We know what our product can achieve in surface disinfection
- If FreeBact® Surface works for surface disinfection, can I use it on my hands?
This is a question we often receive from customers, and one that we at Xinix have ourselves been working on for several years.
FreeBact® Surface contains chlorine dioxide (ClO₂), an active substance with well-documented disinfecting properties. Through our own tests and external laboratory analyses, we have documented the product's effectiveness against microorganisms on surfaces.
We have therefore spent several years working to investigate the possibility of also getting the product approved for hand disinfection, an area of use covered by EU biocidal category PT1.
The path there has proven to be significantly more complicated than we originally expected.
For us as a smaller Swedish clean-tech company, it has been a challenge to navigate a comprehensive European regulatory framework, with different product types, assessment processes, and regulatory responsibilities. During the process, we have had to sort out several regulatory issues without yet reaching a defined path for a potential approval.
We find the process both time-consuming and frustrating, not least because chlorine dioxide already has an established use and approval (by the Swedish Food Agency) for the disinfection of drinking water and our product range FreeBact® Water.
To move forward, we have hired an external regulatory consultant with the task of investigating the conditions, clarifying which requirements apply, and identifying possible next steps.
That is where we stand today. We are continuing the work and at the same time want to be completely open about what applies in the meantime.
Documented effect, what do our tests show?
Independent laboratory tests show that FreeBact® Surface has a documented effect against bacteria, viruses, yeast and mould.
Bacteria and fungi, EN 13697:2023
In tests carried out by Chelab/Mérieux NutriSciences in Italy in 2025, according to EN 13697:2023, FreeBact® Surface achieved:
- Over 99.99% reduction of bacteria within 5 minutes, including E. coli, Staphylococcus aureus, Pseudomonas aeruginosa and Enterococcus hirae.
- At least 99.9% reduction of yeast and mould within 15 minutes, against Candida albicans and Aspergillus brasiliensis.
The tests were carried out on non-porous surfaces under controlled laboratory conditions.
Viruses, EN 14476
As early as 2018, independent virus tests were carried out according to EN 14476 by MICROMUN/Hygiene Nord in Germany.
The tests were carried out under the product's former name SanDes, which is now marketed as FreeBact® Surface.
The results showed a documented effect against poliovirus, adenovirus and murine norovirus within 1 minute, including over 99.999% reduction of murine norovirus under the specified test conditions.
Further documentation, EN 17272:2020
During 2025, Melbec Microbiology in the United Kingdom carried out further laboratory tests with the stabilized chlorine dioxide formulation from Xinix, which is also used in FreeBact® Surface.
The tests were carried out according to EN 17272:2020 and concerned the automated disinfection of enclosed spaces with FreeBact® Fogging.
The results showed a documented effect against the tested bacteria and yeast.
Although the application method differs from standard surface disinfection, the report provides further documentation of the formulation's disinfecting properties.
Documented effect and regulatory approval
The results show that FreeBact® has a documented disinfecting effect against the examined microorganisms under the respective test conditions.
At the same time, it is important to distinguish between documented disinfecting effect and regulatory approval for use on human skin.
The laboratory tests do not replace the specific regulatory requirements applicable to PT1, human hygiene. For FreeBact® Surface to be marketed as a hand disinfectant, the applicable requirements under EU biocidal legislation must be met.
Why is chlorine dioxide permitted in drinking water treatment—but not for use on the skin?
It is one of the questions that we ourselves find particularly interesting—and most frustrating.
Isn't the hand also a surface?
Physically, yes. Regulatorily, no.
Chlorine dioxide has long been used for the disinfection of drinking water and is covered in Sweden by the Swedish Food Agency's regulations for drinking water treatment.
The substance is listed as a treatment chemical for disinfection and oxidation, with specific conditions for its use.
At the same time, there is currently no equivalent regulatory support for chlorine dioxide within PT1, the product type that covers the disinfection of human skin.
For us, this illustrates how different regulations can treat the same active substance depending on the area of use.
This does not mean that a substance approved for use in drinking water treatment is automatically approved for use on the skin. Exposure, concentrations, methods of use, and safety requirements differ.
But this is part of the reason why we believe the question deserves a clear regulatory investigation.
What are PT1 and PT2?
Products applied to or coming into contact with human skin or scalp with the primary purpose of disinfection fall under product type 1, PT1, human hygiene.
Disinfectants used on surfaces, materials and equipment normally fall under product type 2, PT2.
It is therefore the product's intended use that determines which regulatory framework applies. Hand disinfectants are a typical example of a PT1 product.
The fact that a substance or product has a disinfecting effect does not automatically mean that it may be marketed or used for all types of disinfection. Regulatory support must be in place for the relevant product type.
What is the regulatory situation for chlorine dioxide and PT1?
FreeBact® Surface is based on chlorine dioxide, ClO₂.
Chlorine dioxide is included in the EU regulatory framework for several other product types. However, chlorine dioxide is currently not covered by the EU assessment program for active substances within PT1, human hygiene.
The Swedish Chemicals Agency states that disinfectants containing active substances that are neither approved nor under evaluation for the relevant product type may not be sold or used for that product type.
It is the regulatory situation that Xinix complies with.
What does that mean for FreeBact® Surface today?
FreeBact® Surface is marketed and supplied as a surface disinfectant.
Xinix does not market FreeBact® Surface as a hand disinfectant and does not instruct users to apply the product to hands or other skin for disinfection purposes.
This should not be interpreted as a claim about the product's efficacy or disinfectant properties. It is solely about which area of use currently has regulatory support.
Is Xinix working on the issue?
Yes.
Xinix Global AB has engaged external regulatory expertise to investigate the potential regulatory pathway for use within PT1 and what requirements apply to chlorine dioxide within this product type.
The purpose is to obtain clear answers on what regulatory conditions apply, what requirements need to be met, the costs, and whether there is a possible way forward.
The work includes, among other things, the regulatory status of the active substance, the EU Biocidal Products Regulation, and what steps would be required before a product can be marketed for human hygiene.
Until there is clear regulatory support, Xinix will not market FreeBact® Surface for use as a hand disinfectant.
At this time, we cannot provide any timeline for potential approval and do not wish to anticipate the outcome of the ongoing investigation.
Our ambition is to continue developing effective disinfection solutions within the framework permitted by legislation.
We will update this page when there is new, verified information to share.
Why are we publishing this information?
We believe it is important to be clear about both what our products can be used for and the regulatory limitations that apply.
The regulations for biocides are extensive, and the same active substance may be subject to different requirements depending on its intended use.
Therefore, we prefer to describe the issue openly rather than provide a simplified answer.
If the regulatory status changes, this page will be updated.
Official sources
The information on this page is primarily based on:
- The Swedish Chemicals Agency, regulations for disinfectants and biocidal products
- The European Chemicals Agency, ECHA, product types and status of active substances
- Regulation (EU) No 528/2012 of the European Parliament and of the Council on biocidal products
Regulatory information from Xinix Global AB. This page is intended to explain current product use and ongoing regulatory assessment work. It does not mean that FreeBact® Surface is approved for PT1.
If you have any questions, please contact
Alexandra Németh, Deputy CEO & Marketing Manager
alexandra@xinix.se
Last reviewed: 2026-10-28
