EU moves to fast-track biopesticide access, cutting approval times

As regulatory delays risk driving innovation away from Europe, a newly announced plan of the EU executive aims to speed up approvals for biopesticides and biocontrol technologies.

The European Commission is set to overhaul the current framework for marketing the two, announcing new EU rules to fast-track approvals in the last quarter of this year, followed by the much-anticipated 2026 Biotech Act expected to fill any remaining gaps.

With pesticide reduction targets shelved indefinitely, the most significant development outlined in the Vision for Agriculture and Food concerns alternatives to chemical pesticides.

Biopesticides, derived from natural materials, offer pest control solutions with a lower environmental impact than conventional pesticides. These include fungi that infect and kill aphids and beetles, viruses that target certain caterpillars, and essential oils like clove oil, which repels pests.

Similarly, biocontrol solutions use living organisms — such as ladybugs that feed on aphids and lacewing larvae that consume small insect pests — as natural enemies of pests rather than chemical-based pest management.

Recently, new substances, including micro-organisms, peptides, proteins, hormones, dead cells, fermentation material, microbial extracts and even RNA, have been introduced for both biopesticides and biocontrol applications.

However, the approval process for these substances in the EU is outdated, based on a framework established over 15 years ago.

It is also notably slow, with marketing approval taking an average of seven to nine years, compared to just two to three years in regions such as the Americas and Asia.

Stalled regulation’s orphan

Efforts to improve the current framework for biopesticides and biocontrol were included in the major reform of the EU’s pesticide framework — the sustainable use of pesticide regulation or SUR — and gained broad political support before discussions stalled.

When negotiations faltered, the Belgian presidency of the EU Council attempted to salvage at least this part of the proposal, focusing on addressing the legal vacuum surrounding aerial application and biocontrol.

However, this effort collapsed along with the rest of the pesticide framework after the European Commission withdrew the proposal.

“It was disheartening given the amount of work that went into it,” said Jennifer Lewis, Executive Director at the International Biocontrol Manufacturers Association (IBMA).

The new legislation now under consideration aims to introduce a clear definition of biocontrol substances and allow member states to provisionally authorise plant protection products containing biological substances while their evaluations are still ongoing.

“The objective is to ensure easier market access while maintaining environmental and health protections,” said a senior Commission official. The official also pointed out that the goal is to streamline the market approval process through a fast-track procedure, ensuring these products reach the market more efficiently.

An issue of competitiveness

The forthcoming Biotech Act, set for next year, could further contribute by providing a legislative vehicle to support improvements in the current framework and accelerate the authorisation of biocontrol products.

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“Since these improvements were already planned within the SUR proposal, it should be a quick process to integrate them into the Biotech Act,” said Lewis.

In an interview with Euronews, European Commissioner for Agriculture and Food Christophe Hansen highlighted the importance of the Biotech Act in this sense.

“We need harmless alternatives to classic pesticides, to get them on the market and make the approval procedures much shorter. This will bring real change on the ground,” Hansen said.

However, the lengthy approval process is already having a significant impact. The current authorisation timeline means that more than 100 substances set for submission between 2024 and 2028 would not receive approval until between 2031 and 2037.

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This delay makes Europe less attractive for biocontrol companies deprioritising the EU market, with some shifting their global submission programs to North America and Brazil, where approval takes only two to three years or even just one to two years, respectively.

“Europe is seeing companies develop biocontrol solutions in publicly funded EU Horizon projects, only for these products to be launched and marketed outside Europe due to shorter authorisation processes elsewhere,” IBMA’s Lewis noted.

A similar challenge exists for biopesticide companies. “The return on investment in Europe is 30% lower compared to other parts of the world. If you are an entrepreneur looking at these dynamics, you might question whether it is worth investing here,” said Olivier De Matos, the director general of the EU’s plant protection product lobby Croplife Europe.

An internal Croplife survey seen by Euronews revealed that 55.7% of 85 respondents, representing industry, trade associations, academics, and government bodies, said they do not plan to submit a biochemical active substance or similar product for EU approval.

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Regulatory hurdles and unclear or excessive data requirements were cited as key reasons, with 67.2% of respondents deciding against pursuing EU registration despite initial interest.

Only 27.9% reported having registered novel technology outside the EU, mainly in the US, Brazil and New Zealand.

Other continents have identified agriculture as a strategic sector, ensuring their farmers have access to the necessary tools to remain competitive, according to Croplife’s De Matos. “We need to do the same in Europe if we are serious about competitiveness and want to maintain our leading role,” he added.