REPORT on ensuring the faster registration and uptake of biological control agents

MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION

on ensuring the faster registration and uptake of biological control agents

(2025/2086 (INI))

The European Parliament,

- having regard to Articles 114 and 191 of the Treaty on the Functioning of the European Union,

- having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC[1]('Regulation 1107/2009'),

- having regard to the Commission proposal of 22 June 2022 for a regulation of the European Parliament and of the Council on the sustainable use of plant protection products and amending Regulation (EU) 2021/2115 (COM(2022)0305),

- having regard to its draft resolution laying down a legal definition and categorisation of biological control substances in the sustainable use of plant protection products,

- having regard to the Commission communication of 20 May 2020 entitled 'A Farm to Fork Strategy - for a fair, healthy and environmentally-friendly food system' (COM(2020)0381) and the Commission communication of 20 May 2020 entitled 'EU Biodiversity Strategy for 2030 - Bringing nature back into our lives' (COM(2020)0380),

- having regard to the joint deliberations of the Committee on the Environment, Climate and Food Safety and the Committee on Agriculture and Rural Development under Rule 59 of the Rules of Procedure,

- having regard to the Commission's response to Council Decision (EU) 2022/2572 of 19 December 2022 requesting the Commission to submit a study complementing the impact assessment of the proposal for a Regulation of the European Parliament and of the Council on the sustainable use of plant protection products, and amending Regulation (EU) 2021/2115 of the European Parliament and of the Council, and to propose follow-up actions, if appropriate in view of the outcomes of the study[2],

- having regard to the Commission communication of 19 February 2025 entitled 'A Vision for Agriculture and Food - Shaping together an attractive farming and agri-food sector for future generations' (COM(2025)0075),

- having regard to Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides[3],

- having regard to its resolution of 23 November 2023 on the revised Pollinators Initiative - A new deal for pollinators[4],

- having regard to Decision 15/4 of the United Nations' Conference of the Parties to the Convention on Biological Diversity of 19 December 2022 entitled 'Kunming-Montreal Global Biodiversity Framework',

- having regard to the Commission communication of 12 May 2021 entitled 'Pathway to a Healthy Planet for All - EU Action Plan: "Towards Zero Pollution for Air, Water and Soil"' (COM(2021)0400),

- having regard to its resolution of 16 January 2019 on the Union's authorisation procedure for pesticides[5],

- having regard to Rule 55 of its Rules of Procedure,

- having regard to the report of the Committee on the Environment, Climate and Food Safety and the Committee on Agriculture and Rural Development (A10-0234/2025)

A. whereas a plant protection product (PPP) is a product containing a substance that prevents, destroys or controls a harmful organism ('pest'); whereas biological control, originating from nature or identical to nature if synthesised, is a method of controlling pests and diseases using other organisms or parts of them, often in combination with physical techniques, to disrupt pest reproductive cycles or limit crop susceptibility to pests;

B. whereas pursuant to Regulation (EC) No 1107/2009, active substances must be approved at EU level before Member States may authorise PPPs containing them; whereas the current list of approximately 420 approved active substances comprises both conventional active substances and an increasing number of biocontrol active substances[6]; whereas the authorisation of biological control products also falls under Regulation (EC) No 1107/2009; whereas more than 100 requests for approval of biocontrol agents on the EU market are expected by 2028, and these requests may not receive approval before 2031 to 2037; whereas the time between submitting a request for authorisation and the placing on the market of a biocontrol agent can take up to 10 or 15 years depending on their classification; whereas the lengthy approval process has an impact on the availability of plant protection solutions; whereas, while they do not have the same risk profile as conventional PPPs, these biocontrol products nonetheless may in some cases present risks[7]and require risk assessment methods suited to the mode of action and nature of the product to evaluate their safety and efficacy; whereas this requirement should be proportionate to the risk posed, and a competitive, science-based, and innovation-friendly regulatory environment is essential for ensuring both sustainability and productivity in the EU agri-food sector;

C. whereas there is currently no harmonised EU-wide legal definition of biological control;

D. whereas biological control solutions can be active substances and agents, invertebrate biocontrol that control pests and diseases, as well as products that contain one or more biological control active substance; whereas biological control solutions are used as part of holistic plant health strategies that may also combine preventive agronomic measures and other approaches, in order to both optimise effectiveness and ensure that their use remains complementary and need-based;

E. whereas biological control can occur via: (a) living macro- and microorganisms, (b) semiochemicals, (c) extracts from natural sources, in particular plants and algae, and substances produced by microorganisms, (d) substances identical to those produced by biological organisms or that are constituents of biological organisms and (e) inorganic substances occurring in nature, with the exception of heavy metals and their salts;

F. whereas invertebrate biological control, such as beneficial insect predators, including parasitoids, mites and nematodes, already play an essential role in integrated pest management and organic farming systems; whereas, unlike substance-based biological control products, they are not covered by Regulation (EC) No 1107/2009, and so remain subject to diverse and fragmented national rules; whereas faster authorisation processes for macro-organisms while maintaining high safety standards for health and the environment would increase their market accessibility and could help address plant health concerns;

FG. whereas biological control solutions are frequently combined to form blends of semiochemicals, plant extracts or microbial consortia which enhance effectiveness, target multiple pests or diseases and improve environmental adaptability, and are often incorporated into other pest control techniques, for example integrated pest management (IPM); whereas, for this reason, it is not always possible to substitute one conventional PPP by one single biocontrol product;

H. whereas biological control is often associated with lower levels of toxicity, persistence and environmental pollution, and with due attention can complement conventional plant protection products; whereas this can enable farmers, in some cases, to reduce their dependency on the use of conventional PPPs by providing safe and effective additions to the farmers' toolbox, thereby contributing to healthier soils and reducing impacts on biodiversity, ecosystems, water quality, food chains and public health;

I whereas the fast-track processing and placing on the EU market of biological control would increase availability and provide an opportunity to combat the resistance of pests and diseases to current PPPs; whereas this would help to promote more sustainable agricultural practices and increase the resilience and competitiveness of the agricultural sector by keeping the farmers' toolbox of pest control options as broad as possible;

J. whereas, in its 2025 Vision for Agriculture and Food[8], the Commission states that 'farmers need a more advanced toolbox to be able to farm in a nature-friendly way and achieve the set objectives. This toolbox requires a well-calibrated mix of a better targeted public support from the future CAP, investments into nature-friendly solutions, more economic incentives, tailored advice drawing on advances in research and innovation, and a more agile regulatory environment. One such example is the EU ambition to reduce the use of harmful pesticides. This is important both for the long-term resilience of farming, nature and health protection. However, the introduction of alternatives in a form of biological or innovative low-risk plant protection products has not followed with the same pace as the withdrawal of active substances from the EU market. If this trend continues, it can affect the EU's ability to ensure food production. The Commission will therefore carefully consider any further ban of pesticides if alternatives are not yet available, unless the pesticide in question represents a threat to human health or to the environment that agriculture relies upon for its viability';

K. whereas there is often a lack of expertise, experience and resources required to process biological control applications in EFSA and in Member States' competent authorities, especially regarding microbiology; whereas, to aid their market introduction, guidelines and data requirements should match the specific characteristics of biological control solutions, avoiding excessive burdens, costs, lengthy approval procedures and legal deadlines; whereas faster, more affordable and less complex authorisation procedures for biological control products could help attract more investment to the EU and strengthen its global leadership in sustainable plant protection;

L. whereas the effective deployment of biocontrol products often depends on adapted practices, highlighting the need for continued investment in training, infrastructure, and advisory support to ensure their successful uptake;

M. whereas EU-based small and medium-sized biocontrol enterprises represent approximately 70 % of the EU biocontrol sector; whereas these companies are key drivers of sustainable innovation; whereas the approval of active substances for PPPs, including biological control agents in the EU, entails significant costs, with overall investment, including data generation, regulatory fees and national authorisations, estimated at between EUR 1.5 and EUR 4 million per substance;

Legal definitions, scope and principles

1. Calls on the Commission to establish, at EU level, a clear legal definition of biological control solutions, as well as a framework for the accelerated approval of biological control active substances at EU level and for the authorisation of biological control products at Member State level; considers that such a framework should be accompanied by clear data requirements and updated guidance documents, with a view to enhancing legal certainty, fostering the EU's innovation efforts, and promoting investment in sustainable alternatives; insists, further, that the Commission should aim to prevent market fragmentation and reduce administrative burdens;

2. Notes that regulatory certainty will facilitate innovation, especially among SMEs, and stimulate the development of a competitive EU biological control sector; stresses, furthermore, the importance of legislative coherence and consistency with relevant EU laws, including Regulation (EU) 2018/848[9], and strategies, and of providing, where appropriate, for specific provisions on biological control agents;

3. Underlines that biological control agents generally have different risk profiles from conventional chemical PPPs, as they do not share the same properties, modes of action or ecological impacts; stresses, however, that they are not risk free and therefore require suitable science-based risk assessment; emphasises that risk assessment methods should be adapted to the specific characteristics of biological control agents, while ensuring that regional agronomic specificities are duly considered, as well as a high level of protection for health, non-target organisms, biodiversity and the environment, in line with the One Health approach and the precautionary principle; recalls, in particular, the need to assess their potential effects on beneficial species, ecosystems and biodiversity, including when living organisms such as microorganisms, natural enemies or sterile insects or their constituent parts are introduced into the environment;

4. Calls on the Commission, in the impact assessment accompanying the legislative proposal, to evaluate the suitability of current risk assessments during the approval of active substances exerting biocontrol and the authorisation of biological control products, and, if necessary, to develop tailored risk assessment protocols for each biocontrol solution; underlines that risk assessments for biocontrol agents must always ensure targeted, appropriate and proper risk management and a high level of protection of health and the environment; stresses that authorisation procedures must include harmonised environmental and biodiversity impact criteria at EU level to prevent divergences between Member States; stresses that such biological control products must only be approved if they meet the relevant approval criteria[10]that guarantee safe and effective use, and that effectiveness is scientifically verified and results are available, while safeguarding business-sensitive information; recalls that procedures must be simplified to avoid delays that would disadvantage EU innovators and farmers; notes that risk assessments procedures should be transparent and clear;

Targeted amendment of Regulation (EC) No 1107/2009

5. Calls on the Commission, in the shorter term, to adapt the current Regulation (EC) No 1107/2009 to cater specifically for active substances exerting biocontrol and biocontrol products;

6. Welcomes the Commission's forthcoming presentation of a targeted revision of Regulation (EC) No 1107/2009 as part of the announced simplification package, focusing on the approval and authorisation of active substances exerting biological control and products solely containing these, to allow for the accelerated assessment of applications for biological control products, and to facilitate the renewal process of biocontrol active substances that have already been approved, in order to increase the supply of available PPPs in the short term and support the move to production systems using less harmful active substances;

Mutual recognition

7. Encourages Member States to use the current mutual recognition procedure under Article 40 of Regulation (EC) No 1107/2009 to accelerate the authorisation of biological control products in order to increase the uptake and availability of biocontrol products across the EU; calls on the Commission to pay particular attention to the implementation of Article 40 and to set up follow-up initiatives to ensure its full implementation where appropriate;

8. Notes that the targeted amendment of Regulation (EC) No 1107/2009 should strengthen, facilitate and operationalise the principle of mutual recognition with regard to EU biological control authorisation procedures, thereby reducing duplication of national assessments while respecting the precautionary principle and differences between local conditions;

9. Calls on the Commission to work on a roadmap looking towards automatic mutual recognition of solely biocontrol products and the possibility for applicants to apply with a single dossier for a biological control product in several Member States at the same time, while ensuring a high level of protection for health and the environment, and to consider a single EU-wide authorisation zone that would ensure that the same scientific standards, efficacy criteria and safety levels are demonstrably met across the EU; stresses that such a roadmap should work towards a potential legislative framework that would be subject to, and should only be established after, a robust and rigorous impact assessment and that could be developed stepwise, beginning with enhanced cooperation and data-sharing between competent authorities, then streamlining of the zonal assessment procedures for biocontrol products under Regulation (EC) No 1107/2009, such as tasking rapporteur Member States to assess, in collaboration with Member States, from each of the other geographical zones, conditions for authorisation in all geographical zones in order to build mutual trust between competent national authorities, in order to avoid bureaucratic duplication, facilitate uptake by farmers of more sustainable solutions and improve uniform market access while maintaining rigorous standards for health and environmental protection;

Minor uses

10. Calls on the Member States to facilitate and to speed up, where appropriate, solely the extension of the authorisation of PPPs that have already been authorised and contain active substances exerting biological control to cover minor uses, including but not limited to most controlled-environment agriculture, unless the competent authority identifies a specific and scientifically justified risk;

11. Calls on the Commission to assess the impact, including risk and benefits, on a case-by-case basis, of the automatic extension solely of PPPs that have already been authorised and contain biological control products to cover minor uses in accordance with the safeguards set out in Article 51 of Regulation (EC) No 1107/2009;

12. Calls on the Commission to consider extending the maximum period for the first approval and renewal of active substances exerting biological control to up to 25 years; calls on the Commission to establish and maintain a list of biological control products that, based on their profile, nature and mode of action, may be eligible for authorisation with an extended time frame of up to 25 years for the first authorisation; emphasises that such a list must not be closed and must reflect the most recent scientific standards and remain dynamic, meaning that inclusion on the list must not be considered permanent; calls on the Commission to periodically review and update the list in the light of new data or scientific developments; calls on the Commission to assess potential conditions upon which, biological control active substances and products that have been shown to have no or negligible risk profile could be granted indefinite approval and authorisation;

13. Calls, furthermore, on the Commission to consider establishing an approval mechanism for specific low-risk biocontrol categories at EU level;

Fast-track procedures

14. Recommends streamlining, optimising and accelerating the authorisation procedure as well as the re-authorisation, approval and re-approval procedures for biological control solutions, including through the establishment of fast-track procedures, in order to reduce unnecessary bureaucratic burdens to better keep in line with legal evaluation deadlines while properly assessing and managing the associated risk;

15. Stresses, however, that any fast-tracking of procedures for placing biocontrol products on the market must still be subject to rigorous scientific assessment, including risk analysis also covering non-target organisms and efficacy under a range of relevant climatic conditions;

Provisional authorisation

16. Calls on the Commission, in its revision of Regulation (EC) No 1107/2009, to amend Article 30 to consider allowing provisional authorisation solely for biocontrol PPPs that fulfil the relevant safety criteria therein; believes that provisional, conditional authorisations should be coupled with necessary monitoring; recalls the established principle that if new data show unacceptable risk to health or the environment, including to non-target species, then provisional authorisation should be reviewed and withdrawn;

Looking ahead: strategy, gap analysis and a longer-term legislative perspective

17. Calls for the Commission's impact assessment accompanying its legislative proposal to evaluate the appropriateness of the current legislative framework and risk assessments, during the approval of active substances exerting biocontrol and the authorisation of biological control products, inter alia, in terms of data requirements, approval criteria and mutual recognition; calls for the accompanying impact assessment to identify areas where the current regulation could be adjusted to be more adequate for bringing biocontrol solutions to market, as called for in the Strategic Dialogue, and to fulfil farmers' need for a more advanced and comprehensive toolbox;

18. Calls on the Commission to provide a comprehensive biocontrol strategy and a toolbox assessment of expected challenges in crop protection in the coming 10 years for specific crops, pests and diseases, with a view to supporting the development of alternative PPPs and IPM measures, especially using effective and affordable alternatives to identify gaps in plant protection and to anticipate withdrawals from the market, to allow users to plan sufficient transition periods during phase-out with the goal of creating a future-proof and fit-for-purpose framework;

19. Calls on the Commission to look into the possibility, in the longer term, of a new stand-alone biocontrol regulation, including the conditions upon which a centralised approach may apply, to better tailor the assessment, approval and authorisation procedures for biocontrol solutions;

Clearing backlogs

20. Calls for, as appropriate, sufficient resources to clear the backlog of delayed biological control applications, with the establishment of a priority lane, provided that it has received dedicated additional funding for the approval of biological control agents, within the approval and authorisation procedures for active substances and products under Regulation (EC) No 1107/2009, while also assessing and updating approval and authorisation procedures on the basis of scientific and technical developments; underlines that speeding up the assessment and authorisation of biocontrol solutions should not lead to any further delay in the risk assessment and authorisation of conventional substances and PPPs or delayed reviews of those that have been on the market for more than 10 years, in order to ensure a high level of protection;

Support for applicants

21. Notes the current provisions regarding help for applicants from the European Chemicals Agency and the European Medicines Agency; calls on the Member States and EFSA to provide technical support for applications from small and medium-sized enterprises, especially during the application preparation process, while applying clear safeguards to avoid conflicts of interest; calls on EFSA, while respecting the foregoing, to create a one-stop shop for SMEs producing biocontrol agents and to provide clear guidance and support for applicants on dossier preparation, providing explanations of data requirements and submission procedures, with the aim of improving the quality of applications, thus reducing delays in the assessment and authorisation process and facilitating the placing on EU markets of approved biocontrol agents;

22. Calls on the Member States to create time-efficient, clear and easy-to-understand administrative procedures adapted to biocontrol products, and risk assessments appropriate for their mode of action and nature of the product, and to establish dedicated helpdesks;

23. Calls on the Commission to urgently adopt updated guidance documents specific to biological control products to promote their uptake and enhance consistency across the Member States;

The application of Directive 2009/128/EC to promote biological controls, including via integrated pest management

24. Calls for the Member States to include, in their national action plans (NAPs) under Directive 2009/128/EC, in particular, planned and adopted measures to improve the authorisation procedures for biological control and other low-risk products;

25. Calls also on the Commission and the Member States, in coordination with farmers, to ensure the effective implementation of Directive 2009/128/EC, establishing easier access to biocontrol products, and to accompany farmers adopting more sustainable practices;

Potential of biological control solutions

26. Recognises the high potential of biological control approaches in reducing the dependency on conventional PPPs; notes that biological control solutions can complement conventional PPPs if due attention is paid, making them a useful addition to a broad and balanced farmers' toolbox alongside other crop protection methods; stresses that the specific characteristics of biological control agents give them a different risk profile so they can offer targeted action with smaller off-target or residual effects, making them more compatible with IPM and, especially, organic farming practices; insists that the broader uptake of biological control can thereby significantly contribute to achieving EU environmental, food security and health objectives while maintaining agricultural productivity and ensuring that farmers are not left without effective and affordable alternatives to protect their crops;

27. Notes that facilitating the authorisation and uptake of biological control should be coupled with scaling-up the uptake of IPM and reducing the risks associated with and the dependency on conventional PPPs;

29. Calls on the Commission to ensure the effective implementation and enforcement of the sustainable use of pesticides under Directive 2009/128/EC and Regulation (EC) No 1107/2009, particularly in relation to the timely processing of authorisation requests and integrated pest management; notes that in an integrated IPM approach, using authorised conventional products for which all the safety requirements for health and the environment have been met, always remain an option for farmers;

Assessment of performance capacities and resources

30. Calls on the Commission and the Member States to assess their administrative performance and institutional capacities and appropriateness of the resources allocated to, respectively, EFSA and the relevant national competent authorities to enable them to fulfil their tasks; emphasises that investment is needed in (re)assessment capacity in the Member States and EFSA;

31. Calls on the Commission to allocate the necessary additional funding for training and employing additional staff, including with appropriate and specialised expertise, within EFSA, and to establish dedicated and sufficient resources within EFSA's organisational structure for biological control, in order to prevent undue delays in the approval process of active substances exerting biological control and to ensure tailored assessments and reduce bottlenecks; calls on the Commission to take appropriate follow-up actions to enable the acceleration of the approval procedure and increased uptake of biocontrol;

Strong Member State funding

32. Calls on the Member States to ensure sufficient budget is ring-fenced for the relevant national competent authorities, which is essential to prevent undue delays in biological control authorisation procedures and to accelerate the uptake of biocontrol; insists that the Member States should guarantee that the relevant national competent authorities have the sufficient budget, staff and expertise to carry out (re-) assessments in a timely and effective manner; highlights the benefits of Member States exchanging best practice;

33. Calls, likewise, on the Commission to propose measures and identify mechanisms and resources to support Member States in accelerating their authorisation procedures; proposes, in this regard, that the Commission develop guidance on necessary and minimum resources and capacity, applicable across the EU Member States, necessary to assess biological control products;

Research and investment

34. Calls on the Commission and the Member States to foster investment in public and private research and partnerships for the development of biological control and IPM strategies, including through research centres, universities and regional innovation hubs, EU innovation partnerships and lighthouse projects, with a special focus on SMEs through targeted programmes, as well as for fostering a competitive environment that enables and nurtures EU innovation and reduces the dependencies of EU agriculture;

35. Underlines the importance of research and development in biocontrol technologies over the coming decades, particularly research into addressing the protection gaps in specific crop-pest/disease combinations, for which few or no alternative pest control solutions exist, in order to direct innovation and regulatory efforts towards where they are most urgently needed;

Farmers' access to knowledge

36. Notes that the use of biological control requires different approaches, knowledge bases and skill sets, particularly regarding the care of beneficial species that act to protect crops; notes that this is already partially incorporated into IPM and other production systems; underlines, however, that further knowledge, training, information and practical guidance on the effective use of biocontrol products is necessary in cooperation with farmers;

37. Notes that wide disparities remain between Member States' access to knowledge and advisory services; calls for advice on the use and application of biological control options to be offered as part of suitably resourced, continued, independent advisory systems, that should be accessible to all farmers;

38. Calls on the Commission and the Member States, in collaboration with end users, to provide a digital EU platform, building on the 'INSIGNIA' pilot project, including long-term monitoring for pollinators, and the successful Parliament-initiated 'IPM toolbox for farmers' pilot project, for the dissemination of good practices and proven biological control solutions aiming to help farmers make informed decisions on the most effective type of biological control for the pest population structure and pedo-climatic conditions of the farm concerned, calls, furthermore, on the Commission to promote a wider toolbox including by making this digital platform a continued, more accessible and permanent initiative available in all EU languages, and to secure the involvement of all relevant stakeholders;

39. Stresses the need to increase access to knowledge through farmer training to build technical capacity using demonstration networks, peer-to-peer exchange and local technical support and incentives, including financial, with a view to promoting the safe, effective and widespread use of biological control; recognises the usefulness of monitoring access to knowledge and the dissemination of best practices regarding the uptake of biological control; notes the Member States' and the EU's current possibilities to co-fund and encourage farmer training through investments or extension services under farm advisory systems in the common agricultural policy; calls on the Commission and the Member States to provide appropriate support for biological control training, technical support and practical guidance and to consider how to best facilitate such voluntary training to incentivise more farmers to adopt biological control and IPM;

Cooperation between all actors

40. Calls for more scientific research, knowledge exchange, cooperation and capacity-building between all relevant actors involved in the process of the development, approval, authorisation, uptake and dissemination of biological control and best practices in implementing IPM across the EU, as well as in the process of exchanging knowledge and best practice with partners in non-EU countries;

Funding of advisory systems

41. Calls for details on advisory system funding, as well as training and capacities in biological control and IPM, to be included in the Member States' NAPs; stresses that the development and availability of IPM crop- and pest-specific guidance remains inconsistent between Member States; encourages Member States to revise their NAPs to strengthen farmers' access to crop- and pest-specific guidance that reflects regional realities and includes biological control options, their possible integration into IPM programmes and compatibility with other PPPs, where available and appropriate;

Monitoring progress

42. Calls for the Commission to regularly monitor the market uptake, availability and affordability of biological control solutions;

43. Calls on the Commission to monitor the EU's and the Member States' progress on the approval and authorisation of biological control solutions, looking at the number of applications, the associated administrative capacities, staffing levels and dedicated budgets, and especially the implementation of a priority lane with dedicated additional resources for biological control product authorisation, once it has been established; calls on the Commission to publish a report of the findings and submit it to Parliament and the Council;

Outermost regions

44. Calls on the Commission and the Member States to ensure that the EU's outermost regions can benefit from the uptake of biological control by ensuring that authorisation processes account for their unique agro-ecological conditions and pest profiles, and by providing targeted training, advisory services, and funding support to farmers and SMEs in these regions; calls strongly for the development of crop- and pest-specific guidance and knowledge platforms that reflect the realities of outermost regions in order to enhance their access to safe, effective and sustainable biological control solutions;

°

° °

45. Instructs its President to forward this resolution to the Council and the Commission and the governments and parliaments of the Member States.

EXPLANATORY STATEMENT

This report addresses the need to accelerate the authorisation process for biological plant protection products ('biocontrols') in the European Union. Biocontrols include natural substances and organisms that can provide effective plant protection with lower associated risks than conventional chemical plant protection products and are a cornerstone of integrated pest management (IPM) and thus align with overarching EU strategies on biodiversity, food security and sustainable, competitive and resilient agricultural systems. To this day, it takes a very long time for biocontrol solutions to enter the market, since the current legal framework is not adapted to their nature, specificities and mode of action. Many farmers face increasing regulatory pressure to reduce the use of chemical plant protection products, while simultaneously needing to maintain crop yields and plant health. Applicants, who are often small and medium-sized enterprises, face high costs, legal uncertainty and fragmented national procedures. This discourages innovation and delays the availability of sustainable and affordable plant protection products for farmers.

The co-rapporteurs call for a harmonised and innovation-friendly framework with a clear EU-wide definition of biological control, robust risk-assessment methods tailored to the specific nature of these products, and better use of mutual recognition between Member States to reduce duplication and speed up market access.

Other short-term measures aim to establish a clearer regulatory pathway for biocontrol solutions within the current framework for plant protection products. Approval processes could be accelerated through dedicated review mechanisms, increased resources, extended approval periods for low-risk biocontrol products, and the possibility of provisional authorisations under defined conditions. In the long term, the report suggests exploring the creation of a dedicated regulatory framework for biocontrol, supported by a thorough impact assessment, to promote greater coherence, predictability, and efficiency in their approval and authorisation.

It is also stressed that faster approval must never come at the expense of safety. All authorisations should remain science-based, ensuring a high level of protection for health, non-target organisms, biodiversity and the environment. The aim of this report is not to eliminate conventional plant protection products but to establish a balanced, integrated plant protection system where safe and sustainable options are readily accessible and building on a broader toolbox for farmers, with the aim of building an efficient, predictable and science-based regulatory framework that improves fairness and planning certainty for farmers and the environment.

Beyond the necessary regulatory framework, uptake depends on knowledge, capacity, and investment. The report therefore calls for adequate resources for EFSA and national competent authorities, stronger training and advisory systems for farmers, the inclusion of biocontrol measures in Member States' national action plans under Directive 2009/128/EC, enhanced cooperation between researchers, authorities and the private sector, and public and private investment in research and innovation to fill remaining pest-control gaps.

The report reflects a broad consensus that current regulatory pathways need to be improved to ensure the availability of sustainable crop protection alternatives for farmers.

ANNEX: DECLARATIONS OF INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteurs declare that they included in their report input on matters pertaining to the subject of the file that they received, in the preparation of the report, prior to the adoption thereof in committee, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register[11], or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:

The list above is drawn up under the exclusive responsibility of the rapporteurs.

Where natural persons are identified in the list by their name, by their function or by both, the rapporteurs declare that they have submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.

INFORMATION ON ADOPTION IN COMMITTEE RESPONSIBLE

NFORMATION ON ADOPTION
BY COMMITTEE RESPONSIBLE

FINAL VOTE BY ROLL CALL BY THE COMMITTEE RESPONSIBLE

Key to symbols:

+ : in favour

- : against

0 : abstention