What is it used for?
Products providing 100 milligrams or more of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), per day. Potency information for docosapentaenoic acid (DPA) is optional
Source of omega-3 fatty acids for the maintenance of good health [Source note 2].
Source of the omega-3 fatty acids such as EPA, (and) DHA (and DPA¹) [Source note 3].
Source of eicosapentaenoic acid (EPA), (and) docosahexaenoic acid (DHA) (and docosapentaenoic acid (DPA)¹) for the maintenance of good health [Source note 4].
¹Note:Docosapentaenoic acid (DPA) can be included in the claim if the potency information for this constituent is also listed.
Products providing 200 milligrams or more of EPA and DHA, per day
Helps support/maintain (normal) heart/cardiovascular health [Source note 5].
Helps support/maintain (normal) heart/cardiovascular function [Source note 6].
Products providing 1,000 milligrams or more of EPA and DHA, per day
Helps reduce (blood) triglyceride(s)/triacylglycerol(s) (levels) [Source note 7].
Helps support/maintain normal (blood) triglyceride/triacylglycerol levels [Source note 8].
The above uses can be combined on the product label (e.g., Helps reduce triglycerides and maintain cardiovascular health).
The terms 'Helps' or 'Helps to' can be used interchangeably on the label.
What this guide covers
this reference only covers naturally-occurring fatty acids in krill oil with EPA, DHA and DPA, including concentrated oils, but excludes krill oils spiked with additional fatty acids.
Who does this guide cover?
Adults 18 years and older
How is it taken?
Oral
Which forms are covered?
this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.
Although delayed release dosage forms are usually not supported by the source authority's references, this reference includes ‘Capsule, soft, enteric-coated’ which is commonly used for marine oil products.
Quantities
Method of preparation: Standardized fixed oil
Not to exceed 4.1 grams of krill oil, per day; providing 100 milligrams or more eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day [Source note 9].
Notes:
The potency information for docosapentaenoic acid (DPA) is optional on the product documentation form.
The following potency information is considered as additional information and can be included on the label: XX% or mg total omega-3 fatty acids.
How is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
How long is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Warnings and precautions
Ask a healthcare professional before use if you are pregnant or breastfeeding.
When should it be avoided?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Possible side effects
Stop use if hypersensitivity/allergy occurs [Source note 10].
Storage
Must be established in accordance with the requirements described in the applicable product regulations.
All products, except those encapsulated
Refrigerate after opening [Source note 11].
All products (information for industry; not for labelling)
To be packaged in airtight container, protected from light [Source note 12].
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Source material(s) | Source information / Part(s) |
|---|---|---|---|
| Krill oil | Krill oil |
| Whole |
References: Proper name: US FDA 2008, Bunea et al. 2004, Takaichi et al. 2003; Common name: US FDA 2008, Bunea et al. 2004, Takaichi et al. 2003; Source information: US FDA 2008, Bunea et al. 2004, Takaichi et al. 2003.
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Preparation and quality requirements
The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance.
The active ingredient must comply with the requirements outlined in the source ingredient database.
Peroxide, anisidine, and totox values of krill oil or omega-3 fatty acids derived from krill oil must be in accordance with the methods set out by the Association of Analytical Community (AOAC) and/or Pharmacopoeial analytical methods. These specifications are necessary to ensure the oxidative stability of the krill oil and the omega-3 fatty acids from krill oil [Source note 13]. The maximum peroxide value (PV) must be 5 mEq/kg, the maximum anisidine value (AV) must be 20 while the maximum Totox value must be 26 (calculated as 2 X PV + AV).
The dioxins, polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs); the dioxin-like polychlorinated biphenyls (DL PCBS); and the polychlorinated biphenyls (PCBs) are contaminants in oils from marine sources. Testing for these contaminants is required. As indicated in the source’s product quality guidance, testing should be performed using appropriate analytical methods, such as method No. 1613 revision B of the Environmental Protection Agency for PCDDs and PCDFs and method No. 1668B of the Environmental Protection Agency for chlorinated biphenyl congeners. product authorization holders are advised to consult the Commission of the European Communities documents on dioxins and dioxin-like PCB contaminants in marine oil for further information. Refer to the source’s product quality guidance for more information on the acceptable limits of dioxins and dioxin-like PCBs.
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- September 26, 2025
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
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