The safety of Nisin for pregnant women and infants

Nisin, as a natural antimicrobial peptide, its safety for consumption in pregnant women and infants has long been a focus of research and regulatory attention. Based on existing studies and evaluations by authoritative institutions, its safety can be analyzed from the following aspects:

I. Safety for Pregnant Women

Toxicological research basis: Nisin is produced by fermentation of Streptococcus lactis and belongs to natural polypeptide substances. It can be decomposed into amino acids by proteases in the human digestive tract, with no risk of residual accumulation. Multiple acute toxicity and subchronic toxicity tests have shown that no obvious toxic side effects, including damage to the reproductive system, are observed even with high-dose intake of Nisin.

Attitude of authoritative institutions: The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has set the acceptable daily intake (ADI) of Nisin as "not specified", considering it safe for the general population, including pregnant women, when used within reasonable ranges. The U.S. Food and Drug Administration (FDA) has also classified it as a "Generally Recognized as Safe (GRAS)" substance, allowing its use in food in accordance with Good Manufacturing Practices (GMP).

Considerations in practical application: Pregnant women have higher requirements for food safety, but there is currently no research indicating that Nisin at conventional doses will cause adverse effects on pregnant women or fetuses. However, when consuming foods containing Nisin, pregnant women should still follow the "principle of moderation" and avoid long-term excessive intake of single additive-containing foods to ensure dietary diversity.

II. Safety for Infants and Young Children

Adaptability to infant physiological characteristics: The digestive and immune systems of infants are not yet fully developed, making them more sensitive to the tolerance of food components. However, the natural origin and easy degradability of Nisin give it certain advantages in infant food. For example, in some infant formula foods or dairy products, Nisin, as a preservative, can reduce the risk of microbial contamination, indirectly ensuring the dietary safety of infants.

Support from research evidence: Existing animal experiments and limited clinical observations have shown that infants do not experience allergic reactions, digestive disorders, or abnormal growth and development after consuming food containing Nisin. Its decomposition products are amino acids, which are compatible with the nutritional components required by infants and do not increase metabolic burden.

Regulatory standard restrictions: Some countries and regions have stricter restrictions on the use of Nisin in infant food, such as clearly specifying the allowed food categories and maximum addition levels to avoid potential risks. For example, China's GB 2760 National Food Safety Standard for the Use of Food Additives contains specific provisions on the use of Nisin in infant formula foods, requiring that its addition amount does not exceed the relevant limits and meets the special safety requirements for infant food.

III. Summary

Overall, under the premise of complying with regulatory standards, the reasonable use of Nisin in food for pregnant women and infants is safe. Its natural origin, easy degradability, and long-term usage history data support this conclusion. However, it should be noted that the use of any food additive should follow the "principle of necessity", i.e., it should only be used when necessary to ensure food quality and safety, with strict control over the addition amount. For special populations, it is recommended to prioritize natural foods with few additives to minimize potential risks. In the future, more long-term follow-up studies targeting pregnant women and infants are still needed to further verify its safety.