Nisin's regulatory policies and market access in the European market

Nisin is subject to strict regulation in the European market, with clear provisions for its market access. The specific details are as follows:

Regulatory Policies

Coding and Classification

In the EU food additive coding system, nisin is classified as a preservative, with the corresponding EU code E234. This code is uniformly established by the EU Food Additive Regulation (Regulation (EC) No 1333/2008) and is used to standardize the labeling, scope of application, and maximum usage limits of food additives.

Safety Assessment

The EU adopts a "positive list system" for the control of food additives—only additives explicitly included in the approved list can be used in specific food categories. The safety of nisin has been evaluated by the European Food Safety Authority (EFSA). After a re-evaluation in 2017, EFSA confirmed that no upper limit needs to be set for its Acceptable Daily Intake (ADI).

Scope of Application and Maximum Usage Limits

According to Annex II of Regulation (EU) No 1129/2011 of the European Commission, nisin is approved for use in pasteurized or ultra-high temperature (UHT)-treated dairy products, heat-treated meat products, bakery products, and liquid egg products, among others. Specific maximum usage limits are set separately based on differences in food matrices: for example, the maximum allowable addition level in hard cheeses is 12.5 mg/kg, and in ready-to-eat meat products, it shall not exceed 25 mg/kg. However, the addition of nisin is prohibited in fermented dairy products and infant formula foods.

Market Access

Requirements for Production Process Documentation

Enterprises seeking to market products containing nisin in Europe must provide production process documentation that complies with EU standards. This includes a bacterial strain identification report, fermentation process control parameters, and a purity test certificate for nisin A in the finished product—with the purity requirement being ≥900 IU/mg.

Compliance Statement

Enterprises must ensure that the use of nisin in their products meets all requirements of EU regulations, including the scope of application and maximum usage limits. They must also be able to provide relevant compliance statements and supporting documents.