Natamycin's Legal Status: The EU Framework
Natamycin, a natural antifungal agent also known as E235, is a polyene macrolide fungicide produced by the bacterium Streptomyces natalensis. Its legality in Europe is governed by the comprehensive framework of EU food additive legislation, primarily Regulation (EC) No 1333/2008. This regulation establishes a Union list of approved food additives and their conditions of use. Under this framework, natamycin is permitted, but its application is highly specific and limited, reflecting careful consideration of food safety and public health.
Specific Applications and Restrictions in the EU
European legislation restricts the use of natamycin to the surface treatment of certain products to prevent mold and yeast growth. Legal applications include the surface treatment of certain hard, semi-hard, and semi-soft cheeses, with a strict maximum surface concentration and a penetration limit of 5 mm. It is also approved for the surface treatment of dried and cured sausages for the same purpose. Products treated with natamycin must be clearly labeled as such.
Comparison: Natamycin vs. Other Preservatives
The following table compares natamycin's use with other common food preservatives, highlighting the distinct EU regulatory approaches.
| Feature | Natamycin (E235) | Sorbic Acid (E200-E203) | Nitrites/Nitrates (E249-E252) |
|---|---|---|---|
| Application | Surface treatment only for specific cheeses and sausages. | Can be used within a wide range of food products, including baked goods and beverages. | Used within cured meats to prevent botulism. |
| Origin | Natural antifungal derived from bacteria. | Synthetic or natural (e.g., from rowan berries). | Synthetic chemical preservatives. |
| Labeling | Requires specific labeling indicating surface treatment. | Standard food additive labeling (E-number). | Standard food additive labeling (E-number). |
| Action | Primarily effective against yeasts and molds. | Broad spectrum antimicrobial and antifungal agent. | Curing agent, prevents bacteria like Clostridium botulinum. |
| EU Regulations | Strictly limited to surface application with specific depth penetration rules. | Approved for a wide range of applications and foods. | Restricted for use in meat products due to health concerns related to nitrosamine formation. |
The Role of Regulatory Bodies
The European Food Safety Authority (EFSA) assesses the safety of food additives and informs the European Commission's decisions on authorization and conditions of use. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) also provides a global perspective on safety that can influence national authorities.
Conclusion: Navigating the EU's Food Additive Landscape
Natamycin is legally permitted in Europe under specific, highly regulated conditions. Its use is limited to the surface treatment of certain cheeses and dried cured sausages, with strict concentration and penetration limits, and mandatory labeling. This controlled approach allows for effective mold and yeast prevention while ensuring food safety and consumer transparency. Consumers can identify its use by the E235 designation on product labels.
