What is it used for?
Products providing 100-5,000 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), per day
Source of omega-3 fatty acids for the maintenance of good health [Source note 4].
Source of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) [Source note 5] for the maintenance of good health
Products providing 150-5,000 mg EPA and DHA including at least 100 mg DHA, per day
Helps support/maintain cognitive health (EFSA 2012; van de Rest et al. 2008; Freund-Levi et al. 2006; Fontani et al. 2005a,b; Haag 2003; Morris et al. 2003; IOM 2002).
Helps support/maintain brain function (EFSA 2012; van de Rest et al. 2008; Freund-Levi et al. 2006; Fontani et al. 2005a,b; Haag 2003; Morris et al. 2003; IOM 2002).
Products for children up to 12 years old and providing 200-2,000 mg EPA and DHA including at least 150 mg DHA, per day
Helps support/maintain (healthy) development of brain/(and), eyes/(and) nerves in children up to 12 years of age [Source note 6].
Products providing 200-5,000 mg EPA and DHA, per day
Helps support/maintain (normal) heart/cardiovascular health [Source note 7].
Helps support/maintain (normal) heart/cardiovascular function [Source note 8].
Products providing 1,000-5,000 mg EPA and DHA, per day
Helps reduce (blood) triglyceride(s)/triacylglycerol(s) (levels) [Source note 9].
Helps support/maintain normal (blood) triglyceride/triacylglycerol levels [Source note 10].
Products for adults and providing 2,800-5,000 mg EPA and DHA, per day and containing a ratio of EPA:DHA between 0.5:1 and 2:1
In conjunction with conventional therapy, helps reduce the pain of rheumatoid arthritis in adults [Source note 11].
Products providing 1,500-5,000 mg EPA and DHA including at least 1000 mg EPA, per day
Helps promote healthy mood balance (EFSA 2012; Nemets et al. 2006; Sontrop and Campbell 2006; Fontani et al. 2005a,b; Zanarini and Frankenburg 2003; Peet and Horrobin 2002; Stoll et al. 1999).
Notes:
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
There are many N-3 polyunsaturated fatty acids, popularly known as omega-3 acids/ω-3 fatty acids [Source note 1]. this reference is specific to eicosapentaenoic acid (C20:5 n-3; EPA) and docosahexaenoic acid (C22:6 n-3; DHA).
this reference only covers naturally-occurring fatty acids in fish oil with both EPA and DHA. Fish oils can be concentrated but not 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: Although delayed release dosage forms are usually not supported by 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 fish oil, the potency information must be expressed as the quantity (milligrams) and/or percent (%) of EPA and DHA (% w/w) relative to the total quantity of fish oil.
| Subpopulation(s) | Subpopulation(s) | EPA+DHA (mg/day) / Minimum¹ | EPA+DHA (mg/day) / Maximum² |
|---|---|---|---|
| Children | 1-8 years | 100 | 1,500 |
| Children | 9-11 years | 100 | 2,000 |
| Adolescents | 12-13 years | 100 | 2,000 |
| Adolescents | 14-17 years | 100 | 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 are 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
Pain of rheumatoid arthritis
Ask a healthcare professional if symptoms worsen.
Healthy mood balance
Ask a healthcare professional before use if you have psychological disorders such as anxiety or depression.
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 12].
All products (information for industry; not for labelling)
To be packaged in airtight container, protected from light [Source note 13].
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)¹ | Source information / Part(s) | Source information |
|---|---|---|---|---|
| Fish oil | Fish oil |
| Whole |
References: Proper name: BP 2023, Ph.Eur. 2023; Common name: BP 2023, Ph.Eur. 2023; Source information: BP 2023, Ph.Eur. 2023, Froese and Pauly 2022.
¹Corresponds to oil from the whole body of one or more of species of the families listed in Table 1 in its natural and/or concentrated triglyceride/triacylglycerol form and/or its concentrated esterified form [Source note 3]. The species common names and not the family could be listed on the label.
²For fish oils including species of Gadidae as a source material, the vitamin A and D content should be tested to ensure that the daily maximum amounts meet the Multi-Vitamin/Mineral Supplements reference for each age group.
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 fish oil and omega-3 fatty acids derived from fish 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 fish oil and the omega-3 fatty acids from fish oil [Source note 14]. 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.
For fish oils including Gadidae as a source material, the vitamin A and D content should be tested to ensure that their respective daily maximum amounts meet the Multi-Vitamin/Mineral Supplements reference for each age group.
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
- December 19, 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.
Taking a medication too?
Explore our supplement–medication interaction checker. Its coverage and review status are shown with the results; a missing finding does not establish that a combination is safe.