ECHA (EU) Registration

Within our sector there are a certain mandatory rules and approvals, that must be followed by every disinfectant supplier. In light of the current Covid-19 pandemic there is a rise of companies offering somewhat similar products (self-sanitizing coatings). Therefore, we want to highlight that any self-sanitizing (disinfecting) coating needs to have an ECHA registration. If this registration cannot be demonstrated by the supplier or re-seller, then this coating and/or company is in violation with European law.

ECHA stands for European Chemical Agency and is the regulatory organization, whether a chemical product may be entered and sold on the market. Acquiring an ECHA registration will take several years. For more information about ECHA and their procedures please visit their website by clicking here.

Our coating has been registered on the ECHA article 95 list since 2018 (latest prepared as of 18-Feb-2021). PretainCoat™ has 4 dossiers covering Product Types: PT2, PT4, PT9, and PT21. Furthermore, PretainCoat™ has been tested on bacterial and viral properties via numerous EN standards (10) such as; EN 14476:2013+A2:2019, EN 14348:2005, EN 13624 and EN 13697 incl. all amendments. ASTM standards; E1317-19 and D6361 / D6361M – 98(2020) and as a consequence approved by numerous EU Directives related to the above mentioned Product Types such as; EC No: 1935/2004, EC No:10/2011, EC No: 450/2009 and EC.No:528/2012 incl all amendments.

Not only has PretainCoat™ been tested in the above mentioned (mandatory) lab tests, but has also been exposed in many clinical tests in several sectors to the most abundant bacteria and viruses that exist today, with a success rate of at least 5 log 10 (99.999%).

All our products are produced using good manufacturing practice and in accordance with regulation (EC 2023/2006, latest amended No. 282/2008 dated 27-mar-2008).

Declaration of
Conformity (DOC)

A Declaration of Conformity (DoC), also known as an EC declaration of conformity, CE certificate or EU declaration of conformity, is an official declaration by the manufacturer or his representative that the product concerned is in compliance with all relevant requirements of the European product safety Directives. It is proof that a product is designed and constructed in compliance with the appropriate conformity assessment requirements.

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FDA & EPA (US) Registrations

The FDA and EPA are leading government bodies that set out legislation for any product in the US. In avoiding duplication of legislation the US follows the EU directives and ECHA registrations, under Gras (generally regarded as safe). This means that there are legislation crossovers. With regards to United States and its territories, our coating is in accordance with the US legislation and constantly upgraded proactively under the following directives:


  • 21CFR.175.105 (code of federal regulations)
    • 302KZX2NIS
    • N3GP2YSD88
  • EPA dossier NR: (Pending)
    • 190744 EPA/ US
    • 25361 EPA/ US
  • 21CFR. 73.1991
  • 40CFR.180
  • Gras EC10/2011 (General regarded as safe)

For more information about FDA and EPA regulations visit their website by clicking the following links: EPA Website & FDA Website.

Let’s Work Together

Prevents against harmful
micro-organisms & Maintains
a safe environment