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Biocides | March 15, 2021

In PT1 - disinfectants for human hygiene - efficacy tests to prove the biocidal effect against bacteria and yeasts depend on the intended use.

For general and professional use (outside the medical field), according to the Chemicals Office, “efficacy must be demonstrated at least in the first stage of testing - i.e. phase 2 step 1 efficacy tests for bacteria (EN1276) and yeasts (EN1650).”

Exceptions currently include a simplified procedure “for the notification of dedicated disinfectants containing alcohol (ethanol, ethanol/ propanol) at a concentration of 76% v/v (= 70% w/w) or more for PT1.” The reason is that this alcohol content" complies with the ECDC recommendations for disinfection for COVID-19”.

However, in this case, you should not state that it is a disinfectant, and can only claim “antiviral activity against enveloped viruses” on the product label. This small but significant difference - when a biocide is allowed to be considered a "disinfectant" and when it is not - makes this exception impractical for wider commercial use.

For professional use in medicine (all healthcare facilities where patients are treated), however, the Chemicals Office states that “efficacy must be demonstrated at two stages of testing”. Firstly, the "phase 2 step 1 efficacy tests for bacteria (EN13727) and yeast (EN13624)".And secondly, it is necessary to have phase 2 step 2 tests “(EN1500 - hygienic hand disinfection; EN1499 - hygienic hand wash; EN12791 - surgical hand disinfection)”.

However, if the disinfectant is intended for both of the above uses, then “the efficacy tests indicated for professional use in medicine are sufficient to prove efficacy”.

We wrote about how the Chemicals Office assesses the effectiveness of hand sanitizers (PT1) here. We also wrote about what the simplified notification procedure for disinfectants based on ethanol is – link to the article here.

If you also need help notifying biocides as soon as possible, feel free to contact me. We will guide you through the entire process and make sure you have the products on the market as quickly as possible.

 

Disclaimer:
Information on this blog is prepared with utmost care, but it is not about (chemical) consulting, and the provider does not assume any responsibility or liability for the correctness, accuracy and up-to-dateness of published content. If you need advice for a specific case, you can write to us at bojan.dimic@bens-consulting.com

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