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Approval of Active Chlorine

The approval date for active chlorine has been officially scheduled for July 2022. Companies intending to apply for product authorization need to start acting now, as the approval date is quite close.

Details

Approval of Active Chlorine released
from Hypochlorous Acid as an Active Substance
: July 2022

The European Commission published on 26th February 2021 the implementing regulations 2021/364 and 2021/365 approving active chlorine. For Product Types (PT) 2, 3, 4, and 5 active chlorine, both electrolytically generated in situ and released from hypochlorous acid for later use, will officially be approved on July, 01 2022. For PT1 the approval date was July, 01 2021. Nevertheless, corresponding applications for authorization of disinfectants of human skin could still be submitted.
For all these types of disinfectant products, it will be necessary to submit an application for authorization before the approval date in order to market these products.

Active   can be found in water treatments, pool hygiene, sanitation products or just general hygiene. Active chlorine is the active form of chlorine, effective against bacteria, viruses, and algae.

To complete the application dossier, it is necessary to carry out procedures to assess the substance and various tests to reveal the risks associated with its use.

If you need guidance on submitting dossiers, CSB Compliance can help. Our experienced consulting team has helped clients in navigating the BPR from active substance approval applications to gaining product authorizations across Europe for a wide range of products and use cases. We can guide you, tailored to your needs, through the complete process or just through individual steps and together with you we create and submit a successful application.

We can help you with:

  • Planning of a product family
  • Weighing up the different authorization options
  • Authority contacts
  • "Data gap analysis" & test strategies
  • Literature search
  • Communication with data owners
  • Commissioning and monitoring of studies
  • Creation of the technical dossier (IUCLID 6 data set)
  • Preparation of the endocrine disruptor (ED-) assessment
  • Supervision/support during the approval process

To learn more about our services, please contact us at .

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