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Micro-organisms used in plant protection products
The EU’s policy on micro-organisms used in plant protection products aims to make biological alternatives to chemical pesticides more available, while keeping the same basic requirement of safety for human and animal health and the environment. The page explains that micro-organisms such as bacteria, fungi, viruses and protozoa can be used to control pests and plant diseases, and that they have long been used in biological control because they occur naturally in the environment and some strains have useful protective properties.
A key policy shift came with four Commission implementing regulations that have applied since 21 November 2022. These rules were introduced to reflect the specific biological properties of micro-organisms and the latest scientific developments, rather than regulating them through criteria largely designed for chemical substances. The Commission presents this reform as a way to facilitate both the approval of micro-organisms as active substances and the authorisation of products containing them, so that farmers can access more sustainable crop-protection tools.
The four acts are Commission Regulation (EU) 2022/1438, which amended Annex II to Regulation (EC) No 1107/2009 on specific approval criteria for micro-organisms; Commission Regulation (EU) 2022/1439, which updated data requirements for active substances; Commission Regulation (EU) 2022/1440, which updated data requirements for plant protection products containing micro-organisms; and Commission Regulation (EU) 2022/1441, which amended the uniform principles for evaluation and authorisation of such products.
The practical logic of the reform is to make the system more fit for purpose. According to the Commission, the new approach is based on the biology and ecology of each micro-organism, which means the data requirements become more targeted and conditional on the characteristics of the organism in question. The Commission argues that this should lead to streamlined dossiers, more straightforward risk assessment, shorter timelines for market access, and also less animal testing, because fewer irrelevant experiments should be required. At the same time, the core safeguard remains unchanged: a micro-organism can only be approved if it is shown not to cause disease in humans or animals.
The policy is also explicitly linked to the EU’s broader sustainability agenda. The Commission says the new rules are aligned with the European Green Deal and contribute to the Farm to Fork Strategy, because they are intended to reduce dependence on chemical plant protection products and expand the availability of biological solutions, including for organic farming and integrated pest management. The page notes that more than 60 micro-organisms are currently approved in the EU after scientific risk assessment confirmed that their use in plant protection products is safe.
To support implementation, the Commission also published in June 2023 two communications listing the relevant test methods and guidance documents for preparing application dossiers under the revised rules, together with explanatory notes on the data requirements. Overall, the EU’s policy in this area is to create a more scientifically adapted and innovation-friendly approval system for biological plant protection products, while maintaining a strict pre-market safety assessment.
A key policy shift came with four Commission implementing regulations that have applied since 21 November 2022. These rules were introduced to reflect the specific biological properties of micro-organisms and the latest scientific developments, rather than regulating them through criteria largely designed for chemical substances. The Commission presents this reform as a way to facilitate both the approval of micro-organisms as active substances and the authorisation of products containing them, so that farmers can access more sustainable crop-protection tools.
The four acts are Commission Regulation (EU) 2022/1438, which amended Annex II to Regulation (EC) No 1107/2009 on specific approval criteria for micro-organisms; Commission Regulation (EU) 2022/1439, which updated data requirements for active substances; Commission Regulation (EU) 2022/1440, which updated data requirements for plant protection products containing micro-organisms; and Commission Regulation (EU) 2022/1441, which amended the uniform principles for evaluation and authorisation of such products.
The practical logic of the reform is to make the system more fit for purpose. According to the Commission, the new approach is based on the biology and ecology of each micro-organism, which means the data requirements become more targeted and conditional on the characteristics of the organism in question. The Commission argues that this should lead to streamlined dossiers, more straightforward risk assessment, shorter timelines for market access, and also less animal testing, because fewer irrelevant experiments should be required. At the same time, the core safeguard remains unchanged: a micro-organism can only be approved if it is shown not to cause disease in humans or animals.
The policy is also explicitly linked to the EU’s broader sustainability agenda. The Commission says the new rules are aligned with the European Green Deal and contribute to the Farm to Fork Strategy, because they are intended to reduce dependence on chemical plant protection products and expand the availability of biological solutions, including for organic farming and integrated pest management. The page notes that more than 60 micro-organisms are currently approved in the EU after scientific risk assessment confirmed that their use in plant protection products is safe.
To support implementation, the Commission also published in June 2023 two communications listing the relevant test methods and guidance documents for preparing application dossiers under the revised rules, together with explanatory notes on the data requirements. Overall, the EU’s policy in this area is to create a more scientifically adapted and innovation-friendly approval system for biological plant protection products, while maintaining a strict pre-market safety assessment.
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