Changes from plenary report to adopted text

– 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,

– 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,

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

– 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,

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

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; 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 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;

G. 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;

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, 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 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;