Has ε-Polylysine hydrochloride been approved for use in all countries?

ε-Polylysine hydrochloride, a natural cationic polymer with antimicrobial properties, has gained attention as a food preservative. This article explores the regulatory status and restrictions on the use of ε-polylysine hydrochloride in different countries. It highlights the approval process, regulatory authorities involved, and any specific limitations or guidelines imposed on its use.

United States:
In the United States, the regulatory authority responsible for the approval of food additives, including ε-polylysine hydrochloride, is the Food and Drug Administration (FDA). It has approved the use of ε-polylysine hydrochloride as a food preservative. However, specific usage levels and restrictions may apply, and manufacturers must adhere to the guidelines outlined by the FDA.

European Union:
Within the European Union (EU), the European Food Safety Authority (EFSA) evaluates the safety and efficacy of food additives. ε-Polylysine hydrochloride has been approved for use as a food preservative in the EU, and its specific conditions of use are regulated by the EU Commission. The maximum permitted levels and specific requirements may vary depending on the food category.

Japan:
In Japan, the Ministry of Health, Labour, and Welfare (MHLW) oversees the regulation of food additives, including ε-polylysine hydrochloride. It has approved the use of ε-polylysine hydrochloride as a food preservative, specifying the permitted usage levels and any restrictions for different food categories.

China:
The use of food additives in China is regulated by the Ministry of Health (MoH) and the National Health Commission (NHC). ε-Polylysine hydrochloride is approved as a food preservative in China, subject to specific regulations and maximum permitted levels established by the National Food Safety Standard for Food Additives.

Canada:
In Canada, the regulatory authority responsible for the approval of food additives is Health Canada. ε-Polylysine hydrochloride has received regulatory approval as a food preservative, and its permitted usage levels are outlined in the Food and Drug Regulations.

Australia and New Zealand:
Food Standards Australia New Zealand (FSANZ) regulates food additives in Australia and New Zealand. ε-Polylysine hydrochloride has been approved as a food preservative, and its usage levels are specified in the Food Standards Code.

Codex Alimentarius:
The Codex Alimentarius Commission, established by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), develops international food standards. While not legally binding, Codex standards often influence national regulations. ε-Polylysine hydrochloride is included in the Codex General Standard for Food Additives, indicating its recognition and acceptance at the international level.

Regulatory Restrictions and Limitations:
While ε-polylysine hydrochloride has obtained regulatory approval in several countries, it is important to note that there may be restrictions or limitations on its use. These restrictions can include maximum permitted levels, specific labeling requirements, and limitations on food categories or processing methods. Manufacturers must comply with these regulations to ensure the safe and legal use of ε-polylysine hydrochloride.

Conclusion:
ε-Polylysine hydrochloride has received regulatory approval for use as a food preservative in several countries, including the United States, the European Union, Japan, China, Canada, and Australia/New Zealand. The regulatory authorities in these countries have evaluated its safety and established guidelines for its usage levels. However, specific restrictions and limitations may apply, such as maximum permitted levels and food category-specific requirements. Manufacturers and food producers should consult the regulatory guidelines of each country to ensure compliance and responsible use of ε-polylysine hydrochloride as a food preservative.