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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:
|Type||Description||Case type||Authority||Submission date|
|PT2||Disinfectants and algaecides not intended for direct application to humans or animals.||AS-APP||MSCA Netherlands||30/08/2016|
|PT3||Veterinary hygiene.||AS-APP||MSCA Netherlands||30/08/2016|
|PT4||Food and feed area.||AS-APP||MSCA Netherlands||30/08/2016|
|PT5||Drinking water.||AS-APP||MSCA Netherlands||30/08/2016|
|PT7||Film preservatives.||AS-APP||MSCA Netherlands||30/08/2016|
|PT11||Preservatives for liquid-cooling and processing systems.||AS-APP||MSCA Netherlands||30/08/2016|
|PT13||Working or cutting fluid preservatives.||AS-APP||MSCA Netherlands||30/08/2016|
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:
- Finland (coming soon)
- France (coming soon)
- 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.