Is ε-Polylysine hydrochloride approved for use in all countries?

ε-Polylysine hydrochloride is a natural antimicrobial agent that has been used as a food preservative for several decades. It is a cationic peptide polymer produced by the bacterium Streptomyces albulus and is known for its broad-spectrum antimicrobial activity against bacteria, fungi, and yeasts. ε-Polylysine hydrochloride has been approved as a food preservative in several countries, including the United States, Japan, and China. In this article, we will discuss the approval status of ε-Polylysine hydrochloride in various countries.

United States:

In the United States, ε-Polylysine hydrochloride has been approved for use as a food preservative by the Food and Drug Administration (FDA). It is listed as a Generally Recognized as Safe (GRAS) substance, which means that it is considered safe for use in food at the levels specified in the regulations. The FDA has set a maximum level of 0.1% ε-Polylysine hydrochloride in food products.

European Union:

In the European Union (EU), ε-Polylysine hydrochloride is not currently approved for use as a food preservative. However, it is listed in the Union List of flavorings and food additives, and its safety is being evaluated by the European Food Safety Authority (EFSA). The EFSA has issued a scientific opinion on ε-Polylysine hydrochloride, concluding that it is safe for use as a food preservative at the maximum level of 500 mg/kg.

Japan:

In Japan, ε-Polylysine hydrochloride has been approved for use as a food preservative since 1972. It is listed as a food additive under the Japanese Food Sanitation Law, and its maximum level is set at 1,000 mg/kg.

China:

In China, ε-Polylysine hydrochloride has been approved for use as a food preservative since 2006. It is listed as a food additive in the Chinese National Food Safety Standard, and its maximum level is set at 500 mg/kg.

Korea:

In Korea, ε-Polylysine hydrochloride has been approved for use as a food preservative since 2001. It is listed as a food additive in the Korean Food and Drug Administration’s Food Code, and its maximum level is set at 1,000 mg/kg.

Other countries:

In other countries, the approval status of ε-Polylysine hydrochloride varies. In some countries, it is approved for use as a food preservative, while in others, it is not. For example, in Australia and New Zealand, ε-Polylysine hydrochloride is listed as a food additive, but its use is restricted to certain food categories. In Canada, ε-Polylysine hydrochloride is not currently approved for use as a food preservative.

In conclusion, ε-Polylysine hydrochloride has been approved for use as a food preservative in several countries, including the United States, Japan, China, and Korea. Its approval status in other countries varies, and its safety and effectiveness as a food preservative are being evaluated by regulatory agencies in the European Union. As with all food additives, the use of ε-Polylysine hydrochloride should be based on scientific evidence of its safety and efficacy, and its maximum levels in food products should be strictly observed.