Safety Profile
Known Safety Concerns
- Contributes very little vitamin C at preservative amounts
- FDA GRAS -- no documented adverse effects at typical use levels
- May generate free palmitate at high doses
- Generally considered extremely safe
Contraindications
- Contributes very little vitamin C at preservative amounts
- FDA GRAS -- no documented adverse effects at typical use levels
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Ascorbyl palmitate is a fat-soluble antioxidant preservative and vitamin C ester used to protect oils from oxidation in supplements. It contributes minimal vitamin C to the formulation at the amounts used. FDA GRAS. Generally well tolerated. The palmitate component is a saturated fat and does not raise meaningful concern at these doses.
Biological and Chemical Classification
- Scientific Name
- L-Ascorbyl 6-palmitate (E304)
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
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Excipient
- Evidence consistency: High consistency across studies (100%)
- Contributes very little vitamin C at preservative amounts
- FDA GRAS -- no documented adverse effects at typical use levels
- May generate free palmitate at high doses
- Generally considered extremely safe
The available scientific evidence for Ascorbyl Palmitate 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 | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 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: 25 მარ 2026, 13:01
Evidence Distribution
-
Observational / other LOW evidence YELLOWPrevention of colorectal cancer and modulation of murine gut microbiota using functional meats. ↗McAlpine PL et al.. Prevention of colorectal cancer and modulation of murine gut microbiota using functional meats.. Food Funct. 2026. PMID:41725423.PMID 41725423 ↗Journal Food FunctYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41725423/
-
Observational / other LOW evidence YELLOWHigh drug-loaded supramolecular microgels enabled by controlled in-droplet self-assembly for adaptive treatment of inflammatory arthritis. ↗Wei Z et al.. High drug-loaded supramolecular microgels enabled by controlled in-droplet self-assembly for adaptive treatment of inflammatory arthritis.. Bioact Mater. 2026. PMID:41323204.PMID 41323204 ↗Journal Bioact MaterYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41323204/
-
Observational / other LOW evidence YELLOWFasciola hepatica vaccine based on Kunitz-type molecule reduces adult worm fecundity in experimentally infected sheep. ↗Ahumada M et al.. Fasciola hepatica vaccine based on Kunitz-type molecule reduces adult worm fecundity in experimentally infected sheep.. Vet Parasitol. 2026. PMID:41297438.PMID 41297438 ↗Journal Vet ParasitolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41297438/
-
Observational / other LOW evidence YELLOWFisetin topical delivery via ascorbyl palmitate/hyaluronan-enhanced limosomes: a novel paradigm for preventing UVB-induced skin photoaging. ↗Elwan AH et al.. Fisetin topical delivery via ascorbyl palmitate/hyaluronan-enhanced limosomes: a novel paradigm for preventing UVB-induced skin photoaging.. J Drug Target. 2026. PMID:41070921.PMID 41070921 ↗Journal J Drug TargetYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41070921/
-
Observational / other LOW evidence YELLOWDevelopment of ascorbyl palmitate based hydrophobic gold nanoparticles as a nanocarrier system for gemcitabine delivery. ↗Rezaei H et al.. Development of ascorbyl palmitate based hydrophobic gold nanoparticles as a nanocarrier system for gemcitabine delivery.. Sci Rep. 2025. PMID:41453958.PMID 41453958 ↗Journal Sci RepYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41453958/
-
Observational / other LOW evidence YELLOWAssessment of the feed additives consisting of ascorbic acid (3a300), sodium ascorbate (1b301), calcium ascorbate (1b302), ascorbyl palmitate (1b304), sodium calcium ascorbyl… ↗Villa RE et al.. Assessment of the feed additives consisting of ascorbic acid (3a300), sodium ascorbate (1b301), calcium ascorbate (1b302), ascorbyl palmitate (1b304), sodium calcium ascorbyl phosphate (3a312) and sodium ascorbyl phosphate (3a311) (as sources of vitamin C) for all animal species for the renewal of their authorisations (DSM Nutritional Products Ltd., NHU Europe GmbH and Orffa Additives B.V.).. EFSA J. 2025. PMID:41158677.PMID 41158677 ↗Journal EFSA JYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41158677/
-
Observational / other LOW evidence YELLOWInfluence of Arabic Gum/Gelatin/Ascorbyl Palmitate Coating on Quality Parameters of Hazelnut Kernels Stored in Plastic Boxes. ↗Kowalczyk D et al.. Influence of Arabic Gum/Gelatin/Ascorbyl Palmitate Coating on Quality Parameters of Hazelnut Kernels Stored in Plastic Boxes.. Molecules. 2025. PMID:41157143.PMID 41157143 ↗Journal MoleculesYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41157143/
-
Observational / other LOW evidence YELLOWASCORBYL PALMITATE ENHANCES ANTI-PROLIFERATIVE EFFECT OF TRASTUZUMAB IN HER2-POSITIVE BREAST CANCER CELLS. ↗Serttas R et al.. ASCORBYL PALMITATE ENHANCES ANTI-PROLIFERATIVE EFFECT OF TRASTUZUMAB IN HER2-POSITIVE BREAST CANCER CELLS.. Exp Oncol. 2025. PMID:41058465.PMID 41058465 ↗Journal Exp OncolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41058465/
-
Observational / other LOW evidence YELLOWAcetylated Epigallocatechin Gallate and Ascorbyl Palmitate: Comparative Study on Antioxidant Activity and Retardation of Lipid Oxidation in Fish Mince and Shrimp Oil. ↗Rajasekaran B et al.. Acetylated Epigallocatechin Gallate and Ascorbyl Palmitate: Comparative Study on Antioxidant Activity and Retardation of Lipid Oxidation in Fish Mince and Shrimp Oil.. J Food Sci. 2025. PMID:41030112.PMID 41030112 ↗Journal J Food SciYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41030112/
-
Observational / other LOW evidence YELLOWOral multifunctional gel beads for the targeted treatment of inflammatory bowel disease. ↗Hu D et al.. Oral multifunctional gel beads for the targeted treatment of inflammatory bowel disease.. J Control Release. 2025. PMID:40972823.PMID 40972823 ↗Journal J Control ReleaseYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40972823/
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 Ascorbyl Palmitate. 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 Ascorbyl Palmitate
A score of 2.5 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.