Safety and published studies
Safety is our first priority.
We publish the studies behind our ingredients, so anyone can read and check them.
Open science, open data
This page lists publicly available studies on Fooditive’s food biotechnology. We share them to support transparency and scientific understanding.
For Fooditive Sweetener® Keto-Fructose (5-keto-D-fructose, 5-KDF), five open-access studies form the 5-KDF safety file. They cover genotoxicity, human cell models and the test material itself.
What these studies showWhat these studies show
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OECD Test Guideline 471
Ames test (bacterial reverse mutation)
No gene mutations in five bacterial strains, with and without metabolic activation: 5-KDF was non-mutagenic.
DOI 10.5281/zenodo.18212959 (Ames test (bacterial reverse mutation))
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OECD Test Guideline 473
Chromosomal aberration in human cells
No structural chromosome damage in human blood lymphocytes, with and without metabolic activation: 5-KDF was non-clastogenic.
DOI 10.5281/zenodo.18212986 (Chromosomal aberration in human cells)
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Caco-2 human intestinal cells
Human intestinal cell model
No intrinsic cytotoxicity up to 100 mM. Effects at higher doses matched those of iso-osmolar sugar controls, so they reflect osmotic stress.
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HepG2 human liver cells
Human liver cell model
No adverse effects on cell viability or metabolic function were observed.
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Material analysis
Material characterisation
Explains how material purity, in-situ Maillard reactions and osmolarity controls affect test results for sugars such as 5-KDF.
These laboratory studies support a safety assessment of 5-KDF as a food ingredient.
The 5-KDF safety file
Every study in one place
The safety file brings the five studies together, with the methods, results and links. In these tests, 5-KDF showed no genotoxic effects.
Regulators, scientists, manufacturers and journalists are welcome to review it.
Safety and regulatory milestones
- 2024
Self-affirmed GRAS
Based on an independent expert panel assessment.
- 13 Jan 2026
The 5-KDF safety file published
Five open-access studies, including OECD-aligned genotoxicity testing and human cell data.
- 29 Jan 2026
GRAS notice GRN 1326 submitted to FDA
For the 5-KDF sweetener.
- 18 Feb 2026
Sweetener development milestone, with public safety data
Our press release on the milestone.
Good to know
What is the U.S. regulatory status of 5-KDF?
Self-affirmed GRAS (2024, independent expert panel). GRAS notice GRN 1326 submitted to FDA on 29 January 2026.
What do these studies support?
They are laboratory studies that support a safety assessment of 5-KDF as a food ingredient.
Where are the detailed results and methods?
Detailed results and methods for the OECD 471 and 473 studies are in the Fooditive Sweetener® 5-KDF Toxicology Data Supplement, available on request.
Will you publish more studies?
Yes. Additional studies will be added to this page as they become available.
Questions about our safety data?
Scientists, regulators and manufacturers are welcome to ask. Tell us what you need and we will reply.