‘The timelines are too long’: Regulation ‘holding back’ biologicals in Europe, firms complain

Speaking to AgTechNavigator at the sidelines of the recent World Agri-Tech Innovation Summit in the UK​​, Biotalys CEO Kevin Helash says there’s “no shortage” of biocontrol innovation happening.

Biotalys, for example, a spin-out of the Flemish Institute for Biotechnology (VIB) in Belgium, is developing crop protection products by using llama antibodies​.

But long-winded regulation in European markets is threatening these efforts, he warns.

“The thing that worries me about Europe in general is it's one of the longest timelines for registration in the world.” The region is therefore unlikely to be “the number one” target for new launches, he says.

“The concern for me is that European farmers are potentially lagging behind for something's that completely out of their control. They want the new technology; we the industry want to bring it to them. It's just the timelines are too long.” 

A lengthy and complex regulatory process​

Europe has strict safety and efficacy standards for biological products, which necessitate extensive testing and documentation. Biological products are more complex than traditional chemical pesticides or fertilisers, which can extend the development and approval timeline.

But biologicals have huge potential to disrupt conventional agricultural practices, Biotalys believes. That’s thanks to both to their environmental benefits and as the need for new modes of action around fungicides and insecticides becomes more urgent as pests develop resistance to existing products on the marketplace.

The environmental wins are generally viewed as ‘nice to have’, believes Helash.

Crop protection solutions must be able offer similar or better performance than synthetic alternatives, he says.

“If the technology works – ideally in a similar fashion to what they are using today – and they have the efficacy and the predictability of the efficacy, I don’t worry about the adoption, the farmers will use the product. They don't really care if it's biological or not.”

In this regard, Helash believes the biologicals sector is moving rapidly into the next phase of efficacy and predictability of efficacy. “We are now truly able to bridge between traditional biologicals and synthetic chemistry in terms of a product that the farmers can seamlessly integrate into their operation and not sacrifice anything. On top of that, the ability for biologicals to bring a product to the market at one tenth the cost of a synthetic is phenomenal, whilst also leaving very little residual.”

Enko Chem CEO Jacqueline Heard agrees Europe's regulatory environment is slowing the ability of new solutions to reach the market. 

Enko is using AI and machine learning technology to screen and identify promising molecules more efficiently to discover new ways to combat pests whilst addressing issues such as resistance to existing products. It then partners with established agricultural companies for product distribution.

Larger agricultural companies have experience navigating complex regulatory environments. But regulation still remains a bottleneck, Heard says. 

“Today small molecules have issues in that they are very few molecules coming to the market because of the time and cost.”