foods and advice [1]. Evidence: Referenced
Delivery form and bioavailabilityFish OilA review explains that the chemical binding form, the food matrix and the galenic form, such as emulsification, influence the bioavailability of long-chain omega-3 fatty acids [3]. Evidence: Referenced
Triglyceride and cardiovascular outcomesEPAThe Cochrane review found that increasing long-chain omega-3 intake lowered serum triglycerides by about 15% in a dose-dependent way, with little or no effect on all-cause mortality and cardiovascular events [1]. Evidence: Mixed

The amounts are examples that a brand moves up or down for its market. Oxidation of marine oils may affect the benefit and harm reported in trials, and the oxidative state of an oil can be set from peroxide and anisidine values [2].

Available Formats

The omega-3 reference formula is built for a liquid version and a softgel version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Liquid1 packet (10 mL)2000 mg oil (omega-3 650 mg, EPA 350 mg)30 packetsWater, emulsifier, mixed tocopherols, natural flavor, preservative, acidulantDefault example; emulsified oil in a single-serve packet
Softgel2 softgels2000 mg oil (omega-3 650 mg, EPA 350 mg)120 softgels (60 servings)Gelatin or plant-based shell, glycerin, mixed tocopherolsFamiliar format; 1,000 mg of oil per softgel

Raw Material Input & Fill (Design Estimate)

Design estimates. The oil input is the declared oil weight at an assumed 100% assay with mixed tocopherols carried inside the oil weight, so 2000 mg of oil per serving is the input for both formats.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Liquid2000 mg oil per packet10 mL packetWater, emulsifier, flavor and preservative systemEmulsion stability, droplet size, taste, preservative efficacy, peroxide and anisidine values through shelf life
Softgel1000 mg oil per softgel (2 per serving)1000 mg fill in an oblong shellShell weight is separate from the fillShell integrity, leak test, peroxide and anisidine values, content assay of EPA and omega-3

Powder and gummy versions are separate projects, because dry or chewable oil systems need their own encapsulation and oxidation work.

Formulation Considerations

Emulsified liquid. A packet that mixes 2000 mg of oil into 10 mL of water needs an emulsifier and a droplet size that stay stable through shelf life. The example label lists an egg-yolk emulsion, and the emulsifier choice also sets the allergen and dietary statements of the product.
Preservation of a water-based system. A liquid with water needs a preservative and an acidulant, and oil oxidation continues inside the emulsion. Peroxide and anisidine values are measured at release and at the end of shelf life, as the review in [2] recommends for marine oils.
Declared fatty acids. The label declares the oil, the total omega-3 and the EPA. The specification fixes the basis for the weights and the tolerance for each, and the content assay of the finished packet or softgel is run on that basis.
Delivery form. The review in [3] points to binding form, food matrix and emulsification as drivers of bioavailability, so the liquid and the softgel are separate specifications and are not treated as equal in a claim. Claims on a finished product are reviewed for each sales market before a product is developed.

Customization Options

Brands adjust the oil weight, the omega-3 and EPA concentration, the format and the flavor system.

ParameterRangeNote
Oil per serving1000, 2000, 2400 or 4500 mgOptions for the brand; omega-3 and EPA content scale with the oil weight
Omega-3 and EPA per gram of oil300 and 180 mg, 325 and 175 mg, or 350 and 150 mgOptions for the brand; concentrate changes oil cost and stability
FormatLiquid packet or softgelPowder and gummy are separate projects
Flavor and shellLemon, orange, mint; gelatin or plant-basedSets the odor profile and the dietary label
Add-onsVitamin D, vitamin EFat-soluble add-ons are dissolved in the oil and change the specification

The pilot run confirms emulsion stability of the packet, softgel seal integrity, peroxide and anisidine values of the first fills, taste of the liquid, and the content assay of EPA and omega-3 against the labeled amounts.

Flavor Options

FormatSuggested FlavorsWhy
LiquidLemon, orange, mintCitrus and mint profiles cover the marine note of the emulsion
SoftgelLemon (in the fill)A light citrus note limits fishy aftertaste

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (Fish Oil 2000 mg + Omega-3 Fatty Acids 650 mg + EPA 350 mg on the label of CF045990, a liquid packet; example DSLD label 321658). The label names fish oil with omega-3 fatty acids and EPA; the triglyceride form is set as the form.
SpecificationSet in formulationRefined fish oil, 2,000 mg per serving with omega-3 fatty acids 650 mg and EPA 350 mg; fatty acid basis, peroxide value, anisidine value and contaminant limits and method are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Abdelhamid AS, Brown TJ, Brainard JS, et al. Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020;3(3):CD003177. DOI · PubMed<br>[2] Albert BB, Cameron-Smith D, Hofman PL, et al. Oxidation of marine omega-3 supplements and human health. Biomed Res Int. 2013;2013:464921. DOI · PubMed<br>[3] Schuchardt JP, Hahn A. Bioavailability of long-chain omega-3 fatty acids. Prostaglandins Leukot Essent Fatty Acids. 2013;89(1):1-8. DOI · PubMed

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