Regulatory Compliance

The Association is a grouping of 14 well-known textile research and test institutes in Europe and Japan, with representative agencies and contact offices in over 40 countries worldwide. Oeko-Tex® is responsible for independent tests for harmful substances according to Oeko-Tex® Standard 100.

The active ingredient in NanoHorizons’ SmartSilver additives is registered with the U.S. Environmental Protection Agency (EPA), in accordance with FIFRA Section 3(c)(7)(A), as an antimicrobial additive for materials preservation. Under the EPA registration, SmartSilver additives may be incorporated into a wide variety of materials including coatings, fibers, adhesives, sealants, ceramics, glazes, glasses, and plastics.

Antimicrobial additives are subject to government regulations relating to consumer and environmental safety. Non-compliance with these regulations may have serious legal results. In the U.S., the EPA and the Federal Drug Administration (FDA) are the two key governmental organizations with regulatory oversight of antimicrobial products.

NanoHorizons is supported by a regulatory staff with expertise in EPA regulations and claims language guidelines for non-public health applications. In the healthcare market, clinical trials on medical devices containing SmartSilver antimicrobial additives and data development to support the FDA 501(k) registrations for medical products are currently underway.

Based on our experience with the EPA and FDA, we offer our customers guidance and extensive informational resources to help them successfully navigate product registration requirements.

In addition, NanoHorizons is a member of the Silver Nanotechnology Working Group (SNWG), a program of the Silver Institute. The SNWG serves as a data sharing body for scientific information on the benefits and safe use of antimicrobial nanoscale silver.

For customers with questions regarding regulatory requirements, contact:

James Delattre, PhD
Phone: (814)355-4700, ext 121
jdelattre@nanohorizons.com