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| 24.11.2022 | EN | Official Journal of the European Union | L 304/94 |

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Corrigendum to Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms

(
[Official Journal of the European Union L 227 of 1 September 2022](http://publications.europa.eu/resource/oj/JOL_2022_227_R_TOC)
)

On page 17, Annex II, the following Table of contents shall be inserted after the title ‘PART B – ACTIVE SUBSTANCES THAT ARE MICRO-ORGANISMS
’:

‘
Table of contents

INTRODUCTION TO PART B

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| 1. | Identity of the applicant, identity of the active substance and manufacturing information | |

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| 1.1. | Applicant | |

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| 1.2. | Producer | |

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| 1.3. | Identity, taxonomy and phylogeny of the micro-organism | |

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| 1.4. | Specification of the microbial pest control agent as manufactured | |

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| 1.4.1. | Content of the active substance | |

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| 1.4.2. | Identity and quantification of additives, relevant contaminating micro-organisms and relevant impurities | |

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| 1.4.2.1. | Identity and quantification of additives | |

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| 1.4.2.2. | Identity and content of relevant contaminating micro-organisms | |

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| 1.4.2.3. | Identity and quantification of relevant impurities | |

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| 1.4.3. | Analytical profile of batches | |

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| 1.5. | Information on manufacturing process and control measures for the active substance | |

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| 1.5.1. | Production and quality control | |

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| 1.5.2. | Recommended methods and precautions concerning handling, storage, transport or fire | |

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| 1.5.3. | Procedures for destruction or decontamination | |

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| 2. | Biological properties of the micro-organism | |

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| 2.1. | Origin, occurrence and history of use | |

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| 2.1.1. | Origin and isolation source | |

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| 2.1.2. | Occurrence | |

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| 2.1.3. | History of use | |

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| 2.2. | Ecology and life cycle of the micro-organism | |

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| 2.3. | Mode of action on the target organism and host range | |

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| 2.4. | Growth requirements | |

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| 2.5. | Infectivity to the target organism | |

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| 2.6. | Relationship to known human pathogens and to pathogens to non-target organisms | |

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| 2.7. | Genetic stability and factors affecting it | |

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| 2.8. | Information on metabolites of concern | |

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| 2.9. | Presence of transferable antimicrobial resistance genes | |

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| 3. | Further information | |

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| 3.1. | Function and target organism | |

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| 3.2. | Field of use envisaged | |

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| 3.3. | Crops or products protected or treated | |

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| 3.4. | Information on possible development of resistance in the target organism(s) | |

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| 3.5. | Literature data | |

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| 4. | Analytical methods | |

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| 4.1. | Methods for the analysis of the MPCA as manufactured | |

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| 4.2. | Methods to determine the density of the micro-organism and quantify residues | |

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| 5. | Effects on human health | |

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| 5.1. | Medical data | |

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| 5.1.1. | Therapeutic and first aid measures | |

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| 5.1.2. | Medical surveillance | |

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| 5.1.3. | Information on sensitisation and allergenicity | |

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| 5.1.4. | Direct observation | |

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| 5.2. | Assessment on potential infectivity and pathogenicity of the micro-organism to humans | |

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| 5.3. | Infectivity and pathogenicity studies on the micro-organism | |

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| 5.3.1. | Infectivity and pathogenicity | |

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| 5.3.1.1. | Oral infectivity and pathogenicity | |

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| 5.3.1.2. | Intratracheal/ intranasal infectivity and pathogenicity | |

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| 5.3.1.3. | Intravenous, intraperitoneal or subcutaneous single exposure | |

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| 5.3.2. | Cell culture study | |

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| 5.4. | Specific infectivity and pathogenicity studies on the micro-organism | |

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| 5.5. | Information and toxicity studies on metabolites | |

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| 5.5.1. | Information on metabolites | |

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| 5.5.2. | Additional toxicity studies on metabolites of concern | |

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| 6. | Residues in or on treated products, food and feed | |

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| 6.1. | Estimation of consumer exposure to residues | |

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| 6.2. | Data generation on residues | |

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| 7. | Environmental occurrence of the micro-organism, including fate and behaviour of metabolites of concern | |

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| 7.1. | Environmental occurrence of the micro-organism | |

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| 7.1.1. | Predicted environmental density of the micro-organism | |

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| 7.1.1.1. | Soil | |

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| 7.1.1.2. | Water | |

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| 7.1.2. | Exposure to micro-organisms known to be pathogenic either for plants or for other organisms | |

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| 7.1.3. | Qualitative exposure assessment of the micro-organism | |

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| 7.1.4. | Experimental exposure data of the micro-organism | |

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| 7.2. | Fate and behaviour of metabolite(s) of concern | |

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| 7.2.1. | Predicted environmental concentration | |

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| 7.2.2. | Qualitative exposure assessment | |

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| 7.2.3. | Experimental exposure data | |

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| 8. | Ecotoxicological studies | |

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| 8.1. | Effects on terrestrial vertebrates | |

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| 8.2. | Effects on aquatic organisms | |

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| 8.2.1. | Effects on fish | |

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| 8.2.2. | Effects on aquatic invertebrates | |

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| 8.2.3. | Effects on algae | |

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| 8.2.4. | Effects on aquatic macrophytes | |

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| 8.3. | Effects on bees | |

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| 8.4. | Effects on non-target arthropods other than bees | |

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| 8.5. | Effects on non-target meso- and macro-organisms in soil | |

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| 8.6. | Effects on non-target terrestrial plants | |

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| 8.7. | Additional studies on the micro-organism | |

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| 8.8. | Information and toxicity studies on metabolites | |

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| 8.8.1. | Information on metabolites | |

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| 8.8.2. | Additional toxicity studies on metabolites of concern’ | |

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