What is it used for?
Products providing daily doses of vitamin A at or above the Recommended Dietary Allowance (RDA) or Adequate Intake (AI) (adjusted for the life stage groups)
Helps to prevent vitamin A deficiency [Source note 2].
Products providing daily doses of vitamin D at or above the Recommended Dietary Allowance (RDA) or Adequate Intake (AI) (adjusted for the life stage groups)
Helps to prevent vitamin D deficiency [Source note 3].
Products providing 138-3,000µg retinol activity equivalents (RAE) (µg vitamin A/all-trans retinol (palmitate)), per day
As per the current source authority Multi-vitamin/Mineral Supplements reference.
Products providing 1.15-25 µg vitamin D₃/cholecalciferol, per day
As per the current source authority Multi-vitamin/Mineral Supplements reference.
Products providing 100-1,360 mg eicosapentaenoic acid (EPA) + 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) for the maintenance of good health [Source note 5]
Products providing 150-1,360 mg EPA + DHA including at least 100 mg DHA, per day
Helps support/maintain cognitive health (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 (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 200-765 mg EPA + 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].
Notes:
Refer to Appendix IV of the source authority Multivitamin/mineral Supplements reference for the RDA and AI of Vitamin A and Vitamin D.
The above uses can be combined on the product label (e.g., Helps support cognitive health and to prevent vitamin A and D deficiency).
The terms ‘Helps’ or ‘Helps to’ can be used interchangeably on the label.
What this guide covers
The use(s) or purpose(s) statements in this reference are based on the efficacy of vitamin A, vitamin D, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) that are present in cod liver oil. The references used to support these statements refer to the efficacy of these individual constituents and are not specific to cod liver oil.
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:
Infants 0 - 12 months, and Children 1-2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations drops (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 drops (Giacoia et al. 2008; EMA/CHMP 2006).
Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the dosage form drop-down list of the source’s list of accepted product forms. 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
Note:
The potencies of vitamin A, vitamin D₃ and EPA + DHA must be indicated on the product documentation and label, in addition to the dose of Cod liver oil.
| Subpopulation(s) | Subpopulation(s) | Cod liver oil / Minimum² / (ml/day)⁴ | Cod liver oil / Minimum² / (g/day) | Cod liver oil / Maximum³ / (ml/day)⁴ | Cod liver oil / Maximum³ / (g/day) |
|---|---|---|---|---|---|
| Infants | 0-12 month(s) | 0.83 | 0.77 | 0.87 | 0.80 |
| Children | 1-3 year(s) | 0.83 | 0.77 | 0.87 | 0.80 |
| Children | 4-8 years | 0.83 | 0.77 | 1.3 | 1.2 |
| Children | 9-11 years | 0.83 | 0.77 | 2.4 | 2.2 |
| Adolescents | 12-13 years | 0.83 | 0.77 | 2.4 | 2.2 |
| Adolescents | 14-17 years | 0.83 | 0.77 | 4.0 | 3.7 |
| Adults | 18 years and older | 0.83 | 0.77 | 4.3 | 4.0 |
¹BP 2012, Ph.Eur. 2012 or USP-NF 2023 grade Cod liver oil must be used to ensure that potencies of vitamin A, vitamin D3, and EPA + DHA listed in Tables 3, 4 and 5 are met. ²The minimum dose of Cod liver oil is based on the minimum quantities of EPA + DHA required for efficacy. ³The maximum dose is based on the quantity of Cod liver oil providing the maximum daily amount of vitamin A, in µg RAE, according to the UL [Source note 7]. For adults, the same maximum of oil was established for 18 years and older; however, the amount of vitamin A should not exceed the maximum values as per Table 3. ⁴Based on the specific gravity of Cod liver oil [Source note 8]
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 13].
Potencies
| Subpopulation(s) | Subpopulation(s) | Vitamin A (µg RAE/day) / Minimum ² | Vitamin A (µg RAE/day) / Maximum³ |
|---|---|---|---|
| Infants | 0-12 month(s) | 138 | 600 |
| Children | 1-3 year(s) | 138 | 600 |
| Children | 4-8 years | 138 | 900 |
| Children | 9-11 years | 138 | 1,700 |
| Adolescents | 12-13 years | 138 | 1,700 |
| Adolescents | 14-17 years | 138 | 2,800 |
| Adults | 18 years | 138 | 2,800 |
| Adults | 19 years and older | 138 | 3,000 |
¹References for the potency of vitamin A are: BP 2012, Ph.Eur. 2012, and Tischer 1938. ²Calculated as the minimum amount of vitamin A available in 0.77 g Cod liver oil, which is the based on the minimum quantities of EPA + DHA required for efficacy. ³Maximum potency based on the UL [Source note 9].
| Subpopulation(s) | Subpopulation(s) | Vitamin D₃ (µg/day) / Minimum² | Vitamin D₃ (µg/day) / Maximum³ |
|---|---|---|---|
| Infants | 0-12 month(s) | 1.15 | 5.00 |
| Children | 1-3 year(s) | 1.15 | 5.00 |
| Children | 4-8 years | 1.15 | 7.50 |
| Children | 9-11 years | 1.15 | 14.06 |
| Adolescents | 12-13 years | 1.15 | 14.06 |
| Adolescents | 14-17 years | 1.15 | 23.12 |
| Adults | 18 years | 1.15 | 23.12 |
| Adults | 19 years and older | 1.15 | 25.00 |
¹References for the potency of vitamin D₃ are: BP 2012, Ph.Eur. 2012, and Green 1951. ²Based on the minimum amount of vitamin D₃ available in 0.77g Cod liver oil, and supported by the RDA and AI for.vitamin D [Source note 10]. ³For all subpopulations, the maximum potencies are based on the amount of vitamin D₃ available in the quantity of Cod liver oil which provides the maximum daily amount of vitamin A, in µg RAE, according to the UL [Source note 11].
| Subpopulation(s) | Subpopulation(s) | EPA + DHA (mg/day) / Minimum ² | EPA + DHA (mg/day) / Maximum ³ |
|---|---|---|---|
| Infants⁴ | 0-12 month(s) | 100 | 272 |
| Children | 1-3 year(s) | 100 | 272 |
| Children | 4-8 years | 100 | 408 |
| Children | 9-11 years | 100 | 765 |
| Adolescents | 12-13 years | 100 | 765 |
| Adolescents | 14-17 years | 100 | 1,258 |
| Adults | 18 years and older | 100 | 1,360 |
¹References for the potency of EPA + DHA are: BP 2012 and Ph.Eur. 2012. ²Restrictions to minimum potency may apply according to Use(s) or Purpose(s) section above. ³The maximum potencies are based on the amount of EPA + DHA available in the quantity of Cod liver oil which provides the maximum daily amount of vitamin A, in µg RAE, according to the UL [Source note 12]. For adults, the same maximum of oil was established for 18 years and older; however, the amount of vitamin A should not exceed the maximum values as per Table 3. ⁴USP-NF 35 2023; Rajakumar and Thomas 2005; Stene et al 2003; Linday et al. 2002.
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) |
|---|---|---|---|
| Cod liver oil |
| Gadidae¹ | Liver |
References: Proper name: USP-NF 2023; Ph.Eur. 2012; Common names: USP-NF 2023; Ph.Eur. 2012; Source information: USP-NF 2023; BP 2012, Ph.Eur. 2012.
¹The species common names and not the family could be listed on the label.
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 cod liver oil and omega-3 fatty acids derived from cod liver oil must be in accordance with the methods set out by the Association of Analytical Communities (AOAC) and/or Pharmacopoeial analytical methods. These specifications are necessary to ensure the oxidative stability of the cod liver oil and the omega-3 fatty acids from cod liver 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 marine oils. Testing for these contaminants is required. 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 (Ph. Eur: EPA 2008; EPA 1994). 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 (EU 2006a.b; EU 2001). 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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