Icaridin: EU approval and submission deadline

April 08, 2021

Following icaridin’s approval for use in repellents (Product Type 19) by the European Commission, the active substance will be added to the Union List of approved substances on 1 February 2022 (Implementing Regulation (EU) No 2020/1086).

Companies intending to submit an application for EU/GB product authorisation still have time to prepare their dossier; however it is important to begin the process now in case additional efficacy studies are needed to support the product’s claims. Not only can studies take several weeks to organise, if semi field or field studies are required, it is important that they coincide with the fly/flea/tick/mosquito season which is about to start in Europe.

Dossiers

If your product is a 10-20% based icaridin hydroethanolic pump spray for application on human skin, you may want to join the substance supplier’s dossier. However, if your product is for application on animal skin or if you have a family of repellents (spray, lotion, etc.) your company will need to prepare its own dossier.

Demonstrating safe use to the environment for animal application can be challenging and TSG can advise on risk mitigation measures.

How TSG can help

Our team of regulatory consultants has many years of experience working on repellent active substance and biocidal products dossiers. In addition, our Project Manager, Samantha Walker, has been nominated as an expert for the Partner Expert Group (PEG) addressing the development of the Guidance on Biocidal Products Regulation: Volume II Efficacy, Assessment and Evaluation (Parts B+C), to update chapter 5.6.5 on PT19 Repellents and Attractants.

We can help you with: 

  • Identifying data gaps
  • Commissioning, monitoring and securing space for studies
  • Providing expertise on exposure modelling, human health and environmental risk assessments, toxicology and ecotoxicology, and environmental fate modelling
  • Proposing appropriate risk mitigation measures

To find out more information about our services, please contact us at info@tsgconsulting.com

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