IBMA's quest for faster biocontrol approval in EU – Interview with Jennifer Lewis

Date:11-19-2024

According to the IBMA member survey, the European biocontrol market has grown to 1.6 billion Euros. However, the market faces significant regulatory challenges. The industry is constrained by lengthy EU authorization processes that take up to ten years to get a product approved, which is much longer than the two to three years in the US and Brazil.

Jennifer Lewis, IBMA Executive Director, offers a critical perspective on the EU's regulations for biocontrol products. Her insights reveal the complex barriers hindering biocontrol innovation and the potential consequences for European agriculture's competitiveness. She also provides advice and discusses IBMA's efforts to drive regulatory changes.

How has the slow EU authorization process affected biocontrol innovation and competitiveness of European agricultural products?

The slow authorization process for biocontrol products in the EU has had significant negative impacts on innovation and the competitiveness of European agriculture. While farmers in regions like the US and Brazil can get approval for new biocontrol products in just two to three years, European farmers face waits of up to ten years. This disparity in approval times has made Europe less attractive for investment in biocontrol technologies and already means  some companies prioritize other markets where the return on investment is faster. The European Union should ensure this negative impact does not continue. 

There is urgent need for a fast-track authorisation process for biocontrol products. How is IBMA working to put it on the agenda of the European Commission Work Programme?

At IBMA, as the Biocontrol industry association, we are working hard to ensure that a fast-track authorization process for biocontrol products is placed on the agenda of the European Commission’s Work Programme. We’ve engaged in multiple discussions with European policymakers, in the relevant Directorates and the European Commission Secretariat General as well as with Member States, farmer organisations and other interested parties.  We have highlighted the need to prioritize biocontrol and speed up the approval process. This would help address EU priorities such as food security, economic growth, and competitiveness while still be in line with the Green Deal goals

Regulatory reform requires immediate measures including prioritisation of biocontrol at Member State level and better implementation of Regulation 1107, including mutual recognition and re-instatement of a provisional authorisation procedure.  Ultimately, a new regulation for biocontrol is needed to ensure a fast and effective authorisation process for biocontrol.   Our aim is to make sure the European Commission considers biocontrol in its broader vision for agriculture, as it plays a critical role in meeting the EU’s agricultural goals, both in terms of sustainability and productivity.

What specific changes does IBMA propose for a fast-track authorization process for biocontrol products?

First and foremost, we need an EU wide biocontrol definition. Working with nature, biocontrol solutions effectively regulate pests and diseases but are currently subject to the same authorization processes as chemical plant protection products in Europe. More experts in evaluation of biocontrol are required in Member States and European Institutions to facilitate this.

By virtue of its different mode of action, biocontrol reduces risks to people and the planet while supporting ecosystem services, and effectively controlling pests and diseases without risk of pest resistance.

Introducing a biocontrol definition would lead to biocontrol being recognized as a group of products distinct from chemical pesticides. This means they could be prioritized in the authorization process at European and Member State level speeding up their availability to farmers. Targeted changes to Regulation 1107, such as provisional authorisation, facilitated label expansion and a reduced frequency of re-registration procedures, could be applied to this recognised group of biocontrol products.

Can the biocontrol industry work with EU authorities to improve the efficiency/shorten review time for registration? If so, how can they work together? Would you like to give some advice?

Here, we can look to Brazil for inspiration where in the last 2 years, around an additional 100 biological products have been registered for use there and this number grows every year. Biocontrol is used on 46 million acres, about 60% of agricultural land in Brazil. Amid problems of pest resistance and farmers were looking for solutions compatible with their production systems that provided effective pest control and productive crops. Biocontrol provided these solutions, and the authorities ensured their authorisation was prioritised.

Now, when a biocontrol product is registered for authorisation, it is fast-tracked to the front of the queue, assessed, and approved -where appropriate-in 2 years, compared to the almost decade wait European farmers often face.

IBMA is working with regulators to look at ways to speed up authorisation. The sharing of the biocontrol industry pipeline with the European authorities was an important step to highlight the hundreds of solutions in the submission pipeline and so the urgency of the situation.  The authorities are well aware of the need and the possible solutions, and the Single Market Enforcement Task Force is working with industry and Member States to look at prioritisation and better implementation of Regulation 1107 at Member State level. In addition, to working with regulators it is important to prepare farmers for these new solutions. 

• Raise awareness of biocontrol by ensuring knowledge-sharing with farmers so they are ready to use biocontrol. In Brazil, only 90% of farmers have heard of biocontrol and 98% that have used biocontrol want to use it again, whereas in the US, 86% of farmers don’t know about it.

• Train regulators in evaluation of biocontrol – IBMA is working in EU Horizon projects with IBMA members, academics and authorities to develop educational material describing the characteristics and risk assessment considerations for biocontrol.  

• Make biocontrol available, invite farmers to demonstrations, show them how it works. IBMA is working with farmers and IBMA members to provide examples and demonstrations of biocontrol in action. 

With over 6,500 green industry jobs in the European biocontrol market, how do you see employment trends evolving in the coming years?

Predictions vary as to the growth of the biocontrol industry in Europe. Europe is investing in clean green technologies such as biocontrol and the regulatory changes to allow biocontrol to reach the market are crucial to the development of the industry.  We have excellent innovation in Europe, but we need to ensure it reaches the market so that entrepreneurial companies and their investors see a return on their investment and are able to grow their businesses and so the industry. Without that certainty of reaching the market in a reasonable timeframe the industry will continue to deprioritize Europe, but with a faster registration process that allows companies and investors a globally competitive return on investment, the industry and jobs will evolve exponentially.