Biopesticides are becoming more and more a major part of our daily lives, but they’re not necessarily getting easier or cheaper to register. In fact, most people don’t realize that it takes an average of 5-10 years and £3-5 million in the EU compare to $300-400k registration and regulatory fee in the US.
So, how hard is it to obtain biopesticide registration for your new product?
SMEs are struggling to register biocontrol products due to an expensive and overly complex regulatory process. This guide offers the necessary insights for bringing your products to market, navigating the regulatory system with minimal fuss and expense.
Regulation and legal background
A key difference between requirements for the US EPA, compared with the EFSA and HSE in the EU and UK, is that the US EPA recognises that biopesticides are natural products, that they act differently to conventional chemical pesticides, and therefore the data required for registration of biopesticides in the US is markedly different to the data required for chemical pesticides.
Unfortunately, the EU and UK are still lagging behind in understanding the difference between chemical pesticides and biopesticides, and they treat both types of products very similarly – even though one is a chemical product, and the other is biological.
This makes the current EU and UK regulatory processes for new biopesticides overly complex, frequently requesting unnecessary or unsuitable data and adding unnecessary expense to the registration procedure.
Source: AgroPages Dec. 14, 2021 (Dr. Minshad A Ansari)