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 (Text with EEA relevance)
Corrected by
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)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 contentsINTRODUCTION TO PART B1.Identity of the applicant, identity of the active substance and manufacturing information1.1.Applicant1.2.Producer1.3.Identity, taxonomy and phylogeny of the micro-organism1.4.Specification of the microbial pest control agent as manufactured1.4.1.Content of the active substance1.4.2.Identity and quantification of additives, relevant contaminating micro-organisms and relevant impurities1.4.2.1.Identity and quantification of additives1.4.2.2.Identity and content of relevant contaminating micro-organisms1.4.2.3.Identity and quantification of relevant impurities1.4.3.Analytical profile of batches1.5.Information on manufacturing process and control measures for the active substance1.5.1.Production and quality control1.5.2.Recommended methods and precautions concerning handling, storage, transport or fire1.5.3.Procedures for destruction or decontamination2.Biological properties of the micro-organism2.1.Origin, occurrence and history of use2.1.1.Origin and isolation source2.1.2.Occurrence2.1.3.History of use2.2.Ecology and life cycle of the micro-organism2.3.Mode of action on the target organism and host range2.4.Growth requirements2.5.Infectivity to the target organism2.6.Relationship to known human pathogens and to pathogens to non-target organisms2.7.Genetic stability and factors affecting it2.8.Information on metabolites of concern2.9.Presence of transferable antimicrobial resistance genes3.Further information3.1.Function and target organism3.2.Field of use envisaged3.3.Crops or products protected or treated3.4.Information on possible development of resistance in the target organism(s)3.5.Literature data4.Analytical methods4.1.Methods for the analysis of the MPCA as manufactured4.2.Methods to determine the density of the micro-organism and quantify residues5.Effects on human health5.1.Medical data5.1.1.Therapeutic and first aid measures5.1.2.Medical surveillance5.1.3.Information on sensitisation and allergenicity5.1.4.Direct observation5.2.Assessment on potential infectivity and pathogenicity of the micro-organism to humans5.3.Infectivity and pathogenicity studies on the micro-organism5.3.1.Infectivity and pathogenicity5.3.1.1.Oral infectivity and pathogenicity5.3.1.2.Intratracheal/ intranasal infectivity and pathogenicity5.3.1.3.Intravenous, intraperitoneal or subcutaneous single exposure5.3.2.Cell culture study5.4.Specific infectivity and pathogenicity studies on the micro-organism5.5.Information and toxicity studies on metabolites5.5.1.Information on metabolites5.5.2.Additional toxicity studies on metabolites of concern6.Residues in or on treated products, food and feed6.1.Estimation of consumer exposure to residues6.2.Data generation on residues7.Environmental occurrence of the micro-organism, including fate and behaviour of metabolites of concern7.1.Environmental occurrence of the micro-organism7.1.1.Predicted environmental density of the micro-organism7.1.1.1.Soil7.1.1.2.Water7.1.2.Exposure to micro-organisms known to be pathogenic either for plants or for other organisms7.1.3.Qualitative exposure assessment of the micro-organism7.1.4.Experimental exposure data of the micro-organism7.2.Fate and behaviour of metabolite(s) of concern7.2.1.Predicted environmental concentration7.2.2.Qualitative exposure assessment7.2.3.Experimental exposure data8.Ecotoxicological studies8.1.Effects on terrestrial vertebrates8.2.Effects on aquatic organisms8.2.1.Effects on fish8.2.2.Effects on aquatic invertebrates8.2.3.Effects on algae8.2.4.Effects on aquatic macrophytes8.3.Effects on bees8.4.Effects on non-target arthropods other than bees8.5.Effects on non-target meso- and macro-organisms in soil8.6.Effects on non-target terrestrial plants8.7.Additional studies on the micro-organism8.8.Information and toxicity studies on metabolites8.8.1.Information on metabolites8.8.2.Additional toxicity studies on metabolites of concern"