EU finished products, online sales and national interfaces

Which regulatory route applies to each product and intended use in each EU market?

The company sets out its European position for one product, the NanoFlashing™ Air Filter, under one instrument, Regulation (EU) No 528/2012.

The Statement of Regulatory Status records how the company applies Article 3 of Regulation (EU) No 528/2012 to the filter. It addresses that question only, and it states no efficacy data. The filter is not a biocidal product and not a treated article. The company therefore classifies the NanoFlashing™ Air Filter as neither a biocidal product nor a treated article. The Regulation therefore does not apply to the filter. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. The statement covers that one filter and that one Regulation; it does not decide the route for another product or another intended use. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — About, https://cpolar.tech/about/.

Reviewed on 21 September 2026.

How has the company distinguished a material claim from a claim about the finished article's primary purpose?

The company describes the polarity as a property of the material and classifies the finished filter as a finished article.

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 Statement of Regulatory Status states at 3.4 that the filter is supplied as a finished article, that it is not a substance and not a mixture, and at 3.5 that it has not been treated with a biocidal product and does not incorporate one. The Terms of Use state that, as of their effective date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications, and that they do not describe finished products currently available from C-POLAR for those uses. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; C-POLAR — About, https://cpolar.tech/about/; C-POLAR — Terms of Use, section 4, https://cpolar.tech/terms/.

Reviewed on 21 September 2026.

Which entity can supply the technical and compliance documents to authorities in the relevant market?

Each company document names the entity that issues it: the Statement of Regulatory Status is issued by C-POLAR Technologies, Inc., and the Statement of Classification by NF Technical Products Inc.

A document held by a manufacturing partner for its own finished product is supplied by that partner. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; NF Technical Products Inc. — Statement of Classification for NanoFlashing™ Air Filter; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on 21 September 2026.

What evidence addresses the physical-or-mechanical-action criterion in BPR Article 3 for the exact product placed on the market?

The evidence the company sets out on the physical-or-mechanical-action criterion is its own Statement of Regulatory Status and the single-pass laboratory test named in it.

The Statement of Regulatory Status addresses that criterion at paragraphs 2.1 to 2.6 and 3.4, for the NanoFlashing™ Air Filter itself. 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. The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. The air leaving the filter has had nothing added to it. The filter captures airborne particles mechanically and by electrostatic attraction. The filter is intended to destroy the viruses, bacteria and fungal spores it captures. It destroys them on direct contact with the positive electric charge, by physical means, and only while the organism is captured by the positive electric charge. The charge is measured on every production run, and the measurement can be repeated on any filter, upon request. The statement also records a single-pass laboratory test in which the filter captured pine-needle smoke and ultrafine particles better than the control filter, and smoke is neither a pest nor alive: LMS Technologies, Inc., Pine-Needle Smoke Report, LMS#10471, 20 October 2025, single-pass fractional efficiency, ASHRAE 52.2 test duct. The filter is not a biocidal product and not a treated article. The Regulation therefore does not apply to the filter.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026. A copy may be made available on our review of the request.

Reviewed on 21 September 2026.

How has the company kept its account of the physical mechanism consistent between US and EU materials?

The mechanism section is the same text in both documents.

Section 2, paragraphs 2.1 to 2.6, is word for word identical in the Statement of Classification for the United States and the Statement of Regulatory Status for the European Union. It opens with the same sentence in both: “NanoFlashing™ is a permanent positive polarity engineered into filter media itself. It is a physical property of the filter.” and closes with the same sentence in both: “The filter is intended to destroy the viruses, bacteria and fungal spores it captures. It destroys them on direct contact with the positive electric charge, by physical means, and only while the organism is captured by the positive electric charge.”

Source: NF Technical Products Inc. — Statement of Classification for NanoFlashing™ Air Filter; C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

Which EU position document is current, and what record shows the status of earlier capture-only and later destruction wording?

The current European position document is the Statement of Regulatory Status for NanoFlashing™ Air Filter, dated 11 September 2026.

Its wording on destruction is at 2.6: “The filter is intended to destroy the viruses, bacteria and fungal spores it captures. It destroys them on direct contact with the positive electric charge, by physical means, and only while the organism is captured by the positive electric charge.” The statement records: “Every provision quoted in this statement was verified against its published text on 11 September 2026. Every web page cited was viewed on the same day.” The statement is the company's one current position document for the European Union, and the company publishes no record of earlier versions.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

Has a competent authority issued any product-specific classification or authorization, or is the stated position currently the company's legal argument?

No authority has issued a classification or an authorisation for the filter, and the company classifies the filter itself.

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 filter is not a biocidal product and not a treated article. The company therefore classifies the NanoFlashing™ Air Filter as neither a biocidal product nor a treated article. The statement records one exchange with a European institution, and it is general. On 22 October 2025 a Member of the European Parliament put written question E-004160/2025 to the Commission on Regulation (EU) No 528/2012 and filtration technologies. 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”. That answer is a statement about the scope of the Regulation. It is not a decision about this product.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; European Parliament — answer given by Mr Várhelyi on behalf of the European Commission to question E-004160/2025, 16 December 2025, https://www.europarl.europa.eu/doceo/document/E-10-2025-004160-ASW_EN.pdf.

Reviewed on 21 September 2026.

If a treated-article route is asserted, what documents establish each relevant Article 58 condition for this exact article?

The company does not assert a treated-article route.

The Statement of Regulatory Status states at 3.5: “The filter has not been treated with a biocidal product and does not incorporate one, as stated at 3.3 and 3.4. It is therefore not a treated article, and the final sentence of Article 3(1)(a), ‘A treated article that has a primary biocidal function shall be considered a biocidal product’, does not apply to it.” The company therefore classifies the NanoFlashing™ Air Filter as neither a biocidal product nor a treated article. Article 58 applies to treated articles, and the company does not place the filter on the market as one.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

What is the documented basis for any proposed transitional route, and does it establish every eligibility condition under the applicable version?

The company does not propose a transitional route.

The filter is not a biocidal product and not a treated article. The Regulation therefore does not apply to the filter. 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.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

Which Member State requirements have been checked beyond the EU-level legal analysis?

The statement sets out how Member States apply the Regulation to air cleaners, in the words of their own documents.

Italy: the Istituto Superiore di Sanità, Rapporto ISS COVID-19 n. 12/2021 of 20 May 2021, section 6, concerns treatment systems that work by physical systems or equipment, and states that they are not among the authorised biocidal products and are not medical devices, and may be freely sold provided that they comply with the Consumer Code. The Ministry of Health circular of 11 June 2021 on air purification products states that such a product may be placed on the market under the responsibility of the manufacturer. The Decree of the President of the Council of Ministers of 26 July 2022, sections 2 and 6.7 of its Annex, names electrostatic filtration among the air purification technologies for schools. Spain: the Ministry of Health information note of November 2020 on air purifiers states that all those based exclusively on filtration systems are considered physical methods and are therefore outside the scope of the Biocides Regulation. Belgium: the Royal Decree of 9 February 2024 sets the conditions for placing on the market air purification systems for the fight against airborne viruses outside medical uses, regulates them as equipment, and does not mention Regulation (EU) No 528/2012. Those are the Member States addressed here. Requirements in any other Member State are not addressed.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; Istituto Superiore di Sanità — Rapporto ISS COVID-19 n. 12/2021, 20 May 2021, section 6, https://www.iss.it/documents/20126/0/Rapporto+ISS+COVID-19+12_2021.pdf/4eeb2ce8-648d-b045-4a8c-5dfe1fc7b56a?t=1622470558049; Ministerio de Sanidad — Nota informativa sobre dispositivos purificadores de aire, November 2020, https://www.sanidad.gob.es/areas/sanidadAmbiental/biocidas/docs/informativa_docs/notapurificadores.pdf; Arrêté royal du 9 février 2024, Moniteur belge, 17 April 2024, https://www.ejustice.just.fgov.be/eli/arrete/2024/02/09/2024003119/moniteur.

Reviewed on 21 September 2026.

What submitted files, case numbers, requested amendments or pending questions exist for the product in each relevant EU authority process?

The company publishes no file, case number, requested amendment or pending question for the filter in a European authority process.

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 one exchange with a European institution that the statement records is a written question in the European Parliament, E-004160/2025, tabled on 22 October 2025, and the Commission’s answer of 16 December 2025. It is a question about the Regulation, not a file on the product.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

What review determines whether Article 72 advertising restrictions apply to the product and its proposed claims?

Article 72 sits in a Regulation that the company’s statement concludes does not apply to the filter.

The Statement of Regulatory Status states at 5.1 that the Regulation “shall apply to biocidal products and treated articles” under Article 2(1). The filter is not a biocidal product and not a treated article. The Regulation therefore does not apply to the filter. What is said about a finished product made by a manufacturing partner is the partner’s. Development runs configuration by configuration, and each partner controls what is said about the work.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; C-POLAR — About, https://cpolar.tech/about/.

Reviewed on 21 September 2026.

Have the primary texts and product facts actually been checked before relying on another seller's legal position or a cited EU decision?

Yes for the primary texts: every provision quoted in the European statement was verified against its published text, and every web page it cites was viewed, on 11 September 2026.

The statement records: “Every provision quoted in this statement was verified against its published text on 11 September 2026. Every web page cited was viewed on the same day.” The statement records the same for the four sellers it quotes at 4.8 to 4.11: “Each page was viewed on 11 September 2026.” Those four sellers are quoted in their own words to show what is already on sale in the Union. The company does not rely on another seller’s legal position. NanoFlashing™ is a technology; the name, rating and sale of a product that carries it are set by that product's maker and seller.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

What separate evidence establishes that each research application is ready for the particular EU intended use being proposed?

Readiness for a particular use is settled with the manufacturing partner for that product, configuration by configuration.

Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. Development runs configuration by configuration, and each partner controls what is said about the work. The Terms of Use put the testing, validation, compatibility work, risk review and quality controls for a proposed product on the partner that proposes it. 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. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.

Source: C-POLAR — About, https://cpolar.tech/about/; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on 21 September 2026.

What actions would follow if a competent authority rejected the claimed route or found that the advertised performance was unsupported?

The company publishes no plan for that case; its position is the one it sets out in its Statement of Regulatory Status.

The Statement of Regulatory Status records how the company applies Article 3 of Regulation (EU) No 528/2012 to the filter. It addresses that question only, and it states no efficacy data. The filter is not a biocidal product and not a treated article. The company therefore classifies the NanoFlashing™ Air Filter as neither a biocidal product nor a treated article. 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.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

Which EU legislation actually requires CE marking for the proposed finished product?

The company does not state that a NanoFlashing™ material or filter carries a CE mark.

C-POLAR markets a materials technology. The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. The company’s European position addresses one question only. The Statement of Regulatory Status records how the company applies Article 3 of Regulation (EU) No 528/2012 to the filter. It addresses that question only, and it states no efficacy data. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — About, https://cpolar.tech/about/; C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

Can a supplier avoid implying that every filtration material is eligible for a CE mark?

Yes, and the company makes no CE marking claim for any NanoFlashing™ material.

C-POLAR markets a materials technology. Images and descriptions may show concepts or prototypes. They are not specifications, instructions, validation reports, recommendations, warranties, offers, promises, or commitments. The Terms of Use state that Site Content is not to be used to select, design, manufacture, validate, or make claims for a finished product. The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement. Nothing on the Site authorizes anyone to manufacture, integrate, market, resell, or describe a product as C-POLAR-enabled. Nothing authorizes anyone to describe itself as a C-POLAR partner. Written permission is required.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on 21 September 2026.

Does the declaration of conformity identify the complete product's applicable legislation?

A declaration of conformity for a finished product is issued by the manufacturer of that product, not by C-POLAR.

C-POLAR markets a materials technology. The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement. The Terms of Use put the testing, validation, compatibility work, risk review and quality controls for a proposed product on the partner that proposes it. What the company holds is its own record: its statements for the air filter and the reports and certificates named on the Validation page. A copy may be made available on our review of the request.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — Validation, https://cpolar.tech/validation/.

Reviewed on 21 September 2026.

Who maintains the technical documentation for a private-label appliance sold in the EU?

The manufacturer of that appliance maintains its technical documentation.

The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. The Terms of Use put the testing, validation, compatibility work, risk review and quality controls for a proposed product on the partner that proposes it. What the company holds is its own record: its statements for the air filter and the reports and certificates named on the Validation page. A copy may be made available on our review of the request. NanoFlashing™ is a technology; the name, rating and sale of a product that carries it are set by that product's maker and seller.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — About, https://cpolar.tech/about/; C-POLAR — Validation, https://cpolar.tech/validation/.

Reviewed on 21 September 2026.

Can a marketplace listing identify the required responsible economic operator?

A listing for a finished product is the seller’s, and the seller names the operator responsible for it.

The Site does not sell products or accept orders. A link between the Site and a separate store does not bring the store under the Terms of Use. The Terms of Use name two such stores, shop.cpolartechnologies.com and shopusa.cpolartechnologies.com; those two stores are C-POLAR's own. The store and every purchase from it are governed only by the terms presented there. The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on 21 September 2026.

Does an online offer give EU consumers the required product safety information before purchase?

The offer is the seller’s, and the product information given with it is the seller’s.

The Site does not sell products or accept orders. A link between the Site and a separate store does not bring the store under the Terms of Use. The Terms of Use name two such stores, shop.cpolartechnologies.com and shopusa.cpolartechnologies.com; those two stores are C-POLAR's own. The store and every purchase from it are governed only by the terms presented there. The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement. For its own air filter, the company's label carries the directions for use, the operating conditions, the storage and disposal directions and the caution. NanoFlashing™ is a technology; the name, rating and sale of a product that carries it are set by that product's maker and seller.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; NanoFlashing™ Air Filter label.

Reviewed on 21 September 2026.

Would a connected purifier require a cybersecurity assessment alongside its filtration assessment?

The NanoFlashing™ Air Filter has nothing to connect.

The filter is passive. It draws no power, and it has no power supply, electrode, lamp or reservoir. In a forced-air system, the system’s own fan moves air through the filter. A connected appliance built around the filter is assessed by its maker. NanoFlashing™ is a technology; the name, rating and sale of a product that carries it are set by that product's maker and seller.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on 21 September 2026.

Can a PPE claim for a wearable filter be separated from a general hygiene claim?

The company publishes no personal protective equipment classification or conformity assessment for a NanoFlashing™ material.

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. The Textile page states that the NanoFlashing™ Textile has a permanent positive polarity, a fixed positive charge, and that the fabric stays waterproof, breathable, strong and washable. When a captured pollutant has a fragile structure, NanoFlashing™ destroys it on contact through a physical mechanism.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Textile, https://cpolar.tech/textile/.

Reviewed on 21 September 2026.

Would the proposed EU medical-device classification require notified-body assessment of the antimicrobial function or allow self-declaration?

The company does not place a medical device on the European market and gives no medical device classification for a NanoFlashing™ material.

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. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. For the air filter, the label states: “It is not a medical device and is not intended to diagnose, treat, cure or prevent disease.”

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — About, https://cpolar.tech/about/; NanoFlashing™ Air Filter label.

Reviewed on 21 September 2026.

Would a food-contact use involve national measures beyond harmonised EU rules?

The company has published no food-contact assessment, at European level or national level.

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. The Food packaging chapter states that NanoFlashing™ Food Packaging has a permanent positive polarity, a fixed positive charge. When a captured pollutant has a fragile structure, NanoFlashing™ destroys it on contact through a physical mechanism. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Food, https://cpolar.tech/food-packaging/.

Reviewed on 21 September 2026.

Can an importer rely on a laboratory report that is not available in a language acceptable to the authority?

The company has not published a rule on the language in which a laboratory report is supplied.

What it publishes is the record itself: the Validation page names the institutions that tested the pathogens, and it names the air-filter and safety records by institution and number, among them LMS Technologies, Report LMS#9904, 28 April 2025, on a 24 × 24 × 2 in. pleated air filter; Eurovent Certita Certification, Certificate No. 15.06.011; and Product Safety Labs, Study 65321. Certificate No. 15.06.011 is on a ten-pocket bag filter, not on a flat panel filter, and a rating belongs to the construction that was tested and to the conditions in the report. Each report is the issuing laboratory’s document and is supplied as that laboratory issued it. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830. Certificate No. 15.06.011 can be looked up at source in the Eurovent Certita Certification certified product directory.

Source: C-POLAR — Validation, https://cpolar.tech/validation/; Eurovent Certita Certification certified product directory, read 19 September 2026, https://www.eurovent-certification.com/. A copy may be made available on our review of the request.

Reviewed on 21 September 2026.

Who handles safety notifications for an EU product sold under several brand names?

The manufacturer and seller of each finished product makes any notification required for it, under each of its brand names.

The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. A warranty, manual, statement, order confirmation, or other document issued only by a manufacturer, seller, distributor, or other third party does not bind C-POLAR. NanoFlashing™ is a technology; the name, rating and sale of a product that carries it are set by that product's maker and seller.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — About, https://cpolar.tech/about/.

Reviewed on 21 September 2026.

Does a consumer-appliance return need separate handling from a material quality complaint?

Yes: a return is handled by the seller of the appliance, and a question about the material is answered by the company.

The Terms of Use state that they do not govern the sale, delivery, installation, return, warranty, or use of a finished product. The Site does not sell products or accept orders. The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement. The charge is measured on every production run, and the measurement can be repeated on any filter, upon request. NanoFlashing™ is a technology; the name, rating and sale of a product that carries it are set by that product's maker and seller.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

Can a withdrawn certification mark remain on goods manufactured before withdrawal?

A mark on a finished product is the responsibility of the manufacturer and seller of that product, and the body that issued the mark sets its terms.

The company names each certificate and report with the body that issued it, and with its number where it carries one, so that its status can be checked with that body. Among them are OEKO-TEX Service GmbH, Certificate 17.0.25812; Eurovent Certita Certification, Certificate No. 15.06.011; and Intertek Building & Construction, Report 105169484SAT-001. Nothing on the Site authorizes anyone to manufacture, integrate, market, resell, or describe a product as C-POLAR-enabled. Nothing authorizes anyone to describe itself as a C-POLAR partner. Written permission is required. Both numbers can be checked at source: certificate 17.0.25812 in OEKO-TEX’s public label check, and Certificate No. 15.06.011 in the Eurovent Certita Certification certified product directory. Certificate No. 15.06.011 is on a ten-pocket bag filter, not on a flat panel filter, and a rating belongs to the construction that was tested and to the conditions in the report.

Source: C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, https://cpolar.tech/terms/; OEKO-TEX Label Check, read 19 September 2026, https://www.oeko-tex.com/en/label-check; Eurovent Certita Certification certified product directory, read 19 September 2026, https://www.eurovent-certification.com/. A copy may be made available on our review of the request.

Reviewed on 21 September 2026.

Would German public procurement require evidence different from permission to place the product on the market?

The company has not published anything on German public procurement.

What it holds is its own record: the Statement of Regulatory Status for the European Union, the Statement of Classification and the label for the United States, and the reports and certificates named on the Validation page. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; C-POLAR — Validation, https://cpolar.tech/validation/.

Reviewed on 21 September 2026.

Could French consumer labelling requirements affect the wording on a multilingual package?

Package wording is set by the manufacturer and seller of the finished product.

The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement. Development runs configuration by configuration, and each partner controls what is said about the work. For its own air filter, the company sets out its directions on its label.

Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — About, https://cpolar.tech/about/; NanoFlashing™ Air Filter label.

Reviewed on 21 September 2026.

Does local market surveillance have access to the relevant confidential technical file?

An authority that asks the company for its documents has that request reviewed and answered.

The company holds the Statement of Regulatory Status, the Statement of Classification and the label for the air filter, and the reports and certificates named on the Validation page. The charge is measured on every production run, and the measurement can be repeated on any filter, upon request. The technical file for a finished product is held by the manufacturer of that product. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, https://cpolar.tech/terms/.

Reviewed on 21 September 2026.

Can an EU free-movement argument resolve a product-specific safety objection raised by an authority?

The company makes no free-movement argument.

The Statement of Regulatory Status records how the company applies Article 3 of Regulation (EU) No 528/2012 to the filter. It addresses that question only, and it states no efficacy data. The filter is not a biocidal product and not a treated article. The company therefore classifies the NanoFlashing™ Air Filter as neither a biocidal product nor a treated article. 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.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026.

Reviewed on 21 September 2026.

Is the European Commission's written answer of 16 December 2025 a legally binding ruling, or an informal opinion?

The company cites it as the European Commission's written answer to a Member of the European Parliament; it is a statement about the scope of the Regulation, not a decision about this product.

The company's Statement of Regulatory Status states: “On 22 October 2025 a Member of the European Parliament put a written question to the Commission on Regulation (EU) No 528/2012 and filtration technologies.” 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 statement reads that answer alongside the text of the Regulation and the positions of the authorities of Italy, Spain and Belgium, and it states: “No prior decision of any authority is required. The company classifies the filter itself.”

Source: Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 3.6, 4.1 and 5.2, C-POLAR Technologies, Inc., 11 September 2026; European Parliament, question for written answer E-004160/2025 to the Commission, tabled 22 October 2025, https://www.europarl.europa.eu/doceo/document/E-10-2025-004160_EN.pdf; European Parliament, answer given by Mr Várhelyi on behalf of the European Commission to question E-004160/2025 (16 December 2025), https://www.europarl.europa.eu/doceo/document/E-10-2025-004160-ASW_EN.pdf.

Reviewed on 21 September 2026.

Has any EU member state other than Italy, Spain and Belgium ruled on this kind of technology?

The company's Statement of Regulatory Status sets out the published positions of Italy, Spain and Belgium, and it names no other member state's position.

The statement states: “The authorities of Italy, Spain and Belgium apply the Regulation to air cleaners in the same way, as set out at 4.2 to 4.6.” For Italy it cites Report ISS COVID-19 No 12/2021 of the Istituto Superiore di Sanità, 20 May 2021; the Ministry of Health circular of 11 June 2021 on air purification products; and the guidelines for schools adopted by Decree of 26 July 2022. For Spain it cites the Ministry of Health information note on air purifiers of November 2020. For Belgium it cites the Royal Decree of 9 February 2024 on air purification systems against airborne viruses. It also sets out the European Commission's answer of 16 December 2025 to a written parliamentary question. The company publishes no review of any other member state's position.

Source: Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 3.6 and 4.1 to 4.6, C-POLAR Technologies, Inc., 11 September 2026.

Reviewed on 21 September 2026.

Why does C-POLAR's EU regulatory statement cite four unrelated Italian companies' own marketing claims as supporting evidence?

The Statement of Regulatory Status cites four sellers' own published words to show that air cleaners that use electricity to destroy microorganisms are already on sale in the European Union.

The statement states: “Air cleaners that use electricity to destroy microorganisms are already on sale in the Union. Four are set out at 4.8 to 4.11, in the words of the sellers themselves. Each page was viewed on 11 September 2026.” The four are Expansion Electronic Srl, Igeamed S.r.l., VMC Italia S.r.l. and Atenatech srl, all in Italy. The statement gives each seller's words in Italian, with an English translation. It then states: “The filter is an instrument of the same kind as the air cleaners at 4.8 to 4.11. It captures airborne particles by electrostatic attraction, as stated at 2.5. It destroys the viruses, bacteria and fungal spores it captures by physical means, as stated at 2.6. It uses no active substance, as stated at 3.3. It is outside the Regulation, for the reasons given at 4.1.” The statement describes no relationship between C-POLAR and the four sellers.

Source: Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 4.7 to 4.12, C-POLAR Technologies, Inc., 11 September 2026.

Reviewed on 21 September 2026.