Manufacturers of biopesticides for agricultural applications can accelerate time to market by taking a global perspective on regulations say experts at TSG Consulting.
Regulatory complexity and divergence between international frameworks are perceived as barriers to entry in some markets, according to the consultancy. However, a deep understanding of regulatory agencies' data requirements combined with knowledge of relevant international guidelines can overcome some challenges.
To support manufacturers looking to harness growing demand for biopesticides, TSG has published a free whitepaper, An international perspective on biopesticide regulation. It considers regulations which impact biopesticides in North America and Europe, highlighting similarities and differences.
The classification of biopesticides as active substances under EU regulations means that plant protection products containing them must fulfil criteria devised for conventional chemicals. However, since US regulations consider biopesticides 'usually inherently less toxic' than conventional pesticides, their registration tends to be quicker and simpler.
Iain Watt, Head of Plant Protection at TSG, says the aim of the whitepaper is to help manufacturers see that while complexities do exist, they are not insurmountable. With a considered approach it is possible to navigate international regulations cost-effectively and keep commercial strategies on track.
"One of the biggest perceived obstacles is the lack of dedicated biopesticide regulations in the EU," he explains. "The US Environmental Protection Agency has a standalone division for biopesticides, which facilitates product registration. In other markets, the process is more convoluted, but measures can be taken to overcome some of the hurdles. For instance, leveraging the OECD's Mutual Acceptance of Data system across member countries can result in a more streamlined approach."
Consultants and regulatory scientists from TSG are attending the Annual Biocontrol Industry Meeting (ABIM) in Switzerland, taking place on October 19 and 20. Available at Booth 4, they can advise on strategies to obtain approval for new active substances and authorisation for plant protection products across Europe and North America.
To download An international perspective on biopesticide regulation visit www.tsgconsulting.com/advisory/international-biopesticide-regulation