Biocontrol Coalition
The Biocontrol Coalition is a multi-stakeholder coalition advocating for the European Union to rethink its framework for agriculture and food, particularly for biocontrol, so that the EU proactively fosters innovation whilst ensuring health, safety and environmental protection.
ID: 715938853121-73
Lobbying Activity
Response to Food and Feed Safety Simplification Omnibus
14 Oct 2025
The Biocontrol Coalition welcomes the opportunity to contribute to the Commissions Call for Evidence on the Food and Feed Safety Simplification Omnibus. We are a multistakeholder platform advocating for a fit-for-purpose framework that enlarges the farmer toolbox through safe, science-based biocontrol solutions. A harmonised, innovation-friendly, and future-proof definition of biocontrol is essential to enable consistent and predictable regulation across the EU. It ensures safety while accelerating access to effective, sustainable tools. We welcome the Commissions acknowledgment that farmers face a shrinking toolbox as biocontrol products reach the market too slowly under Regulation (EC) 1107/2009. While targeted simplifications are valuable, they will not by themselves resolve the structural inefficiencies preventing innovation and uptake. The Coalition strongly supports the goals of reducing unnecessary burdens while upholding high safety and environmental standards, strengthening competitiveness, and cutting administrative costs for operators and SMEs. Biocontrol products, derived from natural organisms or materials, directly contribute to the bioeconomy and sustainable productivity, yet their regulatory treatment currently limits availability and affordability. Measures such as stronger mutual recognition and simplified renewal procedures are welcome but insufficient. Duplication of dossiers across Member Statesup to 27 per productremains a core barrier. National capacity constraints create systemic delays and unequal access. Guidance lacks the legal force needed to streamline approvals for low-risk, biologically based products. To make the system competitive globally, biocontrol approvals should take two to three years. The Coalition has identified six priority reforms: a harmonised, future-proof definition of biocontrol; removal of re-registration unless trigger conditions arise; automatic mutual recognition across the EU; reintroduction of provisional authorisations; interzonal evaluation; and facilitating label extensions. The absence of a Single Market for biocontrol artificially raises costs and fragments markets. Establishing one would radically improve accessibility, affordability, and competitiveness, especially for SMEs and lower-margin crops. The Commissions recognition that slow biocontrol approvals undermine both competitiveness and bioeconomy objectives is correct. Numerous analyses and stakeholder inputs confirm that a dedicated biocontrol framework is needed to achieve full simplification and ensure the EU remains globally competitive. Such a framework should recognise the low-risk nature of biocontrol agents, introduce proportionate, streamlined evaluation pathways inspired by other EU sectors such as veterinary medicines, feed additives, and fertilisers, and ensure future-proofing for scientific and climate developments. We therefore recommend that the Commission enforce automatic mutual recognition unless justified scientific objections exist, reduce dossier duplication and move towards a Single Market model, use the Omnibus as a bridge to a dedicated legislative process in 2026, and align measures with the Bioeconomy Strategy, Competitiveness Compass, and Farm to Fork objectives. We commend the Commissions efforts to simplify and accelerate sustainable innovation. However, without a dedicated legislative framework for biocontrol, the EU will continue to lag behind global peers. We urge the Commission to make this Omnibus the first step toward a full Better Regulation process for biocontrol legislation, ensuring EU farmers gain timely access to safe, innovative, and sustainable tools.
Read full responseMeeting with Flavio Facioni (Cabinet of Commissioner Olivér Várhelyi) and Asociación Agraria Jóvenes Agricultores and Alliance Biocontrôle
2 Jul 2025 · Biocontrol solutions
Response to Towards a Circular, Regenerative and Competitive Bioeconomy
23 Jun 2025
The Biocontrol Coalition (BC) argues that the European Unions current regulatory framework for biocontrol products is outdated, fragmented, and counterproductive to the goals of the EU Bioeconomy Strategy. Biocontrol productsplant protection solutions often derived from biobased sourcesare essential for sustainable agriculture and should be central to a circular, regenerative, and competitive bioeconomy. Key Points: · Biocontrol as Bioeconomy Innovation: These products are environmentally friendly and support sustainable biomass production. However, EU farmers face limited access due to regulatory and market barriers. · Regulatory Challenges: Regulation (EC) 1107/2009 is ill-suited for biocontrol products. It was designed for chemical-based solutions and imposes high costs and long approval times (79 years), making it inaccessible for SMEs and startups. · Market Fragmentation: The lack of a unified EU market forces companies to submit up to 27 separate dossiers for product approval, increasing costs and delaying market entry. This duplication wastes resources and discourages innovation. · Declining Access: Since 2019, the EU has seen a net loss of biocontrol active ingredients, while conventional options have also declined. This reduces farmers ability to manage pests and diseases, threatening productivity and competitiveness. · Global Disadvantage: Other regions, like Brazil and the U.S., have faster approval processes (23 years), attracting EU-funded innovations and startups to foreign markets. This results in EU public funds indirectly benefiting non-EU farmers. · Call for a Single Market: BC advocates for a harmonized EU regulatory framework for biocontrol products. This would: · Ensure equal access for all EU farmers · Reduce regulatory costs and time-to-market · Encourage SME participation and innovation · Maintain high safety and environmental standards · Economic Impact: The ROI for biocontrol innovation in the EU is 30% below the global average. A streamlined system would improve competitiveness and align with the EUs Startup and Scaleup Strategy and Competitiveness Compass goals. · Urgency and Opportunity: With increasing climate volatility and pest threats, farmers need timely access to innovative solutions. The upcoming agri simplification package and Bioeconomy Strategy revision offer chances to reform the system. Conclusion: The Biocontrol Coalition urges the European Commission to initiate a Better Regulation process to create a dedicated, fit-for-purpose framework for biocontrol products. This would unlock innovation, support sustainable farming, and ensure the EU meets its bioeconomy and food security goals.
Read full responseResponse to Biotech Act
11 Jun 2025
The Biocontrol Coalition argues that the current EU regulatory framework under Regulation (EC) 1107/2009 is ill-suited for biocontrol products, which are essential for sustainable agriculture. The fragmented, system built for chemistry-based products hinders innovation, delays market entry, and disproportionately affects SMEs. Despite EU ambitions to foster innovation and entrepreneurship, the regulatory environment remains a major barrier. A key recommendation is the creation of a Single Market for biocontrol products, which would: Ensure equal access for all EU farmers. Reduce regulatory duplication and costs. Accelerate time-to-market. Improve competitiveness and pricing. Currently, companies must submit up to 28 dossiers for EU-wide access, making the process costly and slow. This favors large corporations and discourages SMEs and startups. The ROI for biocontrol in the EU is 30% below the global average, pushing innovators to launch products outside Europe, despite EU-funded R&D. The decline in available plant protection products, including biocontrol options, has hurt farmer resilience. Since 2019, the total number of approved biocontrol active substances has shrunk by 5. Emergency authorisations are increasingly used as a stopgap, but they lack predictability and long-term viability, and they exacerbate the administrative load of national authorities. The Coalition highlights successful precedents for harmonised EU regulation, such as for animal feed and fertilisers, and urges similar treatment for biocontrol. A streamlined, one-step EU process would cut administrative burdens, enhance safety evaluations, and support the goals of the Competitiveness Compass. In conclusion, the Biotech Act is a critical opportunity to modernise the regulatory framework, enabling faster, fairer access to biocontrol innovations and supporting EU farmers in facing climate and pest challenges. The Biotech Act provides an opportunity to introduce more radical changes beyond the targeted amendments to Reg (EC) 1107/2009 that are expected to be part of the agri simplification package in Q4 2025. These targeted amendments will provided much needed immediate relief but cannot address the full range of issues that must be resolved to arrive at a truly fit-for-purpose framework. The attached document provides links to data and sources of evidence to support our arguments.
Read full responseMeeting with Antonella Rossetti (Cabinet of Commissioner Christophe Hansen), Maxi Espeter (Cabinet of Commissioner Christophe Hansen) and Prospero & Partners
26 Feb 2025 · Biocontrol legislation
Meeting with Klaus Berend (Director Health and Food Safety) and
12 Feb 2025 · Exchange on Commission initiatives on biocontrol
Response to Single Market Strategy 2025
31 Jan 2025
The call for evidence says the single market strategy should take into consideration the needs of businesses, workers and citizens. Farmers are all three, yet their needs are rarely considered through the lens of whether they benefit from the Single Market. Many elements of EU farmer toolboxes such as biocontrol products are not available on a Single Market, with the following negative consequences for farmer competitiveness: Little choice of plant protection tools to combat increasing and changing patterns of pests and diseases. EU farmers have been losing plant protection products for decades, but the trend has worsened in recent years. No new biocontrol active ingredient has been approved in the past two years, and there has been a net loss of 8 biocontrol active ingredients since 2019. This is against a background of EU farmers losing 1/3 of their conventional plant protection solutions since 2017. (In addition to the negative impacts on market dynamics, this narrowing of available active ingredients increases the chance of pest resistance.) Insufficient market dynamics to ensure competitive prices for existing plant protection tools. The fragmented regulatory process entails unnecessary duplication and delays, which also push product prices higher than under a streamlined process. The current regulatory framework favors large-scale companies and is out-of-reach for SMEs who cannot wait 8-10 years to start having revenue streams. Undue administrative burdens have inadvertently favored a de facto oligopoly because only very large companies have the capacity to defer income for a decade or more to enter the EUs fragmented national markets. Perversely, EU-funded innovation is available to farmers elsewhere in the world but not in the EU. EU start-ups under pressure from investors to start having any revenue go to market in countries where the process is significantly shorter (2-3 years in Brazil and the USA). This means that the EU is inadvertently subsidising non-EU farmers! Since MS are involved in the EU process of approving active ingredients and national authorisations, the current 2-step pressure increases pressure on resourced-stretched national authorities by multiplying the number of files per product. The current process for bringing a plant protection product to market entails registering an active ingredient at the European level followed by national authorisation for products. In theory, companies should be able to benefit from a single evaluation by a Rapporteur member States in each of the four defined agroclimatic zones followed by easy mutual recognition. In reality, companies have to submit dossiers to every country, making the return on investment unattractive for small markets. From a safety perspective, there is no justification for this bureaucratic duplication. A single European process in which Member States have a role could evaluate safety once and specify the appropriate conditions for use, which farmers and their advisors could then take into account when making informed decisions. Creating a Single Market would greatly increase farmer choice, reduce the time of bringing products to market, unleash competitive pricing dynamics and be much more accessible to start-ups and SMEs. Slashing unnecessary administrative duplication would contribute to achieving the goal of the Competitiveness Compass of cutting by at least 25% the administrative burden for firms and by at least 35% for SMEs. Moving to a one-step process would dramatically reduce the number of dossiers and therefore allow for a more efficient use of public authorities time and financial resources. Precedents show that a Single Market approach is politically and technically feasible: Animal feed has been under a harmonised European approval process for over a decade, and Regulation 2019/1009 created a pathway to the Single Market for all types of fertilising products. The attachment contains supporting evidence.
Read full responseMeeting with Andreea Ticheru (Cabinet of Executive Vice-President Margrethe Vestager), Thomas Woolfson (Cabinet of Executive Vice-President Margrethe Vestager)
5 Jun 2024 · Discussion on Single Markets and Biocontrols