How does NanoFlashing fit US federal rules?

Is the NanoFlashing™ Air Filter a pesticide?

The company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of FIFRA, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a), not as a pesticide.

FIFRA and the regulation define the two separately. Section 2(u) defines a pesticide as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest”. 40 C.F.R. § 152.500(a) defines a device as “any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus, or other microorganism on or in living man or living animals) but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom.” An air filter is an instrument. The notice that 40 C.F.R. § 152.500(b) cites, Pest Control Devices and Device Producers, 41 Fed. Reg. 51065 (19 November 1976), records that devices subject to FIFRA sections 2(q)(1) and 7 include, but are not limited to, “certain ultraviolet light systems, ozone generators, water filters and air filters (except those containing substances or mixtures of substances which are pesticides), and ultrasonic devices, for which claims are made to kill, inactivate, entrap, or suppress the growth of fungi, bacteria, or viruses in various sites”. EPA has stated the test for a device in these words: “A device must work solely by physical means (such as electricity, light or mechanics).” 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. The Statement of Classification states: “A device is not required to be registered under FIFRA section 3.” 40 C.F.R. § 152.500(b) lists the requirements that apply to a device instead: labelling; establishment registration and reporting; books and records; inspection of establishments; violations, enforcement and penalties; import and export; child-resistant packaging; and the Agency's authority under FIFRA section 25(c)(4). The company accepts that each of them applies to the article. The company's classification is its own statement of how the law applies to the filter, and it is not a decision by any authority. No agency has approved, registered or cleared the filter, and for a device there is no such approval to obtain, because EPA does not review a device for safety or efficacy before it is sold.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 3.5, 3.6, 3.7 and 4.1, issued by NF Technical Products Inc.; Federal Insecticide, Fungicide, and Rodenticide Act, section 2(u), 7 U.S.C. § 136(u), text as posted by EPA, https://www.epa.gov/sites/default/files/documents/fifra.pdf; EPA, Compliance Advisory 305F20004 (October 2020), at 1, https://www.epa.gov/sites/default/files/2020-10/documents/uvlight-complianceadvisory.pdf; 40 C.F.R. § 152.500, https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-152/subpart-Z/section-152.500; EPA, Pest Control Devices and Device Producers, 41 Fed. Reg. 51065 (19 November 1976), https://www.epa.gov/sites/default/files/2015-06/documents/frn-devices.pdf; C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

Why is the NanoFlashing™ Air Filter not registered with the EPA?

A device is not required to be registered under FIFRA section 3, and the company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of FIFRA, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a).

EPA has stated the test for a device in these words: “A device must work solely by physical means (such as electricity, light or mechanics).” The notice that 40 C.F.R. § 152.500(b) cites, Pest Control Devices and Device Producers, 41 Fed. Reg. 51065 (19 November 1976), records that devices subject to FIFRA sections 2(q)(1) and 7 include, but are not limited to, “certain ultraviolet light systems, ozone generators, water filters and air filters (except those containing substances or mixtures of substances which are pesticides), and ultrasonic devices, for which claims are made to kill, inactivate, entrap, or suppress the growth of fungi, bacteria, or viruses in various sites”. 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. 40 C.F.R. § 152.500(b) lists the requirements that apply to a device instead: labelling; establishment registration and reporting; books and records; inspection of establishments; violations, enforcement and penalties; import and export; child-resistant packaging; and the Agency's authority under FIFRA section 25(c)(4). The company accepts that each of them applies to the article. No agency has approved, registered or cleared the filter, and for a device there is no such approval to obtain, because EPA does not review a device for safety or efficacy before it is sold.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 2.1, 3.5, 3.6, 3.7 and 4.1, issued by NF Technical Products Inc.; EPA, Compliance Advisory 305F20004 (October 2020), at 1, https://www.epa.gov/sites/default/files/2020-10/documents/uvlight-complianceadvisory.pdf; 40 C.F.R. § 152.500, https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-152/subpart-Z/section-152.500; EPA, Pest Control Devices and Device Producers, 41 Fed. Reg. 51065 (19 November 1976), https://www.epa.gov/sites/default/files/2015-06/documents/frn-devices.pdf; C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

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.

What intended uses and claims would change the regulatory position described for this product?

The position turns on two things: what the article is intended to do, and what performs that purpose.

A device is defined at 40 C.F.R. § 152.500(a) as “any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus, or other microorganism on or in living man or living animals) but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom.” EPA states the test for a device in its own words: “A device must work solely by physical means (such as electricity, light or mechanics).” That sentence is EPA's published interpretation in a compliance advisory, not the text of the statute. Three things would change the filter’s classification under FIFRA, by taking it outside the device definition at 40 C.F.R. § 152.500(a): a substance or a mixture of substances incorporated into it to perform its intended pesticidal purpose, being equipment for applying a separately supplied pesticide, and intended use on or in living man or living animals. A claim to diagnose, treat, cure or prevent disease is a different law again, and the company's label states that the filter is not a medical device and is not intended to diagnose, treat, cure or prevent disease. For the NanoFlashing™ Air Filter, the Statement of Classification states at 3.3: “The filter is not intended for use on or in living man or living animals.” At 3.4 it states: “The filter is not equipment for applying a separately supplied pesticide. It is not sold or packaged with any pesticide.” The Terms of Use state: “As of the Effective Date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications. They do not describe finished products currently available from C-POLAR for those uses.” 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.

Source: 40 C.F.R. § 152.500, as published on eCFR; EPA Compliance Advisory 305F20004, EPA Regulations About UV Lights that Claim to Kill or Be Effective Against Viruses and Bacteria (October 2020), at 1; NanoFlashing™ Air Filter label, About This Product; Statement of Classification for the NanoFlashing™ Air Filter, sections 2.1, 3.3, 3.4 and 3.6, issued by NF Technical Products Inc.; C-POLAR — Terms of Use, section 4, https://cpolar.tech/terms/; C-POLAR — United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

What does each displayed federal identifier identify, and what does it fail to establish about performance or authorization?

An EPA establishment number identifies the place where an article was produced.

It identifies nothing else. 40 C.F.R. § 156.10(f) is the provision that puts it on a label: “The producing establishment registration number preceded by the phrase ‘EPA Est.,’ of the final establishment at which the product was produced may appear in any suitable location on the label or immediate container.” It is not a registration of the product, it is not an approval, and it carries no finding about how the article performs. EPA states in Chapter 13 of its Pesticide Registration Manual that “EPA establishment numbers, which are required for devices, are not the same as EPA pesticide registration numbers required for pesticide products”, https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices. The company classifies the article itself. No agency has approved, registered or cleared the NanoFlashing™ Air Filter, and EPA does not review a device for safety or efficacy before it is sold.

Source: 40 C.F.R. § 156.10, as published on eCFR; EPA, Pesticide Registration Manual, Chapter 13: Devices, https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices; NanoFlashing™ Air Filter label; C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

Have website pages, downloadable files, packaging and partner copy been checked for consistent claim scope?

Under 7 U.S.C. § 136(p)(2), labelling means “all labels and all other written, printed, or graphic matter — (A) accompanying the pesticide or device at any time; or (B) to which reference is made on the label or in literature accompanying the pesticide or device”. The label carries its own limits in its own words: it is not a medical device and is not intended to diagnose, treat, cure or prevent disease, it works alongside ventilation and cleaning rather than in place of them, and results in a building depend on the system, the airflow and how well the filter fits its track. Each published page is at its own address on cpolar.tech, and the Terms of Use state that the Site does not include shop.cpolartechnologies.com, shopusa.cpolartechnologies.com, another online store that displays separate terms, or a C-POLAR page hosted on a third-party platform. NanoFlashing™ is a technology; the name, rating and sale of a product that carries it are set by that product's maker and seller. Every commercial NanoFlashing™ product is made by a manufacturing partner, and each partner controls what is said about the work.

Source: C-POLAR — About, https://cpolar.tech/about/; NanoFlashing™ Air Filter label, About This Product; 7 U.S.C. § 136(p), as published by EPA; C-POLAR — Home, https://cpolar.tech/; C-POLAR — Terms of Use, section 1, https://cpolar.tech/terms/.

Reviewed on 6 October 2026.

Which exact product, intended purpose and claim set support the company's reliance on the device definition in FIFRA section 2(h)?

The product is the NanoFlashing™ Air Filter, a panel air filter for forced-air heating, ventilation and air-conditioning systems.

It is a dry, solid, finished article. 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 intended purpose is stated in the company's Statement of Classification: the filter is intended to destroy the viruses, bacteria and fungal spores it captures, on direct contact with the positive electric charge, by physical means, and only while the organism is captured by the positive electric charge. 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. The filter is not equipment for applying a separately supplied pesticide, and it is not sold or packaged with any pesticide. This classification is stated for that article. It is not stated for any other construction, any other size or any other product.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 1.2, 2.1, 2.6, 3.4, 3.6, 3.7 and 4.1, issued by NF Technical Products Inc.; 40 C.F.R. § 152.500, as published on eCFR.

Reviewed on 21 September 2026.

How does the current marketed product compare with the product and supporting materials addressed in the April determination?

The company’s classification does not rest on any agency decision, and the company publishes and claims none.

No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. 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. The company publishes no agency decision about the article and claims none, because no advance classification is issued for a device: the producer applies the definition and carries the duties that come with it. Where the company cites an agency document, it cites it for what it is. A compliance advisory is EPA's published guidance to producers generally, and it names no company and no product. The text of a regulation is the text of a regulation. Neither is a decision about this article. The article the company classifies is the one described in its Statement of Classification: the NanoFlashing™ Air Filter, a panel air filter for forced-air heating, ventilation and air-conditioning systems.

Source: C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/; Statement of Classification for the NanoFlashing™ Air Filter, sections 1.2, 3.7 and 4.1, issued by NF Technical Products Inc.; 40 C.F.R. § 152.500, as published on eCFR.

Reviewed on 6 October 2026.

Is there a written agency disposition that withdraws, replaces or modifies the April determination, separate from later reported comments?

The company’s classification does not rest on any agency decision, and the company publishes and claims none.

No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. 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. The company publishes no agency decision about the article and claims none, because no advance classification is issued for a device: the producer applies the definition and carries the duties that come with it. Where the company cites an agency document, it cites it for what it is. A compliance advisory is EPA's published guidance to producers generally, and it names no company and no product. The text of a regulation is the text of a regulation. Neither is a decision about this article. The article the company classifies is the one described in its Statement of Classification: the NanoFlashing™ Air Filter, a panel air filter for forced-air heating, ventilation and air-conditioning systems.

Source: C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/; Statement of Classification for the NanoFlashing™ Air Filter, sections 1.2, 3.7 and 4.1, issued by NF Technical Products Inc.; 40 C.F.R. § 152.500, as published on eCFR.

Reviewed on 6 October 2026.

Which current production establishments make each sold product, and what assigned establishment number belongs to each physical site?

An EPA establishment number identifies the place where an article was produced, and it identifies nothing else. Under 40 C.F.R. §§ 167.3 and 167.20(c) that number is held by the party that operates the establishment, and it is assigned before any production occurs at the site where the label is applied.

40 C.F.R. § 156.10(f) is the provision that puts that number on a label: “The producing establishment registration number preceded by the phrase ‘EPA Est.,’ of the final establishment at which the product was produced may appear in any suitable location on the label or immediate container.”

Source: 40 C.F.R. §§ 156.10 and 167.20, as published on eCFR.

Reviewed on 6 October 2026.

What production reports have actually been submitted for the establishments involved, and how do reported products and quantities match operating records?

A production report is made by the party that operates the registered establishment, and 40 C.F.R. § 167.85 sets when it is due.

Under 40 C.F.R. § 167.85 an initial production report follows registration of the establishment within thirty days, and an annual report is due on or before 1 March each year, including a year with no production. The records behind it are the records of devices produced, received and shipped required by 40 C.F.R. § 169.2(b) to (d), each retained two years, and the current record of devices in stock required by § 169.2(e).

Source: 40 C.F.R. §§ 167.85 and 169.2, as published on eCFR.

Reviewed on 21 September 2026.

What current records demonstrate compliance with each continuing obligation applicable under 40 CFR 152.500?

40 C.F.R. § 152.500(b) lists the requirements that apply to a device, and records are set out for three of them, in 40 C.F.R. parts 156, 167 and 169.

40 C.F.R. § 152.500(b) states that a device is not required to be registered under FIFRA section 3 and that a device is subject to the requirements for labelling, establishment registration and reporting, books and records, inspection of establishments, violations, enforcement and penalties, import and export, child-resistant packaging, and the Agency’s authority under FIFRA section 25(c)(4). The label is set by 40 C.F.R. part 156, establishment registration and the production reports by 40 C.F.R. part 167, and the records of devices produced, received and shipped by 40 C.F.R. § 169.2(b) to (d), each retained two years, with a current record of devices in stock under § 169.2(e). The other requirements rest on FIFRA sections 9, 12 to 14, 17, 25(c)(3) and 25(c)(4), as 40 C.F.R. § 152.500(b) states.

Source: Statement of Classification for the NanoFlashing™ Air Filter, section 4.1, issued by NF Technical Products Inc.; 40 C.F.R. §§ 152.500, 156.10, 167.20, 167.85 and 169.2, as published on eCFR.

Reviewed on 21 September 2026.

How was the overall impression of headings, surrounding text, comparisons and credentials assessed against 40 CFR 156.10(a)(5)?

40 C.F.R. § 156.10(a)(5) states that “a pesticide or a device declared subject to the Act pursuant to § 152.500, is misbranded if its labeling is false or misleading in any particular including both pesticidal and non-pesticidal claims.” Among the examples it lists are “a false or misleading statement concerning the effectiveness of the product as a pesticide or device”, “a false or misleading comparison with other pesticides or devices” and “a true statement used in such a way as to give a false or misleading impression to the purchaser”. The last of those is the one that reaches headings, surrounding text and credentials. The rule is read as it is written, and it reaches the impression a page gives, not only the sentences on it.

Source: 40 C.F.R. § 156.10(a)(5), as published on eCFR.

Reviewed on 6 October 2026.

What evidence supports the physical-mechanism account while separately addressing the legal identity of the product that performs that mechanism?

They are two separate questions, and the company keeps them separate.

The mechanism first. NanoFlashing™ is a permanent positive polarity engineered into filter media itself. It is a physical property of the filter. The polarity is a positive electric charge at rest, measured as surface charge density in nanocoulombs per square centimetre; the coulomb is the unit of electric charge, and the National Institute of Standards and Technology gives the quantity the coulomb measures as “electric charge, amount of electricity”. The charge is measured on every production run, and the measurement can be repeated on any filter, upon request. The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. It generates no ozone and emits nothing into the air passing through it. The air leaving the filter has had nothing added to it. The filter captures airborne particles mechanically and by electrostatic attraction. The legal identity second. 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. A charge being a physical property does not by itself settle the classification of the whole article; the classification also rests on what the article is intended to do, which the Statement of Classification sets out.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 2.1 to 2.6, 3.6 and 3.7, issued by NF Technical Products Inc.; National Institute of Standards and Technology, Guide for the Use of the International System of Units (SI), NIST Special Publication 811 (2008 ed.), § 4.2.1, Table 3, at 5; 40 C.F.R. § 152.500, as published on eCFR.

Reviewed on 21 September 2026.

Which current pages, labels and promotional materials were actually included in each regulatory submission or review?

Each published page is at its own address on cpolar.tech. The company's classification rests on two things and nothing else: the definition of a device at 40 C.F.R. § 152.500(a), and the article as described in the company's Statement of Classification.

The company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a). A request for the material behind a particular question can be made through the contact route at https://cpolar.tech/contact/.

The company classifies the article itself, publishes no agency decision about the article and claims none. No agency has approved, registered or cleared the filter, and for a device there is no such approval to obtain, because EPA does not review a device for safety or efficacy before it is sold.

Source: C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/; Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1, issued by NF Technical Products Inc.; C-POLAR — Contact, https://cpolar.tech/contact/; C-POLAR — Home, https://cpolar.tech/.

Reviewed on 6 October 2026.

Can a reported absence of registrations be reproduced in a documented primary-source search with a defined date and scope?

Yes.

EPA's own registration record is public and can be searched by anyone, on any date. The Pesticide Product and Label System, at https://ordspub.epa.gov/ords/pesticides/f?p=PPLS:1, describes itself as providing “a collection of pesticide product labels that have been accepted by EPA under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)”, and it can be searched by EPA registration number, by company name or by company number. A device is not required to be registered under FIFRA section 3: that is what 40 C.F.R. § 152.500(b) says. The requirements that apply instead are labelling; establishment registration and reporting; books and records; inspection of establishments; violations, enforcement and penalties; import and export; child-resistant packaging; and the Agency's authority under FIFRA section 25(c)(4). So there is no section 3 registration for a device to find, and finding none is the expected result rather than a discrepancy. The absence of a registration is not an approval either. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself.

Source: 40 C.F.R. § 152.500, as published on eCFR; EPA Pesticide Product and Label System (PPLS), read 19 September 2026, https://ordspub.epa.gov/ords/pesticides/f?p=PPLS:1.

Reviewed on 21 September 2026.

How does the public account distinguish the text of law, agency guidance, a company legal argument and a product-specific decision?

By naming each one for what it is, every time it appears.

The text of the law is the text of the law: 40 C.F.R. § 152.500(a) defines a device, and 40 C.F.R. § 152.500(b) states that a device is not required to be registered under FIFRA section 3 and lists the requirements that apply instead. The requirements that apply instead are labelling; establishment registration and reporting; books and records; inspection of establishments; violations, enforcement and penalties; import and export; child-resistant packaging; and the Agency's authority under FIFRA section 25(c)(4). Agency guidance is the Agency's published interpretation, not the statute: EPA states the test for a device in its own words, “A device must work solely by physical means (such as electricity, light or mechanics)”, and that sentence is EPA's published interpretation in a compliance advisory, not the text of the statute. A company legal argument is the company's own: the Statement of Classification is issued by NF Technical Products Inc., and it records how the company applies the definition to its article. A product-specific decision is a decision by an agency about a named product, and the company publishes none and claims none. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself.

Source: 40 C.F.R. § 152.500, as published on eCFR; EPA Compliance Advisory 305F20004 (October 2020), at 1; Statement of Classification for the NanoFlashing™ Air Filter, issued by NF Technical Products Inc.

Reviewed on 21 September 2026.

Does the agency correspondence identify the exact addressee entitled to rely on it?

The company's position rests on written documents that name their own audience, and on no correspondence at all.

No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. 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. The company publishes no agency decision about the article and claims none. Where the company cites an agency document, it cites it for what it is. A compliance advisory is EPA's published guidance to producers generally, and it names no company and no product. The text of a regulation is the text of a regulation. Neither is a decision about this article. The same rule holds for the European Commission's answer that the company's Statement of Regulatory Status quotes. On 16 December 2025 the European Commission answered a written question in the European Parliament about filtration technologies. The answer did not name the company or the product.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1; Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 3.6; 40 C.F.R. § 152.500, as published on eCFR.

Reviewed on 21 September 2026.

Can a confidential agency submission support a public claim broader than its stated question?

The company's classification rests on two things and nothing else: the definition of a device at 40 C.F.R. § 152.500(a), and the article as described in the company's Statement of Classification.

40 C.F.R. § 156.10(a)(5) lists as misbranding “a true statement used in such a way as to give a false or misleading impression to the purchaser”, and a public claim drawn wider than the question that was actually asked would be exactly that. The company publishes no agency decision about the article and claims none. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 3.6 and 3.7, issued by NF Technical Products Inc.; 40 C.F.R. §§ 152.500 and 156.10, as published on eCFR.

Reviewed on 21 September 2026.

Was the agency given all relevant composition information when the classification question was posed?

The company classifies the article itself, on a basis it sets out in full in its Statement of Classification.

The company's classification rests on two things and nothing else: the definition of a device at 40 C.F.R. § 152.500(a), and the article as described in the company's Statement of Classification. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. The company publishes no agency decision about the article and claims none. That basis is this. 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. The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 2.1 to 2.4, 3.6 and 3.7, issued by NF Technical Products Inc.; 40 C.F.R. § 152.500, as published on eCFR.

Reviewed on 21 September 2026.

Does an agency response contain conditions that are omitted from the company's summary?

The Commission’s answer that the company quotes carries further conditions of its own, and they are quoted here with its first sentence.

The statement is this. On 22 October 2025 a Member of the European Parliament put a written question to the European Commission on Regulation (EU) No 528/2012 and filtration technologies, describing “technologies with a physical effect (e.g., permanent electrostatic charge or ‘NanoFlashing’)”. On 16 December 2025 the Commission answered: “The Commission considers that mere filtration systems which do not use any active substance would not be covered by the scope of Regulation (EU) 528/2012 (BPR), as the regulation excludes products acting by ‘mere physical or mechanical action’ (Article 3(1)(a)).” The Commission added that “an action which is physical, but also biological/chemical, remains within the scope of the BPR”. The Commission also stated: “The Court has adopted a broad interpretation on what constitutes a biocidal product under the biocides’ legislation (e.g. Cases C-420/10 and C-592/18), with each case assessed on its own merits. Member States have a primary responsibility to monitor the application of the relevant legal provisions and to take the necessary steps for enforcement.” The question named the technology. The Commission's answer did not name the company or the product. It is a general statement of how the Commission reads its own regulation, given in answer to a question; it is not an approval and not a decision about this product.

Source: European Parliament, question for written answer E-004160/2025/rev.1, tabled 22 October 2025; answer given by Mr Várhelyi on behalf of the European Commission, 16 December 2025; Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 3.6.

Reviewed on 6 October 2026.

Would adding an ingredient that contributes a separate pesticidal effect change the classification analysis?

It would, and that is the line the definition draws.

40 C.F.R. § 152.500(a) defines a device as an instrument or contrivance intended for trapping, destroying, repelling or mitigating a pest. EPA states the test for a device in its own words: “A device must work solely by physical means (such as electricity, light or mechanics).” That sentence is EPA's published interpretation in a compliance advisory, not the text of the statute. If something were incorporated into an article to perform its intended pesticidal purpose, the article would no longer answer that description, and it would fall to be considered as a pesticide under 7 U.S.C. § 136(u) instead. The company's position on its own article is unchanged. 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.

Source: 40 C.F.R. § 152.500, as published on eCFR; EPA Compliance Advisory 305F20004 (October 2020), at 1; Statement of Classification for the NanoFlashing™ Air Filter, section 3.6.

Reviewed on 21 September 2026.

Can an importer rely on a foreign manufacturer's establishment information without checking the imported configuration?

Each shipment requires a Notice of Arrival of Pesticides and Devices, EPA Form 3540-1, before it arrives, under 19 C.F.R. § 12.112(a).

An importer relying on a manufacturer's paperwork without checking what is in the container is relying on a description, not on the goods: a different configuration is a different article, and the classification at 40 C.F.R. § 152.500(a) turns on the article itself.

Source: 40 C.F.R. § 152.500, as published on eCFR; 19 C.F.R. § 12.112(a).

Reviewed on 21 September 2026.

Does offering a product at a US trade show create obligations before a sale occurs?

Yes.

Offering is already within the statutory term, before any money changes hands. 7 U.S.C. § 136(gg) defines “to distribute or sell” as “to distribute, sell, offer for sale, hold for distribution, hold for sale, hold for shipment, ship, deliver for shipment, release for shipment, or receive and (having so received) deliver or offer to deliver”. Labelling duties travel with the article: under 7 U.S.C. § 136(p)(2), labelling means “all labels and all other written, printed, or graphic matter — (A) accompanying the pesticide or device at any time; or (B) to which reference is made on the label or in literature accompanying the pesticide or device”. A brochure, a sign or a card placed with the device on a stand is written or graphic matter accompanying it.

Source: 7 U.S.C. § 136(gg) and (p)(2), FIFRA as posted by EPA.

Reviewed on 21 September 2026.

Could an email sent with a quotation be considered part of the product's claims?

It could.

Labelling is defined by what accompanies the device, not by the form the words arrive in. 7 U.S.C. § 136(p)(2) defines labelling as “all labels and all other written, printed, or graphic matter — (A) accompanying the pesticide or device at any time; or (B) to which reference is made on the label or in literature accompanying the pesticide or device”. 40 C.F.R. § 156.10(a)(5) states that “a pesticide or a device declared subject to the Act pursuant to § 152.500, is misbranded if its labeling is false or misleading in any particular including both pesticidal and non-pesticidal claims.” A quotation sent to a buyer is written matter, and a claim made in it is a claim.

Source: 7 U.S.C. § 136(p)(2), FIFRA as posted by EPA; 40 C.F.R. § 156.10(a)(5), as published on eCFR.

Reviewed on 21 September 2026.

Does a QR code on packaging lead to material that needs to be included in label review?

It does, if the label points to it.

7 U.S.C. § 136(p)(2) defines labelling as “all labels and all other written, printed, or graphic matter — (A) accompanying the pesticide or device at any time; or (B) to which reference is made on the label or in literature accompanying the pesticide or device”. 40 C.F.R. § 156.10(a)(5) states that “a pesticide or a device declared subject to the Act pursuant to § 152.500, is misbranded if its labeling is false or misleading in any particular including both pesticidal and non-pesticidal claims.” A code printed on a package is a reference made on the label, and what it leads to is reached by limb (B). Every page the company publishes about the filter is at its own address on cpolar.tech.

Source: 7 U.S.C. § 136(p)(2), FIFRA as posted by EPA; 40 C.F.R. § 156.10(a)(5), as published on eCFR.

Reviewed on 21 September 2026.

Can archived web copy remain relevant to products still bearing a link to it?

It can.

Material a current product still points to is reached by the definition, however old the page is. 7 U.S.C. § 136(p)(2) defines labelling as “all labels and all other written, printed, or graphic matter — (A) accompanying the pesticide or device at any time; or (B) to which reference is made on the label or in literature accompanying the pesticide or device”. 40 C.F.R. § 156.10(a)(5) states that “a pesticide or a device declared subject to the Act pursuant to § 152.500, is misbranded if its labeling is false or misleading in any particular including both pesticidal and non-pesticidal claims.” A link that is still live on a package or in literature is still a reference, and limb (B) does not expire. Each published page is at its own address on cpolar.tech.

Source: 7 U.S.C. § 136(p)(2), FIFRA as posted by EPA; 40 C.F.R. § 156.10(a)(5), as published on eCFR; C-POLAR — Home, https://cpolar.tech/.

Reviewed on 21 September 2026.

Does the intended target claim distinguish a public-health use from another use category?

The target named in a claim is what defines the intended purpose, and the company's named targets are the airborne viruses, bacteria and fungal spores the filter captures.

40 C.F.R. § 152.5 treats fungi, bacteria and viruses as pests. The company's Statement of Classification states the intended purpose in one sentence: the filter is intended to destroy the viruses, bacteria and fungal spores it captures, on direct contact with the positive electric charge, by physical means, and only while the organism is captured by the positive electric charge. NanoFlashing™ is a permanent positive polarity engineered into filter media itself. It is a physical property of the filter. The label sets the boundary of that purpose in the company's own words: it is not a medical device and is not intended to diagnose, treat, cure or prevent disease, and it works alongside ventilation and cleaning, not in place of them. A device is not registered under FIFRA section 3. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 2.6 and 3.2; NanoFlashing™ Air Filter label, About This Product; 40 C.F.R. §§ 152.5 and 152.500, as published on eCFR; C-POLAR — United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

Can a contractual disclaimer change the regulatory meaning of a prominent product claim?

The company’s Terms of Use state that their technical-operation section “does not limit responsibility for a factual advertising statement that applicable law requires to be truthful and supported when made.”

The filter’s own limits are printed on its label, in the same place as its directions. The label states that the filter is used in dry air only, that it is replaced when the pressure drop or the interval stated on it is reached, and that it is not washed, vacuumed, brushed, blown out or reused. A claim is read where it is made and at the size it is made, and the company’s answer to a question about a claim is the claim itself, stated plainly.

Source: NanoFlashing™ Air Filter label, Directions for Use and Operating Conditions; C-POLAR — Terms of Use, section 13, https://cpolar.tech/terms/.

Reviewed on 6 October 2026.

Who is authorised to respond to an EPA information request on behalf of each involved entity?

Each entity answers for itself, and each is named on the document it issued.

NF Technical Products Inc. issues the Statement of Classification for the NanoFlashing™ Air Filter. C-POLAR Technologies, Inc. issues the Statement of Regulatory Status for the same filter under the European Union's Biocidal Products Regulation. Inspection of establishments under FIFRA section 9 reaches the establishment, which is why the establishment is the entity that answers for it. General enquiries reach the company at https://cpolar.tech/contact/.

Source: Statement of Classification for the NanoFlashing™ Air Filter, section 1.1; Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 1.1; C-POLAR — Contact, https://cpolar.tech/contact/.

Reviewed on 21 September 2026.

Can the company obtain clarification of an ambiguous agency response without treating silence as agreement?

No advance classification is issued for a device: every device producer applies the definition at 40 C.F.R. § 152.500(a) to its own article and carries the duties that come with it.

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. Where the company cites an agency document, it cites it for what it is. A compliance advisory is EPA's published guidance to producers generally, and it names no company and no product. The text of a regulation is the text of a regulation. Neither is a decision about this article.

Asking is not a decision, and an answer to a question is not an approval. The company’s classification does not rest on any agency response, and it publishes and claims none. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself.

Source: C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/; 40 C.F.R. § 152.500, as published on eCFR; Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1.

Reviewed on 6 October 2026.

Does a change in trade name require a different action from a change in composition?

They are different changes with different consequences.

A trade name is what the label and the records call the article. 40 C.F.R. § 169.2(b) requires a device producer to keep the brand name and the quantity of each device produced, retained two years, and 40 C.F.R. § 156.10(a)(5) makes labelling that is false or misleading in any particular a misbranding. So a change of name changes the label and the records that name it. A change to what performs the intended pesticidal purpose goes further, because the classification at 40 C.F.R. § 152.500(a) turns on the article and on its working by physical means. EPA states the test for a device in its own words: “A device must work solely by physical means (such as electricity, light or mechanics).” That sentence is EPA's published interpretation in a compliance advisory, not the text of the statute.

Source: 40 C.F.R. §§ 152.500, 156.10 and 169.2, as published on eCFR; EPA Compliance Advisory 305F20004 (October 2020), at 1.

Reviewed on 21 September 2026.

What record shows that a regulator's oral comment was confirmed accurately in writing?

The company's position rests on written documents, and on nothing anyone said.

No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. 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. The company publishes no agency decision about the article and claims none. Where the company cites an agency document, it cites it for what it is. A compliance advisory is EPA's published guidance to producers generally, and it names no company and no product. The text of a regulation is the text of a regulation. Neither is a decision about this article. Where EPA's own words are quoted, they are quoted from a published compliance advisory, named and dated. The company's own Statement of Classification is issued by NF Technical Products Inc.

Source: 40 C.F.R. § 152.500, as published on eCFR; EPA Compliance Advisory 305F20004 (October 2020), at 1; EPA Compliance Advisory 305F22003, What You Need to Know About Producing, Distributing or Selling Pesticide Devices (February 2023), at 2; Statement of Classification for the NanoFlashing™ Air Filter.

Reviewed on 21 September 2026.

Can the company distinguish voluntary discussion with an agency from a formal decision process?

Yes: a voluntary request to an agency is a question, a formal decision is an agency act about a named product, and the company's classification rests on neither.

No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. 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. The company publishes no agency decision about the article and claims none. Where the company cites an agency document, it cites it for what it is. A compliance advisory is EPA's published guidance to producers generally, and it names no company and no product. The text of a regulation is the text of a regulation. Neither is a decision about this article. No advance classification is issued for a device: every device producer applies the definition at 40 C.F.R. § 152.500(a) to its own article and carries the duties that come with it.

Source: C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/; 40 C.F.R. § 152.500, as published on eCFR; Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1.

Reviewed on 6 October 2026.

Is NanoFlashing approved by the EPA or the FDA to fight COVID?

The company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of FIFRA, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a). A device is not required to be registered under FIFRA section 3. The NanoFlashing™ Air Filter label states: “It is not a medical device and is not intended to diagnose, treat, cure or prevent disease.”

No agency has approved, registered or cleared the filter, and for a device there is no such approval to obtain, because EPA does not review a device for safety or efficacy before it is sold.

Source: Statement of Classification for the NanoFlashing™ Air Filter, NF Technical Products Inc., sections 3.7 and 4.1; NanoFlashing™ Air Filter label; C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

The company “classifies” its own product under FIFRA and the EU Biocidal Products Regulation. Does that self-classification carry the same weight as an official government approval?

The company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of FIFRA, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a).

For the United States, the Statement of Classification states: “A device is not required to be registered under FIFRA section 3.” It lists the requirements that 40 C.F.R. § 152.500(b) applies to a device instead: labelling; establishment registration and reporting; books and records; inspection of establishments; violations, enforcement and penalties; import and export; child-resistant packaging; and the Agency's authority under FIFRA section 25(c)(4). The company accepts that each of them applies to the article. For the European Union, the company's Statement of Regulatory Status states: “No authorisation, approval, notification or registration under the Regulation is required. No prior decision of any authority is required. The company classifies the filter itself.” The company's classification is its own statement of how the law applies to the filter, and it is not a decision by any authority. No agency has approved, registered or cleared the filter, and for a device there is no such approval to obtain, because EPA does not review a device for safety or efficacy before it is sold.

Source: Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 5.2, C-POLAR Technologies, Inc., 11 September 2026; Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1, issued by NF Technical Products Inc.; C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

Is it a pesticide?

The company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of FIFRA, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a), not as a pesticide.

FIFRA and the regulation define the two separately. Section 2(u) defines a pesticide as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest”. 40 C.F.R. § 152.500(a) defines a device as “any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus, or other microorganism on or in living man or living animals) but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom.” An air filter is an instrument. The notice that 40 C.F.R. § 152.500(b) cites, Pest Control Devices and Device Producers, 41 Fed. Reg. 51065 (19 November 1976), records that devices subject to FIFRA sections 2(q)(1) and 7 include, but are not limited to, “certain ultraviolet light systems, ozone generators, water filters and air filters (except those containing substances or mixtures of substances which are pesticides), and ultrasonic devices, for which claims are made to kill, inactivate, entrap, or suppress the growth of fungi, bacteria, or viruses in various sites”. EPA has stated the test for a device in these words: “A device must work solely by physical means (such as electricity, light or mechanics).” 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. The Statement of Classification states: “A device is not required to be registered under FIFRA section 3.” 40 C.F.R. § 152.500(b) lists the requirements that apply to a device instead: labelling; establishment registration and reporting; books and records; inspection of establishments; violations, enforcement and penalties; import and export; child-resistant packaging; and the Agency's authority under FIFRA section 25(c)(4). The company accepts that each of them applies to the article. The company's classification is its own statement of how the law applies to the filter, and it is not a decision by any authority. No agency has approved, registered or cleared the filter, and for a device there is no such approval to obtain, because EPA does not review a device for safety or efficacy before it is sold.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 3.5, 3.6, 3.7 and 4.1, issued by NF Technical Products Inc.; Federal Insecticide, Fungicide, and Rodenticide Act, section 2(u), 7 U.S.C. § 136(u), text as posted by EPA, https://www.epa.gov/sites/default/files/documents/fifra.pdf; EPA, Compliance Advisory 305F20004 (October 2020), at 1, https://www.epa.gov/sites/default/files/2020-10/documents/uvlight-complianceadvisory.pdf; 40 C.F.R. § 152.500, https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-152/subpart-Z/section-152.500; EPA, Pest Control Devices and Device Producers, 41 Fed. Reg. 51065 (19 November 1976), https://www.epa.gov/sites/default/files/2015-06/documents/frn-devices.pdf; C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

Does selling an antimicrobial air filter without EPA registration break FIFRA?

A device is not required to be registered under FIFRA section 3, so selling an air filter that is a device without an EPA registration does not break that requirement.

The company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of FIFRA, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a). C-POLAR does not describe NanoFlashing™ as an antimicrobial treatment, and it states that the filter has not been treated with a biocidal product and does not incorporate one. EPA has stated the test for a device in these words: “A device must work solely by physical means (such as electricity, light or mechanics).” 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. 40 C.F.R. § 152.500(b) lists the requirements that apply to a device instead: labelling; establishment registration and reporting; books and records; inspection of establishments; violations, enforcement and penalties; import and export; child-resistant packaging; and the Agency's authority under FIFRA section 25(c)(4). The company accepts that each of them applies to the article. The company does not give legal advice, and it does not comment on how a claim would be decided. This classification is stated for that article, not for any other construction, size or product. No agency has approved, registered or cleared the filter, and for a device there is no such approval to obtain, because EPA does not review a device for safety or efficacy before it is sold.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 2.1, 3.5, 3.6, 3.7 and 4.1, issued by NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 2.5 and 3.5, C-POLAR Technologies, Inc., 11 September 2026; EPA, Compliance Advisory 305F20004 (October 2020), at 1, https://www.epa.gov/sites/default/files/2020-10/documents/uvlight-complianceadvisory.pdf; 40 C.F.R. § 152.500, https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-152/subpart-Z/section-152.500; C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

What regulatory duties apply to a pesticidal device in the United States?

40 C.F.R. § 152.500(b) states that a device is not required to be registered under FIFRA section 3 and that a device is subject to the requirements for labelling, establishment registration and reporting, books and records, inspection of establishments, violations, enforcement and penalties, import and export, child-resistant packaging, and the Agency’s authority under FIFRA section 25(c)(4).

The label is set by 40 C.F.R. part 156, establishment registration and the production reports by 40 C.F.R. part 167, and the records of devices produced, received and shipped by 40 C.F.R. § 169.2(b) to (d), each retained two years, with a current record of devices in stock under § 169.2(e). The other requirements rest on FIFRA sections 9, 12 to 14, 17, 25(c)(3) and 25(c)(4), as 40 C.F.R. § 152.500(b) states. The company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of FIFRA, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a), and it accepts that each of the requirements 40 C.F.R. § 152.500(b) lists for a device applies to the article. No agency has approved, registered or cleared the filter, and for a device there is no such approval to obtain, because EPA does not review a device for safety or efficacy before it is sold.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1, issued by NF Technical Products Inc.; 40 C.F.R. §§ 152.500, 156.10, 167.20, 167.85 and 169.2, as published on eCFR; C-POLAR — NanoFlashing™ Air Filter: United States regulatory status, https://cpolar.tech/reference/us-regulatory-status/.

Reviewed on 6 October 2026.

Has any agency approved or cleared NanoFlashing?

EPA does not review a device for safety or efficacy before it is sold, so for this class of product there is no approval to give or to withhold. EPA states it plainly in Chapter 13 of its Pesticide Registration Manual: “Unlike registrants of pesticide products, FIFRA does not require device producers to submit any data concerning either safety or efficacy of a device prior to distribution or sale.”

The company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of FIFRA, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a). Air filters appear in EPA’s own list of devices. In the notice that 40 C.F.R. § 152.500(b) cites, Pest Control Devices and Device Producers, 41 Fed. Reg. 51065 (19 November 1976), EPA records that devices subject to FIFRA sections 2(q)(1) and 7 include, but are not limited to, “certain ultraviolet light systems, ozone generators, water filters and air filters (except those containing substances or mixtures of substances which are pesticides), and ultrasonic devices, for which claims are made to kill, inactivate, entrap, or suppress the growth of fungi, bacteria, or viruses in various sites”.

The exclusion inside that sentence is the test, and the company answers it rather than passing over it. EPA’s rule is that “If a product consists of an object or article that incorporates a substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest, the entire product is considered to be a pesticide and is subject to registration under FIFRA section 3.” EPA has put the same test in stricter words, in Compliance Advisory 305F20004 (October 2020): “A device must work solely by physical means (such as electricity, light or mechanics).” 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. EPA also states how the question is settled: in applying the definition of a device in FIFRA section 2(h), “EPA examines each individual product on a case-by-case basis.”

Not being registered is not the same as being unregulated, and the company does not treat it that way. The 1976 notice states: “while a device, unlike a pesticide, is not subject to the section 3 registration requirement of FIFRA, section 12 of the Act makes clear the intent of the Act that subject devices and persons dealing with devices be held responsible for those obligations, other than registration, that are imposed by the Act.” 40 C.F.R. § 152.500(b) lists those requirements: labelling; establishment registration and reporting; books and records; inspection of establishments; violations, enforcement and penalties; import and export; child-resistant packaging; and the Agency’s authority under FIFRA section 25(c)(4). The company accepts that each of them applies to the article.

Establishment registration is the requirement people ask about, and EPA is precise about what it is. “Pesticidal devices must be produced in an EPA registered pesticide-producing establishment.” An establishment number identifies the site where an article is produced. It is not a registration of the product and not a finding about it: EPA states that “EPA establishment numbers, which are required for devices, are not the same as EPA pesticide registration numbers required for pesticide products”, and that “Obtaining an establishment number is an administrative process, completed upon request to the EPA.” The number that belongs on a finished product is the number of the establishment that produced it, and it is stated by that producer on that product.

For the European Union, the company’s Statement of Regulatory Status states: “No authorisation, approval, notification or registration under the Regulation is required. No prior decision of any authority is required. The company classifies the filter itself.”

No agency has approved, registered or cleared the NanoFlashing™ Air Filter. For a device, EPA does not review safety or efficacy before sale. The company classifies the article itself, and carries every duty that the classification brings with it.

Source: EPA, Pesticide Registration Manual, Chapter 13: Devices, https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices, read 22 September 2026; EPA, Compliance Advisory 305F20004 (October 2020), at 1, https://www.epa.gov/sites/default/files/2020-10/documents/uvlight-complianceadvisory.pdf; EPA, Pest Control Devices and Device Producers, 41 Fed. Reg. 51065 (19 November 1976), https://www.epa.gov/sites/default/files/2015-06/documents/frn-devices.pdf, read 22 September 2026; 40 C.F.R. § 152.500, https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-152/subpart-Z/section-152.500; Statement of Classification for the NanoFlashing™ Air Filter, sections 2.1, 3.5, 3.6, 3.7 and 4.1, issued by NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 5.2, C-POLAR Technologies, Inc., 11 September 2026.

Reviewed on 21 September 2026.