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NATAMYCIN — Pimaricin · E-235

Name: Natamycin
SKU: 0

Natural Polyene Macrolide Antifungal · Surface Biopreservative

C₃₃H₄₇NO₁₃ · MW 665.73 Da · CAS 7681-93-8 · EC 231-683-5
Polyene Macrolide Antibiotic · Produced by Streptomyces natalensis & S. chattanoogensis

Doc: TDS-NAT-001
Rev: 01 · June 2026

📋 Product Identification

Product Name

NATAMYCIN (Pimaricin)

E Number

E-235

INS Number

INS 235

CAS Number

7681-93-8

EC Number

231-683-5

Chemical Class

Polyene Macrolide Antifungal

Molecular Formula

C₃₃H₄₇NO₁₃

Molecular Weight

665.73 Da

Source Organisms

Streptomyces natalensis, S. chattanoogensis

Production Method

Submerged aerobic fermentation (non-GMO)

Appearance

Off-white colour powder

Carrier / Excipient

Lactose (50 %)

Trademark

YOTABIO

Origin

Made in China

Grade

Food Grade · GRAS Status

Discovery

1955, Natal Province, South Africa

🔬 Product Description

Natamycin (also known as pimaricin, E-235) is a naturally occurring polyene macrolide antifungal compound produced by submerged aerobic fermentation of Streptomyces natalensis and related species. It is the only globally recognized antifungal food bio-preservative, capable of highly effective and broad-spectrum suppression of mould and yeast growth even at very low concentrations.

Natamycin acts as a true fungistatic — it stops the development of microscopic fungi rather than destroying them and their spores. Its unique mechanism of action involves binding specifically to ergosterol in the fungal cell membrane, inhibiting membrane transport proteins and blocking cell division — without permeabilizing the membrane. This distinguishes Natamycin from chemically synthesized preservatives such as sorbates and benzoates.

Critically, Natamycin has no activity against bacteria, meaning it does not interfere with beneficial starter cultures in cheese-making, sausage fermentation, or yoghurt production. It is approved for use in over 150 countries worldwide and is recognized by the WHO, EFSA, and the US FDA.

🍄

Antifungal Specialist

Effective against all major moulds & yeasts at ultra-low concentrations

🧫

Bacteria-Safe

No effect on bacteria — preserves starter cultures & ripening flora

🌿

100% Natural

Fermentation-derived from Streptomyces — clean label solution

🧬

Non-GMO

EU Reg. (EC) 1829/2003 & 1830/2003 compliant

🎯

Surface Action

Low solubility keeps it on the surface where fungi grow

🛡️

Mycotoxin Prevention

Blocks mould growth & prevents mycotoxin production

⚙️ Mechanism of Action

Natamycin employs a unique antifungal mechanism that distinguishes it from all other polyene antibiotics (nystatin, filipin, amphotericin B). Rather than forming pores and permeabilizing the membrane, Natamycin exerts its effect through ergosterol-specific binding and inhibition of membrane transport.

🎯

Ergosterol Binding

Natamycin binds specifically to ergosterol, the primary sterol in fungal cell membranes, targeting the double bonds in the sterol's B-ring. Binding occurs at a stoichiometry of approximately 1:1 with an affinity of ~100 μM.

🚫

Transport Inhibition

The Natamycin–ergosterol complex inhibits essential membrane transport proteins (amino acid and glucose transporters) without compromising the barrier function of the membrane. This starves the cell of nutrients.

⛔

Growth Arrest

Loss of membrane transport and enzyme function results in inhibition of cell division and arrest of fungal growth. Against spores, Natamycin inhibits germination. The cell dies without membrane lysis — a true fungistatic action.

⚖️

KEY DISTINCTION vs OTHER POLYENES: Unlike nystatin and filipin, Natamycin does not form ion pores and does not permeabilize the plasma membrane. This novel non-pore-forming mechanism was confirmed by Te Welscher et al. (2008, J. Biol. Chem.) using ITC and direct binding studies.

🔬

SELECTIVITY: Bacteria lack ergosterol in their cell membranes, which makes Natamycin completely inactive against all bacterial species. This is why Natamycin does not disturb starter cultures, ripening bacteria, or beneficial microflora in fermented foods.

🍄 Antimicrobial Spectrum

✅ Effective Against (Fungi)

Moulds:
Aspergillus spp. (A. flavus, A. niger, A. parasiticus)
Penicillium spp. (P. roqueforti, P. commune, P. chrysogenum)
Fusarium spp., Cladosporium spp.
Mucor spp., Rhizopus spp., Alternaria spp.
Botrytis cinerea, Trichoderma spp.
MIC: 0.5–6 μg/mL (some species 10–25 μg/mL)

Yeasts:
Candida spp. (C. albicans, C. parapsilosis)
Saccharomyces spp., Zygosaccharomyces spp.
Rhodotorula spp., Debaryomyces spp.
Pichia spp., Kluyveromyces spp.
MIC: 1–5 μg/mL

❌ Not Effective Against

All bacteria:
Gram-positive and Gram-negative bacteria are unaffected
(bacterial membranes lack ergosterol)

Protozoa & Viruses:
No activity against protozoa or viruses

Beneficial for food:
Does NOT inhibit starter cultures or ripening bacteria
(Lactobacillus, Streptococcus thermophilus, Propionibacterium, etc.)

For antibacterial protection, combine with YOTABIO Nisin (E-234) for complete Gram(+) bacteria + antifungal coverage.

📊 Product Specifications

Test Parameter	Specification
Physical & Chemical Properties
Appearance	Off-white colour powder
Natamycin Content (E-235)	≥ 50 % ± 1 %
Carrier / Excipient	Lactose — 50 %
pH (aqueous solution)	5.5 – 7.5
Moisture / Loss on Drying	≤ 8.0 %
E Number	E-235
Solubility in Water (25 °C)	~30–100 mg/L (very low)
Solubility — Other	Slightly soluble in ethanol; soluble in dilute HCl, glacial acetic acid, DMSO; insoluble in most organic solvents
Optimal pH Range	pH 3–9 (activity decreases at pH >9 or <3)
Thermal Stability	Active below 50 °C; degrades at higher temperatures
UV Sensitivity	Sensitive to UV light — store away from direct sunlight
Heavy Metals
Lead (Pb)	Max. 1.2 mg/kg
Arsenic (As)	< 1 mg/kg
Mercury (Hg)	Max. 1 mg/kg
Microbiological
Total Plate Count	< 100 CFU/g
Salmonella spp. (in 25 g)	Absent
E. coli (in 1 g)	Absent
Additional
Allergens	Contains Lactose (dairy-derived carrier)
GMO Status	Non-GMO (EU Reg. EC 1829/2003 & 1830/2003)

🧪 Composition

YOTABIO Natamycin preparation is a standardized blend of the active polyene macrolide on a lactose carrier. This ensures uniform distribution, stable potency, and easy dispersibility for suspension preparation.

Component	Content
Natamycin (E-235) — Active Ingredient	≥ 50 % ± 1 %
Lactose — Carrier / Excipient	~50 %

📝

EXCIPIENT OPTIONS: Natamycin 50 % preparations are also available with alternative carriers — NaCl (salt) or glucose (dextrose) — depending on the application. Salt-based carriers are preferred for meat products; lactose or glucose for dairy. Contact YOTABIO for specific carrier requirements.

⚖️ Natamycin vs Chemical Preservatives

Natamycin offers significant advantages over traditional chemical antifungal preservatives (sorbates, benzoates) due to its natural origin, surface-retention properties, and selective antifungal action.

Property	Natamycin (E-235)	Sorbate (E-200/202)	Benzoate (E-210/211)
Origin	Natural (fermentation)	Synthetic	Synthetic
Target	Moulds & yeasts only	Moulds, yeasts, some bacteria	Moulds, yeasts, some bacteria
Bacteria Impact	None — preserves starter cultures	Inhibits some bacteria	Inhibits some bacteria
Water Solubility	Very low (~40 ppm)	High	High
Surface Retention	Excellent — stays on surface	Poor — migrates into food	Poor — migrates into food
Penetration Depth	≤ 5 mm	Throughout product	Throughout product
Effective Concentration	0.5–25 μg/mL (MIC)	1,000–3,000 ppm	500–2,000 ppm
Taste / Flavour Impact	None	Possible off-taste	Possible off-taste
Consumer Perception	Clean label / natural	Chemical preservative	Chemical preservative
Resistance Development	No reports in vivo	Emerging resistance	Variable

📝 Direction for Use

Natamycin can be applied via several methods. The very low water solubility (~40 ppm) is advantageous for surface treatment, as it ensures the active compound remains concentrated where fungal growth occurs — on the food surface.

Method	Description
🫧 Dipping / Immersion	Immerse food (cheese, sausage) in a 0.05–0.28 % Natamycin suspension for 2–4 minutes. Add 8–10 % NaCl to the bath for bacteriostatic effect and improved elasticity. Agitate to ensure even crystal distribution. Most common method for post-salted cheese.
💨 Spraying	Spray a 0.05–0.28 % suspension evenly over the entire surface of cheese heads or sausage casings. Ensure complete coverage of all surfaces. Allow to dry before packaging.
🧴 Coating Addition	Add 0.05 % Natamycin to cheese coatings, artificial dispersions, or polymer films applied to the rind of specific cheese types.
🧂 Brine Treatment	Add 30–50 g per ton of brine. Dissolve in a small amount of brine first, stirring 15–30 minutes. Turn off microfiltration 2–3 days before addition. Replenish at 1 kg per 100 tons every 2 weeks.
🧪 Direct Addition	For liquid foods (yoghurt, sour cream, juices): mix Natamycin into a water suspension, then add directly to the product. Mix time depends on viscosity.
🥩 Casing Soak	Natural casings: soak ~2 hours in 1 g/L suspension with 8–10 % NaCl. Protein/cellulose casings: soak 20–60 minutes in 1–2 g/L suspension.

⚠️

IMPORTANT NOTES:
• Temperature: Always use cold water (< 15 °C) for suspension preparation. Natamycin degrades above 50 °C — do NOT add to hot processes.
• UV Light: Natamycin is UV-sensitive. Store suspension in a cool, dark place. Heat used bath to 64 °C for 10 min every 2–3 days to control bacteria, then cool.
• Concentration for dipping: 2–3 g/L for vacuum-packed cheese; 4 g/L for naturally-ripened cheese.

⚗️ Dosage Guide by Application

Natamycin is effective at concentrations ranging from 2.5–500 ppm depending on application type and food matrix. The table below provides sector-specific guidance.

Application	Dosage / Method	Effect & Notes
🧀 Dairy Products
Cheese — Dipping	0.05–0.28 % suspension, 2–4 min	Immerse post-salted cheese. Prevents mould on surface throughout ripening. Increases cheese yield by ≥ 20 %; reduces ripening labour by 20–30 %.
Cheese — Spraying	0.05–0.28 % suspension	Spray entire surface. Effective on hard, semi-hard and semi-soft varieties. Improves presentation and quality.
Cheese — Coating	0.05 % in coating dispersion	Added to cheese shell / artificial polymer coatings. Protects rind during maturation.
Cheese — Brine	30–50 g per ton of brine	Suppresses yeast & mould in brine pools. Replenish 1 kg/100 tons every 2 weeks. Turn off microfiltration 2 days before adding.
Yoghurt / Acidophilic Milk	5–10 ppm	Extends shelf life to over 4 weeks. Does not affect fermentation cultures.
🥩 Meat Products
Dry/Ripening Sausages	0.05–0.2 % (w/v) spray or dip	Surface treatment of casings. Max 1 mg/dm² at point of sale (EU). Effectively suppresses mould & yeast on casing.
Sausage Casings — Natural	1 g/L, soak ~2 hours	Add 8–10 % NaCl for bacteriostatic effect and elasticity. Prepare fresh slurry for each batch.
Sausage Casings — Protein/Cellulose	1–2 g/L, soak 20–60 min	Fully immerse casings. Agitate before loading. Add NaCl.
Grilled Meat, Roast Duck, Dried Fish	0.05–0.1 % spray	Surface spray application extends shelf life by controlling mould growth.
🍞 Bakery Products
Tortillas, Volovans, Pre-fried Dough	100–500 ppm surface spray	Applied post-baking to surfaces. Do NOT add to dough (heat degrades). Prevents mould & yeast growth.
Steamed Bread	Surface treatment	Effectively suppresses mould formation post-steaming.
🍷 Beverages & Juices
Grape Juice	20–100 ppm	20 ppm inhibits yeast-induced fermentation; 100 ppm eliminates fermentation completely.
Orange Juice	1.25–20 ppm	1.25 ppm extends shelf life to 8 weeks at 2–4 °C without quality loss. 10 ppm controls yeast at 10 °C; 20 ppm at room temperature.
Apple Juice	30 ppm	Inhibits fermentation for 6 weeks without altering flavour or texture.
Tomato Juice	70 ppm	Effective against mould and yeast growth.
Wines & Beer	5–10 ppm	Suppresses spoilage yeasts during storage. Does not affect desired fermentation.
🥫 Other Applications
Soy Sauce	15 ppm	Suppresses mould formation on surface.
Salad Dressings / Mayonnaise	10–20 ppm	Controls mould in high-fat products. 10 ppm shows no deterioration during testing.
Marmalades, Gelatins, Marinades	Application-specific	Contact YOTABIO for product-specific recommendations.

🏆 Key Benefits

Benefit	Description
🛡️ Mycotoxin Prevention	Protects products from mould growth and prevents mycotoxin production — improving food safety
⏱️ Shelf-Life Extension	Controls and retards fungal & yeast growth, extending or maintaining product shelf life
🌿 Natural Alternative	Replaces chemical preservatives (sorbates, benzoates) with a natural, fermentation-derived solution
🧫 Culture-Safe	No effect on bacteria — preserves beneficial starter cultures and natural fermentation processes
👅 No Sensory Impact	Little or no effect on taste, flavour, colour, or nutritional value of treated products
💰 Cost-Effective	High efficacy at very low concentrations (MIC 0.5–6 μg/mL for moulds); reduces product loss
🎯 Surface Action	Low solubility ensures preservation stays on the food surface where fungi attack
🧀 Yield Improvement	Increases cheese yield by ≥ 20 %, reduces ripening labour by 20–30 %, saves packaging material
✅ No Resistance	No in-vivo resistance development reported; factories using Natamycin for years show no increase in resistant organisms

🏭 Application Matrix

Food Sector	Product Examples	Method
🧀 Dairy	Hard, semi-hard & semi-soft ripened cheese; processed cheese; cheese spreads; Suluguni; cream cheese; yoghurt; sour cream; homemade cheese	Dip, spray, coating, brine, direct addition
🥩 Meat	Dry/ripening sausages, fermented sausages, grilled meat, roast duck, dried fish, cold meats	Casing soak, surface dip/spray
🍞 Bakery	Tortillas, volovans, pre-fried dough, steamed bread, pastries, bread	Post-baking surface spray
🧃 Juices	Orange juice, apple juice, grape juice, tomato juice, fruit juice concentrates	Direct addition
🍷 Wines & Beverages	Wine, beer, grape must, vinegar	Direct addition
🥗 Condiments	Soy sauce, salad dressings, mayonnaise, marmalades, gelatins, marinades	Direct addition

📜 Regulatory & Compliance Status

🇪🇺

European Union

Food Additive E-235
Reg. (EC) 1333/2008
Surface treatment only
Max 1 mg/dm² (5 mm depth)

🇺🇸

United States FDA

21 CFR § 172.155
GRAS Status
Max 20 ppm on cheese
Antimycotic use

🌐

FAO / WHO (JECFA)

ADI: 0–0.3 mg/kg bw/day
Confirmed 2024 (99th meeting)
Codex GSFA Listed

🇨🇳

China (GB Standards)

GB 2760 Approved
Cheese, meat, juices,
sauces, wine

🇦🇺

Australia / NZ (FSANZ)

Code number 235
Preservative class
Surface treatment

🌍

Global Approvals

Approved in 150+
countries incl. Canada,
Japan, South Africa, MENA

Regulatory status and maximum use levels vary by country. Outside the EU, please confirm compliance with local food regulations before use. In the EU, Natamycin is only authorized for surface treatment of cheese and dried sausages.

🇪🇺 EU Authorised Uses (Reg. EC 1333/2008 + Reg. EU 2015/647)

Food Category	Max. Level	Conditions
Uncut hard, semi-hard & semi-soft ripened cheese	1 mg/dm² surface	External treatment only; not present at depth of 5 mm
Dried, cured sausages (heat-treated or not)	1 mg/dm² surface	Surface treatment only

🇺🇸

USA (FDA 21 CFR § 172.155): Natamycin may be applied on cheese as an antimycotic in amounts not to exceed 20 mg/kg (20 ppm) in the finished product. May be applied as dry mix, dip, or spray using an aqueous solution of 200–300 ppm. GRAS for additional uses in ready-to-drink tea beverages, fruit-flavoured beverages, energy & sport drinks.

🧬 GMO Declaration

🌿

NON-GMO DECLARATION: In accordance with EU Regulation (EC) No 1829/2003 and Regulation (EC) No 1830/2003, the product supplied — NATAMYCIN + LACTOSE — is neither a GMO nor does it contain GMOs. The ingredients themselves do not contain genetically modified organisms, are not derived from GMO raw materials, and no GMOs have been used in the production process. No production process in the manufacturing plant is in contact with GMOs. There is no risk of cross-contamination.

🛡️ Safety & Toxicology

Natamycin has been evaluated extensively by JECFA (1968, 1976, 2002, 2024), EFSA (2009), and the FDA. It is very poorly absorbed orally, which adds a significant safety buffer. The ADI was re-affirmed in June 2024 at the 99th JECFA meeting in Geneva.

Safety Parameter	Value / Status
ADI (JECFA, confirmed 2024)	0–0.3 mg/kg body weight/day
NOAEL — 13-week Rat Study	42 mg/kg bw/day
NOAEL — 1-year Rat Study	26 mg/kg bw/day
Reproductive NOAEL	~50 mg/kg bw/day (no teratogenic signal)
Safety Factor Applied	100× (interspecies + intraspecies)
EFSA High-End Exposure (Children)	< 0.1 mg/kg bw/day (97.5th percentile)
FDA Classification	Food Additive (21 CFR § 172.155) + GRAS
Oral Absorption	Very poorly absorbed — minimal systemic exposure
Allergens	Contains Lactose (carrier). Natamycin itself: no allergic or sensory reactions reported
Antimicrobial Resistance	No concern for induction of AMR (JECFA 2024, EFSA 2009)
Microbiome Impact	Low risk of disrupting human GI tract microbiome (JECFA 2024)

✅

JECFA 2024 CONCLUSION: "There is no concern for the induction of antimicrobial resistance and the risk of natamycin having a disrupting effect on the microbiome of the human gastrointestinal tract is low." The ADI of 0–0.3 mg/kg bw was re-affirmed with new NOAEL data supporting this limit.

🔗 Synergistic Combinations

Since Natamycin targets only fungi and Nisin targets only Gram-positive bacteria, the combination provides comprehensive antimicrobial coverage for food preservation:

Combination Partner	Spectrum Added	Benefit
Nisin (E-234)	Gram-positive bacteria (Listeria, Clostridium, Staph. aureus)	Complete antimicrobial coverage: antifungal + antibacterial. Proven synergy in cheese — extends shelf life of sliced mozzarella by +6 days in cellulose film.
ε-Polylysine	Broad-spectrum (Gram ±, fungi)	Extended spectrum for high-pH and high-moisture products. Complements Natamycin's fungal control.
Yota-Guard™ Series	Cultured dextrose / cultured whey	Clean-label organic acid synergy for dairy and meat applications. Enhances overall hurdle effect.
Lysozyme (E-1105)	Gram-positive cell wall lysis	Combined with Natamycin for cheese and wine — antibacterial + antifungal dual protection.
Chitosan	Antimicrobial film / coating	Chitosan-Natamycin edible coatings for cheese surfaces — sustained release of antifungal activity.
NaCl (8–10 %)	Bacteriostatic	Added to dipping/soaking baths to slow bacterial growth and improve casing elasticity.

📦 Storage, Handling & Packaging

🌡️

Temperature

< 20 °C

💨

Conditions

Dry · Sealed · No Sunlight

📅

Shelf Life

24 Months

☀️

UV Sensitivity

High — Protect from Light

Packaging Options:

Format	Description	Notes
500 g Bottles	Polyethylene bottles with integral tamper-proof seals	Loaded in 10 kg carton boxes
25 kg Drums	Industrial drums for bulk applications	Available on request

📄 Available Documents

Document	Format
Natamycin Technical Data Sheet	PDF — available on request
Natamycin Application Book	PDF — available on request
Certificate of Analysis (COA)	PDF — batch-specific (e.g. NTR2302001)
Non-GMO Declaration	Available on request
MSDS / SDS	Available on request
Allergen Declaration	Available on request (contains Lactose)

Ready to Eliminate Mould & Yeast from Your Products?

Contact YOTABIO for samples, COA documents, dosage optimisation, or Natamycin in alternative carriers (NaCl, glucose).

✉ Email Us Request Sample

YOTA BIO-ENGINEERING CO., LTD (YOTABIO)
398 Huai'an Road, RETDA, Rizhao, Shandong 276826, P.R. China
Tel: +86 633 2959965 / 2959969 · Email: sales@yotabio.cn · www.yotabio.cn

The information contained herein is accurate to the best of our knowledge. Recommendations and suggestions are made without guarantee since conditions of use are beyond our control. It is the responsibility of the user to ensure compliance with all applicable local food regulations. This TDS does not constitute a specification.
© Yota Bio-Engineering Co., Ltd — All Rights Reserved

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