Fish Oil Concentrate
Also known as: Concentrated fish oil, EPA/DHA concentrate
This ingredient is classified as unclassified risk (GIRI score: 2.0/10).
Safety Profile
Information not yet available for this ingredient profile.
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Concentrated fish oil provides high amounts of EPA and DHA omega-3 fatty acids. At therapeutic doses it is well tolerated. High doses (>3 g/day EPA+DHA) can suppress platelet aggregation and should be used cautiously with anticoagulants. Fishy aftertaste and GI upset are common. Oxidation of fish oil products is a quality concern. People with fish allergies should avoid.
Biological and Chemical Classification
Information not yet available for this ingredient profile.
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 5 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Omega / EFAs
- Evidence consistency: High consistency across studies (100%)
- No significant safety signals identified in the reviewed literature.
The available scientific evidence for Fish Oil Concentrate indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 5/40 |
| Evidence consistency | 20/20 |
| Safety signals | 10/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 5 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 5 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 26 მარ 2026, 13:57
Evidence Distribution
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Observational / other LOW evidence YELLOWA Comprehensive Study via Proton Nuclear Magnetic Resonance of a Variety of Omega-3 Lipid-Rich Supplements Available in the Spanish Market: Acyl Group… ↗Weinbinder DD et al.. A Comprehensive Study via Proton Nuclear Magnetic Resonance of a Variety of Omega-3 Lipid-Rich Supplements Available in the Spanish Market: Acyl Group Profile, Minor Components, and Oxidative Status.. Foods. 2025. PMID:41464924.PMID 41464924 ↗Journal FoodsYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41464924/
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Observational / other LOW evidence YELLOWToxicological evaluation of a fish oil concentrate containing Very Long Chain Fatty Acids. ↗Tobin D et al.. Toxicological evaluation of a fish oil concentrate containing Very Long Chain Fatty Acids.. Food Chem Toxicol. 2024. PMID:38387522.PMID 38387522 ↗Journal Food Chem ToxicolYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38387522/
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Observational / other LOW evidence YELLOWNovel Approaches for Elongation of Fish Oils into Very-Long-Chain Polyunsaturated Fatty Acids and Their Enzymatic Interesterification into Glycerolipids. ↗Honzu00edkovu00e1 T et al.. Novel Approaches for Elongation of Fish Oils into Very-Long-Chain Polyunsaturated Fatty Acids and Their Enzymatic Interesterification into Glycerolipids.. J Agric Food Chem. 2023. PMID:37947776.PMID 37947776 ↗Journal J Agric Food ChemYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/37947776/
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Observational / other LOW evidence YELLOWGenotoxicity evaluation of a fish oil concentrate containing Very Long Chain Fatty Acids. ↗Tobin D et al.. Genotoxicity evaluation of a fish oil concentrate containing Very Long Chain Fatty Acids.. Toxicol Rep. 2023. PMID:37752908.PMID 37752908 ↗Journal Toxicol RepYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/37752908/
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Observational / other LOW evidence YELLOWModification of subcutaneous white adipose tissue inflammation by omega-3 fatty acids is limited in human obesity-a double blind, randomised clinical trial. ↗Fisk HL et al.. Modification of subcutaneous white adipose tissue inflammation by omega-3 fatty acids is limited in human obesity-a double blind, randomised clinical trial.. EBioMedicine. 2022. PMID:35247847.PMID 35247847 ↗Journal EBioMedicineYear 2022Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/35247847/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Fish Oil Concentrate. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Low classification for Fish Oil Concentrate
A score of 2.0 places this ingredient in the Low band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.