Safety Profile
Known Safety Concerns
- Emerging evidence for gut microbiome alteration
- Genotoxicity concerns at very high doses in recent animal studies (relevance to humans unclear)
- May form chlorinated compounds when heated -- baking use concern
- ADI 5 mg per kg per day -- rarely exceeded at supplement use levels
Contraindications
- Emerging evidence for gut microbiome alteration
- Genotoxicity concerns at very high doses in recent animal studies (relevance to humans unclear)
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Sucralose is 600x sweeter than sugar and widely used in supplement sweetening. An FDA-approved additive with an acceptable daily intake of 5 mg per kg body weight. Emerging research suggests sucralose may alter gut microbiome composition and, at very high doses, may form potentially harmful chlorinated compounds when heated. Recent animal studies raised genotoxicity concerns at very high doses. Generally considered safe at current use levels.
Biological and Chemical Classification
- Scientific Name
- 1,6-Dichloro-1,6-dideoxy-beta-D-fructofuranosyl-4-chloro-4-deoxy-alpha-D-galactopyranoside
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%)
- Emerging evidence for gut microbiome alteration
- Genotoxicity concerns at very high doses in recent animal studies (relevance to humans unclear)
- May form chlorinated compounds when heated -- baking use concern
- ADI 5 mg per kg per day -- rarely exceeded at supplement use levels
The available scientific evidence for Sucralose 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 | 9/10 |
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: 24 მარ 2026, 08:55
Evidence Distribution
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Observational / other LOW evidence YELLOWRelationship Between Diet Quality, Intestinal Permeability, and Gut Microbiota Features in Individuals with Obesity. ↗Eaton SM et al.. Relationship Between Diet Quality, Intestinal Permeability, and Gut Microbiota Features in Individuals with Obesity.. Nutrients. 2026. PMID:41829945.PMID 41829945 ↗Journal NutrientsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41829945/
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Observational / other LOW evidence YELLOWCoordination-driven high sucralose loading, releasing and purifying performance of edible u03b2-cyclodextrin metal-organic frameworks. ↗Jie H et al.. Coordination-driven high sucralose loading, releasing and purifying performance of edible u03b2-cyclodextrin metal-organic frameworks.. J Sci Food Agric. 2026. PMID:41807283.PMID 41807283 ↗Journal J Sci Food AgricYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41807283/
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Observational / other LOW evidence YELLOWMolecular mechanism of aspartame recognition by the human sweet taste receptor T1R2-T1R3 revealed by homology modeling and molecular dynamics simulations. ↗Tong M et al.. Molecular mechanism of aspartame recognition by the human sweet taste receptor T1R2-T1R3 revealed by homology modeling and molecular dynamics simulations.. J Comput Aided Mol Des. 2026. PMID:41803465.PMID 41803465 ↗Journal J Comput Aided Mol DesYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41803465/
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Observational / other LOW evidence YELLOWAspartame exacerbates cerebral ischemia-reperfusion injury via mitochondrial dysfunction and ERK/CREB1 pathway suppression. ↗Bai Y et al.. Aspartame exacerbates cerebral ischemia-reperfusion injury via mitochondrial dysfunction and ERK/CREB1 pathway suppression.. Ecotoxicol Environ Saf. 2026. PMID:41762991.PMID 41762991 ↗Journal Ecotoxicol Environ SafYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41762991/
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Observational / other LOW evidence YELLOWSucralose and PMMA Microplastics Synergistically Induce Obesity with Altered Locomotion and Metabolism in Caenorhabditis elegans. ↗Liang Y et al.. Sucralose and PMMA Microplastics Synergistically Induce Obesity with Altered Locomotion and Metabolism in Caenorhabditis elegans.. Environ Sci Technol. 2026. PMID:41739734.PMID 41739734 ↗Journal Environ Sci TechnolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41739734/
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Observational / other LOW evidence YELLOWArtificial sweeteners and male infertility: Network toxicology and experimental evidence reveal FGFR1 as the critical target. ↗Meng C et al.. Artificial sweeteners and male infertility: Network toxicology and experimental evidence reveal FGFR1 as the critical target.. Reprod Toxicol. 2026. PMID:41713522.PMID 41713522 ↗Journal Reprod ToxicolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41713522/
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Observational / other LOW evidence YELLOWRe-evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E… ↗Castle L et al.. Re-evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery wares.. EFSA J. 2026. PMID:41710869.PMID 41710869 ↗Journal EFSA JYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41710869/
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Observational / other LOW evidence YELLOWPlain language summary of the Re-evaluation of sucralose (E 955) as a food additive. ↗Plain language summary of the Re-evaluation of sucralose (E 955) as a food additive.. EFSA J. 2026. PMID:41710867.PMID 41710867 ↗Journal EFSA JYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41710867/
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Observational / other LOW evidence YELLOWGlycemic Impact of Non-Nutritive Sweeteners in Health and Type 2 Diabetes. ↗Rose BD et al.. Glycemic Impact of Non-Nutritive Sweeteners in Health and Type 2 Diabetes.. Nutr Rev. 2026. PMID:41706019.PMID 41706019 ↗Journal Nutr RevYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41706019/
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Observational / other LOW evidence YELLOWSucralose as a Way to Enhance Regulatory T Cells, the SWEET Trial: Clinical Research Protocol. ↗Bourguignon L et al.. Sucralose as a Way to Enhance Regulatory T Cells, the SWEET Trial: Clinical Research Protocol.. Can J Kidney Health Dis. 2026. PMID:41694241.PMID 41694241 ↗Journal Can J Kidney Health DisYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41694241/
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 Sucralose. 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 Sucralose
A score of 3.5 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.