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Tests, approvals and evaluations

To ensure high-quality and reliability.

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ECHA authorization

In the EU, Leitha CleanCoatTM is considered a biocide*, which is regulated by the European Chemicals Agency (“ECHA”) and the European legislative regulation called “The Biocidal Products Regulation” (“BPR”), or by its formal name “Regulation (EU) 528/2012”**.

Leitha Clean Technologies A/S and Leitha CleanCoatTM are compliant with the BPR by being listed on the so called “Article 95-list” with the active substance “Free radicals generated in situ from ambient air or water” which is the legal name, for the light-activated process characterizing Leitha CleanCoatTM, described above.

The active substance is registered for use in 9 different product types (“PTs”), comprising of:

TypeDescriptionCase typeAuthoritySubmission date
PT2Disinfectants and algaecides not intended for direct application to humans or animals.AS-APPMSCA Netherlands30/08/2016
PT3Veterinary hygiene.AS-APPMSCA Netherlands30/08/2016
PT4Food and feed area.AS-APPMSCA Netherlands30/08/2016
PT5Drinking water.AS-APPMSCA Netherlands30/08/2016
PT7Film preservatives.AS-APPMSCA Netherlands30/08/2016
PT11Preservatives for liquid-cooling and processing systems.AS-APPMSCA Netherlands30/08/2016
PT12Slimicides.AS-APPMSCA Netherlands30/08/2016
PT13Working or cutting fluid preservatives.AS-APPMSCA Netherlands30/08/2016

You can access the Article 95-list on the official ECHA website here.

Certain national rules might also apply in the EU to products under evaluation covered by the BPR, Article 95-list. Currently Leitha CleanCoatTM complies with, or are soon to comply with, certain product types under national rules for use in the following EU or EEA countries:

  • Denmark
  • Finland (coming soon)
  • France (coming soon)
  • Germany
  • Norway (coming soon)
  • Switzerland (coming soon)

Other rules might apply outside the EU and EEA.

*A biocide is a chemical substance or microorganism intended to destroy, deter, render harmless, or exert a controlling effect on any harmful organism.

**The purpose of the BPR is “[…] to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment. […]”, see BPR, preamble, paragraph 3.

EN Test 2021

Leitha CleanCoat™ has been proven effective against numerous bacteria, virus, and mold through various EN-tests performed by internationally acknowledge laboratories as for example Dr. Brill & Dr. Steinmann lab, ISI Food Protection and Chang Gung University.

EN numberTypeOrganismesEN requirement reductionAchieved Log reductionReaction TimeTesting laboratory
EN 13704SporesBacillus Subtilislog 3> log 3,2< 24 hrs. (*)ISI Food Protection, Aarhus, Denmark
EN 13624Mould & Yeast (Phase 2, Step 1)Aspergillus brasiliensislog 4> log 5,3< 24 hrs. (*)ISI Food Protection, Aarhus, Denmark
EN 13624Mould & Yeast (Phase 2, Step 1)Candida albicanslog 4> log 5,4< 24 hrs. (*)ISI Food Protection, Aarhus, Denmark
EN 14348Mycobacteria (Phase 2, Step 1)Mycobacterium avium, M. terraelog 4> log 7,6< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 14563Mycobacteria (Phase 2, Step 2)Mycobacterium avium, M. terraelog 4> log 6,5< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 14476Virus (Phase 2, Step 1)Polioviruslog 4> log 5,38< 1 min.Laboratory Brill + Steinmann, Hamburg, Germany
EN 14476Virus (Phase 2, Step 1)Adenoviruslog 4> log 5,75< 1 min.Laboratory Brill + Steinmann, Hamburg, Germany
EN 14476Virus (Phase 2, Step 1)Murine Noroviruslog 4> log 5,13< 5 min.Laboratory Brill + Steinmann, Hamburg, Germany
prEN 16777Virus, Quantitive Carrier TestAdenoviruslog 4> log 5,19< 5 min.Laboratory Brill + Steinmann, Hamburg, Germany
prEN 16777Virus, Quantitive Carrier TestMurine Noroviruslog 4> log 5,44< 5 min.Laboratory Brill + Steinmann, Hamburg, Germany
EN 14562Mould & Yeast (Phase 2, Step 2)Aspergillus brasiliensislog 4> log 4,5< 24 hrs. (*)ISI Food Protection, Aarhus, Denmark
EN 14562Mould & Yeast (Phase 2, Step 2)Candida albicanslog 4> log 5,7< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 13727Bacteria (Phase 2, Step 1)P. aeruginosalog 5> log 5,8< 1 min.ISI Food Protection, Aarhus, Denmark
EN 13727Bacteria (Phase 2, Step 1)S. aureuslog 5> log 6,2< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 13727Bacteria (Phase 2, Step 1)E. hiraelog 5> log 6,5< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 14561Bacteria (Phase 2, Step 2)P. aeruginosalog 5> log 7,2< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 14561Bacteria (Phase 2, Step 2)S. aureuslog 5> log 6,9< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 14561Bacteria (Phase 2, Step 2)E. hiraelog 5> log 7,1< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 13727Bacteria (Phase 2, Step 1)Salmonellalog 5>log 7,2< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 13727Bacteria (Phase 2, Step 1)MRSAlog 5>log 6,8< 60 min.(*)ISI Food Protection, Aarhus, Denmark
EN 13727Bacteria (Phase 2, Step 1)Choleralog 5not concluded yet
EN 13727Spot on lawn assayListeriaNo growth(*)ISI Food Protection, Aarhus, Denmark
EN 13727Gram positive pathogens, Well diffusion assayClostridiumNo growth(*)ISI Food Protection, Aarhus, Denmark
DSEN 14476Virus (Phase 2, Step 1)EV-71< 30 min.(*)Chang Gung University, Taipei, Taiwan
DSEN 14476Virus (Phase 2, Step 1)Influenza A< 30 min.(*)Chang Gung University, Taipei, Taiwan
DSEN 14476Virus (Phase 2, Step 1)Influenza B< 30 min.(*)Chang Gung University, Taipei, Taiwan

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