Technical Specifications & Lab Data
U.S. FDA Compliance & GRAS Status for DF-100 Natural Preservative
Executive Summary for R&D:
The ingredients used in the formulation of DF-100 have been reviewed by the United States Food and Drug Administration (U.S. FDA) and the Department of Health & Human Services. All active substances in DF-100 are classified under GRAS (Generally Recognized As Safe) and comply with the specific Code of Federal Regulations (CFR) Title 21 for use in human foods and animal feeds.
1. U.S. FDA Status for Human Food Applications
Based on the U.S. FDA regulatory review, the substances used in DF-100 are generally recognized as safe for use in foods when used in accordance with good manufacturing practices.
Regulatory Status Table (Human Food):
| Ingredient / Substance | U.S. FDA Regulation Code | Safety Status |
| Nitrogen | 21 CFR 182.1540 | Approved Food Additive |
| Ascorbic Acid (Vitamin C) | 21 CFR 182.3013 | Approved Food Additive |
| Glycerin | 21 CFR 182.1320 | Approved Food Additive |
| Dextrose | GRAS | Generally Recognized As Safe |
| Propylene Glycol | 21 CFR 184.1666 | Approved Food Additive |
“Thus all substances used in ‘DF-100’ are generally recognized as safe for use in foods when used in accordance with good manufacturing practices.”
— U.S. Food and Drug Administration (Washington DC)
2. U.S. FDA Status for Animal Feed & Pet Food Applications
In addition to human food, DF-100’s formulation has also been reviewed by the FDA’s Center for Veterinary Medicine. The ingredients are officially acceptable for use as animal feed ingredients.
Regulatory Status Table (Animal Feed):
| Ingredient / Substance | U.S. FDA Regulation Code | Safety Status |
| Ascorbic Acid | 21 CFR 582.3013 | Approved Feed Additive |
| Glycerin | 21 CFR 582.1320 | Approved Feed Additive |
| Propylene Glycol | 21 CFR 582.1666 | Approved Feed Additive |
| Dextrose | GRAS | Generally Recognized As Safe |
| Supernat 22S (Silicon Dioxide) | 21 CFR 573.940 | Approved Feed Additive |
| Glycine (Aminoacetic Acid) | 21 CFR 582.5049 | Approved Feed Additive |
“We have reviewed your submission and find that the substances you listed are generally recognized as safe (GRAS), or the subject of an approved food additive regulation. Therefore, they are acceptable for use as animal feed ingredients…”
— George Graber, PhD, Director, Division of Animal Feeds, U.S. FDA
Local Efficacy Validation: University of Malaya (Universiti Malaya) Lab Report
Executive Summary for R&D:
To ensure its effectiveness against local pathogenic strains, DF-100 was subjected to rigorous laboratory testing by the Department of Genetics & Cellular Biology at the University of Malaya (Universiti Malaya), Malaysia’s premier academic institution.
The study specifically evaluated the antimicrobial effect of DF-100 on pathogenic microorganisms commonly encountered in the Malaysian food, poultry, and meat processing industries.
Official Conclusion from the Department of Microbiology:
The laboratory study, endorsed by Dr. Tan Eng Lee, Ph.D. (Associate Professor in Microbiology), confirmed the profound antimicrobial properties of DF-100.
“DF-100 was found to be effective in eliminating the microorganisms usually encountered by poultry in Malaysia.”
— Universiti Malaya, Department of Genetics & Cellular Biology
Minimum Inhibition Concentration (M.I.C) Highlights
Based on the extensive local and international laboratory trials (measured in parts per million / ppm of active material), DF-100 demonstrates extremely high efficacy at very low concentrations against common food spoilage bacteria:
| Pathogenic Microorganism (Spoilage Bacteria) | Industry Risk Area | M.I.C required (ppm) |
| Staphylococcus aureus | Meat & Poultry Processing | 4 – 5 ppm |
| Escherichia coli (E. coli) | General Food Contamination | 5 – 7 ppm |
| Salmonella choleraesuis | Raw Meat & Seafood | 9 ppm |
| Proteus vulgaris | Spoilage & Odor in Fish/Meat | 1 – 3 ppm |
| Aspergillus flavus (Fungi) | Bakery & Dry Foods Mold | 50 ppm |
Ministry of Health Malaysia (KKM) Approval & Local Compliance
Executive Summary for QA/QC & Regulatory Affairs:
For food manufacturers operating within Malaysia, regulatory compliance with local health authorities is mandatory. DF-100 (Liquid and Powder formats) has been officially reviewed and granted approval for use in food applications by the Ministry of Health Malaysia (Kementerian Kesihatan Malaysia – KKM).
Utilizing DF-100 ensures that your food processing lines and final products remain fully compliant with Malaysian food safety standards, significantly smoothing the process for your factory’s MeSTI, GMP, HACCP, and Halal certification audits.
Official KKM Approval Details:
Approving Authority: Ministry of Health Malaysia (Bahagian Perkhidmatan Kesihatan)
Official Reference Number: (102)dlm.KKM-163(7/0)
Approved Formats: DF-100 Liquid and DF-100 Kilol Powder
Regulatory Verdict:
Following a comprehensive review of the scientific literature and formulations, the Ministry of Health Malaysia has provided the following official confirmation:
“This Division in principle has no objections to the application of DF-100 in foods provided it is used in accordance with good manufacturing practices and comply to the requirements of the Food Act 1983 and Food Regulations 1985.”
— Deputy Director of Health, Ministry of Health Malaysia
By choosing DF-100, local manufacturers can confidently replace controversial chemical preservatives while remaining 100% compliant with the Food Act 1983 and Food Regulations 1985.
Singapore Export Compliance & Food Control Approval (Seafood Applications)
Executive Summary for Exporters & QA Managers:
Exporting seafood products to Singapore requires strict adherence to some of the most rigorous food safety regulations in Southeast Asia. For Malaysian seafood and shrimp processors targeting the Singaporean market, DF-100 has been officially reviewed by the Food Control Department, Ministry of the Environment, Republic of Singapore.
This official clearance allows seafood processors to utilize DF-100 as a highly effective, natural antimicrobial wash, ensuring exported shipments meet strict cross-border safety criteria without relying on harmful chemical preservatives.
Official Singapore Authority Approval Details:
Approving Authority: Food Control Department, Ministry of the Environment, Singapore
Official Reference Number: EH/FD 337.1 (1)
Approved Application: Shrimp and Seafood Applications (Antimicrobial Liquid)
Approved Formulation & Usage Protocol:
The Singaporean authorities specifically acknowledged the natural and safe composition of DF-100 (50% Grapefruit Seed and Pulp Extract, 25% Glycerine USP, and 25% Propylene Glycol USP).
They have established a clear protocol for seafood processors:
“We have in principle no objection to the use of ‘DF-100’… at a concentration between 100 ppm to 200 ppm to rinse fresh shrimp and other seafoods, provided that the seafoods are to be re-rinsed and leave behind no residue of ‘DF-100’, or its related compound in the products.”
— Director of Food Administration, Republic of Singapore
By integrating DF-100 into your seafood rinsing and processing SOPs at the recommended 100-200 ppm concentration, manufacturers can drastically reduce microbial loads, prevent early spoilage during transit, and confidently secure export clearance to Singapore.
