Global Ingredient Risk Index Botanical

Lycopene

Lycopene from Lycopersicon esculentum (tomato)

Also known as: lycopene, tomato extract, all-trans-lycopene, lyco-o-mato

25 მარ 2026

LOW RISK 2.5/10 How?

This ingredient is classified as unclassified risk (GIRI score: 2.5/10).

Known Safety Concerns

Skin yellowing at very high doses
RCTs have not confirmed prostate cancer prevention despite observational data
High-dose supplements may interact with warfarin
Generally one of the safer carotenoid supplements

Contraindications

Skin yellowing at very high doses
RCTs have not confirmed prostate cancer prevention despite observational data

═══════════════════════════════════════════════════════════════════════ -->

Information not yet available for this ingredient profile.

Lycopene is a carotenoid antioxidant from tomatoes associated with reduced prostate cancer risk in observational studies. However RCTs have not confirmed a protective effect. Generally very well tolerated. Skin yellowing at very high doses. May interact with warfarin in high-dose supplements.

Scientific Name: Lycopene from Lycopersicon esculentum (tomato)

Information not yet available for this ingredient profile.

SETI Score 50/100

Risk Level High risk

Scientific Confidence Low

Evidence Strength Limited

Key Benefit Botanical

Key Safety Concern Skin yellowing at very high doses

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 Botanical

Main Safety Concern Skin yellowing at very high doses

Ingredient Lycopene

Scientific name Lycopene from Lycopersicon esculentum (tomato)

Scientific Evidence Overview

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

Safety Signals

Skin yellowing at very high doses
RCTs have not confirmed prostate cancer prevention despite observational data
High-dose supplements may interact with warfarin
Generally one of the safer carotenoid supplements

Evidence Strength Limited

Final Scientific Assessment

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

Ingredient Lycopene

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

Scientific name Lycopene from Lycopersicon esculentum (tomato)

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: 31 მარ 2026, 07:11

Evidence Distribution

10 Other / unclassified

Observational / other LOW evidence YELLOW
Dynamic Lysine Acetylation Disrupts Isocitrate Lyase Function and Enables Metabolic Optimisation. ↗

PMID 41910453 ↗

Journal Microb Biotechnol

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41910453/

Martu00ednez-Vivancos A et al.. Dynamic Lysine Acetylation Disrupts Isocitrate Lyase Function and Enables Metabolic Optimisation.. Microb Biotechnol. 2026. PMID:41910453.
Observational / other LOW evidence YELLOW
LmCCS Impacts the Flower Colour of Lily by Manipulating the Carotenoid Metabolic Flux. ↗

PMID 41906951 ↗

Journal Physiol Plant

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41906951/

Li H et al.. LmCCS Impacts the Flower Colour of Lily by Manipulating the Carotenoid Metabolic Flux.. Physiol Plant. 2026. PMID:41906951.
Observational / other LOW evidence YELLOW
Lycopene ameliorates swainsonine-induced autophagy in rat renal tubular epithelial cells via the endoplasmic reticulum stress UPR pathway. ↗

PMID 41905027 ↗

Journal Res Vet Sci

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41905027/

Wang P et al.. Lycopene ameliorates swainsonine-induced autophagy in rat renal tubular epithelial cells via the endoplasmic reticulum stress UPR pathway.. Res Vet Sci. 2026. PMID:41905027.
Observational / other LOW evidence YELLOW
Effects of supplementary lighting with different spectral compositions on plant growth, fruit development, and quality formation of facility-grown tomatoes. ↗

PMID 41904292 ↗

Journal Sci Rep

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41904292/

Sun D et al.. Effects of supplementary lighting with different spectral compositions on plant growth, fruit development, and quality formation of facility-grown tomatoes.. Sci Rep. 2026. PMID:41904292.
Observational / other LOW evidence YELLOW
Acute Combination of Nitrogen Deprivation and High Irradiance Induces the Simultaneous Accumulation of Astaxanthin and Lutein in Continuous Cultures of the Microalga… ↗

PMID 41901421 ↗

Journal Plants (Basel)

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41901421/

Morales-Pineda M et al.. Acute Combination of Nitrogen Deprivation and High Irradiance Induces the Simultaneous Accumulation of Astaxanthin and Lutein in Continuous Cultures of the Microalga Chromochloris zofingiensis.. Plants (Basel). 2026. PMID:41901421.
Observational / other LOW evidence YELLOW
The ATP Binding Cassette (ABC) Transporter Gene Family in Lotus (Nelumbo Adans.): Genome-Wide Survey, Characterization and Gene Expression Profile. ↗

PMID 41892229 ↗

Journal Biology (Basel)

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41892229/

Zhao Y et al.. The ATP Binding Cassette (ABC) Transporter Gene Family in Lotus (Nelumbo Adans.): Genome-Wide Survey, Characterization and Gene Expression Profile.. Biology (Basel). 2026. PMID:41892229.
Observational / other LOW evidence YELLOW
Bioconversion of carotenoids into high-value crocins using a marine sponge carotenoid cleavage dioxygenase. ↗

PMID 41889127 ↗

Journal New Phytol

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41889127/

Moreno-Gimu00e9nez E et al.. Bioconversion of carotenoids into high-value crocins using a marine sponge carotenoid cleavage dioxygenase.. New Phytol. 2026. PMID:41889127.
Observational / other LOW evidence YELLOW
Soybean protein complexes as diglyceride nanostructured lipid carriers for lycopene delivery: preparation via metal-phenol network formation. ↗

PMID 41886988 ↗

Journal Food Chem

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41886988/

Guo X et al.. Soybean protein complexes as diglyceride nanostructured lipid carriers for lycopene delivery: preparation via metal-phenol network formation.. Food Chem. 2026. PMID:41886988.
Observational / other LOW evidence YELLOW
Genetic determinants of lycopene concentration in subcutaneous adipose tissue: insights into interindividual variability in adult males. ↗

PMID 41848742 ↗

Journal Food Funct

Year 2026

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41848742/

Zumaraga MP et al.. Genetic determinants of lycopene concentration in subcutaneous adipose tissue: insights into interindividual variability in adult males.. Food Funct. 2026. PMID:41848742.
Observational / other LOW evidence YELLOW
Supplemental Lycopene Reduces Feed Intake, Increases Fluid Consumption, and Enhances Bone and Stomach Growth in Growing Wistar Rats Fed a High-Fructose Diet. ↗

PMID 41870163 ↗

Journal J Med Food

Year 2025

Study type Observational / other

Evidence strength LOW evidence

PubMed link https://pubmed.ncbi.nlm.nih.gov/41870163/

Shafe MO et al.. Supplemental Lycopene Reduces Feed Intake, Increases Fluid Consumption, and Enhances Bone and Stomach Growth in Growing Wistar Rats Fed a High-Fructose Diet.. J Med Food. 2025. PMID:41870163.

Q × L × D × S × 10 = 2.5 / 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 = 2.5 / 10

Final GIRI Score for Lycopene. 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 2.5/10

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

2.5

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

What drove the Low classification for Lycopene

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.

← Back to Ingredient Database

Lycopene

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 Lycopene

ბოლო სიახლეები

500მლ პლასტმასის წყლის ბოთლები: ფარული საზოგადოებრივი ჯანმრთელობის რისკები

სკოლამდელი განათლება – მნიშვნელობა და გამოწვევები

ბავშვის უფლებები სკოლაში

პოპულარული ამბები

საუკეთესო ფილმები კულინარიის მოყვარულებისთვის

როგორ იყენებენ ახალგაზრდები ხელოვნურ ინტელექტს – სტუდენტების ხმა

კატეგორიები

ჩვენ შესახებ

გამოგვყევი სოციალურ ქსელებში