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EU Derogation for Registration Requirements of PT1 & PT2 Disinfectants

EU Derogation for Registration Requirements of PT1 & PT2 Disinfectants

Due to the necessity for additional disinfectant products of PT1 (human hygiene) & PT2 (surface disinfection) uses in the EU countries, some Member States are applying derogation from their current registration requirements (national or EU) so they can help companies to put new disinfectant products in the EU market quickly for the purpose of managing the Covid-19 pandemic.

Applicable rules will depend on the active substance/s content in the product as well as on the specific EU Member State’s measures.

Considering the EU status of the active substances, we can consider three options:

  • “Existing” active substance being evaluated for approval such as Ethanol (PT1&2)
  • “New” active substance being evaluated for approval such as active chlorine generated from sodium chloride by electrolysis or released from hypochlorous acid (PT1)
  • “Approved” active substances such as propanol-1-ol (PT1&2), propanol-2-ol (PT1&2) and hydrogen peroxide (PT1&2)

With regard to “Existing” active substance under evaluation, national rules apply for the marketing of biocidal products. In some EU countries, a notification is needed so these products can be put quickly in the market, as usual. In other EU countries, where registration is needed, some of them are derogating their usual procedure and granting temporary authorisation for these biocidal products.

With regard to the “New” or “Approved” active substances, EU procedure applies in all EU countries and under these exceptional circumstances, some Member States are also derogating the usual BPR procedure for approval to grant temporary authorisations (180 days), basing their action on Article 55.1 of the BPR.

KÆLTIA is in closely contact with All EU Member States so if your company would like to put new disinfectant products of PT1 (human hygiene) & PT2 (surface disinfection), please contact our experts and we will help you to put these products in the market.

Working together for an effective response!

 

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