Other names for the additive (synonyms)
General Information
Natamycin or pimaricin (food additive E235) is a natural antifungal agent used in the food industry to protect products from mold and yeast.
In terms of its role, additive E235 belongs to naturally derived antimicrobial substances and is used in food products as a preservative. It is produced during the fermentation process of the bacterium Streptomyces natalensis.
Natamycin was first discovered in the mid-20th century in South Africa. Initially, it was studied as a medicinal agent against fungal infections, and later it began to be used in the food industry to prevent product spoilage.
The chemical formula of natamycin is C33H47NO13. It is a light-colored powder that is practically insoluble in water. The main feature of additive E235 is that it acts primarily on the surface of the product and is very poorly absorbed in the human body. This is what made it convenient for treating cheeses and sausages.
For the food industry, additive E235 is obtained by cultivating specific bacteria under controlled conditions. After fermentation, the substance is purified, dried, and converted into a powder, which is then used to treat the surface of products.
Effects on the Body
Benefit of Additive E235
Food additive E235 is not a natural component of the human body and does not perform physiological functions. It has no nutritional value and does not provide direct benefits to the body.
However, its benefit lies elsewhere — it prevents the growth of mold on food products, which reduces the risk of fungal toxin formation. According to EFSA (2009), natamycin is used exclusively for surface treatment of cheeses and sausages, which limits consumption levels and reduces health risks.
Risks of Additive E235
After entering the body, food additive E235 is hardly absorbed in the gastrointestinal tract. It passes through the digestive system mostly unchanged and is excreted naturally. This low absorption was one of the factors considered in its safety assessment.
The European Food Safety Authority (EFSA) in 2009 noted that available data had certain limitations (a small number of studies, lack of comprehensive carcinogenicity studies), making it difficult to establish a new acceptable daily intake (ADI). At the same time, exposure assessment showed that even at high consumption levels in children (97.5 percentile), intake would be less than 0.1 mg/kg body weight per day, providing a sufficient safety margin.
Previously, JECFA had established an acceptable daily intake of 0.3 mg/kg body weight per day. EFSA concluded that when used only for surface treatment of cheeses and sausage casings, food additive E235 does not pose a health risk.
EFSA also found no grounds for concern regarding the development of antimicrobial resistance when natamycin is used within permitted limits. The U.S. Food and Drug Administration (FDA) allows the use of natamycin for surface treatment of cheeses within established limits.
Uses
In the food industry, additive E235 is used as an antifungal preservative. Its main purpose is to prevent mold growth during storage.
It is most commonly used for treating the surface of semi-hard and soft cheeses, as well as dry sausages. Importantly, the substance is applied only to the outer layer of the product, usually within a few millimeters of the surface. It is not intended for addition inside the product.
Legal Status
In the European Union, food additive E235 is permitted for surface treatment of cheeses and sausages with limits on maximum application levels according to Regulation (EU) No 1333/2008 on food additives. EFSA confirmed in 2009 that there are no safety concerns when used within established limits.
In Ukraine, food additive E235 is permitted in accordance with regulations harmonized with EU legislation.
In the United States, natamycin is permitted by the FDA for surface treatment of cheeses within defined limits. In Canada and Japan, the substance is also allowed as an antifungal preservative for certain product categories. The acceptable daily intake established by JECFA is 0.3 mg/kg body weight per day.