Abstract
Natamycin (synonym pimaricin) is an antimycotic agent of the polyene macrolide class of antimicrobials used as a surface treatment of cheeses and dried sausages. Natamycin exerts its fungicidal activity by preventing the growth of fungi and germination of fungal spores through binding to ergosterol located in fungal cellular membranes.
At its Fifty-first Session, the CCFA requested a re-evaluation of the safety of natamycin including any data on “(i) promoting antimicrobial resistance, as well as speeding up virulence and pathogenic potential of food-borne human pathogens; and (ii) unbalancing the immunity and other bodily functions due to effects on gastrointestinal microflora; dietary intake and specifications” (174). Natamycin was evaluated by the previous Committee at its Twelfth, Twentieth, Fifty-seventh and Sixty-seventh meetings (103,175–177). At the Twelfth meeting, the Committee established a conditional ADI18 of 0–0.25 mg/kg bw. The conditional ADI was converted to an ADI of 0–0.3 mg/kg bw at the Twentieth meeting based on observations of gastrointestinal effects in humans (176). At the Fifty-seventh meeting, the Committee confirmed the previously established ADI of 0–0.3 mg/kg bw for natamycin (177).
The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) evaluated natamycin in 2017 and concluded that the available evidence was inadequate to draw a conclusion on the genotoxicity and carcinogenic potential of natamycin (178). JMPR did not establish an ADI for natamycin because of the inadequate database available to the 2017 meeting.
The sponsor submitted studies investigating the toxicity and microbiological effects of natamycin. Comprehensive literature searches were also undertaken on the toxicological, antimicrobial resistance and dietary exposure aspects of this assessment in databases such as PubMed and Web of Science from 2001 to 2024, using keywords including “natamycin”, “pimaricin”, “metabolite”, “toxicity”, “polyene”, “microbiome”, “intestinal microbiota”, “microbiota”, “microbiome”, “gastrointestinal microbiota”, “gastrointestinal microbiome”, “antimicrobial resistance”, “dietary intake”, “dietary exposure”, “occurrence” and “concentration”.
At its Fifty-first Session, the CCFA requested a re-evaluation of the safety of natamycin including any data on “(i) promoting antimicrobial resistance, as well as speeding up virulence and pathogenic potential of food-borne human pathogens; and (ii) unbalancing the immunity and other bodily functions due to effects on gastrointestinal microflora; dietary intake and specifications” (174). Natamycin was evaluated by the previous Committee at its Twelfth, Twentieth, Fifty-seventh and Sixty-seventh meetings (103,175–177). At the Twelfth meeting, the Committee established a conditional ADI18 of 0–0.25 mg/kg bw. The conditional ADI was converted to an ADI of 0–0.3 mg/kg bw at the Twentieth meeting based on observations of gastrointestinal effects in humans (176). At the Fifty-seventh meeting, the Committee confirmed the previously established ADI of 0–0.3 mg/kg bw for natamycin (177).
The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) evaluated natamycin in 2017 and concluded that the available evidence was inadequate to draw a conclusion on the genotoxicity and carcinogenic potential of natamycin (178). JMPR did not establish an ADI for natamycin because of the inadequate database available to the 2017 meeting.
The sponsor submitted studies investigating the toxicity and microbiological effects of natamycin. Comprehensive literature searches were also undertaken on the toxicological, antimicrobial resistance and dietary exposure aspects of this assessment in databases such as PubMed and Web of Science from 2001 to 2024, using keywords including “natamycin”, “pimaricin”, “metabolite”, “toxicity”, “polyene”, “microbiome”, “intestinal microbiota”, “microbiota”, “microbiome”, “gastrointestinal microbiota”, “gastrointestinal microbiome”, “antimicrobial resistance”, “dietary intake”, “dietary exposure”, “occurrence” and “concentration”.
| Original language | English |
|---|---|
| Title of host publication | Safety evaluation of certain food additives : prepared by the ninety-ninth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) |
| Number of pages | 27 |
| Publisher | Food and Agriculture Organization of the United Nations |
| Publication date | 2024 |
| Pages | 79-105 |
| ISBN (Print) | 978-92-5-139151-8, 978-92-4-010098-5 |
| ISBN (Electronic) | 978-92-4-010097-8 |
| Publication status | Published - 2024 |
| Series | WHO FOOD ADDITIVES SERIES |
|---|---|
| Number | 90 |
| ISSN | 0300-0923 |