Global Ingredient Risk Index Excipient

Carnauba Wax

Copernicia cerifera (carnauba) wax (E903)

Also known as: carnauba wax, E903, Brazilian wax, palm wax

25 მარ 2026

LOW RISK 1.5/10 How?

This ingredient is classified as unclassified risk (GIRI score: 1.5/10).

Known Safety Concerns

Essentially inert and not absorbed
No documented human toxicity
FDA GRAS and E903 approved in EU
Vegan-friendly alternative to shellac

Contraindications

Essentially inert and not absorbed
No documented human toxicity

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Information not yet available for this ingredient profile.

Carnauba wax is a plant-derived wax from the leaves of the Brazilian palm, used as a tablet coating and polish. It is inert and not absorbed. FDA GRAS status. Vegan-friendly. No significant adverse effects documented at levels used in food and supplements.

Scientific Name: Copernicia cerifera (carnauba) wax (E903)

Information not yet available for this ingredient profile.

SETI Score 50/100

Risk Level High risk

Scientific Confidence Low

Evidence Strength Limited

Key Benefit Excipient

Key Safety Concern Essentially inert and not absorbed

Evidence Reviewed 10 PubMed studies

Scientific Confidence Low

Based on study quality, consistency, and recency

Executive Summary — Ingredient Assessment

SETI Score 50/100

Risk Level High risk

Evidence Strength Limited

Main Benefit Excipient

Main Safety Concern Essentially inert and not absorbed

Ingredient Carnauba Wax

Scientific name Copernicia cerifera (carnauba) wax (E903)

Scientific Evidence Overview

10 studies reviewed
0 high-quality studies (meta-analysis or RCT)
Main clinical benefit observed: Excipient
Evidence consistency: High consistency across studies (100%)

Safety Signals

Essentially inert and not absorbed
No documented human toxicity
FDA GRAS and E903 approved in EU
Vegan-friendly alternative to shellac

Evidence Strength Limited

Final Scientific Assessment

The available scientific evidence for Carnauba Wax indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.

Ingredient Carnauba Wax

Evidence reviewed 10 peer-reviewed studies (last 10 years)

Scientific name Copernicia cerifera (carnauba) wax (E903)

50 /100

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, 12:59

Evidence Distribution

10 Other / unclassified

Observational / other LOW evidence YELLOW
Tailoring Polyvinyl Alcohol/Carnauba Wax Film Properties Through Plasticizer Selection: A Pathway to Optimized Biodegradable Materials. ↗

PMID 41829324 ↗

Journal Polymers (Basel)

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41829324/

Tijani AT et al.. Tailoring Polyvinyl Alcohol/Carnauba Wax Film Properties Through Plasticizer Selection: A Pathway to Optimized Biodegradable Materials.. Polymers (Basel). 2026. PMID:41829324.
Observational / other LOW evidence YELLOW
Disc-Toroid Hybrid Lipid Nanoparticles for Efficient Drug Encapsulation and Subcutaneous Delivery. ↗

PMID 41815035 ↗

Journal Small

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41815035/

van Niekerk Z et al.. Disc-Toroid Hybrid Lipid Nanoparticles for Efficient Drug Encapsulation and Subcutaneous Delivery.. Small. 2026. PMID:41815035.
Observational / other LOW evidence YELLOW
Spray-dried polymeric nanoparticles for enhanced vodobatinib oral dissolution kinetics: formulation design and effects of hydrophobic co-core. ↗

PMID 41802502 ↗

Journal Int J Pharm

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41802502/

Dasaro SR et al.. Spray-dried polymeric nanoparticles for enhanced vodobatinib oral dissolution kinetics: formulation design and effects of hydrophobic co-core.. Int J Pharm. 2026. PMID:41802502.
Observational / other LOW evidence YELLOW
Ethyl cellulose-stabilized Pickering emulsion template for fabricating bio-based phase change foams from carnauba wax and AESO for food packaging. ↗

PMID 41794243 ↗

Journal Int J Biol Macromol

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41794243/

Cao H et al.. Ethyl cellulose-stabilized Pickering emulsion template for fabricating bio-based phase change foams from carnauba wax and AESO for food packaging.. Int J Biol Macromol. 2026. PMID:41794243.
Observational / other LOW evidence YELLOW
A novel, single-step LC-ELSD method to characterize the aliphatic fraction of natural waxes. ↗

PMID 41785768 ↗

Journal Food Chem

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41785768/

Brykczynski H et al.. A novel, single-step LC-ELSD method to characterize the aliphatic fraction of natural waxes.. Food Chem. 2026. PMID:41785768.
Observational / other LOW evidence YELLOW
Carotenoid bioaccessibility in food-grade Bigels: Impact of hydrogel:Oleogel ratio and 3D printing. ↗

PMID 41740380 ↗

Journal Food Chem

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41740380/

Fernandes AS et al.. Carotenoid bioaccessibility in food-grade Bigels: Impact of hydrogel:Oleogel ratio and 3D printing.. Food Chem. 2026. PMID:41740380.
Observational / other LOW evidence YELLOW
Tailoring network structures of water-in-Oleogel emulsions by modulating oil-to-water ratios for the fabrication of croissants: Effects on rheological properties and final product… ↗

PMID 41707256 ↗

Journal Food Chem

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41707256/

Huang Z et al.. Tailoring network structures of water-in-Oleogel emulsions by modulating oil-to-water ratios for the fabrication of croissants: Effects on rheological properties and final product texture.. Food Chem. 2026. PMID:41707256.
Observational / other LOW evidence YELLOW
Bio-Inspired Multifunctional Biodegradable Mulch Film for Sustainable Agriculture. ↗

PMID 41592544 ↗

Journal J Agric Food Chem

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41592544/

Feng M et al.. Bio-Inspired Multifunctional Biodegradable Mulch Film for Sustainable Agriculture.. J Agric Food Chem. 2026. PMID:41592544.
Observational / other LOW evidence YELLOW
Functional evaluation of wax-based oleogels as solid fat replacers for designing low saturated fat plant-based meat analogues. ↗

PMID 41545363 ↗

Journal NPJ Sci Food

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41545363/

Park YS et al.. Functional evaluation of wax-based oleogels as solid fat replacers for designing low saturated fat plant-based meat analogues.. NPJ Sci Food. 2026. PMID:41545363.
Observational / other LOW evidence YELLOW
Effects of Rumen-Protected Lysine and Tannins on Meat Quality and Fatty Acid Profile in Lambs. ↗

PMID 41517115 ↗

Journal Foods

Year 2025

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41517115/

Almeida Inu00f4 CF et al.. Effects of Rumen-Protected Lysine and Tannins on Meat Quality and Fatty Acid Profile in Lambs.. Foods. 2025. PMID:41517115.

Q × L × D × S × 10 = 1.5 / 10

The GIRI Score is the product of four independently computed evidence components, each normalised to 0–1, then scaled to 0–10. Every component is derived exclusively from peer-reviewed references and regulatory data — no editorial judgement is applied.

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)

50%

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.

Benefit

Risk

50%

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.

50%

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.

0Q × 5L × 5D × 5S = 1.5 / 10

Final GIRI Score for Carnauba Wax. 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.

LOW RISK 1.5/10

Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.

LOW
0–3.0

MODERATE
3.0–5.5

HIGH
5.5–7.5

CRITICAL
7.5–10

1.5

The score pin shows exactly where this ingredient falls on the fixed risk scale.

What drove the Low classification for Carnauba Wax

A score of 1.5 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.

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Carnauba Wax

Safety Profile

Known Safety Concerns

Contraindications

Interactions

Evidence and Scientific Findings

Ingredient Overview

Biological and Chemical Classification

Mechanism of Action

Clinical Evidence of Effectiveness

Pharmacokinetics

Recommended Dosage

SETI — Scientific Evidence Transparency Index

Executive Summary — Ingredient Assessment

Evidence Summary

Evidence Policy

Evidence Distribution

Score Transparency

Risk Level Classification

What drove the Low classification for Carnauba Wax

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