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Food Safety

Micro-organisms used in plant protection products

About Micro-organisms

Micro-organisms such as bacteria, fungi, viruses, and protozoa can be used to protect plants, as some of them are parasites or pathogens of insects or other organisms that are pests or cause disease in plants. Because of their biological properties, these micro-organisms have been used world-wide (including in the EU) for decades in the biological control of pests and plant diseases.

Micro-organisms are naturally occurring in the environment and the strains with the best properties are those used in biological control to fight pests and diseases in crop protection.

However, before micro-organism are allowed to be used, it needs to be verified that their use is safe and has no negative consequences for human and animal health or towards other non-target organisms.

Latest developments

Four implementing Regulations are applicable from 21 November 2022 onwards. The new rules reflect the latest scientific developments and are based on the specific biological properties of micro-organisms.

The new rules facilitate the approval of micro-organisms for use as active substances in plant protection products and the authorisation of products containing them. The purpose is that farmers across the European Union have better access to biological alternatives to chemical pesticides and can protect their crops in a more sustainable manner.

The new rules are fully aligned with the ambitions of the European Green Deal and will also contribute to achieving the objectives of the Farm to Fork strategy.

  • Commission Regulation (EU) 2022/1438, amending Annex II to Regulation (EC) No 1107/2009 as regards specific criteria for the approval of active substances that are micro-organisms
  • Commission Regulation (EU) 2022/1439, amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms
  • Commission Regulation (EU) 2022/1440, amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms
  • Commission Regulation(EU) 2022/1441, amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms

In addition, two Commission Communications listing test methods and guidance documents which are relevant for the harmonised implementation of Part B of the Annex to Regulation (EU) No 283/2013 and of Part B of the Annex to Regulation (EU) No 284/2013, were published on 9 June 2023. In these, Applicants can find there the most up to date list of test methods and guidelines to prepare their application dossiers.

Questions and answers

See some frequently asked questions. This list will be updated as more questions get asked.