What evidence establishes the regulatory category for each product and each advertised use?

What evidence establishes the regulatory category for each product and each advertised use?

A regulatory category is not established by test evidence.

It follows from the definition in the law and from what the article is intended to do. The company classifies the NanoFlashing™ Air Filter as a device under section 2(h) of the Federal Insecticide, Fungicide, and Rodenticide Act and the definition at 40 C.F.R. § 152.500(a). Under 40 C.F.R. § 152.500(b), a device is not required to be registered under FIFRA section 3, and the requirements listed there apply instead. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. The basis is the one set out in the company's Statement of Classification. NanoFlashing™ is a permanent positive polarity engineered into filter media itself. It is a physical property of the filter. A charge is a physical property. It is not a substance or a mixture of substances. The filter therefore incorporates no substance or mixture of substances to perform its intended pesticidal purpose. For the same filter in the European Union, the company's Statement of Regulatory Status classifies it as neither a biocidal product nor a treated article under Regulation (EU) No 528/2012. Both statements are written for the NanoFlashing™ Air Filter, and neither covers the water, textile, food packaging or medical materials.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 1.2, 2.1, 3.6 and 3.7, issued by NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 1.2 and 3.7, issued by C-POLAR Technologies, Inc.; 40 C.F.R. § 152.500, as published on eCFR.

Reviewed on 21 September 2026.