About
Natamycin is a natural polyene macrolide antifungal produced by the soil bacterium Streptomyces natalensis; it targets ergosterol in fungal cell membranes to inhibit mould and yeast growth. It is used as a surface preservative on cheeses, cured sausages, yoghurt, juices, and wines to extend shelf life and prevent mycotoxin contamination.
Safety summary
Natamycin has very low oral toxicity because gastrointestinal absorption is negligible; WHO/JECFA established an ADI of 0.3 mg/kg body weight per day. No evidence of mutagenicity, allergenicity, or carcinogenicity has been found in authoritative reviews by EFSA (2009), JECFA, and FDA. A minority scientific concern exists around the use of soluble cyclodextrin-natamycin complexes in beverages, which may foster polyene resistance in intestinal Candida spp., though EFSA concluded there is no safety concern for antimicrobial resistance induction at permitted food-additive use levels.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Permitted for surface treatment only of semi-hard and semi-soft ripened cheeses and dry cured sausages at ≤1 mg/dm² in the outer 5 mm; must not be detectable at 5 mm depth. Governed by Directive 95/2/EC and Regulation (EC) No 1333/2008. EFSA 2009 re-evaluation confirmed no antimicrobial resistance concern.source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Approved | Retained under Assimilated Regulation (EC) No 1333/2008 Annex III post-Brexit; same scope as EU: surface treatment of cheese and cured sausages only.source |
| FDA (Food and Drug Administration) (United States) | Approved | Permitted as an antimycotic agent under 21 CFR 172.155 for surface application on cut or sliced cheese; also subject to GRAS notifications (GRN No. 517). It is the only antifungal food additive with GRAS status.source |
Who should approach with care
Research citations
- 1PubMed. Natamycin as a safe food additive to control postharvest green mould and sour rot in citrus, 2022. pubmed.ncbi.nlm.nih.gov
- 2PubMed. Natamycin: a natural preservative for food applications—a review, 2021. pubmed.ncbi.nlm.nih.gov
- 3PubMed. Does use of the polyene natamycin as a food preservative jeopardise the clinical efficacy of amphotericin B? A word of concern, 2015. pubmed.ncbi.nlm.nih.gov
- 4EFSA. Scientific Opinion on the use of natamycin (E 235) as a food additive, 2009. efsa.europa.eu
- 5WHO. Evaluation of Certain Food Additives – Twentieth Report of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), 1976. fao.org
