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.
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.
- 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.
- Commission Communications for the implementation of Part B of the Annex to Regulation (EU) No 283/2013 (as amended by Commission Regulation (EU) 2022/1439)
- Commission Communications for the implementation of Part B of the Annex to Regulation (EU) No 284/2013 (as amended by Commission Regulation (EU) 2022/1440)
Questions and answers
See some frequently asked questions. This list will be updated as more questions get asked.
The Commission adopted four legal acts which simplify the process of approval and authorisation of biological plant protection products which contain micro-organisms. The objective is to provide farmers with tools to substitute chemical plant protection products.
These acts reflect the latest scientific developments and are based on the specific biological properties of micro-organisms.
Farmers are keen to have access to sustainable solutions to protect crops. By facilitating the placing on the market of these biological plant protection products, farmers – including those producing organic crops - will have more alternatives available for sustainable crop protection.
With these acts, the Commission is delivering on the objectives of the Farm-to-Fork Strategy.
The acts are applicable from 21 November 2022 onwards.
So far, the requirements for micro-organisms have been based on principles very similar to those relating to chemical active substances.
The new acts follow a different approach, which is based on the biology and ecology of each micro-organism and takes into account the most recent scientific knowledge.
In this way, the regulatory requirements for micro-organisms are made more "fit-for-purpose" and flexible. In addition, only focusing on relevant data also means less animal testing, because fewer experiments on animals will be required.
The biological properties of the micro-organisms play a central role for the risk assessments and much of the data required in the new implementing acts is conditional to the biology and ecology of the particular micro-organism. In any case, a micro-organism can only be approved for use if it is proven that it does not cause disease in humans or animals.
More "fit for purpose" and flexible requirements also imply streamlined application dossiers, more straight forward risk assessment, and shorter timelines to get access to the EU market.
These new Regulations are based on the most up to date science. They make the EU one of the most advanced regulators on the global stage for these products.
The Farm to Fork Strategy and the Green Deal aim at reducing dependency on and use of chemical plant protection products.
Micro-organisms used as biocontrol agents in plant protection products provide farmers with alternative tools to substitute chemical plant protection products. They can also be used in organic agriculture.
The new requirements are expected to lead to a faster access to the EU market for micro-organism and plant protection products containing them.
Micro-organisms have been used for almost as long as humanity exists for bread, cheese, beer and wine-making purposes, for example. In modern times, their uses have been widened. They can be used as fundamental components of probiotics of food/feed additives, or for manufacturing medicinal active substances.
Micro-organisms are naturally-occurring and most of them are harmless. Many of them play key roles in the ecosystems, for instance by decomposing organic matter in the soil to make it available for other organisms, or by enriching the soil with atmospheric nitrogen (“nitrogen fixation”) to make it available for plants.
-Like all the other active substances used in plant protection products, micro-organisms can only be approved for use if they fulfil the approval criteria laid down in the Regulation on placing on the market of plant protection products.
The Member States, the European Food Safety Authority (EFSA) and the European Commission evaluate every active substance for safety for humans and the environment before it can be placed on the market and used in a plant protection product. In a second regulatory step, Member States authorise each plant protection product containing approved active substances for the intended use.
Currently more than 60 micro-organisms are approved in the EU after a scientific risk assessment confirmed that their use in plant protection products is safe.
Several viruses that are highly specific to insects or plants are currently approved in the EU for plant protection purposes and have been proven to be safe for many years. Because they are highly specific towards a narrow group of plant pests, they cannot infect humans or other organisms which are not plant pests.
It is important to underline that viruses, like other micro-organisms, will not be approved if they cause disease in humans because each of them needs to be evaluated before approval, with regard to its safety for human health and the environment by the Member States and the European Food Safety Authority.
Biological plant protection products containing micro-organisms may be as effective as chemicals when used correctly in optimal conditions. Where conditions are less optimal they may be less efficient than chemicals, because as living organisms, they require “optimal conditions of use” to be successful in controlling pests. They usually have effect on a small range of organisms that are pests to plants. This makes them inherently safer than chemicals.
The use of such biological alternatives plays a key role in organic farming, where farmers can use micro-organisms as biological control agents. Micro-organisms also play a key role in Integrated Pest Management, which farmers have to apply in the EU. Farmers must give preference to preventive actions, monitoring and biological plant protection alternatives (including micro-organism based products), before using chemical plant protection products.
Integrated Pest Management also aims to keep the use of pesticides and other forms of intervention only to levels that are economically and ecologically justified, and other measures like crop rotation, selection of appropriate cultivars and cultivation techniques could also be used.
In 2019 there were almost 330.000 organic farmers in EU, reaching up to 20% share of farming area in certain Member States. In addition, one of the targets of the Farm to Fork Strategy concerns the increase the total farmland under organic farming in EU, with at least 25% of the EU’s agricultural land to be under organic farming by 2030.
Biological plant protection products can be used in organic agriculture. The new Regulations will fasten access to the market for micro-organisms used in biological plant protection products and, therefore, make new sustainable alternatives available to EU organic farmers for controlling plant pests.