![]() 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. Micro-organisms are naturally-occurring and most of them are harmless. They can be used as fundamental components of probiotics of food/feed additives, or for manufacturing medicinal active substances. In modern times, their uses have been widened. Micro-organisms have been used for almost as long as humanity exists for bread, cheese, beer and wine-making purposes, for example. They make the EU one of the most advanced regulators on the global stage for these products. These new Regulations are based on the most up to date science. 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. 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. ![]() 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 addition, only focusing on relevant data also means less animal testing, because fewer experiments on animals will be required. In this way, the regulatory requirements for micro-organisms are made more "fit-for-purpose" and flexible. 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. So far, the requirements for micro-organisms have been based on principles very similar to those relating to chemical active substances. 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). ![]() 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).In these, Applicants can find there the most up to date list of test methods and guidelines to prepare their application dossiers. 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. 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.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. ![]()
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