Blue Frog Scientific recently submitted a dossier for the approval of a new fungicidal active substance in the EU under Regulation (EC) 1107/2009. While this active substance is chemically synthesised, it is identical to the naturally occurring form found in plants, which is already consumed by humans and used as a food additive.

By leveraging open-literature studies on metabolism and toxicity, and combining them with a theoretical worst-case scenario of European population exposure, Blue Frog Scientific demonstrated that additional mammalian studies on reproduction, developmental, and neurotoxicity were not necessary to prove the safe use of this substance on crops.

Regulation (EC) 1107/2009 and related regulations were originally designed to assess traditional active substances. Strict adherence to these regulations may result in unnecessary studies. In some cases, dossiers are considered incomplete if certain studies are not included, leading to rejection until the data are provided. This was the initial challenge faced in this submission. However, through effective communication with the rapporteur member state (RMS) and robust scientific arguments, Blue Frog Scientific gained the confidence of the RMS, allowing the dossier to progress to peer review without the need for new animal testing.

Blue Frog Scientific’s client was incredibly happy with regards to the reduction in the use of animals and of course a reduction in testing costs estimated In the range of millions of euros. It also demonstrated the changing attitude to regulators in the EU when assessing substances which are out of the scope of what may be considered a 'traditional' active substance. A win-win for both scientific innovation and ethical consideration.

If you need regulatory support for your plant protection product dossier submissions, call and speak with one of our agrochemical experts today.