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

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.