About
Nisin is a natural antimicrobial polypeptide (bacteriocin) of 34 amino acids produced by fermentation of Lactococcus lactis subsp. lactis; it is used as a food preservative to inhibit the growth of gram-positive spoilage and pathogenic bacteria including Listeria monocytogenes, Clostridium, Staphylococcus, and Bacillus species. It is active primarily in processed cheese, dairy products, canned foods, and heat-treated meat products.
Safety summary
Nisin is broadly considered safe; EFSA (2017) established a revised ADI of 1 mg/kg bw/day based on a NOAEL of 225 mg/kg bw/day from a 90-day rat study, and JECFA (2013) set an ADI of 2 mg/kg bw/day; dietary exposure consistently falls well below both ADIs across all population groups. Ingested nisin is rapidly degraded by proteolytic enzymes (pepsin, trypsin) in the gastrointestinal tract, making systemic exposure unlikely. EFSA noted that potential effects on gut microbiota and antimicrobial resistance induction were outside the scope of the food additive safety review, but concluded cross-resistance to therapeutic antibiotics is not expected.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Approved under Annex II of Regulation (EC) 1333/2008 for multiple food categories. ADI revised upward from the prior SCF/EFSA 2006 value of 0.13 mg/kg bw to 1 mg/kg bw/day in the 2017 EFSA opinion. Maximum use levels include: unripened cheese at 12 mg/kg and heat-treated meat products at 25 mg/kg. EFSA recommended a separate evaluation of antimicrobial resistance (AMR) risk linked to nisin's use as a food additive.source |
| FDA (Food and Drug Administration) (United States) | Approved | GRAS status affirmed in 1988 (21 CFR 184.1538) for use as an antimicrobial agent in pasteurized process cheese and cheese spreads, produced by Lactococcus lactis subsp. lactis. FDA noted an ADI of 2.9 mg/person/day based on chronic feeding studies at the time of GRAS affirmation.source |
Who should approach with care
Research citations
- 1PubMed. A natural food preservative peptide nisin can interact with the SARS-CoV-2 spike protein receptor human ACE2, 2020. pmc.ncbi.nlm.nih.gov
- 2EFSA. Safety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use, 2017. efsa.europa.eu
- 3PubMed. Safety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use, 2017. pubmed.ncbi.nlm.nih.gov
- 4WHO. JECFA 77th Meeting – Nisin (INS 234) toxicological evaluation and ADI establishment, 2013. apps.who.int
- 5FDA. Code of Federal Regulations Title 21 – Section 184.1538: Nisin preparation, 1988. accessdata.fda.gov