Regulatory considerations for the use of ε-Polylysine hydrochloride in different regions

As a natural antimicrobial agent, ε-Polylysine hydrochloride (ε-PL) has gained significant attention for its potential applications in the food, pharmaceutical, and cosmetic industries. Derived from the fermentation of Streptomyces albulus, ε-PL is a polymer of the amino acid lysine and exhibits broad-spectrum antimicrobial activity, making it particularly useful in food preservation, especially in the prevention of microbial growth in minimally processed foods and packaged products. However, as with any bioactive ingredient, the use of ε-Polylysine hydrochloride is subject to regulatory oversight to ensure its safety and efficacy in consumer products. Regulatory frameworks vary significantly across regions, and understanding these differences is essential for manufacturers, food producers, and other stakeholders involved in its application.

1. Regulatory Status in the United States
In the United States, the use of food ingredients and additives is primarily regulated by the Food and Drug Administration (FDA). For ε-Polylysine hydrochloride, the regulatory pathway depends on the specific application and the intended use of the product.

Food Use: ε-PL has been evaluated by the FDA and has been granted Generally Recognized as Safe (GRAS) status for use in food preservation. The GRAS designation is granted to substances that are considered safe for consumption based on scientific evidence or a long history of safe use. The FDA’s GRAS notice system allows manufacturers to submit a notification that their ingredient meets the criteria for GRAS status, though they are not required to seek FDA approval. This status allows ε-Polylysine hydrochloride to be used in various food applications, such as preventing microbial growth in ready-to-eat meals, extending the shelf life of fresh-cut fruits and vegetables, and improving the safety of refrigerated or frozen foods.

Food Packaging: The FDA also regulates the use of food-contact materials. If ε-Polylysine hydrochloride is used in packaging materials (for example, as an antimicrobial agent in packaging films), it must comply with the Food Contact Substance (FCS) regulations. The FDA evaluates food-contact substances for safety to ensure that they do not migrate into food at harmful levels. Manufacturers are required to submit data demonstrating the safety of ε-PL in packaging before it can be used in these applications.

Pharmaceutical and Cosmetic Use: For pharmaceutical or cosmetic applications, ε-PL would require approval as an active ingredient, with its safety and efficacy evaluated according to FDA standards for drugs or cosmetics. While its use in topical formulations or drug delivery systems has not been widely reported in the U.S., any such claims would be subject to rigorous regulatory scrutiny and may require pre-market approval.

2. Regulatory Status in the European Union
In the European Union (EU), the regulatory framework for food ingredients is overseen by the European Food Safety Authority (EFSA), while other industries (pharmaceuticals, cosmetics) are regulated by separate bodies like the European Medicines Agency (EMA) and European Commission’s Cosmetics Directive.

Food Use: Like in the U.S., ε-Polylysine hydrochloride has been recognized for its potential as a food preservative. In the EU, ε-PL has been evaluated by EFSA, which has assessed its safety in food applications. In 2011, EFSA concluded that ε-PL is safe for use as a food preservative when used within specific limits. The European Commission has included ε-PL in its list of authorized food additives under the Regulation (EC) No 1333/2008 on food additives, where it is typically approved for use in certain categories of food, including dairy products, meat, and ready-to-eat meals.

Approval Process: In the EU, any new food additive must undergo a comprehensive safety assessment by EFSA, which includes reviewing toxicity data, potential allergenicity, and any adverse health effects. As part of this process, the additive must be supported by scientific evidence that proves it does not pose a risk to human health when consumed at the intended levels.
Food Packaging: If used in food packaging, ε-Polylysine hydrochloride would also need to comply with EU regulations governing food contact materials (Regulation (EC) No 1935/2004), which ensures that substances used in packaging do not migrate into food at harmful levels. The use of ε-PL in packaging would require approval by the European Commission for specific types of food contact materials.

Pharmaceutical and Cosmetic Use: In cosmetics, ε-PL is evaluated under the EU Cosmetics Regulation (EC) No 1223/2009. This regulation mandates that ingredients used in cosmetic products must be safe for human health when used under normal or reasonably foreseeable conditions. If ε-PL were to be used in cosmetics, manufacturers would need to ensure that it complies with the safety requirements and does not pose any risk of irritation or toxicity.

3. Regulatory Status in Japan
In Japan, the Ministry of Health, Labour and Welfare (MHLW) regulates food additives through the Food Sanitation Act. ε-Polylysine hydrochloride has been evaluated and approved as a food preservative in Japan, where it is listed as a permitted additive for use in food products under specific conditions.

Food Use: The use of ε-PL in food products in Japan is permitted for a range of applications, including as an antimicrobial agent in beverages, dairy products, and meats. Its use is subject to the approval of the Japan Food Additive Standards and is closely monitored to ensure that it does not exceed safe concentrations.

Pharmaceutical and Cosmetic Use: As in other regions, the use of ε-PL in pharmaceutical or cosmetic products would be subject to additional safety assessments by the MHLW. Its use in these products would be subject to rigorous testing to ensure safety and efficacy.

4. Regulatory Status in China
China regulates food ingredients and additives through the National Health Commission of the People’s Republic of China (NHC), which establishes safety standards for food additives and preservatives.

Food Use: ε-Polylysine hydrochloride has been approved for use in a variety of food products in China, including meats, dairy, and ready-to-eat meals. It is listed in the National Food Safety Standards for Food Additives (GB 2760-2014), which outlines permissible levels and applications. The NHC’s evaluation of ε-PL ensures that it is safe for human consumption when used at the recommended levels.

Food Packaging: Like other regions, the use of ε-PL in food packaging would be subject to regulatory approval by the relevant authorities. Packaging materials containing ε-PL must comply with the GB 4806.1-2016 standards for food-contact materials.

Pharmaceutical and Cosmetic Use: For pharmaceutical applications, ε-PL would need to undergo regulatory review by the NHC or the China Food and Drug Administration (CFDA). If used in cosmetics, it would be assessed under the Cosmetic Hygiene Supervision Regulations to ensure its safety for topical use.

5. Other Regional Considerations
In other regions, such as Australia, New Zealand, and various Southeast Asian countries, ε-Polylysine hydrochloride is similarly subject to the safety evaluation and regulatory approval processes of respective health and safety agencies. For example, in Australia and New Zealand, food additives are regulated by Food Standards Australia New Zealand (FSANZ), which has also granted GRAS status to ε-PL for food use.

Conclusion
The regulatory approval and use of ε-Polylysine hydrochloride as a food preservative or in other applications depend on the regulatory frameworks of different regions. While it is widely accepted for food use in the United States, European Union, Japan, and China, the specific conditions, permissible usage levels, and approval processes can vary. Manufacturers must carefully navigate these regional regulations to ensure the safe and compliant use of ε-PL in their products, whether for food, pharmaceutical, or cosmetic applications. As global interest in natural preservatives continues to rise, ε-Polylysine hydrochloride is well-positioned to play a key role in sustainable and safe food preservation strategies.