Monograph: Fish Oil

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. There are many N-3 polyunsaturated fatty acids, popularly known as omega-3 acids/omega-3 fatty acids (Ph.Eur. 2012). This monograph is specific to eicosapentaenoic acid (C20:5 n-3, EPA) and docosahexaenoic acid (C22:6 n-3, DHA). Notes: (i) Text in parentheses is additional optional information which can be included on the Product Licence Application and product labels at the applicants' discretion. (ii) The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.
Date: 2018-09-25

NHPID name

Fish Oil

Proper name(s)

Common name(s)

Fish Oil

Source material

Route Of administration


Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

General For products providing per day


Duration of use

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): No statement is required Contraindication(s): No statement is required Known Adverse Reaction(s): No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Storage conditions


References cited

References reviewed

Appendix 1

Table 1 Daily dose for eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in fish oil
Subpopulation EPA + DHA (mg/day)
Minimum Table 1 Footnote 1 Maximum Table 1 Footnote 2
Children 1-8 y 100 1,500
Adolescents 9-13 y
14-18 y
Adults Table 1 Footnote 3 ≥ 19 y 100 5,000

Table 1 Footnotes

Table 1 Footnote 1

Restrictions to minimum dose may apply according to Use(s) or Purpose(s) section above.

Return to Table 1 footnote 1 referrer

Table 1 Footnote 2

Adult maximum dose supported by US FDA 1997. Children and adolescent maximum doses, calculated as a fraction of the adult dose, are relative to body weight and caloric intake.

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Table 1 Footnote 3

Includes pregnant and breastfeeding women.

Return to Table 1 footnote 3 referrer

Table 2 Fish Oil Monographs published in the American (USP), British (BP) and European (Ph.Eur.) Pharmacopoeias
Pharmacopoeia Monograph
BP Fish Oil, Rich in Omega-3-Acids
Ph.Eur. Fish Oil, Rich in Omega-3-Acids
USP Fish Oil Containing Omega-3 Acids

Table 3 Maximum values of oxidative stability parameters for fish oil (HC 2007)
Oxidative stability parameter Maximum value
Peroxide value (PV) 5 mEq/kg
p-Anisidine value (AV) 20
Totox value 26 (calculated as (2 x PV) + AV)

Table 4 Maximum levels of dioxins, dioxin-like polychlorinated biphenyls (DL PCB) and polychlorinated biphenyls (PCBs) in oils from marine sources
Dioxin, DL PCB, and PCB contaminants Maximum level
EU 1259/2011 USP 35
Dioxins (sum of PCDDs + PCDFs) Table 4 Footnote 1 Table 4 Footnote 2 1.75 pg/g 1.0 pg/g
Sum of dioxins and DL-PCBs Table 4 Footnote 1 Table 4 Footnote 3 6.0 pg/g
PCBs Table 4 Footnote 4 200 ng/g 0.5 ppm Table 4 Footnote 5

Table 4 Footnotes

Table 4 Footnote 1

Expressed in World Health Organization (WHO 2005) toxic equivalents using WHO-toxic equivalent factors (TEFs). Analytical results relating to 17 individual dioxin congeners of toxicological concern are expressed in a single quantifiable unit: 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) toxic equivalent concentration (TEQ) (USP 35; EU 2011)

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Table 4 Footnote 2

Sum of dioxins: WHO-PCDD/F-TEQ (USP 35; EU 2011)

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Table 4 Footnote 3

Sum of dioxins and dioxin-like PCBs: WHO-PCDD/F-PCB-TEQ (EU 2011)

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Table 4 Footnote 4

Sum of PCB congeners 28, 52, 101, 118, 138, 153 and 180 (USP 35; EU 2011).

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Table 4 Footnote 5

Equivalence: 0.5 ppm = 500 ng/g

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