TOMI Environmental Solutions, the Frederick, Maryland-based decontamination technology company, has secured formal approval in Ireland for its BIT Solution disinfection product under the European Union’s Biocidal Products Regulation, extending its SteraMist brand’s authorized footprint to 11 European markets. CEO Dr. Halden Shane tied the approval directly to the demands of Ireland’s life sciences sector: “Ireland’s approval reinforces SteraMist’s position in a market that is home to some of the world’s most demanding contamination-control and decontamination standards. As the region’s life sciences and healthcare sectors continue to raise the bar on validated, documented efficacy, we believe iHP technology is well positioned to meet that demand and expand its footprint across the market.”
What SteraMist Actually Does
TOMI’s core technology, Binary Ionization Technology (BIT), was originally invented under a defense grant tied to DARPA, the U.S. Department of Defense’s research arm. The BIT Solution uses a low-percentage hydrogen peroxide as its only active ingredient, converting it into a fog of ionized hydrogen peroxide, marketed under the SteraMist brand, that disinfects surfaces and fills rooms without leaving behind the corrosive residue associated with harsher chemical fogging methods. The technology is aimed at a wide range of settings beyond hospitals and medical facilities, including cruise ships, schools, food processing plants, military barracks, and even single-family homes, positioning it as a general-purpose infection prevention tool rather than a niche medical device.
Why Ireland Specifically Matters
Ireland represents one of Europe’s most concentrated life sciences and pharmaceutical manufacturing hubs and is also where one of TOMI’s established decontamination and sterilization competitors is headquartered. It isn’t just another market to check off a list. The country is the world’s third-largest pharmaceutical exporter and home to more than 90 pharmaceutical companies, including nine of the top ten global drugmakers, giving it an unusually dense concentration of manufacturers who operate under strict contamination-control standards. The approval gives the company a formal opening to compete directly in a country where regulatory scrutiny around decontamination is already high. The company’s approval came through the same EU Biocidal Products Regulation pathway that governs biocide authorizations across the bloc, meaning the sign-off carries weight specifically because of how demanding that regulatory bar tends to be.
Part of a Steady, Country-by-Country European Buildout
Ireland is the latest addition to a list TOMI has built up market by market rather than through a single continent-wide authorization: SteraMist’s BIT Solution now holds approvals in Austria, Italy, the Netherlands, Belgium, Denmark, Germany, Hungary, Spain, Great Britain, Northern Ireland, and now Ireland. That incremental approach reflects how EU biocide authorization actually works, country by country rather than all at once, and it means each new approval is a genuinely separate regulatory win rather than a formality. TOMI reported second-quarter 2026 revenue of $2.25 million, up 118% year over year, while reaffirming full-year guidance of at least $12 million and pointing to a $35 million sales pipeline with $8.6 million already in advanced stages.
