Biopesticide active substances in the EU: navigating approval

EU measures to reduce the availability of conventional pesticides for agriculture may make increased use of biopesticides easier in the future. But what’s the best way forward in the meantime? Philippe Kuenemann, Managing Director - France at TSG, offers guidance.

It’s just over 12 months since the European Commission announced plans to make the European Union’s agricultural system safer and more sustainable. Among the measures proposed (under the Farm to Fork and Biodiversity strategies) was a target to reduce the use and risk of chemical and more hazardous pesticides by 50% by 2030.

So, what does this mean in practice for Plant Protection Product (PPP) active substances in the EU?

Anecdotally, it’s been suggested that as few as 15% of existing conventional chemical compounds are currently making it through renewal of authorisation. Some might say this finally opens the door for a new wave of biopesticides – such developments have been discussed for years. However, the situation remains far from straightforward at present.

The EU stance on biopesticides

In the EU, biopesticides are defined as ‘a form of pesticide based on microorganisms or natural products’. They originate from nature, don’t cause harm to humans and have minimal impact on the environment, but they are classified as active substances under EU regulations. So, when used in a PPP context, they are subject to active substance approval criteria set out in Regulation (EC) No 1107/2009.

This means biopesticide active substances must fulfill approval criteria and, for the most part, general data requirements, devised for conventional chemicals (although there is some divergence for microbials). Furthermore, biopesticides are generally more expensive to produce and their use is often more technically complex than the chemical alternatives. Together, these factors can be a barrier deterring biopesticide manufacturers from targeting the EU market and slowing the approval process when they do. 

EU versus US requirements

The US takes a different stance on biopesticides, based on the understanding that they are ‘usually inherently less toxic than conventional pesticides’. There’s a separate registration division within the government regulator, and a separate process which is quicker with shorter review timeframes and a tiered approach to data requirements resulting in fewer data required to conventional counterparts. Consequently, there is a wide disparity in the availability of biopesticide products between the US and EU markets.

How to navigate the EU system

It’s widely acknowledged that the EU approval system will need to adapt, and the European Food Safety Authority (EFSA) is engaging with working groups on this matter.

In the meantime, active substance manufacturers wanting to target the PPP market in the EU must work within the existing parameters of Regulation (EC) No 1107/2009. The approval procedure is lengthy for any type of active substance, so thorough planning and preparation is key.

There are several factors to bear in mind which can aid smoother progress.

Firstly, it’s useful to identify which proposed evaluating Rapporteur Member State (RMS) would be best placed to handle the active substance and prepare the draft assessment report (DAR) ahead of wider peer review. Some RMSs have dedicated teams that specialise in biopesticides and are thus better placed to understand their unique properties. Working with such an RMS that holds experience of the type of biopesticide you’re submitting is likely to result in more robust evaluation and quicker completion of the DAR.

When choosing an RMS, it’s also important to note that some have a more efficient and timely active substance evaluation process than others. Some also have a stronger reputation for the rigour of their assessment which may speed up the subsequent peer review.

We’d advise determining which RMS you’d like to engage with and approaching them at the earliest possible stage, well ahead of dossier submission. Those with a good reputation or specialist expertise are in high demand and may not have capacity to take on new applicants for several years. Pre-submission advice is also now available from EFSA, and having the right RMS to participate in this new stage of the application process will deliver benefits.

Change could be on the horizon

There is an interesting dichotomy between the EU and the US when it comes to the approval and uptake of biopesticides versus conventional pesticides for agriculture. As mentioned, in the US, biopesticides have a more curtailed, reduced set of data requirements, and often a quicker route to market. The EU system is more convoluted and not really tailored to biopesticides’ unique properties. Nevertheless, there is greater pressure in the EU than the US to reduce use of conventional pesticides, and this wider context is sure to drive an evolution of regulatory requirements.

Right now, it’s easy to feel frustrated at the EU’s apparent lack of progress on this matter. However, a considered approach to any project can help streamline the approval process.

Here at TSG, the plant protection team has extensive experience in the planning and preparation of dossier submission as well as RMS engagement.