What is it used for?
Products providing 100-5,000 milligrams 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 eicosapentaenoic acid (EPA), (and) docosahexaenoic acid (DHA) (and docosapentaenoic acid (DPA)¹) for the maintenance of good health [Source note 3].
¹Note: Docosapentaenoic acid (DPA) can be included in the claim if the potency information for this constituent is also listed.
Products providing 200-5,000 milligrams of EPA and DHA, per day
Helps support/maintain (normal) heart/cardiovascular health (Mann et al. 2010; Meyer et al. 2009; WHO/FAO 2003).
Helps support/maintain (normal) heart/cardiovascular function (Mann et al. 2010; Meyer et al. 2009; WHO/FAO 2003).
Products providing 1,000-5,000 milligrams of EPA and DHA, per day
Helps reduce (blood) triglyceride(s)/triacylglycerol(s) (levels) [Source note 4].
Helps support/maintain normal (blood) triglyceride/triacylglycerol levels (Mann et al. 2010; Meyer et al. 2009; WHO/FAO 2003).
Products for children up to 12 years old and providing 200-2,000 milligrams of EPA and DHA including at least 150 milligrams DHA, per day (maximum doses of EPA and DHA in Table 2 below apply based on the subpopulations)
Helps support/maintain (healthy) development of the brain/(and), eyes/(and) nerves in children up to 12 years of age [Source note 5].
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 seal oil with EPA, DHA and DPA, including concentrated oils, but excludes seal oils spiked with additional fatty acids.
Who does this guide cover?
As specified below.
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.
Acceptable dosage forms by age group:
Children 1-2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMA/CHMP 2006).
Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMA/CHMP 2006).
Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The 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
In addition to the quantity of seal oil, the potency information must be expressed as the quantity (mg) and/or percent (%) of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (% w/w) relative to the total quantity of seal oil. The potency information for docosapentaenoic acid (DPA) is optional.
| Subpopulation(s) | Subpopulation(s) | EPA + DHA (mg/day) / Minimum¹ | EPA + DHA (mg/day) / Maximum² |
|---|---|---|---|
| Children | 1-8 years 9-11 years | 100 100 | 1,500 2,000 |
| Adolescents | 12-13 years 14-17 years | 100 100 | 2,000 2,500 |
| Adults | 18 years and older | 100 | 5,000 |
¹Restrictions to minimum dose may apply according to Use(s) or Purpose(s) section above. ²Adult maximum dose of EPA + DHA is supported by US FDA 2019 and EFSA 2012. Children and adolescent maximum doses, calculated as a fraction of the adult dose, are relative to body weight and caloric intake.
Note: 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
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
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
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
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 6].
All products (information for industry; not for labelling)
Preserve in tight container, protected from light [Source note 7].
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) |
|---|---|---|---|
| Seal oil | Seal oil |
| Blubber |
References: Proper name: Brox et al. 2001; Østerud et al. 1995; Common name: Brox et al. 2001; Ø sterud et al. 1995; Source information: ITIS 2024; MMR 2018.
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 seal oil or omega-3 fatty acids derived from seal 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 seal oil and the omega-3 fatty acids from seal oil [Source note 8]. 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 (dioxin-like 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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