Antimicrobial textiles have recently gained momentum in the United States due to increased awareness with regard to hygiene, health, and safety. These textile materials are in extremely high demand for various applications, right from the healthcare sector to daily wear. However, one needs to understand that antimicrobial textiles are subjected to strict compliance requirements to ensure their safety and effectiveness and these requirements differ from one region to another.

Regulatory framework in the U.S.

In the United States, antimicrobial textiles’ compliance requirement is governed by the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). Each agency has specific guidelines depending on the intended use of the textile product.

Environmental Protection Agency (EPA)

• Antimicrobial agents in textiles are regulated by the Federal Insecticide, Fungicide, and Rodenticide Act under the EPA. The FIFRA requires that any substance that is used to prevent, destroy or repel pests including microorganisms must be registered with EPA. This is a key component of U.S. antimicrobial textile regulations.

Food and Drug Administration (FDA)

• The FDA regulates products, such as surgical gowns or dressings, that are classified under medical devices. These products must undergo rigorous testing for safety and effectiveness as per the FDA’s medical device regulations before they are approved.

EPA compliance requirements

Manufacturers who aim to market their antimicrobial textiles in the U.S. are required to comply with EPA regulations. The key  antimicrobial textiles’ compliance requirements include:

Registration of antimicrobial agents 

• Any active ingredient used in antimicrobial textiles should be registered under the EPA. This includes submitting data with regard to the safety of the substance and its effects on human health and the environment.

Labeling requirements

• The EPA requires that antimicrobial textiles must be labeled with important information including the active ingredient, its intended function, and associated risks. In addition, the labeling shall not make false or misleading claims about the antimicrobial properties of the product.

Pesticide device classification

• If the antimicrobial agent in the textile falls under the definition of a pesticide, the product must comply with applicable pesticide regulations, including device registration and labeling.

FDA compliance requirements

When antimicrobial textiles are classified as medical devices, they fall under FDA jurisdiction. The  antimicrobial textiles’ compliance requirements include:

Premarket notification (510(k)

• Manufacturers must submit a 510(k) premarket notification to the FDA, demonstrating that the product is substantially equivalent to a legally marketed device. This submission must include data on the product’s safety, efficacy, and biocompatibility.

Quality system regulation (QSR)

• The FDA requires manufacturers to implement a Quality System Regulation (QSR) that outlines procedures for design, manufacturing, labeling, and packaging of medical devices. This regulation ensures that products meet specific quality standards.

Post-market surveillance

• Manufacturers must monitor the product’s performance once it is in the market. Any adverse events or product failures must be reported to the FDA immediately. This post-market surveillance is essential for maintaining product safety.

Testing and certification

The importance of Third-Party testing

Testing is necessary to ensure antimicrobial textiles’ compliance with EPA and FDA regulations.  Third-party labs play an important role in this process by conducting tests that assess the product’s antimicrobial efficacy, safety, and durability. These tests help manufacturers demonstrate that their products meet U.S. textile regulations.

Testing standards

AATCC 100

• This standard measures the antibacterial activity of treated textiles. It is widely used in the industry to assess the effectiveness of antimicrobial treatments.

ISO 20743

• This international standard specifies methods for determining the antibacterial activity of textile products. It is often used alongside AATCC 100 to ensure comprehensive testing.

ASTM E2149

• This standard test method evaluates the antimicrobial activity of immobilized agents under dynamic contact conditions. It is particularly useful for textiles that are subject to movement, such as clothing.

Certification programs

Certification programs, such as the OEKO-TEX® STANDARD 100, provide additional assurance that the textiles treated for antimicrobial properties have complied with very strict safety criteria besides testing. Manufacturers tend to aim for this certification to add value to credibility and further marketability of the products.

Conclusion

Navigating the complexities of U.S. textile regulations is a difficult task for manufacturers and requires careful and timely considerations. Rigorous testing of antimicrobial textiles will help in meeting antimicrobial textiles’ compliance and obtaining market approvals.  This process becomes much easier by partnering with independent third-party testing labs because they produce reliable test results in a reasonable amount of time while at the same time adhering to standard regulations.

At Microbe Investigations Switzerland, we specialize in helping you navigate the complex antimicrobial textiles’ compliance requirements in the U.S. Our comprehensive testing services ensure your textile products meet all necessary regulatory standards for safety and efficacy. Rely on our expertise to streamline your path to compliance and confidently bring your antimicrobial textiles to the U.S. market.

To learn more about our antimicrobial textile testing services or to schedule a consultation, please contact our specialists today.