The 5-KDF Safety File: We Don’t Market Trust. We Publish It.

Five public studies. OECD-aligned genotoxicity testing. Human-relevant mechanistic data. Osmolarity controls. Published with DOIs.

Some companies ask you to trust their science. We ask you to read ours.

Today, Fooditive is making the complete safety profile of 5-D-Keto-Fructose (5-KDF) publicly available. This is not a press stunt. It is a declaration of our standard: if an ingredient is built for the real world, its evidence should be visible to the world.

The Standard: Ethics Meet Rigor

Our approach to safety is not a mood board; it is a set of engineering requirements. We believe that "responsible innovation" only counts when it survives contact with hard data.

• Animal Welfare (The 3Rs): We replace animal testing wherever scientifically justified.

• Human Relevance: We use human intestinal and hepatic models that mimic real biology and real exposure.

• Scientific Integrity: We rely on standardized methods, controlled test materials, and full traceability.

  
  

The Proof Pack: What We Published

We have released a safety-focused package designed around strict regulatory expectations. This data is now open for independent toxicologists, regulators, and competitors to evaluate.

Setting the Record Straight: The Reconciliation

Why publish this now?

A prior publication suggested that "use of 5-KF in the food sector should be avoided." When a claim like that exists in the public record, the only serious response is better science.

In Study 5 (Reconciliation Analysis), we demonstrate exactly why previous testing failed and why our results differ. It comes down to three factors:

1. Material Stability: The previous study used material with "brown coloring" and "additional peaks"—signs of degradation. We used ion-exchange purified, crystalline 5-KDF to prevent in-situ degradation.

2. Osmolarity Controls: High-molarity sugar testing draws water out of cells (osmotic stress). If you don't control for this, it looks like toxicity. We used mannitol and sugar controls to prove that high-dose effects were physical, not toxic.

3. Endpoint Relevance: Bacterial growth inhibition is not a validated surrogate for human safety. Our OECD TG 471 and TG 473 tests are the gold standard—and both were negative.

The Open Access Files

Fooditive has published a complete, open-access safety dossier for 5-Dehydro-D-fructose (5-KDF).

All studies are publicly available, fully traceable, and linked below.

Study 1 — Genotoxicity: Bacterial Reverse Mutation (Ames Test)

OECD Test Guideline 471

• Five bacterial strains (Salmonella typhimurium and Escherichia coli)

• Tested with and without metabolic activation (S9)

• Doses up to 5,000 µg/plate

  Result: Non-mutagenic

🔗 DOI: https://doi.org/10.5281/zenodo.18212959

Study 2 — Genotoxicity: In Vitro Mammalian Chromosomal Aberration

OECD Test Guideline 473

• Human peripheral blood lymphocytes

• Tested with and without metabolic activation

  Result: Non-clastogenic

🔗 DOI: https://doi.org/10.5281/zenodo.18212986

Study 3 — Human Intestinal Safety Model

Caco-2 human intestinal epithelial cells

• Assessed cytotoxicity, oxidative stress, mitochondrial function, and apoptosis

• Included iso-osmolar controls (mannitol, glucose, fructose)

• Exposure up to 200 mM

  Result: No intrinsic cytotoxicity at ≤100 mM; high-dose effects attributable to osmotic stress

🔗DOI: https://doi.org/10.5281/zenodo.18213007

Study 4 — Human Hepatic Safety Model

HepG2 human liver cells

• Evaluated cell viability and metabolic stress

• Human-relevant hepatic exposure model

  Result: No adverse effects on viability or metabolic function

🔗 Zenodo record: https://zenodo.org/records/18215627

Study 5 — Material Characterization & Reconciliation Analysis

• Compares purified crystalline 5-KDF with earlier non-crystalline test material

• Demonstrates the role of:

  • Impurities and catalytic residues

  • In-situ Maillard chemistry

  • Missing osmotic controls in prior studies

    Purpose: Explains why earlier toxicity signals were artifactual and not substance-intrinsic

🔗 Zenodo record: https://zenodo.org/records/18218216

Regulatory & Scientific Integrity Update (January 2026)

Status of Prior Negative Research:

Readers and regulators should be aware that the 2022 publication often cited regarding 5-KDF cytotoxicity (Hövels et al., Frontiers in Microbiology) is currently the subject of a Formal Investigation by the journal's Research Integrity Team.

The Investigation Concerns:

1. Undisclosed Conflict of Interest: Evidence submitted to the publisher and the German Research Foundation (DFG) indicates the authors failed to disclose their status as founders of a direct commercial competitor (Sweethoven Biotech).

2. Methodological Flaws: As demonstrated in our Reconciliation Analysis below the 2022 study utilized non-standardized, degraded test material.

Current Status:

Fooditive Group maintains that the 2022 findings are scientifically invalid and commercially biased. We advise referencing the 2026 OECD-aligned GLP studies below, which utilize purified crystalline material and demonstrate no genotoxicity.

Our Commitment

We will continue to publish safety-relevant work in a way that is ethically grounded, scientifically testable, and regulator-ready.

We don’t ask the world to trust us. We publish the evidence so you don’t have to.

Scientific feedback welcome:

safety@fooditivegroup.com